# Official Journal C 295/2010

| | ISSN 1725-2423
  doi:10.3000/17252423.C_2010.295.eng |
| --- | --- |
| Official Journal
  of the European Union | C 295 |
| | |
| English edition | Information and Notices | Volume 5329 October 2010 |

ISSN 1725-2423

doi:10.3000/17252423.C_2010.295.eng

Official Journal

of the European Union

C 295

English edition

Information and Notices

Volume 5329 October 2010

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| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2010/C 295/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2010 to 31 August 2010 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |
| 2010/C 295/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2010 to 31 August 2010 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC
  or Article 38 of Directive 2001/82/EC) | 17 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2010/C 295/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2010 to 31 August 2010 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council

1

2010/C 295/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2010 to 31 August 2010 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC
  or Article 38 of Directive 2001/82/EC)

Decisions taken pursuant to Article 34 of Directive 2001/83/EC

or Article 38 of Directive 2001/82/EC

17

| EN | |
| --- | --- |

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 29.10.2010 | EN | Official Journal of the European Union | C 295/1 |
| --- | --- | --- | --- |

29.10.2010

EN

Official Journal of the European Union

C 295/1

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2010 to 31 August 2010

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
   (1))

2010/C 295/01

—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | INN
  (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code
  (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 5.7.2010 | Daxas | roflumilast | Nycomed GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | EU/1/10/636/001-003 | Film-coated tablet | R03DX07 | 8.7.2010 |
| 27.7.2010 | Leflunomide medac | leflunomide | medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstrasse 3, D-20354 Hamburg - Deutschland | EU/1/10/637/001-009 | Film-coated tablet | L04AA13 | 30.7.2010 |
| 27.7.2010 | Ozurdex | dexamethasone | Allergan Pharmaceuticals (Ireland) Ltd, Castlebar Road, Westport, Co. Mayo, Ireland | EU/1/10/638/001 | Intravitreal implant in applicator | S01BA01 | 1.8.2010 |
| 26.8.2010 | VPRIV | Velaglucerase alfa | Shire Pharmaceuticals Ireland Limited 5 Riverside Walk, Citywest Business Campus, Dublin 24, Ireland | EU/1/10/646/001-002 | Powder for solution for infusion | A16AB10 | 30.8.2010 |
| 31.8.2010 | PecFent | Fentanyl | Archimedes Development Ltd Nottingham, NGT7 2TN, United Kingdom | EU/1/10/644/001-004 | Nasal spray, solution | N02AB03 | 6.9.2010 |

Date of the decision

Name of the medicinal product

INN

(International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code

(Anatomical Therapeutic Chemical Code)

Date of notification

5.7.2010

Daxas

roflumilast

Nycomed GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland

EU/1/10/636/001-003

Film-coated tablet

R03DX07

8.7.2010

27.7.2010

Leflunomide medac

leflunomide

medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstrasse 3, D-20354 Hamburg - Deutschland

EU/1/10/637/001-009

Film-coated tablet

L04AA13

30.7.2010

27.7.2010

Ozurdex

dexamethasone

Allergan Pharmaceuticals (Ireland) Ltd, Castlebar Road, Westport, Co. Mayo, Ireland

EU/1/10/638/001

Intravitreal implant in applicator

S01BA01

1.8.2010

26.8.2010

VPRIV

Velaglucerase alfa

Shire Pharmaceuticals Ireland Limited 5 Riverside Walk, Citywest Business Campus, Dublin 24, Ireland

EU/1/10/646/001-002

Powder for solution for infusion

A16AB10

30.8.2010

31.8.2010

PecFent

Fentanyl

Archimedes Development Ltd Nottingham, NGT7 2TN, United Kingdom

EU/1/10/644/001-004

Nasal spray, solution

N02AB03

6.9.2010

—   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 1.7.2010 | Enbrel | Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/99/126/001-021 | 6.7.2010 |
| 1.7.2010 | Humira | Abbott Laboratories Limited Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL 6 4XE, United Kingdom | EU/1/03/256/001-010 | 5.7.2010 |
| 1.7.2010 | Invega | Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België | EU/1/07/395/001-095 | 6.7.2010 |
| 1.7.2010 | Kiovig | Baxter AG Industriestraße 67, A - 1221 Wien, Österreich | EU/1/05/329/001-006 | 5.7.2010 |
| 1.7.2010 | Mirapexin | Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland | EU/1/97/051/001-006
  EU/1/97/051/009-033 | 5.7.2010 |
| 1.7.2010 | Orencia | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/07/389/001-003 | 5.7.2010 |
| 1.7.2010 | Pradaxa | Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/08/442/001-008 | 5.7.2010 |
| 1.7.2010 | Rapamune | Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/01/171/001
  EU/1/01/171/007-010 | 5.7.2010 |
| 1.7.2010 | Sifrol | Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/97/050/001-006
  EU/1/97/050/009-033 | 5.7.2010 |
| 1.7.2010 | Sutent | Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | EU/1/06/347/001-008 | 5.7.2010 |
| 1.7.2010 | TachoSil | Nycomed Austria GmbH St.-Peter-Strasse 25, A-4020 Linz, Österreich | EU/1/04/277/001-004 | 5.7.2010 |
| 1.7.2010 | Tarceva | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/05/311/001-003 | 5.7.2010 |
| 1.7.2010 | Taxotere | Aventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony Cedex, France | EU/1/95/002/001-005 | 5.7.2010 |
| 1.7.2010 | Tygacil | Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/06/336/001 | 6.7.2010 |
| 1.7.2010 | Viagra | Pfizer Limited Sandwich, Kent, CT13 9NJ, United Kingdom | EU/1/98/077/002-004
  EU/1/98/077/006-008
  EU/1/98/077/010-019 | 5.7.2010 |
| 2.7.2010 | ellaOne | Laboratoire HRA Pharma 15, rue Béranger, 75003 Paris, France | EU/1/09/522/001 | 6.7.2010 |
| 2.7.2010 | Eucreas | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/07/425/001-018 | 7.7.2010 |
| 2.7.2010 | Galvus | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/07/414/001-010
  EU/1/07/414/018 | 7.7.2010 |
| 2.7.2010 | Intelence | Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België | EU/1/08/468/001 | 7.7.2010 |
| 2.7.2010 | Jalra | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/08/485/001-011 | 7.7.2010 |
| 2.7.2010 | Myocet | Cephalon Europe 5 Rue Charles Martigny, Maisons Alfort 94700, France | EU/1/00/141/001 | 7.7.2010 |
| 2.7.2010 | NovoMix | Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/00/142/004-005
  EU/1/00/142/009-022 | 7.7.2010 |
| 2.7.2010 | Onglyza | Bristol Myers Squibb/AstraZeneca EEIG Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom | EU/1/09/545/001-010 | 7.7.2010 |
| 2.7.2010 | Pegasys | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/02/221/001-010 | 7.7.2010 |
| 2.7.2010 | Sifrol | Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/97/050/001-006
  EU/1/97/050/009-033 | 8.7.2010 |
| 2.7.2010 | Tamiflu | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/02/222/001-004 | 7.7.2010 |
| 2.7.2010 | Tarceva | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/05/311/001-003 | 7.7.2010 |
| 2.7.2010 | Torisel | Wyeth Europa Ltd Huntercombe Lane South, Taplow, Maidenhead, Berkshire SL6 0PH, United Kingdom | EU/1/07/424/001 | 7.7.2010 |
| 2.7.2010 | Velcade | Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België | EU/1/04/274/001-002 | 6.7.2010 |
| 2.7.2010 | Xiliarx | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/08/486/001-011 | 7.7.2010 |
| 2.7.2010 | Xyrem | UCB Pharma Ltd. 208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom | EU/1/05/312/001 | 6.7.2010 |
| 2.7.2010 | Zeffix | Glaxo Group Ltd. Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom | EU/1/99/114/001-003 | 8.7.2010 |
| 2.7.2010 | Zyllt | KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/09/553/001-010 | 7.7.2010 |
| 5.7.2010 | Celvapan | Baxter AG Industriestraße 67, A - 1221 Wien, Österreich | EU/1/08/506/001 | 8.7.2010 |
| 5.7.2010 | Ferriprox | Apotex Europe B.V. Darwingweg 20, 2333 CR Leiden, Nederland | EU/1/99/108/001-003 | 8.7.2010 |
| 5.7.2010 | Icandra | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/08/484/001-018 | 8.7.2010 |
| 5.7.2010 | Rebetol | Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België | EU/1/99/107/001-005 | 13.7.2010 |
| 5.7.2010 | Relistor | Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/08/463/001-003 | 8.7.2010 |
| 5.7.2010 | Reyataz | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/03/267/001-010 | 8.7.2010 |
| 5.7.2010 | Thelin | Encysive (UK) Limited Alder Castle House, 10 Noble Street, London EC2V 7QJ, United Kingdom | EU/1/06/353/001-005 | 8.7.2010 |
| 5.7.2010 | Zomarist | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/08/483/001-018 | 8.7.2010 |
| 6.7.2010 | Avastin | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/04/300/001-002 | 8.7.2010 |
| 6.7.2010 | Docetaxel Winthrop | Aventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony Cedex, France | EU/1/07/384/001-005 | 8.7.2010 |
| 6.7.2010 | Keppra | UCB Pharma SA. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België | EU/1/00/146/001-032 | 9.7.2010 |
| 6.7.2010 | Rapamune | Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/01/171/001
  EU/1/01/171/007-010
  EU/1/01/171/013-014 | 12.7.2010 |
| 6.7.2010 | Savene | TopoTarget A/S Fruebjergvej 3, Copenhagen 2100, Danmark | EU/1/06/350/001 | 12.7.2010 |
| 7.7.2010 | ReFacto AF | Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/99/103/001-004 | 12.7.2010 |
| 13.7.2010 | BeneFIX | Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/97/047/001-007 | 15.7.2010 |
| 13.7.2010 | Kepivance | Biovitrum AB (publ) SE-112 76 Stockholm, Sverige | EU/1/05/314/001 | 15.7.2010 |
| 22.7.2010 | Thelin | Encysive (UK) Limited Alder Castle House, 10 Noble Street, London EC2V 7QJ, United Kingdom | EU/1/06/353/001-005 | 26.7.2010 |
| 27.7.2010 | Baraclude | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/06/343/001-007 | 29.7.2010 |
| 27.7.2010 | Conbriza | Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/09/511/001-004 | 29.7.2010 |
| 27.7.2010 | GONAL-f | Merck Serono Europe Ltd. 56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/95/001/001
  EU/1/95/001/003-005
  EU/1/95/001/009
  EU/1/95/001/012
  EU/1/95/001/021-022
  EU/1/95/001/025-028
  EU/1/95/001/031-035 | 30.7.2010 |
| 27.7.2010 | Iscover | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/98/070/001a-001b
  EU/1/98/070/002a-002b
  EU/1/98/070/003a-003b
  EU/1/98/070/004a-004b
  EU/1/98/070/005a-005b
  EU/1/98/070/006a-006b
  EU/1/98/070/007a-007b
  EU/1/98/070/008-010
  EU/1/98/070/011a-011b
  EU/1/98/070/012 | 29.7.2010 |
| 27.7.2010 | MicardisPlus | Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland | EU/1/02/213/013-016
  EU/1/02/213/020
  EU/1/02/213/022 | 29.7.2010 |
| 27.7.2010 | Plavix | Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France - 75013 Paris, France | EU/1/98/069/001a-001b
  EU/1/98/069/002a-002b
  EU/1/98/069/003a-003b
  EU/1/98/069/004a-004b
  EU/1/98/069/005a-005b
  EU/1/98/069/006a-006b
  EU/1/98/069/007a-007b
  EU/1/98/069/008-010
  EU/1/98/069/011a-011b
  EU/1/98/069/012 | 29.7.2010 |
| 27.7.2010 | Ribavirin Teva | Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland | EU/1/09/509/001-004 | 30.7.2010 |
| 27.7.2010 | Ribavirin Teva Pharma BV | Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland | EU/1/09/527/001-016 | 31.7.2010 |
| 27.7.2010 | Zonegran | Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom | EU/1/04/307/001-021 | 29.7.2010 |
| 28.7.2010 | Aranesp | Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/01/185/001-022
  EU/1/01/185/031-099 | 2.8.2010 |
| 28.7.2010 | DaTSCAN | GE Healthcare Limited Little Chalfont, Bucks HP7 9NA, United Kingdom | EU/1/00/135/001-002 | 2.8.2010 |
| 28.7.2010 | DuoCover | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/10/623/001-015 | 30.7.2010 |
| 28.7.2010 | Dynastat | Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | EU/1/02/209/001-008 | 2.8.2010 |
| 28.7.2010 | Erbitux | Merck KGaA Frankfurter Straße 250, 64271 Darmstadt, Deutschland | EU/1/04/281/001-005 | 2.8.2010 |
| 28.7.2010 | Fendrix | GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique | EU/1/04/299/001-003 | 2.8.2010 |
| 28.7.2010 | Ferriprox | Apotex Europe B.V. Darwingweg 20, 2333 CR Leiden, Nederland | EU/1/99/108/001-006 | 30.7.2010 |
| 28.7.2010 | Helixate NexGen | Bayer Schering Pharma AG 13342 Berlin, Deutschland | EU/1/00/144/001-004 | 30.7.2010 |
| 28.7.2010 | Herceptin | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/00/145/001 | 30.7.2010 |
| 28.7.2010 | Increlex | Ipsen Pharma 65, quai Georges Gorse, 92100 Boulogne-Billancourt, France | EU/1/07/402/001 | 2.8.2010 |
| 28.7.2010 | Invanz | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/02/216/001-002 | 2.8.2010 |
| 28.7.2010 | Invirase | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/96/026/001-002 | 2.8.2010 |
| 28.7.2010 | Kaletra | Abbott Laboratories Limited Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL 6 4XE, United Kingdom | EU/1/01/172/001-007 | 2.8.2010 |
| 28.7.2010 | Kivexa | ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/04/298/001-003 | 2.8.2010 |
| 28.7.2010 | Kogenate Bayer | Bayer Schering Pharma AG 13342 Berlin, Deutschland | EU/1/00/143/001-011 | 30.7.2010 |
| 28.7.2010 | Onsenal | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/03/259/001-006 | 30.7.2010 |
| 28.7.2010 | Prevenar 13 | Wyeth Lederle Vaccines S.A. Rue du Bosquet, 15 B-1348 Louvain-la-Neuve, Belgique | EU/1/09/590/001-006 | 3.8.2010 |
| 28.7.2010 | Simponi | Centocor B.V. Einsteinweg 101, 2333 CB Leiden, Nederland | EU/1/09/546/001-004 | 2.8.2010 |
| 28.7.2010 | Sprycel | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/06/363/001-011 | 2.8.2010 |
| 28.7.2010 | Tyverb | Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | EU/1/07/440/001-003 | 2.8.2010 |
| 6.8.2010 | Abilify | Otsuka Pharmaceutical Europe Ltd Hunton House, Highbridge Business Park, Oxford Road, Uxbridge, Middlesex UB8 1HU, United Kingdom | EU/1/04/276/001-020
  EU/1/04/276/024-036 | 12.8.2010 |
| 6.8.2010 | Arava | Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland | EU/1/99/118/001-010 | 10.8.2010 |
| 6.8.2010 | Byetta | Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland | EU/1/06/362/001-004 | 10.8.2010 |
| 6.8.2010 | Cervarix | GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique | EU/1/07/419/001-012 | 10.8.2010 |
| 6.8.2010 | Crixivan | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/96/024/001-005
  EU/1/96/024/008
  EU/1/96/024/010 | 12.8.2010 |
| 6.8.2010 | DuoPlavin | Sanofi Pharma Bristol-Myers Squibb SNC 174 Avenue de France, F-75013 Paris, France | EU/1/10/619/001-015 | 11.8.2010 |
| 6.8.2010 | Efficib | Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/457/001-016 | 11.8.2010 |
| 6.8.2010 | Evicel | OMRIX biopharmaceuticals S.A./N.V. 200 Chaussée de Waterloo/Waterloosesteenweg 200, B-1640 Rhode-St-Genèse/B-1640 Sint-Genesius-Rode, Belgique/België | EU/1/08/473/001-003 | 11.8.2010 |
| 6.8.2010 | Ferriprox | Apotex Europe B.V. Darwingweg 20, 2333 CR Leiden, Nederland | EU/1/99/108/001-006 | 10.8.2010 |
| 6.8.2010 | Grepid | Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα | EU/1/09/535/001-016 | 10.8.2010 |
| 6.8.2010 | Herceptin | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/00/145/001 | 12.8.2010 |
| 6.8.2010 | Janumet | Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/455/001-016 | 11.8.2010 |
| 6.8.2010 | Januvia | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/383/001-018 | 12.8.2010 |
| 6.8.2010 | Karvea | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/97/049/001-039 | 10.8.2010 |
| 6.8.2010 | Karvezide | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/98/085/001-034 | 10.8.2010 |
| 6.8.2010 | Mepact | IDM PHARMA SAS 11-15 Quai De Dion Bouton, 92816 Puteaux Cedex, France | EU/1/08/502/001 | 13.8.2010 |
| 6.8.2010 | Mycamine | Astellas Pharma Europe B.V. Elisabethhof 19, 2353 EW Leiderdorp, Nederland | EU/1/08/448/001-002 | 10.8.2010 |
| 6.8.2010 | Naglazyme | BioMarin Europe Ltd 164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom | EU/1/05/324/001-002 | 10.8.2010 |
| 6.8.2010 | Olanzapine Mylan | Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | EU/1/08/475/001-034 | 10.8.2010 |
| 6.8.2010 | Rebif | Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/98/063/001-017 | 10.8.2010 |
| 6.8.2010 | Ristaben | Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/10/621/001-018 | 11.8.2010 |
| 6.8.2010 | Ristfor | Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/10/620/001-016 | 11.8.2010 |
| 6.8.2010 | RotaTeq | Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, Lyon 69007, France | EU/1/06/348/001-002 | 10.8.2010 |
| 6.8.2010 | Sildenafil ratiopharm | ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/09/603/001-015 | 11.8.2010 |
| 6.8.2010 | Suboxone | Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België | EU/1/06/359/001-004 | 10.8.2010 |
| 6.8.2010 | Sustiva | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/99/110/001-005
  EU/1/99/110/008-010 | 10.8.2010 |
| 6.8.2010 | Velmetia | Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/456/001-016 | 11.8.2010 |
| 6.8.2010 | Xelevia | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/382/001-018 | 10.8.2010 |
| 10.8.2010 | Trisenox | Cephalon Europe 5 Rue Charles Martigny, 94700 Maisons Alfort, Cedex, France | EU/1/02/204/001 | 12.8.2010 |
| 12.8.2010 | Celvapan | Baxter AG Industriestraße 67, A - 1221 Wien, Österreich | EU/1/08/506/001 | 13.8.2010 |
| 12.8.2010 | Focetria | Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1, 53100 Siena, Italia | EU/1/07/385/001-002
  EU/1/07/385/004 | 13.8.2010 |
| 12.8.2010 | Pandemrix | GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique | EU/1/08/452/001 | 13.8.2010 |
| 16.8.2010 | Fosavance | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/05/310/001-009 | 18.8.2010 |
| 18.8.2010 | alli | Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | EU/1/07/401/007-011 | 24.8.2010 |
| 18.8.2010 | Binocrit | Sandoz GmbH Biochemiestrasse 10, Kundl 6250, Österreich | EU/1/07/410/001-026 | 20.8.2010 |
| 18.8.2010 | Epoetin alfa Hexal | Hexal AG. Industriestrasse 25, D-83607 Holzkirchen, Deutschland | EU/1/07/411/001-026 | 20.8.2010 |
| 18.8.2010 | Gardasil | Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France | EU/1/06/357/001-021 | 20.8.2010 |
| 18.8.2010 | IDflu | Sanofi Pasteur SA 2, avenue Pont Pasteur, F-69007 Lyon, France | EU/1/08/507/001-006 | 20.8.2010 |
| 18.8.2010 | Insulin Human Winthrop | Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland | EU/1/06/368/001-168 | 20.8.2010 |
| 18.8.2010 | Intanza | Sanofi Pasteur MSD SNC 8, rue Jonas Salk, Lyon 69007, France | EU/1/08/505/001-006 | 20.8.2010 |
| 18.8.2010 | Leflunomide Winthrop | Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland | EU/1/09/604/001-010 | 20.8.2010 |
| 18.8.2010 | Neupro | Schwarz Pharma Ltd Shannon, Industrial Estate, Co.Clare, Ireland | EU/1/05/331/001-055 | 20.8.2010 |
| 18.8.2010 | Tesavel | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/435/001-018 | 20.8.2010 |
| 23.8.2010 | Aprovel | Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France - 75013 Paris, France | EU/1/97/046/001-039 | 24.8.2010 |
| 23.8.2010 | CoAprovel | Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France - 75013 Paris, France | EU/1/98/086/001-034 | 24.8.2010 |
| 23.8.2010 | Silgard | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/06/358/001-021 | 25.8.2010 |
| 26.8.2010 | Baraclude | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/06/343/001-007 | 31.8.2010 |
| 26.8.2010 | Cayston | Gilead Sciences International Limited Granta Park, Abington, Cambridge CB21 6GT, United Kingdom | EU/1/09/543/001-002 | 31.8.2010 |
| 26.8.2010 | Cerezyme | Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/97/053/001-005 | 30.8.2010 |
| 26.8.2010 | Cimzia | UCB Pharma SA. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België | EU/1/09/544/001-002 | 30.8.2010 |
| 26.8.2010 | Cubicin | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/05/328/001-004 | 31.8.2010 |
| 26.8.2010 | Docetaxel Teva | Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland | EU/1/09/611/001-002 | 31.8.2010 |
| 26.8.2010 | Elonva | N.V. Organon Kloosterstraat 6, 5349 AB Oss, Nederland | EU/1/09/609/001-002 | 30.8.2010 |
| 26.8.2010 | Emtriva | Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom | EU/1/03/261/001-003 | 31.8.2010 |
| 26.8.2010 | Hirobriz Breezhaler | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom | EU/1/09/594/001-010 | 31.8.2010 |
| 26.8.2010 | Kaletra | Abbott Laboratories Limited Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL 6 4XE, United Kingdom | EU/1/01/172/001-008 | 31.8.2010 |
| 26.8.2010 | Lyrica | Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | EU/1/04/279/001-044 | 31.8.2010 |
| 26.8.2010 | Mircera | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/07/400/001-024 | 31.8.2010 |
| 26.8.2010 | Myozyme | Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/06/333/001-003 | 31.8.2010 |
| 26.8.2010 | Nexavar | Bayer Schering Pharma AG 13342 Berlin, Deutschland | EU/1/06/342/001 | 30.8.2010 |
| 26.8.2010 | Onbrez Breezhaler | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/09/593/001-010 | 31.8.2010 |
| 26.8.2010 | Osseor | Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France | EU/1/04/287/001-006 | 31.8.2010 |
| 26.8.2010 | Pradaxa | Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/08/442/001-008 | 30.8.2010 |
| 26.8.2010 | Prepandrix | GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique | EU/1/08/453/002 | 31.8.2010 |
| 26.8.2010 | Privigen | CSL Behring GmbH Emil-von-Behring-Strasse 76, 35041 Marburg, Deutschland | EU/1/08/446/001-006 | 31.8.2010 |
| 26.8.2010 | Protelos | Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France | EU/1/04/288/001-006 | 31.8.2010 |
| 26.8.2010 | Revatio | Pfizer Limited Sandwich, Kent, CT13 9NJ, United Kingdom | EU/1/05/318/002 | 31.8.2010 |
| 26.8.2010 | Stalevo | Orion Corporation Orionintie 1, FIN-02200 Espoo, Suomi | EU/1/03/260/001-033 | 30.8.2010 |
| 26.8.2010 | Stelara | Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België | EU/1/08/494/001-004 | 30.8.2010 |
| 26.8.2010 | Tasigna | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/07/422/001-004 | 31.8.2010 |
| 26.8.2010 | Telzir | ViiV Healthcare UK Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/04/282/001-002 | 31.8.2010 |
| 26.8.2010 | Thymanax | Servier (Ireland) Industries Limited Gorey Road, Arklow, Co. Wicklow, Ireland | EU/1/08/498/001-008 | 31.8.2010 |
| 26.8.2010 | Valdoxan | Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France | EU/1/08/499/001-008 | 31.8.2010 |
| 26.8.2010 | Viramune | Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland | EU/1/97/055/001-004 | 30.8.2010 |
| 26.8.2010 | Zostavax | Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France | EU/1/06/341/001-013 | 31.8.2010 |
| 31.8.2010 | Abseamed | Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37, D-58638 Iserlohn, Deutschland | EU/1/07/412/001-026 | 2.9.2010 |
| 31.8.2010 | Actos | Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom | EU/1/00/150/001-030 | 2.9.2010 |
| 31.8.2010 | Adenuric | Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg | EU/1/08/447/001-012 | 3.9.2010 |
| 31.8.2010 | Angiox | The Medicines Company UK Ltd 115 L Milton Park, Abingdon, Oxfordshire, OX14 4SA, United Kingdom | EU/1/04/289/002 | 7.9.2010 |
| 31.8.2010 | Ariclaim | Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland | EU/1/04/283/008-012 | 3.9.2010 |
| 31.8.2010 | Arixtra | Glaxo Group Ltd. Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom | EU/1/02/206/001-035 | 2.9.2010 |
| 31.8.2010 | Avastin | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/04/300/001-002 | 2.9.2010 |
| 31.8.2010 | Corlentor | Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France | EU/1/05/317/001-014 | 2.9.2010 |
| 31.8.2010 | Glustin | Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom | EU/1/00/151/001-024 | 2.9.2010 |
| 31.8.2010 | HBVAXPRO | Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France | EU/1/01/183/001
  EU/1/01/183/004-005
  EU/1/01/183/007-008
  EU/1/01/183/011
  EU/1/01/183/013
  EU/1/01/183/015
  EU/1/01/183/018-032 | 2.9.2010 |
| 31.8.2010 | Humira | Abbott Laboratories Limited Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL 6 4XE, United Kingdom | EU/1/03/256/001-010 | 3.9.2010 |
| 31.8.2010 | InductOs | Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/02/226/001 | 3.9.2010 |
| 31.8.2010 | Infanrix hexa | GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique | EU/1/00/152/001-020 | 3.9.2010 |
| 31.8.2010 | Infanrix penta | GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique | EU/1/00/153/001-010 | 3.9.2010 |
| 31.8.2010 | Isentress | Merck Sharp & Dohme Limited Hertford Road, Hodderson, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/436/001-002 | 6.9.2010 |
| 31.8.2010 | Ivemend | Merck Sharp & Dohme Limited Hertford Road, Hodderson, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/437/001-004 | 2.9.2010 |
| 31.8.2010 | Procoralan | Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France | EU/1/05/316/001-014 | 2.9.2010 |
| 31.8.2010 | Truvada | Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom | EU/1/04/305/001-002 | 2.9.2010 |
| 31.8.2010 | Yentreve | Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland | EU/1/04/280/001-008 | 2.9.2010 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

1.7.2010

Enbrel

Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/99/126/001-021

6.7.2010

1.7.2010

Humira

Abbott Laboratories Limited Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL 6 4XE, United Kingdom

EU/1/03/256/001-010

5.7.2010

1.7.2010

Invega

Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België

EU/1/07/395/001-095

6.7.2010

1.7.2010

Kiovig

Baxter AG Industriestraße 67, A - 1221 Wien, Österreich

EU/1/05/329/001-006

5.7.2010

1.7.2010

Mirapexin

Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland

EU/1/97/051/001-006

EU/1/97/051/009-033

5.7.2010

1.7.2010

Orencia

Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/07/389/001-003

5.7.2010

1.7.2010

Pradaxa

Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/08/442/001-008

5.7.2010

1.7.2010

Rapamune

Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/01/171/001

EU/1/01/171/007-010

5.7.2010

1.7.2010

Sifrol

Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/97/050/001-006

EU/1/97/050/009-033

5.7.2010

1.7.2010

Sutent

Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom

EU/1/06/347/001-008

5.7.2010

1.7.2010

TachoSil

Nycomed Austria GmbH St.-Peter-Strasse 25, A-4020 Linz, Österreich

EU/1/04/277/001-004

5.7.2010

1.7.2010

Tarceva

Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/05/311/001-003

5.7.2010

1.7.2010

Taxotere

Aventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony Cedex, France

EU/1/95/002/001-005

5.7.2010

1.7.2010

Tygacil

Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/06/336/001

6.7.2010

1.7.2010

Viagra

Pfizer Limited Sandwich, Kent, CT13 9NJ, United Kingdom

EU/1/98/077/002-004

EU/1/98/077/006-008

EU/1/98/077/010-019

5.7.2010

2.7.2010

ellaOne

Laboratoire HRA Pharma 15, rue Béranger, 75003 Paris, France

EU/1/09/522/001

6.7.2010

2.7.2010

Eucreas

Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/07/425/001-018

7.7.2010

2.7.2010

Galvus

Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/07/414/001-010

EU/1/07/414/018

7.7.2010

2.7.2010

Intelence

Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België

EU/1/08/468/001

7.7.2010

2.7.2010

Jalra

Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/08/485/001-011

7.7.2010

2.7.2010

Myocet

Cephalon Europe 5 Rue Charles Martigny, Maisons Alfort 94700, France

EU/1/00/141/001

7.7.2010

2.7.2010

NovoMix

Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/00/142/004-005

EU/1/00/142/009-022

7.7.2010

2.7.2010

Onglyza

Bristol Myers Squibb/AstraZeneca EEIG Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom

EU/1/09/545/001-010

7.7.2010

2.7.2010

Pegasys

Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/02/221/001-010

7.7.2010

2.7.2010

Sifrol

Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/97/050/001-006

EU/1/97/050/009-033

8.7.2010

2.7.2010

Tamiflu

Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/02/222/001-004

7.7.2010

2.7.2010

Tarceva

Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/05/311/001-003

7.7.2010

2.7.2010

Torisel

Wyeth Europa Ltd Huntercombe Lane South, Taplow, Maidenhead, Berkshire SL6 0PH, United Kingdom

EU/1/07/424/001

7.7.2010

2.7.2010

Velcade

Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België

EU/1/04/274/001-002

6.7.2010

2.7.2010

Xiliarx

Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/08/486/001-011

7.7.2010

2.7.2010

Xyrem

UCB Pharma Ltd. 208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom

EU/1/05/312/001

6.7.2010

2.7.2010

Zeffix

Glaxo Group Ltd. Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/99/114/001-003

8.7.2010

2.7.2010

Zyllt

KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/553/001-010

7.7.2010

5.7.2010

Celvapan

Baxter AG Industriestraße 67, A - 1221 Wien, Österreich

EU/1/08/506/001

8.7.2010

5.7.2010

Ferriprox

Apotex Europe B.V. Darwingweg 20, 2333 CR Leiden, Nederland

EU/1/99/108/001-003

8.7.2010

5.7.2010

Icandra

Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/08/484/001-018

8.7.2010

5.7.2010

Rebetol

Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België

EU/1/99/107/001-005

13.7.2010

5.7.2010

Relistor

Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/08/463/001-003

8.7.2010

5.7.2010

Reyataz

Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/03/267/001-010

8.7.2010

5.7.2010

Thelin

Encysive (UK) Limited Alder Castle House, 10 Noble Street, London EC2V 7QJ, United Kingdom

EU/1/06/353/001-005

8.7.2010

5.7.2010

Zomarist

Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/08/483/001-018

8.7.2010

6.7.2010

Avastin

Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/04/300/001-002

8.7.2010

6.7.2010

Docetaxel Winthrop

Aventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony Cedex, France

EU/1/07/384/001-005

8.7.2010

6.7.2010

Keppra

UCB Pharma SA. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België

EU/1/00/146/001-032

9.7.2010

6.7.2010

Rapamune

Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/01/171/001

EU/1/01/171/007-010

EU/1/01/171/013-014

12.7.2010

6.7.2010

Savene

TopoTarget A/S Fruebjergvej 3, Copenhagen 2100, Danmark

EU/1/06/350/001

12.7.2010

7.7.2010

ReFacto AF

Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/99/103/001-004

12.7.2010

13.7.2010

BeneFIX

Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/97/047/001-007

15.7.2010

13.7.2010

Kepivance

Biovitrum AB (publ) SE-112 76 Stockholm, Sverige

EU/1/05/314/001

15.7.2010

22.7.2010

Thelin

Encysive (UK) Limited Alder Castle House, 10 Noble Street, London EC2V 7QJ, United Kingdom

EU/1/06/353/001-005

26.7.2010

27.7.2010

Baraclude

Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/06/343/001-007

29.7.2010

27.7.2010

Conbriza

Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/09/511/001-004

29.7.2010

27.7.2010

GONAL-f

Merck Serono Europe Ltd. 56, Marsh Wall, London E14 9TP, United Kingdom

EU/1/95/001/001

EU/1/95/001/003-005

EU/1/95/001/009

EU/1/95/001/012

EU/1/95/001/021-022

EU/1/95/001/025-028

EU/1/95/001/031-035

30.7.2010

27.7.2010

Iscover

Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/98/070/001a-001b

EU/1/98/070/002a-002b

EU/1/98/070/003a-003b

EU/1/98/070/004a-004b

EU/1/98/070/005a-005b

EU/1/98/070/006a-006b

EU/1/98/070/007a-007b

EU/1/98/070/008-010

EU/1/98/070/011a-011b

EU/1/98/070/012

29.7.2010

27.7.2010

MicardisPlus

Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland

EU/1/02/213/013-016

EU/1/02/213/020

EU/1/02/213/022

29.7.2010

27.7.2010

Plavix

Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France - 75013 Paris, France

EU/1/98/069/001a-001b

EU/1/98/069/002a-002b

EU/1/98/069/003a-003b

EU/1/98/069/004a-004b

EU/1/98/069/005a-005b

EU/1/98/069/006a-006b

EU/1/98/069/007a-007b

EU/1/98/069/008-010

EU/1/98/069/011a-011b

EU/1/98/069/012

29.7.2010

27.7.2010

Ribavirin Teva

Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/09/509/001-004

30.7.2010

27.7.2010

Ribavirin Teva Pharma BV

Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/09/527/001-016

31.7.2010

27.7.2010

Zonegran

Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom

EU/1/04/307/001-021

29.7.2010

28.7.2010

Aranesp

Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/01/185/001-022

EU/1/01/185/031-099

2.8.2010

28.7.2010

DaTSCAN

GE Healthcare Limited Little Chalfont, Bucks HP7 9NA, United Kingdom

EU/1/00/135/001-002

2.8.2010

28.7.2010

DuoCover

Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/10/623/001-015

30.7.2010

28.7.2010

Dynastat

Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom

EU/1/02/209/001-008

2.8.2010

28.7.2010

Erbitux

Merck KGaA Frankfurter Straße 250, 64271 Darmstadt, Deutschland

EU/1/04/281/001-005

2.8.2010

28.7.2010

Fendrix

GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique

EU/1/04/299/001-003

2.8.2010

28.7.2010

Ferriprox

Apotex Europe B.V. Darwingweg 20, 2333 CR Leiden, Nederland

EU/1/99/108/001-006

30.7.2010

28.7.2010

Helixate NexGen

Bayer Schering Pharma AG 13342 Berlin, Deutschland

EU/1/00/144/001-004

30.7.2010

28.7.2010

Herceptin

Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/00/145/001

30.7.2010

28.7.2010

Increlex

Ipsen Pharma 65, quai Georges Gorse, 92100 Boulogne-Billancourt, France

EU/1/07/402/001

2.8.2010

28.7.2010

Invanz

Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/02/216/001-002

2.8.2010

28.7.2010

Invirase

Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/96/026/001-002

2.8.2010

28.7.2010

Kaletra

Abbott Laboratories Limited Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL 6 4XE, United Kingdom

EU/1/01/172/001-007

2.8.2010

28.7.2010

Kivexa

ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

EU/1/04/298/001-003

2.8.2010

28.7.2010

Kogenate Bayer

Bayer Schering Pharma AG 13342 Berlin, Deutschland

EU/1/00/143/001-011

30.7.2010

28.7.2010

Onsenal

Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/03/259/001-006

30.7.2010

28.7.2010

Prevenar 13

Wyeth Lederle Vaccines S.A. Rue du Bosquet, 15 B-1348 Louvain-la-Neuve, Belgique

EU/1/09/590/001-006

3.8.2010

28.7.2010

Simponi

Centocor B.V. Einsteinweg 101, 2333 CB Leiden, Nederland

EU/1/09/546/001-004

2.8.2010

28.7.2010

Sprycel

Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/06/363/001-011

2.8.2010

28.7.2010

Tyverb

Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/07/440/001-003

2.8.2010

6.8.2010

Abilify

Otsuka Pharmaceutical Europe Ltd Hunton House, Highbridge Business Park, Oxford Road, Uxbridge, Middlesex UB8 1HU, United Kingdom

EU/1/04/276/001-020

EU/1/04/276/024-036

12.8.2010

6.8.2010

Arava

Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland

EU/1/99/118/001-010

10.8.2010

6.8.2010

Byetta

Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland

EU/1/06/362/001-004

10.8.2010

6.8.2010

Cervarix

GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/07/419/001-012

10.8.2010

6.8.2010

Crixivan

Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/96/024/001-005

EU/1/96/024/008

EU/1/96/024/010

12.8.2010

6.8.2010

DuoPlavin

Sanofi Pharma Bristol-Myers Squibb SNC 174 Avenue de France, F-75013 Paris, France

EU/1/10/619/001-015

11.8.2010

6.8.2010

Efficib

Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/08/457/001-016

11.8.2010

6.8.2010

Evicel

OMRIX biopharmaceuticals S.A./N.V. 200 Chaussée de Waterloo/Waterloosesteenweg 200, B-1640 Rhode-St-Genèse/B-1640 Sint-Genesius-Rode, Belgique/België

EU/1/08/473/001-003

11.8.2010

6.8.2010

Ferriprox

Apotex Europe B.V. Darwingweg 20, 2333 CR Leiden, Nederland

EU/1/99/108/001-006

10.8.2010

6.8.2010

Grepid

Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

EU/1/09/535/001-016

10.8.2010

6.8.2010

Herceptin

Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/00/145/001

12.8.2010

6.8.2010

Janumet

Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/08/455/001-016

11.8.2010

6.8.2010

Januvia

Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/07/383/001-018

12.8.2010

6.8.2010

Karvea

Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/97/049/001-039

10.8.2010

6.8.2010

Karvezide

Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/98/085/001-034

10.8.2010

6.8.2010

Mepact

IDM PHARMA SAS 11-15 Quai De Dion Bouton, 92816 Puteaux Cedex, France

EU/1/08/502/001

13.8.2010

6.8.2010

Mycamine

Astellas Pharma Europe B.V. Elisabethhof 19, 2353 EW Leiderdorp, Nederland

EU/1/08/448/001-002

10.8.2010

6.8.2010

Naglazyme

BioMarin Europe Ltd 164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom

EU/1/05/324/001-002

10.8.2010

6.8.2010

Olanzapine Mylan

Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

EU/1/08/475/001-034

10.8.2010

6.8.2010

Rebif

Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom

EU/1/98/063/001-017

10.8.2010

6.8.2010

Ristaben

Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/10/621/001-018

11.8.2010

6.8.2010

Ristfor

Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/10/620/001-016

11.8.2010

6.8.2010

RotaTeq

Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, Lyon 69007, France

EU/1/06/348/001-002

10.8.2010

6.8.2010

Sildenafil ratiopharm

ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland

EU/1/09/603/001-015

11.8.2010

6.8.2010

Suboxone

Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België

EU/1/06/359/001-004

10.8.2010

6.8.2010

Sustiva

Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/99/110/001-005

EU/1/99/110/008-010

10.8.2010

6.8.2010

Velmetia

Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/08/456/001-016

11.8.2010

6.8.2010

Xelevia

Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/07/382/001-018

10.8.2010

10.8.2010

Trisenox

Cephalon Europe 5 Rue Charles Martigny, 94700 Maisons Alfort, Cedex, France

EU/1/02/204/001

12.8.2010

12.8.2010

Celvapan

Baxter AG Industriestraße 67, A - 1221 Wien, Österreich

EU/1/08/506/001

13.8.2010

12.8.2010

Focetria

Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1, 53100 Siena, Italia

EU/1/07/385/001-002

EU/1/07/385/004

13.8.2010

12.8.2010

Pandemrix

GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique

EU/1/08/452/001

13.8.2010

16.8.2010

Fosavance

Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/05/310/001-009

18.8.2010

18.8.2010

alli

Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/07/401/007-011

24.8.2010

18.8.2010

Binocrit

Sandoz GmbH Biochemiestrasse 10, Kundl 6250, Österreich

EU/1/07/410/001-026

20.8.2010

18.8.2010

Epoetin alfa Hexal

Hexal AG. Industriestrasse 25, D-83607 Holzkirchen, Deutschland

EU/1/07/411/001-026

20.8.2010

18.8.2010

Gardasil

Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France

EU/1/06/357/001-021

20.8.2010

18.8.2010

IDflu

Sanofi Pasteur SA 2, avenue Pont Pasteur, F-69007 Lyon, France

EU/1/08/507/001-006

20.8.2010

18.8.2010

Insulin Human Winthrop

Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland

EU/1/06/368/001-168

20.8.2010

18.8.2010

Intanza

Sanofi Pasteur MSD SNC 8, rue Jonas Salk, Lyon 69007, France

EU/1/08/505/001-006

20.8.2010

18.8.2010

Leflunomide Winthrop

Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland

EU/1/09/604/001-010

20.8.2010

18.8.2010

Neupro

Schwarz Pharma Ltd Shannon, Industrial Estate, Co.Clare, Ireland

EU/1/05/331/001-055

20.8.2010

18.8.2010

Tesavel

Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/07/435/001-018

20.8.2010

23.8.2010

Aprovel

Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France - 75013 Paris, France

EU/1/97/046/001-039

24.8.2010

23.8.2010

CoAprovel

Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France - 75013 Paris, France

EU/1/98/086/001-034

24.8.2010

23.8.2010

Silgard

Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/06/358/001-021

25.8.2010

26.8.2010

Baraclude

Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/06/343/001-007

31.8.2010

26.8.2010

Cayston

Gilead Sciences International Limited Granta Park, Abington, Cambridge CB21 6GT, United Kingdom

EU/1/09/543/001-002

31.8.2010

26.8.2010

Cerezyme

Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/97/053/001-005

30.8.2010

26.8.2010

Cimzia

UCB Pharma SA. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België

EU/1/09/544/001-002

30.8.2010

26.8.2010

Cubicin

Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/05/328/001-004

31.8.2010

26.8.2010

Docetaxel Teva

Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/09/611/001-002

31.8.2010

26.8.2010

Elonva

N.V. Organon Kloosterstraat 6, 5349 AB Oss, Nederland

EU/1/09/609/001-002

30.8.2010

26.8.2010

Emtriva

Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom

EU/1/03/261/001-003

31.8.2010

26.8.2010

Hirobriz Breezhaler

Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom

EU/1/09/594/001-010

31.8.2010

26.8.2010

Kaletra

Abbott Laboratories Limited Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL 6 4XE, United Kingdom

EU/1/01/172/001-008

31.8.2010

26.8.2010

Lyrica

Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom

EU/1/04/279/001-044

31.8.2010

26.8.2010

Mircera

Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/07/400/001-024

31.8.2010

26.8.2010

Myozyme

Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/06/333/001-003

31.8.2010

26.8.2010

Nexavar

Bayer Schering Pharma AG 13342 Berlin, Deutschland

EU/1/06/342/001

30.8.2010

26.8.2010

Onbrez Breezhaler

Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/593/001-010

31.8.2010

26.8.2010

Osseor

Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France

EU/1/04/287/001-006

31.8.2010

26.8.2010

Pradaxa

Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/08/442/001-008

30.8.2010

26.8.2010

Prepandrix

GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique

EU/1/08/453/002

31.8.2010

26.8.2010

Privigen

CSL Behring GmbH Emil-von-Behring-Strasse 76, 35041 Marburg, Deutschland

EU/1/08/446/001-006

31.8.2010

26.8.2010

Protelos

Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France

EU/1/04/288/001-006

31.8.2010

26.8.2010

Revatio

Pfizer Limited Sandwich, Kent, CT13 9NJ, United Kingdom

EU/1/05/318/002

31.8.2010

26.8.2010

Stalevo

Orion Corporation Orionintie 1, FIN-02200 Espoo, Suomi

EU/1/03/260/001-033

30.8.2010

26.8.2010

Stelara

Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België

EU/1/08/494/001-004

30.8.2010

26.8.2010

Tasigna

Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/07/422/001-004

31.8.2010

26.8.2010

Telzir

ViiV Healthcare UK Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

EU/1/04/282/001-002

31.8.2010

26.8.2010

Thymanax

Servier (Ireland) Industries Limited Gorey Road, Arklow, Co. Wicklow, Ireland

EU/1/08/498/001-008

31.8.2010

26.8.2010

Valdoxan

Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France

EU/1/08/499/001-008

31.8.2010

26.8.2010

Viramune

Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland

EU/1/97/055/001-004

30.8.2010

26.8.2010

Zostavax

Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France

EU/1/06/341/001-013

31.8.2010

31.8.2010

Abseamed

Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37, D-58638 Iserlohn, Deutschland

EU/1/07/412/001-026

2.9.2010

31.8.2010

Actos

Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom

EU/1/00/150/001-030

2.9.2010

31.8.2010

Adenuric

Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg

EU/1/08/447/001-012

3.9.2010

31.8.2010

Angiox

The Medicines Company UK Ltd 115 L Milton Park, Abingdon, Oxfordshire, OX14 4SA, United Kingdom

EU/1/04/289/002

7.9.2010

31.8.2010

Ariclaim

Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland

EU/1/04/283/008-012

3.9.2010

31.8.2010

Arixtra

Glaxo Group Ltd. Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/02/206/001-035

2.9.2010

31.8.2010

Avastin

Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/04/300/001-002

2.9.2010

31.8.2010

Corlentor

Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France

EU/1/05/317/001-014

2.9.2010

31.8.2010

Glustin

Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom

EU/1/00/151/001-024

2.9.2010

31.8.2010

HBVAXPRO

Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France

EU/1/01/183/001

EU/1/01/183/004-005

EU/1/01/183/007-008

EU/1/01/183/011

EU/1/01/183/013

EU/1/01/183/015

EU/1/01/183/018-032

2.9.2010

31.8.2010

Humira

Abbott Laboratories Limited Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL 6 4XE, United Kingdom

EU/1/03/256/001-010

3.9.2010

31.8.2010

InductOs

Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/02/226/001

3.9.2010

31.8.2010

Infanrix hexa

GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique

EU/1/00/152/001-020

3.9.2010

31.8.2010

Infanrix penta

GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique

EU/1/00/153/001-010

3.9.2010

31.8.2010

Isentress

Merck Sharp & Dohme Limited Hertford Road, Hodderson, Hertfordshire EN11 9BU, United Kingdom

EU/1/07/436/001-002

6.9.2010

31.8.2010

Ivemend

Merck Sharp & Dohme Limited Hertford Road, Hodderson, Hertfordshire EN11 9BU, United Kingdom

EU/1/07/437/001-004

2.9.2010

31.8.2010

Procoralan

Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France

EU/1/05/316/001-014

2.9.2010

31.8.2010

Truvada

Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom

EU/1/04/305/001-002

2.9.2010

31.8.2010

Yentreve

Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland

EU/1/04/280/001-008

2.9.2010

—   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 27.7.2010 | Osigraft | Howmedica International S. de R.L. Division of Stryker Corporation, Raheen Industrial Estate, Raheen, Limerick, Ireland | EU/1/01/179/001 | 29.7.2010 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

27.7.2010

Osigraft

Howmedica International S. de R.L. Division of Stryker Corporation, Raheen Industrial Estate, Raheen, Limerick, Ireland

EU/1/01/179/001

29.7.2010

—   Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 1.7.2010 | Ingelvac CircoFLEX | Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim am Rhein, Deutschland | EU/2/07/079/001-004 | 4.7.2010 |
| 1.7.2010 | Profender | Bayer Animal Health GmbH 51368 Leverkusen, Deutschland | EU/2/05/054/001-031 | 6.7.2010 |
| 1.7.2010 | Suprelorin | VIRBAC S.A. 1ère Avenue 2065 m L.I.D. - 06516 Carros - France | EU/2/07/072/001-004 | 5.7.2010 |
| 2.7.2010 | Cortavance | VIRBAC S.A. 1ère Avenue 2065 m L.I.D. - 06516 Carros - France | EU/2/06/069/001 | 7.7.2010 |
| 2.7.2010 | Metacam | Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim am Rhein, Deutschland | EU/2/97/004/001
  EU/2/97/004/003-040 | 7.7.2010 |
| 5.7.2010 | Metacam | Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim am Rhein, Deutschland | EU/2/97/004/001
  EU/2/97/004/003-042 | 7.7.2010 |
| 27.7.2010 | Equilis Prequenza | Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/05/056/001-004 | 29.7.2010 |
| 27.7.2010 | Equilis Prequenza Te | Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/05/057/001-004 | 29.7.2010 |
| 27.7.2010 | Equilis Te | Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/05/055/001-002 | 29.7.2010 |
| 6.8.2010 | Fevaxyn Pentofel | Fort Dodge Laboratories Ireland Finisklin Industrial Estate - Sligo, Ireland | EU/2/96/002/001-003 | 12.8.2010 |
| 18.8.2010 | Zulvac 8 Bovis | Fort Dodge Animal Health Ltd Flanders Road, Hedge End, Southampton SO30 4QH, United Kingdom | EU/2/09/105/001-002 | 20.8.2010 |
| 18.8.2010 | Zulvac 8 Ovis | Fort Dodge Animal Health Ltd Flanders Road, Hedge End, Southampton SO30 4QH, United Kingdom | EU/2/09/104/001-002 | 20.8.2010 |
| 26.8.2010 | Advocate | Bayer Animal Health GmbH 51368 Leverkusen, Deutschland | EU/2/03/039/001-030 | 30.8.2010 |
| 26.8.2010 | Meloxidyl | CEVA SANTE ANIMALE 10 avenue de la Ballastière, 33500 Libourne, France | EU/2/06/070/001-008 | 27.8.2010 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

1.7.2010

Ingelvac CircoFLEX

Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim am Rhein, Deutschland

EU/2/07/079/001-004

4.7.2010

1.7.2010

Profender

Bayer Animal Health GmbH 51368 Leverkusen, Deutschland

EU/2/05/054/001-031

6.7.2010

1.7.2010

Suprelorin

VIRBAC S.A. 1ère Avenue 2065 m L.I.D. - 06516 Carros - France

EU/2/07/072/001-004

5.7.2010

2.7.2010

Cortavance

VIRBAC S.A. 1ère Avenue 2065 m L.I.D. - 06516 Carros - France

EU/2/06/069/001

7.7.2010

2.7.2010

Metacam

Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim am Rhein, Deutschland

EU/2/97/004/001

EU/2/97/004/003-040

7.7.2010

5.7.2010

Metacam

Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim am Rhein, Deutschland

EU/2/97/004/001

EU/2/97/004/003-042

7.7.2010

27.7.2010

Equilis Prequenza

Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/05/056/001-004

29.7.2010

27.7.2010

Equilis Prequenza Te

Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/05/057/001-004

29.7.2010

27.7.2010

Equilis Te

Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/05/055/001-002

29.7.2010

6.8.2010

Fevaxyn Pentofel

Fort Dodge Laboratories Ireland Finisklin Industrial Estate - Sligo, Ireland

EU/2/96/002/001-003

12.8.2010

18.8.2010

Zulvac 8 Bovis

Fort Dodge Animal Health Ltd Flanders Road, Hedge End, Southampton SO30 4QH, United Kingdom

EU/2/09/105/001-002

20.8.2010

18.8.2010

Zulvac 8 Ovis

Fort Dodge Animal Health Ltd Flanders Road, Hedge End, Southampton SO30 4QH, United Kingdom

EU/2/09/104/001-002

20.8.2010

26.8.2010

Advocate

Bayer Animal Health GmbH 51368 Leverkusen, Deutschland

EU/2/03/039/001-030

30.8.2010

26.8.2010

Meloxidyl

CEVA SANTE ANIMALE 10 avenue de la Ballastière, 33500 Libourne, France

EU/2/06/070/001-008

27.8.2010

—   Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 26.8.2010 | Masivet | AB Science S.A. 3 avenue George V, 75008 Paris, France | EU/2/08/087/001-002 | 31.8.2010 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

26.8.2010

Masivet

AB Science S.A. 3 avenue George V, 75008 Paris, France

EU/2/08/087/001-002

31.8.2010

—   Withdrawal of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 5.7.2010 | Nobilis Influenza H5N6 | Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/07/076/001-004 | 8.7.2010 |
| 7.7.2010 | Nobilis Influenza H7N1 | Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/07/073/001-004 | 9.7.2010 |
| 22.7.2010 | Medicinal Oxygen Air Liquide Santé | Air Liquide Santé International 10 rue Cognacq-Jay, 75341 Paris Cedex 07, France | EU/2/06/067/001-002 | 26.7.2010 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

5.7.2010

Nobilis Influenza H5N6

Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/07/076/001-004

8.7.2010

7.7.2010

Nobilis Influenza H7N1

Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/07/073/001-004

9.7.2010

22.7.2010

Medicinal Oxygen Air Liquide Santé

Air Liquide Santé International 10 rue Cognacq-Jay, 75341 Paris Cedex 07, France

EU/2/06/067/001-002

26.7.2010

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

| The European Medicines Agency |
| --- |
| 7, Westferry Circus, Canary Wharf |
| UK - LONDON E14 4H |

The European Medicines Agency

7, Westferry Circus, Canary Wharf

UK - LONDON E14 4H

---

(1)  OJ L 136, 30.4.2004, p. 1.

---

| 29.10.2010 | EN | Official Journal of the European Union | C 295/17 |
| --- | --- | --- | --- |

29.10.2010

EN

Official Journal of the European Union

C 295/17

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2010 to 31 August 2010

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC
   (1)
  or Article 38 of Directive 2001/82/EC
   (2))

2010/C 295/02

—   Issuing, maintenance or modification of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 16.8.2010 | Porcilis M Hyo and associated names | See Annex I | See Annex I | 17.8.2010 |
| 16.8.2010 | Porcilis PRRS and associated names | See Annex II | See Annex II | 17.8.2010 |
| 7.7.2010 | Levact and associated names | See Annex III | See Annex III | 9.7.2010 |
| 26.8.2010 | Valproic acid/valproate | See Annex IV | See Annex IV | 30.8.2010 |
| 1.7.2010 | Gadolinium | See Annex V | See Annex V | 5.7.2010 |
| 13.7.2010 | Valtrex and associated names | See Annex VI | See Annex VI | 16.7.2010 |
| 27.7.2010 | Famvir and associated names | See Annex VII | See Annex VII | 28.7.2010 |
| 7.7.2010 | Vascace | See Annex VIII | See Annex VIII | 8.7.2010 |
| 13.7.2010 | Atacand and associated names | See Annex IX | See Annex IX | 16.7.2010 |
| 1.7.2010 | Sortis | See Annex X | See Annex X | 6.7.2010 |
| 1.7.2010 | Quinolones and Fluoroquinolones | See Annex XI | See Annex XI | 6.7.2010 |
| 26.8.2010 | Seroquel XR and associated names | See Annex XII | See Annex XII | 30.8.2010 |
| 27.7.2010 | Tiamutin premix and associated names | See Annex XIII | See Annex XIII | 28.7.2010 |
| 5.7.2010 | Daxas | Nycomed GmbH, Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | These Decisions are addressed to the Member States | 7.7.2010 |
| 27.7.2010 | Leflunomide medac | medac Gesellschaft für klinische Spezialpräparate mbH, Fehlandtstrasse 3, D-20354 Hamburg, Deutschland | These Decisions are addressed to the Member States | 29.7.2010 |
| 27.7.2010 | Ozurdex | Allergan Pharmaceuticals (Ireland) Ltd, Castlebar Road, Westport, Co. Mayo, Ireland | These Decisions are addressed to the Member States | 28.7.2010 |
| 1.7.2010 | Retacrit | HOSPIRA Enterprises B.V., Taurusavenue 19-21, 2132 LS HOOFDDORP, Nederland | These Decisions are addressed to the Member States | 9.7.2010 |
| 1.7.2010 | Silapo | STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Deutschland | These Decisions are addressed to the Member States | 5.7.2010 |
| 5.7.2010 | Thelin | Encysive (UK) Limited, Alder Castle House, 10 Noble Street, London EC2V 7QJ, United Kingdom | These Decisions are addressed to the Member States | 7.7.2010 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

16.8.2010

Porcilis M Hyo and associated names

See Annex I

See Annex I

17.8.2010

16.8.2010

Porcilis PRRS and associated names

See Annex II

See Annex II

17.8.2010

7.7.2010

Levact and associated names

See Annex III

See Annex III

9.7.2010

26.8.2010

Valproic acid/valproate

See Annex IV

See Annex IV

30.8.2010

1.7.2010

Gadolinium

See Annex V

See Annex V

5.7.2010

13.7.2010

Valtrex and associated names

See Annex VI

See Annex VI

16.7.2010

27.7.2010

Famvir and associated names

See Annex VII

See Annex VII

28.7.2010

7.7.2010

Vascace

See Annex VIII

See Annex VIII

8.7.2010

13.7.2010

Atacand and associated names

See Annex IX

See Annex IX

16.7.2010

1.7.2010

Sortis

See Annex X

See Annex X

6.7.2010

1.7.2010

Quinolones and Fluoroquinolones

See Annex XI

See Annex XI

6.7.2010

26.8.2010

Seroquel XR and associated names

See Annex XII

See Annex XII

30.8.2010

27.7.2010

Tiamutin premix and associated names

See Annex XIII

See Annex XIII

28.7.2010

5.7.2010

Daxas

Nycomed GmbH, Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland

These Decisions are addressed to the Member States

7.7.2010

27.7.2010

Leflunomide medac

medac Gesellschaft für klinische Spezialpräparate mbH, Fehlandtstrasse 3, D-20354 Hamburg, Deutschland

These Decisions are addressed to the Member States

29.7.2010

27.7.2010

Ozurdex

Allergan Pharmaceuticals (Ireland) Ltd, Castlebar Road, Westport, Co. Mayo, Ireland

These Decisions are addressed to the Member States

28.7.2010

1.7.2010

Retacrit

HOSPIRA Enterprises B.V., Taurusavenue 19-21, 2132 LS HOOFDDORP, Nederland

These Decisions are addressed to the Member States

9.7.2010

1.7.2010

Silapo

STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Deutschland

These Decisions are addressed to the Member States

5.7.2010

5.7.2010

Thelin

Encysive (UK) Limited, Alder Castle House, 10 Noble Street, London EC2V 7QJ, United Kingdom

These Decisions are addressed to the Member States

7.7.2010

—   Refusal of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 22.7.2010 | Ciclosporin IDL | See Annex XIV | See Annex XIV | 29.7.2010 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

22.7.2010

Ciclosporin IDL

See Annex XIV

See Annex XIV

29.7.2010

—   Suspension of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 22.7.2010 | Ciclosporin IDL | See Annex XIV | See Annex XIV | 29.7.2010 |
| 6.8.2010 | Sibutramine | See Annex XV | See Annex XV | 10.8.2010 |
| 22.7.2010 | Tildren | See Annex XVI | See Annex XVI | 23.7.2010 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

22.7.2010

Ciclosporin IDL

See Annex XIV

See Annex XIV

29.7.2010

6.8.2010

Sibutramine

See Annex XV

See Annex XV

10.8.2010

22.7.2010

Tildren

See Annex XVI

See Annex XVI

23.7.2010

—   Revocation of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 27.7.2010 | Bufexamac | See Annex XVII | See Annex XVII | 29.7.2010 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

27.7.2010

Bufexamac

See Annex XVII

See Annex XVII

29.7.2010

---

(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.

---

ANNEX I

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, WITHDRAWAL PERIOD, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State/EEA | Marketing Authorisation Holder | Product name | Strength | Pharmaceutical form | Animal species | Indications | Withdrawal period |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Intervet GmbH |
| Siemensstrasse 107 |
| 1210 Wien |
| Austria |

Member State/EEA

Marketing Authorisation Holder

Product name

Strength

Pharmaceutical form

Animal species

Indications

Withdrawal period

Austria

Intervet GmbH

Siemensstrasse 107

1210 Wien

Austria

PORCILIS M HYO

Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre

Suspension for injection

Pigs (finishing pigs)

For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae.

Zero days

Belgium

| Intervet International bv |
| --- |
| Wim de Koerverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International bv

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

PORCILIS M HYO

Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre

Suspension for injection

Pigs (finishing pigs)

For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae.

Zero days

Cyprus

| Intervet International bv |
| --- |
| Wim de Koerverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International bv

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

PORCILIS M. HYO

Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre

Suspension for injection

Pigs (finishing pigs)

For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae.

Zero days

Czech Republic

| Intervet International bv |
| --- |
| Wim de Koerverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International bv

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

Porcilis M HYO

Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre

Suspension for injection

Pigs (finishing pigs)

For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae.

Zero days

Denmark

| Intervet International bv |
| --- |
| Wim de Koerverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International bv

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

Porcilis M Hyo

Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre

Suspension for injection

Pigs (finishing pigs)

For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae.

Zero days

Estonia

| Intervet International bv |
| --- |
| Wim de Koerverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International bv

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

Porcilis M Hyo

Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre

Suspension for injection

Pigs (finishing pigs)

For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae.

Zero days

Finland

| Intervet International bv |
| --- |
| Wim de Koerverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International bv

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

Porcilis M Hyo

Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre

Suspension for injection

Pigs (finishing pigs)

For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae.

Zero days

France

| Intervet International bv |
| --- |
| Wim de Koerverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International bv

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

PORCILIS M hyo

Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre

Suspension for injection

Pigs (finishing pigs)

For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae.

Zero days

Germany

| Intervet Deutschland GmbH |
| --- |
| Postfach 1130 |
| 85701 Unterschleißheim |
| Germany |

Intervet Deutschland GmbH

Postfach 1130

85701 Unterschleißheim

Germany

Porcilis M Hyo

Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre

Suspension for injection

Pigs (finishing pigs)

For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae.

Zero days

Greece

| Intervet International bv |
| --- |
| Wim de Koerverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International bv

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

PORCILIS M.Hyo

Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre

Suspension for injection

Pigs (finishing pigs)

For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae.

Zero days

Hungary

| Intervet International bv |
| --- |
| Wim de Koerverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International bv

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

Porcilis M Hyo

Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre

Suspension for injection

Pigs (finishing pigs)

For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae.

Zero days

Ireland

| Intervet Ireland Limited, |
| --- |
| Magna Drive |
| Magna Business Park |
| Citywest Road |
| Dublin 24 |
| Ireland |

Intervet Ireland Limited,

Magna Drive

Magna Business Park

Citywest Road

Dublin 24

Ireland

Porcilis M Hyo, suspension for injection

Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre

Suspension for injection

Pigs (finishing pigs)

For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae.

Zero days

Italy

| Intervet International bv |
| --- |
| Wim de Koerverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International bv

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

Porsilis M-HYO

Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre

Suspension for injection

Pigs (finishing pigs)

For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae.

Zero days

Latvia

| Intervet International bv |
| --- |
| Wim de Koerverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International bv

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

PORCILIS M HYO

Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre

Suspension for injection

Pigs (finishing pigs)

For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae.

Zero days

Lithuania

| Intervet International bv |
| --- |
| Wim de Koerverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International bv

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

Porcilis M Hyo

Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre

Suspension for injection

Pigs (finishing pigs)

For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae.

Zero days

Luxembourg

| Intervet International bv |
| --- |
| Wim de Koerverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International bv

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

Porcilis M. Hyo, suspension injectable

Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre

Suspension for injection

Pigs (finishing pigs)

For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae.

Zero days

Malta

| Intervet International bv |
| --- |
| Wim de Koerverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International bv

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

Porcilis M Hyo

Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre

Suspension for injection

Pigs (finishing pigs)

For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae.

Zero days

Norway

| Intervet International bv |
| --- |
| Wim de Koerverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International bv

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

PORCILIS M HYO

Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre

Suspension for injection

Pigs (finishing pigs)

For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae.

Zero days

Poland

| Intervet International bv |
| --- |
| Wim de Koerverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International bv

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

Porcilis M Hyo

Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre

Suspension for injection

Pigs (finishing pigs)

For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae.

Zero days

Portugal

| Intervet Portugal – Saúde Animal, Lda |
| --- |
| Rua Agualva dos Açores, n.o 16, |
| 2735–557 Agualva-Cacém |
| Portugal |

Intervet Portugal – Saúde Animal, Lda

Rua Agualva dos Açores, n.o 16,

2735–557 Agualva-Cacém

Portugal

Porcilis M hyo, suspensão para injecção

Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre

Suspension for injection

Pigs (finishing pigs)

For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae.

Zero days

Slovakia

| Intervet International bv |
| --- |
| Wim de Koerverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International bv

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

Porcillis M.Hyo

Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre

Suspension for injection

Pigs (finishing pigs)

For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae.

Zero days

Slovenia

| Intervet International bv |
| --- |
| Wim de Koerverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International bv

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

Porcilis M Hyo

Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre

Suspension for injection

Pigs (finishing pigs)

For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae.

Zero days

Spain

| POLIG. INDUSTRIAL EL MONTALVO, PARCELA 39 CARBAJOSA DE LA SAGRADA 37188 SALAMANCA |
| --- |
| Spain |

POLIG. INDUSTRIAL EL MONTALVO, PARCELA 39 CARBAJOSA DE LA SAGRADA 37188 SALAMANCA

Spain

PORCILIS M hyo

Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre

Suspension for injection

Pigs (finishing pigs)

For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae.

Zero days

Sweden

| Intervet International bv |
| --- |
| Wim de Koerverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International bv

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

Porcilis M Hyo

Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre

Suspension for injection

Pigs (finishing pigs)

For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae.

Zero days

The Netherlands

| Intervet International bv |
| --- |
| Wim de Koerverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International bv

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

Porcilis M Hyo

Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre

Suspension for injection

Pigs (finishing pigs)

For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae.

Zero days

United Kingdom

Intervet International B.V. represented by

| Intervet UK Ltd |
| --- |
| Walton Manor |
| Walton |
| Milton Keynes |
| Bucks MK7 7AJ |

Intervet UK Ltd

Walton Manor

Walton

Milton Keynes

Bucks MK7 7AJ

Porcilis M Hyo, suspension for injection

Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre

Suspension for injection

Pigs (finishing pigs)

For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae.

Zero days

---

ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, WITHDRAWAL PERIOD, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State/EEA | Marketing Authorisation Holder | Product name | Strength | Pharmaceutical form | Animal species | Indications | Withdrawal period |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Intervet GmbH |
| Siemensstrasse 107 |
| 1210 Wien |
| Austria |

Member State/EEA

Marketing Authorisation Holder

Product name

Strength

Pharmaceutical form

Animal species

Indications

Withdrawal period

Austria

Intervet GmbH

Siemensstrasse 107

1210 Wien

Austria

Porcilis PRRS

live attenuated PRRS virus strain DV: 104.0 - 106.3 TCID50 per dose

Lyophilisate and solvent for suspension for injection

Pigs

For active immunisation of clinically healthy pigs in a PRRS virus contaminated environment, to reduce viraemia caused by infection with European strains of PRRS virus

Zero days

Belgium

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

PORCILIS PRRS

live attenuated PRRS virus strain DV: 104.0 - 106.3 TCID50 per dose

Lyophilisate and solvent for suspension for injection

Pigs

For active immunisation of clinically healthy pigs in a PRRS virus contaminated environment, to reduce viraemia caused by infection with European strains of PRRS virus

Zero days

France

| INTERVET |
| --- |
| RUE OLIVIER DE SERRES |
| ANGERS TECHNOPOLE |
| 49071 BEAUCOUZE |
| France |

INTERVET

RUE OLIVIER DE SERRES

ANGERS TECHNOPOLE

49071 BEAUCOUZE

France

PORCILIS PRRS IM

live attenuated PRRS virus strain DV: 104.0 - 106.3 TCID50 per dose

Lyophilisate and solvent for suspension for injection

Pigs

For active immunisation of clinically healthy pigs in a PRRS virus contaminated environment, to reduce viraemia caused by infection with European strains of PRRS virus

Zero days

Germany

| Intervet Deutschland GmbH |
| --- |
| Postfach 1130 |
| 85701 Unterschleißheim |
| Germany |

Intervet Deutschland GmbH

Postfach 1130

85701 Unterschleißheim

Germany

Porcilis PRRS

live attenuated PRRS virus strain DV: 104.0 - 106.3 TCID50 per dose

Lyophilisate and solvent for suspension for injection

Pigs

For active immunisation of clinically healthy pigs in a PRRS virus contaminated environment, to reduce viraemia caused by infection with European strains of PRRS virus

Zero days

Greece

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

PORCILIS PRRS

live attenuated PRRS virus strain DV: 104.0 - 106.3 TCID50 per dose

Lyophilisate and solvent for suspension for injection

Pigs

For active immunisation of clinically healthy pigs in a PRRS virus contaminated environment, to reduce viraemia caused by infection with European strains of PRRS virus

Zero days

Ireland

| Intervet Ireland Limited |
| --- |
| Magna Drive |
| Magna Business Park |
| Citywest Road |
| Dublin 24 |
| Ireland |

Intervet Ireland Limited

Magna Drive

Magna Business Park

Citywest Road

Dublin 24

Ireland

Porcilis PRRS IM

live attenuated PRRS virus strain DV: 104.0 - 106.3 TCID50 per dose

Lyophilisate and solvent for suspension for injection

Pigs

For active immunisation of clinically healthy pigs in a PRRS virus contaminated environment, to reduce viraemia caused by infection with European strains of PRRS virus

Zero days

Ireland

| Intervet Ireland Limited |
| --- |
| Magna Drive |
| Magna Business Park |
| Citywest Road |
| Dublin 24 |
| Ireland |

Intervet Ireland Limited

Magna Drive

Magna Business Park

Citywest Road

Dublin 24

Ireland

Porcilis PRRS IDAL

live attenuated PRRS virus strain DV: 104.0 - 106.3 TCID50 per dose

Lyophilisate and solvent for suspension for injection

Pigs

For active immunisation of clinically healthy pigs in a PRRS virus contaminated environment, to reduce viraemia caused by infection with European strains of PRRS virus

Zero days

Italy

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

Porsilis PRRS

live attenuated PRRS virus strain DV: 104.0 - 106.3 TCID50 per dose

Lyophilisate and solvent for suspension for injection

Pigs

For active immunisation of clinically healthy pigs in a PRRS virus contaminated environment, to reduce viraemia caused by infection with European strains of PRRS virus

Zero days

Luxembourg

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

PORCILIS PRRS

live attenuated PRRS virus strain DV: 104.0 - 106.3 TCID50 per dose

Lyophilisate and solvent for suspension for injection

Pigs

For active immunisation of clinically healthy pigs in a PRRS virus contaminated environment, to reduce viraemia caused by infection with European strains of PRRS virus

Zero days

Portugal

| Intervet Portugal – Saúde Animal, Lda |
| --- |
| Rua Agualva dos Açores, n.o 16, |
| 2735 – 557 Agualva-Cacém |
| Portugal |

Intervet Portugal – Saúde Animal, Lda

Rua Agualva dos Açores, n.o 16,

2735 – 557 Agualva-Cacém

Portugal

PORCILIS PRSS

live attenuated PRRS virus strain DV: 104.0 - 106.3 TCID50 per dose

Lyophilisate and solvent for suspension for injection

Pigs

For active immunisation of clinically healthy pigs in a PRRS virus contaminated environment, to reduce viraemia caused by infection with European strains of PRRS virus

Zero days

Spain

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

PORCILIS PRSS

live attenuated PRRS virus strain DV: 104.0 - 106.3 TCID50 per dose

Lyophilisate and solvent for suspension for injection

Pigs

For active immunisation of clinically healthy pigs in a PRRS virus contaminated environment, to reduce viraemia caused by infection with European strains of PRRS virus

Zero days

The Netherlands

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

Porcilis PRRS

live attenuated PRRS virus strain DV: 104.0 - 106.3 TCID50 per dose

Lyophilisate and solvent for suspension for injection

Pigs

For active immunisation of clinically healthy pigs in a PRRS virus contaminated environment, to reduce viraemia caused by infection with European strains of PRRS virus

Zero days

United Kingdom

| Intervet UK Ltd. |
| --- |
| Walton Manor, Walton |
| Milton Keynes, |
| Bucks MK7 7AJ |
| United Kingdom |

Intervet UK Ltd.

Walton Manor, Walton

Milton Keynes,

Bucks MK7 7AJ

United Kingdom

Porcilis PRRS

live attenuated PRRS virus strain DV: 104.0 - 106.3 TCID50 per dose

Lyophilisate and solvent for suspension for injection

Pigs

For active immunisation of clinically healthy pigs in a PRRS virus contaminated environment, to reduce viraemia caused by infection with European strains of PRRS virus

Zero days

---

ANNEX III

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES

| Member State EU/EEA | Applicant company name, address | (Invented) Name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Astellas Pharma GmbH |
| Georg-Brauchle-Ring 64 - 66 |
| 80992 München |
| Germany |

Member State EU/EEA

Applicant company name, address

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

Austria

Astellas Pharma GmbH

Georg-Brauchle-Ring 64 - 66

80992 München

Germany

Levact 2,5 mg/ml Pulver für ein Konzentrat zur Herstellung einer Infusionslösung

2,5 mg/ml

Powder for concentrate for solution for infusion

Intravenous use

Belgium

| Astellas Pharma GmbH |
| --- |
| Georg-Brauchle-Ring 64 - 66 |
| 80992 München |
| Germany |

Astellas Pharma GmbH

Georg-Brauchle-Ring 64 - 66

80992 München

Germany

Levact

2,5 mg/ml

Powder for concentrate for solution for infusion

Intravenous use

Denmark

| Astellas Pharma GmbH |
| --- |
| Georg-Brauchle-Ring 64 - 66 |
| 80992 München |
| Germany |

Astellas Pharma GmbH

Georg-Brauchle-Ring 64 - 66

80992 München

Germany

Ribomustin

2,5 mg/ml

Powder for concentrate for solution for infusion

Intravenous use

Finland

| Astellas Pharma GmbH |
| --- |
| Georg-Brauchle-Ring 64 - 66 |
| 80992 München |
| Germany |

Astellas Pharma GmbH

Georg-Brauchle-Ring 64 - 66

80992 München

Germany

Ribomustin

2,5 mg/ml

Powder for concentrate for solution for infusion

Intravenous use

France

| Astellas Pharma GmbH |
| --- |
| Georg-Brauchle-Ring 64 - 66 |
| 80992 München |
| Germany |

Astellas Pharma GmbH

Georg-Brauchle-Ring 64 - 66

80992 München

Germany

Levact

2,5 mg/ml

Powder for concentrate for solution for infusion

Intravenous use

Germany

| Astellas Pharma GmbH |
| --- |
| Georg-Brauchle-Ring 64 - 66 |
| 80992 München |
| Germany |

Astellas Pharma GmbH

Georg-Brauchle-Ring 64 - 66

80992 München

Germany

Levact

2,5 mg/ml

Powder for concentrate for solution for infusion

Intravenous use

Ireland

| Astellas Pharma GmbH |
| --- |
| Georg-Brauchle-Ring 64 - 66 |
| 80992 München |
| Germany |

Astellas Pharma GmbH

Georg-Brauchle-Ring 64 - 66

80992 München

Germany

Levact

2,5 mg/ml

Powder for concentrate for solution for infusion

Intravenous use

Italy

| Astellas Pharma GmbH |
| --- |
| Georg-Brauchle-Ring 64 - 66 |
| 80992 München |
| Germany |

Astellas Pharma GmbH

Georg-Brauchle-Ring 64 - 66

80992 München

Germany

Ribomustin

2,5 mg/ml

Powder for concentrate for solution for infusion

Intravenous use

Luxembourg

| Astellas Pharma GmbH |
| --- |
| Georg-Brauchle-Ring 64 - 66 |
| 80992 München |
| Germany |

Astellas Pharma GmbH

Georg-Brauchle-Ring 64 - 66

80992 München

Germany

Levact

2,5 mg/ml

Powder for concentrate for solution for infusion

Intravenous use

Norway

| Astellas Pharma GmbH |
| --- |
| Georg-Brauchle-Ring 64 - 66 |
| 80992 München |
| Germany |

Astellas Pharma GmbH

Georg-Brauchle-Ring 64 - 66

80992 München

Germany

Levact

2,5 mg/ml

Powder for concentrate for solution for infusion

Intravenous use

Poland

| Astellas Pharma GmbH |
| --- |
| Georg-Brauchle-Ring 64 - 66 |
| 80992 München |
| Germany |

Astellas Pharma GmbH

Georg-Brauchle-Ring 64 - 66

80992 München

Germany

Levact

2,5 mg/ml

Powder for concentrate for solution for infusion

Intravenous use

Spain

| Astellas Pharma GmbH |
| --- |
| Georg-Brauchle-Ring 64 - 66 |
| 80992 München |
| Germany |

Astellas Pharma GmbH

Georg-Brauchle-Ring 64 - 66

80992 München

Germany

Levact

2,5 mg/ml

Powder for concentrate for solution for infusion

Intravenous use

United Kingdom

| Astellas Pharma GmbH |
| --- |
| Georg-Brauchle-Ring 64 - 66 |
| 80992 München |
| Germany |

Astellas Pharma GmbH

Georg-Brauchle-Ring 64 - 66

80992 München

Germany

Ribomustin

2,5 mg/ml

Powder for concentrate for solution for infusion

Intravenous use

---

ANNEX IV

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State | Marketing Authorisation Holder | Product Name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Gerot Pharmazeutika G.m.b.H |
| Arnethgasse 3 |
| A-1160 Wien |
| Austria |

Member State

Marketing Authorisation Holder

Product Name

Strength

Pharmaceutical Form

Route of administration

Austria

Gerot Pharmazeutika G.m.b.H

Arnethgasse 3

A-1160 Wien

Austria

Convulex 150 mg - Kapseln

150 mg

gastro-resistant capsule, soft

Oral Use

Austria

| Gerot Pharmazeutika G.m.b.H |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| Austria |

Gerot Pharmazeutika G.m.b.H

Arnethgasse 3

A-1160 Wien

Austria

Convulex 200 mg - Kapseln

200 mg

gastro-resistant capsule, soft

Oral Use

Austria

| Gerot Pharmazeutika G.m.b.H |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| Austria |

Gerot Pharmazeutika G.m.b.H

Arnethgasse 3

A-1160 Wien

Austria

Convulex 300 mg - Kapseln

300 mg

gastro-resistant capsule, soft

Oral Use

Austria

| Gerot Pharmazeutika G.m.b.H |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| Austria |

Gerot Pharmazeutika G.m.b.H

Arnethgasse 3

A-1160 Wien

Austria

Convulex 300 mg - Filmtabletten

300 mg

film-coated tablet

Oral Use

Austria

| Gerot Pharmazeutika G.m.b.H |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| Austria |

Gerot Pharmazeutika G.m.b.H

Arnethgasse 3

A-1160 Wien

Austria

Convulex 500 mg - Kapseln

500 mg

gastro-resistant capsule, soft

Oral Use

Austria

| Gerot Pharmazeutika G.m.b.H |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| Austria |

Gerot Pharmazeutika G.m.b.H

Arnethgasse 3

A-1160 Wien

Austria

Convulex 50 mg/ml - Sirup für Kinder

50 mg/ml

syrup

Oral Use

Austria

| Gerot Pharmazeutika G.m.b.H |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| Austria |

Gerot Pharmazeutika G.m.b.H

Arnethgasse 3

A-1160 Wien

Austria

Convulex 300 mg/ml - Lösung zum Einnehmen

300 mg/ml

oral solution

Oral Use

Austria

| Gerot Pharmazeutika G.m.b.H |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| Austria |

Gerot Pharmazeutika G.m.b.H

Arnethgasse 3

A-1160 Wien

Austria

Convulex 300 mg - Retardtabletten

300 mg

prolonged-release tablet

Oral Use

Austria

| Gerot Pharmazeutika G.m.b.H |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| Austria |

Gerot Pharmazeutika G.m.b.H

Arnethgasse 3

A-1160 Wien

Austria

Convulex 500 mg - Retardtabletten

500 mg

prolonged-release tablet

Oral Use

Austria

| Sanofi-aventis GmbH |
| --- |
| SATURN Tower, |
| Leonard-Bernstein-Str. 10 |
| Vienna DC, A-1220 Wien |
| Austria |

Sanofi-aventis GmbH

SATURN Tower,

Leonard-Bernstein-Str. 10

Vienna DC, A-1220 Wien

Austria

Depakine chrono retard 300 mg - Filmtabletten

300 mg

prolonged-release tablet

Oral Use

Austria

| Sanofi-aventis GmbH |
| --- |
| SATURN Tower, |
| Leonard-Bernstein-Str. 10 |
| Vienna DC, A-1220 Wien |
| Austria |

Sanofi-aventis GmbH

SATURN Tower,

Leonard-Bernstein-Str. 10

Vienna DC, A-1220 Wien

Austria

Depakine chrono retard 500 mg - Filmtabletten

500 mg

prolonged-release tablet

Oral Use

Austria

| Sanofi-aventis GmbH |
| --- |
| SATURN Tower, |
| Leonard-Bernstein-Str. 10 |
| Vienna DC, A-1220 Wien |
| Austria |

Sanofi-aventis GmbH

SATURN Tower,

Leonard-Bernstein-Str. 10

Vienna DC, A-1220 Wien

Austria

Depakine Chronosphere 500-1 000 mg/Dosis - Retardgranulat

500 -1 000 mg

prolonged-release granules

Oral Use

Austria

| Sanofi-aventis GmbH |
| --- |
| SATURN Tower, |
| Leonard-Bernstein-Str. 10 |
| Vienna DC, A-1220 Wien |
| Austria |

Sanofi-aventis GmbH

SATURN Tower,

Leonard-Bernstein-Str. 10

Vienna DC, A-1220 Wien

Austria

Depakine Chronosphere 50-200 mg/Dosis - Retardgranulat

50 - 200 mg

prolonged-release granules

Oral Use

Austria

| Sanofi-aventis GmbH |
| --- |
| SATURN Tower, |
| Leonard-Bernstein-Str. 10 |
| Vienna DC, A-1220 Wien |
| Austria |

Sanofi-aventis GmbH

SATURN Tower,

Leonard-Bernstein-Str. 10

Vienna DC, A-1220 Wien

Austria

Depakine Chronosphere 50-350 mg/Dosis - Retardgranulat

50 - 350 mg

prolonged-release granules

Oral Use

Austria

| Sanofi-aventis GmbH |
| --- |
| SATURN Tower, |
| Leonard-Bernstein-Str. 10 |
| Vienna DC, A-1220 Wien |
| Austria |

Sanofi-aventis GmbH

SATURN Tower,

Leonard-Bernstein-Str. 10

Vienna DC, A-1220 Wien

Austria

Depakine Chronosphere 100 mg - Retardgranulat in Beuteln

100 mg

prolonged-release granules

Oral Use

Austria

| Sanofi-aventis GmbH |
| --- |
| SATURN Tower, |
| Leonard-Bernstein-Str. 10 |
| Vienna DC, A-1220 Wien |
| Austria |

Sanofi-aventis GmbH

SATURN Tower,

Leonard-Bernstein-Str. 10

Vienna DC, A-1220 Wien

Austria

Depakine Chronosphere 1 000 mg - Retardgranulat in Beuteln

1 000 mg

prolonged-release granules

Oral Use

Austria

| Sanofi-aventis GmbH |
| --- |
| SATURN Tower, |
| Leonard-Bernstein-Str. 10 |
| Vienna DC, A-1220 Wien |
| Austria |

Sanofi-aventis GmbH

SATURN Tower,

Leonard-Bernstein-Str. 10

Vienna DC, A-1220 Wien

Austria

Depakine Chronosphere 250 mg - Retardgranulat in Beuteln

250 mg

prolonged-release granules

Oral Use

Austria

| Sanofi-aventis GmbH |
| --- |
| SATURN Tower, |
| Leonard-Bernstein-Str. 10 |
| Vienna DC, A-1220 Wien |
| Austria |

Sanofi-aventis GmbH

SATURN Tower,

Leonard-Bernstein-Str. 10

Vienna DC, A-1220 Wien

Austria

Depakine Chronosphere 50 mg - Retardgranulat in Beuteln

50 mg

prolonged-release granules

Oral Use

Austria

| Sanofi-aventis GmbH |
| --- |
| SATURN Tower, |
| Leonard-Bernstein-Str. 10 |
| Vienna DC, A-1220 Wien |
| Austria |

Sanofi-aventis GmbH

SATURN Tower,

Leonard-Bernstein-Str. 10

Vienna DC, A-1220 Wien

Austria

Depakine Chronosphere 500 mg - Retardgranulat in Beuteln

500 mg

prolonged-release granules

Oral Use

Austria

| Sanofi-aventis GmbH |
| --- |
| SATURN Tower, |
| Leonard-Bernstein-Str. 10 |
| Vienna DC, A-1220 Wien |
| Austria |

Sanofi-aventis GmbH

SATURN Tower,

Leonard-Bernstein-Str. 10

Vienna DC, A-1220 Wien

Austria

Depakine Chronosphere 750 mg - Retardgranulat in Beuteln

750 mg

prolonged-release granules

Oral Use

Austria

| Sanofi-aventis GmbH |
| --- |
| SATURN Tower, |
| Leonard-Bernstein-Str. 10 |
| Vienna DC, A-1220 Wien |
| Austria |

Sanofi-aventis GmbH

SATURN Tower,

Leonard-Bernstein-Str. 10

Vienna DC, A-1220 Wien

Austria

Depakine 300 mg - Filmtabletten

300 mg

film-coated tablet

Oral Use

Austria

| Sanofi-aventis GmbH |
| --- |
| SATURN Tower, |
| Leonard-Bernstein-Str. 10 |
| Vienna DC, A-1220 Wien |
| Austria |

Sanofi-aventis GmbH

SATURN Tower,

Leonard-Bernstein-Str. 10

Vienna DC, A-1220 Wien

Austria

Depakine 300 mg/ml - Tropfen

300 mg/ml

oral drops, solution

Oral Use

Austria

| Ratiopharm Arzneimittel Vertriebs-GmbH |
| --- |
| Albert-Schweitzer-G. 3 |
| A-1140 Wien |
| Austria |

Ratiopharm Arzneimittel Vertriebs-GmbH

Albert-Schweitzer-G. 3

A-1140 Wien

Austria

Natriumvalproat ‘ratiopharm’ retard 300 mg - Filmtabletten

300 mg

prolonged-release tablet

Oral Use

Austria

| Ratiopharm Arzneimittel Vertriebs-GmbH |
| --- |
| Albert-Schweitzer-G. 3 |
| A-1140 Wien |
| Austria |

Ratiopharm Arzneimittel Vertriebs-GmbH

Albert-Schweitzer-G. 3

A-1140 Wien

Austria

Natriumvalproat ‘ratiopharm’ retard 500 mg - Filmtabletten

500 mg

prolonged-release tablet

Oral Use

Austria

| G. L. Pharma GmbH |
| --- |
| Schloßplatz 1 |
| 8502 Lannach |
| Austria |

G. L. Pharma GmbH

Schloßplatz 1

8502 Lannach

Austria

Natriumvalproat G.L. 300 mg - Retardtabletten

300 mg

prolonged-release tablet

Oral Use

Austria

| G. L. Pharma GmbH |
| --- |
| Schloßplatz 1 |
| 8502 Lannach |
| Austria |

G. L. Pharma GmbH

Schloßplatz 1

8502 Lannach

Austria

Natriumvalproat G.L. 500 mg - Retardtabletten

500 mg

prolonged-release tablet

Oral Use

Belgium

| NYCOMED BELGIUM N.V. |
| --- |
| Gentsesteenweg 615 |
| 1080 Brussels |
| Belgium |

NYCOMED BELGIUM N.V.

Gentsesteenweg 615

1080 Brussels

Belgium

CONVULEX

50 mg/ml

syrup

Oral Use

Belgium

| NYCOMED BELGIUM N.V. |
| --- |
| Gentsesteenweg 615 |
| 1080 Brussels |
| Belgium |

NYCOMED BELGIUM N.V.

Gentsesteenweg 615

1080 Brussels

Belgium

CONVULEX 300

300 mg

gastro-resistant capsule, hard

Oral Use

Belgium

| NYCOMED BELGIUM N.V. |
| --- |
| Gentsesteenweg 615 |
| 1080 Brussels |
| Belgium |

NYCOMED BELGIUM N.V.

Gentsesteenweg 615

1080 Brussels

Belgium

CONVULEX 500

500 mg

gastro-resistant capsule, hard

Oral Use

Belgium

| NYCOMED BELGIUM N.V. |
| --- |
| Gentsesteenweg 615 |
| 1080 Brussels |
| Belgium |

NYCOMED BELGIUM N.V.

Gentsesteenweg 615

1080 Brussels

Belgium

CONVULEX-150

150 mg

gastro-resistant capsule, hard

Oral Use

Belgium

| SANOFI-AVENTIS BELGIUM N.V. |
| --- |
| Culliganlaan 1 C |
| 1831 Diegem |
| Belgium |

SANOFI-AVENTIS BELGIUM N.V.

Culliganlaan 1 C

1831 Diegem

Belgium

DEPAKINE

300 mg/ml

oral drops, solution

Oral Use

Belgium

| SANOFI-AVENTIS BELGIUM N.V. |
| --- |
| Culliganlaan 1 C |
| 1831 Diegem |
| Belgium |

SANOFI-AVENTIS BELGIUM N.V.

Culliganlaan 1 C

1831 Diegem

Belgium

DEPAKINE 300 MG/5 ML

300 mg/5 ml

syrup

Oral Use

Belgium

| SANOFI-AVENTIS BELGIUM N.V. |
| --- |
| Culliganlaan 1 C |
| 1831 Diegem |
| Belgium |

SANOFI-AVENTIS BELGIUM N.V.

Culliganlaan 1 C

1831 Diegem

Belgium

DEPAKINE CHRONO 300

200,00 mg/87,00 mg

prolonged- release tablet

Oral Use

Belgium

| SANOFI-AVENTIS BELGIUM N.V. |
| --- |
| Culliganlaan 1 C |
| 1831 Diegem |
| Belgium |

SANOFI-AVENTIS BELGIUM N.V.

Culliganlaan 1 C

1831 Diegem

Belgium

DEPAKINE CHRONO 500

333,00 mg/145,00 mg

prolonged- release tablet

Oral Use

Belgium

| SANOFI-AVENTIS BELGIUM N.V. |
| --- |
| Culliganlaan 1 C |
| 1831 Diegem |
| Belgium |

SANOFI-AVENTIS BELGIUM N.V.

Culliganlaan 1 C

1831 Diegem

Belgium

DEPAKINE CHRONO MICROGRANULES 0,33 G/G

220,00 mg/g/96,00 mg/g

prolonged-release granules

Oral Use

Belgium

| SANOFI-AVENTIS BELGIUM N.V. |
| --- |
| Culliganlaan 1 C |
| 1831 Diegem |
| Belgium |

SANOFI-AVENTIS BELGIUM N.V.

Culliganlaan 1 C

1831 Diegem

Belgium

DEPAKINE ENTERIC 150

150 mg

gastro-resistant tablet

Oral Use

Belgium

| SANOFI-AVENTIS BELGIUM N.V. |
| --- |
| Culliganlaan 1 C |
| 1831 Diegem |
| Belgium |

SANOFI-AVENTIS BELGIUM N.V.

Culliganlaan 1 C

1831 Diegem

Belgium

DEPAKINE ENTERIC 300

300 mg

gastro-resistant tablet

Oral Use

Belgium

| SANOFI-AVENTIS BELGIUM N.V. |
| --- |
| Culliganlaan 1 C |
| 1831 Diegem |
| Belgium |

SANOFI-AVENTIS BELGIUM N.V.

Culliganlaan 1 C

1831 Diegem

Belgium

DEPAKINE ENTERIC 500

500 mg

gastro-resistant tablet

Oral Use

Belgium

| SANOFI-AVENTIS BELGIUM N.V. |
| --- |
| Culliganlaan 1 C |
| 1831 Diegem |
| Belgium |

SANOFI-AVENTIS BELGIUM N.V.

Culliganlaan 1 C

1831 Diegem

Belgium

DEPAKOTE 250

269,10 mg

gastro-resistant tablet

Oral Use

Belgium

| SANOFI-AVENTIS BELGIUM N.V. |
| --- |
| Culliganlaan 1 C |
| 1831 Diegem |
| Belgium |

SANOFI-AVENTIS BELGIUM N.V.

Culliganlaan 1 C

1831 Diegem

Belgium

DEPAKOTE 500

538,20 mg

gastro-resistant tablet

Oral Use

Belgium

| SANOFI-AVENTIS BELGIUM N.V. |
| --- |
| Culliganlaan 1 C |
| 1831 Diegem |
| Belgium |

SANOFI-AVENTIS BELGIUM N.V.

Culliganlaan 1 C

1831 Diegem

Belgium

DEPAMIDE

300 mg

gastro-resistant tablet

Oral Use

Belgium

| EUROGENERICS N.V. |
| --- |
| Heizel Esplanade b22 |
| 1020 Laken |
| Belgium |

EUROGENERICS N.V.

Heizel Esplanade b22

1020 Laken

Belgium

VALPROATE RETARD EG 300 MG

200,00 mg/87,00 mg

prolonged- release tablet

Oral Use

Belgium

| EUROGENERICS N.V. |
| --- |
| Heizel Esplanade b22 |
| 1020 Laken |
| Belgium |

EUROGENERICS N.V.

Heizel Esplanade b22

1020 Laken

Belgium

VALPROATE RETARD EG 500 MG

333,00 mg/145,00 mg

prolonged- release tablet

Oral Use

Belgium

| MYLAN BVBA/SPRL |
| --- |
| Terhulpsesteenweg 6A |
| 1560 Hoeilaart |
| Belgium |

MYLAN BVBA/SPRL

Terhulpsesteenweg 6A

1560 Hoeilaart

Belgium

VALPROATE RETARD MYLAN 300 MG

300 mg

prolonged- release tablet

Oral Use

Belgium

| MYLAN BVBA/SPRL |
| --- |
| Terhulpsesteenweg 6A |
| 1560 Hoeilaart |
| Belgium |

MYLAN BVBA/SPRL

Terhulpsesteenweg 6A

1560 Hoeilaart

Belgium

VALPROATE RETARD MYLAN 500 MG

500 mg

prolonged- release tablet

Oral Use

Belgium

| SANDOZ N.V. |
| --- |
| Telecom Gardens |
| Medialaan 40 |
| 1800 Vilvoorde |
| Belgium |

SANDOZ N.V.

Telecom Gardens

Medialaan 40

1800 Vilvoorde

Belgium

VALPROATE SANDOZ 300 MG

199,80 mg/87,00 mg

prolonged- release tablet

Oral Use

Belgium

| SANDOZ N.V. |
| --- |
| Telecom Gardens |
| Medialaan 40 |
| 1800 Vilvoorde |
| Belgium |

SANDOZ N.V.

Telecom Gardens

Medialaan 40

1800 Vilvoorde

Belgium

VALPROATE SANDOZ 500 MG

333,00 mg/145,00 mg

prolonged- release tablet

Oral Use

Belgium

| SANOFI-AVENTIS BELGIUM N.V. |
| --- |
| Culliganlaan 1 C |
| 1831 Diegem |
| Belgium |

SANOFI-AVENTIS BELGIUM N.V.

Culliganlaan 1 C

1831 Diegem

Belgium

VALPROIM CHRONO 300

200,00 mg/87,00 mg

prolonged- release tablet

Oral Use

Belgium

| SANOFI-AVENTIS BELGIUM N.V. |
| --- |
| Culliganlaan 1 C |
| 1831 Diegem |
| Belgium |

SANOFI-AVENTIS BELGIUM N.V.

Culliganlaan 1 C

1831 Diegem

Belgium

VALPROIM CHRONO 500

333,00 mg/145,00 mg

prolonged- release tablet

Oral Use

Belgium

| SANOFI-AVENTIS BELGIUM N.V. |
| --- |
| Culliganlaan 1 C |
| 1831 Diegem |
| Belgium |

SANOFI-AVENTIS BELGIUM N.V.

Culliganlaan 1 C

1831 Diegem

Belgium

VALPROIM LA 300

300,00 mg

gastro-resistant tablet

Oral Use

Belgium

| SANOFI-AVENTIS BELGIUM N.V. |
| --- |
| Culliganlaan 1 C |
| 1831 Diegem |
| Belgium |

SANOFI-AVENTIS BELGIUM N.V.

Culliganlaan 1 C

1831 Diegem

Belgium

VALPROIM LA 500

500,00 mg

gastro-resistant tablet

Oral Use

Belgium

| Kristina De Turck |
| --- |
| KDT Consulting |
| Chaussée de Ninove 2 |
| 1540 Herne |
| Belgium |

Kristina De Turck

KDT Consulting

Chaussée de Ninove 2

1540 Herne

Belgium

VALPROSTAT 300 MG

199,80 mg/87,00 mg

prolonged- release tablet

Oral Use

Belgium

| Kristina De Turck |
| --- |
| KDT Consulting |
| Chaussée de Ninove 2 |
| 1540 Herne |
| Belgium |

Kristina De Turck

KDT Consulting

Chaussée de Ninove 2

1540 Herne

Belgium

VALPROSTAT 500 MG

333,00 mg/145,00 mg

prolonged- release tablet

Oral Use

Bulgaria

| AWD. pharma GmbH & Co. KG |
| --- |
| Wasastr. 50 |
| D-01445 Radebeul |
| Germany |

AWD. pharma GmbH & Co. KG

Wasastr. 50

D-01445 Radebeul

Germany

Convulsofin

333 mg

tablet

Oral Use

Bulgaria

| G.L.Pharma GmbH Schlossplatz 1, |
| --- |
| A-8502 Lannach, |
| Austria |

G.L.Pharma GmbH Schlossplatz 1,

A-8502 Lannach,

Austria

Convulex chrono

500 mg

prolonget-release tablet

Oral Use

Bulgaria

| G.L.Pharma GmbH Schlossplatz 1 |
| --- |
| A-8502 Lannach |
| Austria |

G.L.Pharma GmbH Schlossplatz 1

A-8502 Lannach

Austria

Convulex chrono

300 mg

prolonget-release tablet

Oral Use

Bulgaria

| G.L.Pharma GmbH Schlossplatz 1 |
| --- |
| A-8502 Lannach |
| Austria |

G.L.Pharma GmbH Schlossplatz 1

A-8502 Lannach

Austria

Convulex

500 mg

gastro-resistant capsule

Oral Use

Bulgaria

| G.L.Pharma GmbH Schlossplatz 1 |
| --- |
| A-8502 Lannach |
| Austria |

G.L.Pharma GmbH Schlossplatz 1

A-8502 Lannach

Austria

Convulex

150 mg

gastro-resistant capsule

Oral Use

Bulgaria

| G.L.Pharma GmbH Schlossplatz 1 |
| --- |
| A-8502 Lannach |
| Austria |

G.L.Pharma GmbH Schlossplatz 1

A-8502 Lannach

Austria

Convulex

300 mg

gastro-resistant capsule

Oral Use

Bulgaria

| G.L.Pharma GmbH Schlossplatz 1 |
| --- |
| A-8502 Lannach |
| Austria |

G.L.Pharma GmbH Schlossplatz 1

A-8502 Lannach

Austria

Convulex

50 mg/ml

syrup

Oral Use

Bulgaria

| Санофи-Авентис България ЕООД бул. Ал. Стамболийски 103, офис сграда София Тауър ет.8, София 1303, България |
| --- |
| Bulgaria |

Санофи-Авентис България ЕООД бул. Ал. Стамболийски 103, офис сграда София Тауър ет.8, София 1303, България

Bulgaria

Depakine Chrono

300 mg

prolonged release tablet

Oral Use

Bulgaria

| Санофи-Авентис България ЕООД бул. Ал. Стамболийски 103, офис сграда София Тауър ет.8, София 1303, България |
| --- |
| Bulgaria |

Санофи-Авентис България ЕООД бул. Ал. Стамболийски 103, офис сграда София Тауър ет.8, София 1303, България

Bulgaria

Depakine Chrono

500 mg

prolonged release tablet

Oral Use

Bulgaria

| Санофи-Авентис България ЕООД бул. Ал. Стамболийски 103, офис сграда София Тауър ет.8, София 1303, България |
| --- |
| Bulgaria |

Санофи-Авентис България ЕООД бул. Ал. Стамболийски 103, офис сграда София Тауър ет.8, София 1303, България

Bulgaria

Depakine

5,764 g/100 ml

syrup

Oral Use

Bulgaria

| Санофи-Авентис България ЕООД бул. Ал. Стамболийски 103, офис сграда София Тауър ет.8, София 1303, България |
| --- |
| Bulgaria |

Санофи-Авентис България ЕООД бул. Ал. Стамболийски 103, офис сграда София Тауър ет.8, София 1303, България

Bulgaria

Depakine

200 mg

gastro-resistant tablet

Oral Use

Bulgaria

| Санофи-Авентис България ЕООД бул. Ал. Стамболийски 103, офис сграда София Тауър ет.8, София 1303, България |
| --- |
| Bulgaria |

Санофи-Авентис България ЕООД бул. Ал. Стамболийски 103, офис сграда София Тауър ет.8, София 1303, България

Bulgaria

Depakine

500 mg

gastro-resistant tablet

Oral Use

Bulgaria

Санофи-Авентис България ЕООД бул. Ал. Стамболийски 103, офис сграда София Тауър ет.8, София 1303, България

Depakine chronosphere

250 mg

modified-release granules

Oral Use

Bulgaria

Санофи-Авентис България ЕООД бул. Ал. Стамболийски 103, офис сграда София Тауър ет.8, София 1303, България

Depakine chronosphere

100 mg

modified-release granules

Oral Use

Bulgaria

Санофи-Авентис България ЕООД бул. Ал. Стамболийски 103, офис сграда София Тауър ет.8, София 1303, България

Depakine chronosphere

1 000 mg

modified-release granules

Oral Use

Bulgaria

Санофи-Авентис България ЕООД бул. Ал. Стамболийски 103, офис сграда София Тауър ет.8, София 1303, България

Depakine chronosphere

500 mg

modified-release granules

Oral Use

Cyprus

| Sanofi-Aventis Cyprus Ltd |
| --- |
| Charalambou |
| Mouskou 14 |
| 2015 Strovolos |
| Cyprus |

Sanofi-Aventis Cyprus Ltd

Charalambou

Mouskou 14

2015 Strovolos

Cyprus

DEPAKINE CHRONO

500 mg

tablet

Oral Use

Cyprus

| Sanofi-Aventis Cyprus Ltd |
| --- |
| Charalambou |
| Mouskou 14 |
| 2015 Strovolos |
| Cyprus |

Sanofi-Aventis Cyprus Ltd

Charalambou

Mouskou 14

2015 Strovolos

Cyprus

DEPAKINE CHRONOSPHERE

50 mg

modified-release granules

Oral Use

Cyprus

| Sanofi-Aventis Cyprus Ltd |
| --- |
| Charalambou |
| Mouskou 14 |
| 2015 Strovolos |
| Cyprus |

Sanofi-Aventis Cyprus Ltd

Charalambou

Mouskou 14

2015 Strovolos

Cyprus

DEPAKINE CHRONOSPHERE

100 mg

modified-release granules

Oral Use

Cyprus

| Sanofi-Aventis Cyprus Ltd |
| --- |
| Charalambou |
| Mouskou 14 |
| 2015 Strovolos |
| Cyprus |

Sanofi-Aventis Cyprus Ltd

Charalambou

Mouskou 14

2015 Strovolos

Cyprus

DEPAKINE CHRONOSPHERE

250 mg

modified-release granules

Oral Use

Cyprus

| Sanofi-Aventis Cyprus Ltd |
| --- |
| Charalambou |
| Mouskou 14 |
| 2015 Strovolos |
| Cyprus |

Sanofi-Aventis Cyprus Ltd

Charalambou

Mouskou 14

2015 Strovolos

Cyprus

DEPAKINE CHRONOSPHERE

500 mg

modified-release granules

Oral Use

Cyprus

| Sanofi-Aventis Cyprus Ltd |
| --- |
| Charalambou |
| Mouskou 14 |
| 2015 Strovolos |
| Cyprus |

Sanofi-Aventis Cyprus Ltd

Charalambou

Mouskou 14

2015 Strovolos

Cyprus

DEPAKINE CHRONOSPHERE

750 mg

modified-release granules

Oral Use

Cyprus

| Sanofi-Aventis Cyprus Ltd |
| --- |
| Charalambou |
| Mouskou 14 |
| 2015 Strovolos |
| Cyprus |

Sanofi-Aventis Cyprus Ltd

Charalambou

Mouskou 14

2015 Strovolos

Cyprus

DEPAKINE CHRONOSPHERE

1 000 mg

modified-release granules

Oral Use

Cyprus

| Remedica Ltd |
| --- |
| Aharnon street |
| P.O. Box 51706 |
| 3508 Lemesos |
| Cyprus |

Remedica Ltd

Aharnon street

P.O. Box 51706

3508 Lemesos

Cyprus

PETILIN

500 mg

gastro-resistant tablet

Oral Use

Cyprus

| Remedica Ltd |
| --- |
| Aharnon street |
| P.O. Box 51706 |
| 3508 Lemesos |
| Cyprus |

Remedica Ltd

Aharnon street

P.O. Box 51706

3508 Lemesos

Cyprus

PETILIN

200 mg/5 ml

syrup

Oral Use

Czech Republic

| Orion Corporation |
| --- |
| Orionintie 1 |
| FI-02200 Espoo |
| Finland |

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Absenor 300 mg

300 mg

prolonged-release tablet

Oral Use

Czech Republic

| Orion Corporation |
| --- |
| Orionintie 1 |
| FI-02200 Espoo |
| Finland |

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Absenor 500 mg

500 mg

prolonged-release tablet

Oral Use

Czech Republic

| sanofi-aventis, s.r.o. |
| --- |
| Hadovka Office Park |
| Evropská 846/176a |
| 160 00 Praha 6 |
| Czech Republic |

sanofi-aventis, s.r.o.

Hadovka Office Park

Evropská 846/176a

160 00 Praha 6

Czech Republic

DEPAKINE

5,764/100 ml

syrup

Oral Use

Czech Republic

| G.L. Pharma GmbH |
| --- |
| Schlossplatz 1 |
| 8502 Lannach |
| Austria |

G.L. Pharma GmbH

Schlossplatz 1

8502 Lannach

Austria

CONVULEX 300 mg/ml

300 mg/1 ml of drops

oral drops, solution

Oral Use

Czech Republic

| G.L. Pharma GmbH |
| --- |
| Schlossplatz 1 |
| 8502 Lannach |
| Austria |

G.L. Pharma GmbH

Schlossplatz 1

8502 Lannach

Austria

CONVULEX

50 mg/ml

syrup

Oral Use

Czech Republic

| G.L. Pharma GmbH |
| --- |
| Schlossplatz 1 |
| 8502 Lannach |
| Austria |

G.L. Pharma GmbH

Schlossplatz 1

8502 Lannach

Austria

CONVULEX CR 300 mg

300 mg

prolonged-release tablet

Oral Use

Czech Republic

| G.L. Pharma GmbH |
| --- |
| Schlossplatz 1 |
| 8502 Lannach |
| Austria |

G.L. Pharma GmbH

Schlossplatz 1

8502 Lannach

Austria

CONVULEX CR 500 mg

500 mg

prolonged-release tablet

Oral Use

Czech Republic

| G.L. Pharma GmbH |
| --- |
| Schlossplatz 1 |
| 8502 Lannach |
| Austria |

G.L. Pharma GmbH

Schlossplatz 1

8502 Lannach

Austria

CONVULEX 150

150 mg

capsule, soft

Oral Use

Czech Republic

| G.L. Pharma GmbH |
| --- |
| Schlossplatz 1 |
| 8502 Lannach |
| Austria |

G.L. Pharma GmbH

Schlossplatz 1

8502 Lannach

Austria

CONVULEX 300

300 mg

capsule, soft

Oral Use

Czech Republic

| G.L. Pharma GmbH |
| --- |
| Schlossplatz 1 |
| 8502 Lannach |
| Austria |

G.L. Pharma GmbH

Schlossplatz 1

8502 Lannach

Austria

CONVULEX 500

500 mg

capsule, soft

Oral Use

Czech Republic

| sanofi-aventis, s.r.o. |
| --- |
| Hadovka Office Park |
| Evropská 846/176a |
| 160 00 Praha 6 |
| Czech Republic |

sanofi-aventis, s.r.o.

Hadovka Office Park

Evropská 846/176a

160 00 Praha 6

Czech Republic

DEPAKINE CHRONO 500 mg sécable

500 mg (333 mg/145 mg)

modified-release tablet

Oral Use

Czech Republic

| sanofi-aventis, s.r.o. |
| --- |
| Hadovka Office Park |
| Evropská 846/176a |
| 160 00 Praha 6 |
| Czech Republic |

sanofi-aventis, s.r.o.

Hadovka Office Park

Evropská 846/176a

160 00 Praha 6

Czech Republic

DEPAKINE CHRONO 300 mg sécable

300 mg (199,8 mg/87 mg)

modified-release tablet

Oral Use

Czech Republic

| Desitin Arzneimittel GmbH, |
| --- |
| Weg beim Jäger 214 |
| D-22335 Hamburg |
| Germany |

Desitin Arzneimittel GmbH,

Weg beim Jäger 214

D-22335 Hamburg

Germany

Orfiril 150

150 mg

gastro-resistant tablet

Oral Use

Czech Republic

| Desitin Arzneimittel GmbH, |
| --- |
| Weg beim Jäger 214 |
| D-22335 Hamburg |
| Germany |

Desitin Arzneimittel GmbH,

Weg beim Jäger 214

D-22335 Hamburg

Germany

Orfiril 300

300 mg

gastro-resistant tablet

Oral Use

Czech Republic

| Desitin Arzneimittel GmbH, |
| --- |
| Weg beim Jäger 214 |
| D-22335 Hamburg |
| Germany |

Desitin Arzneimittel GmbH,

Weg beim Jäger 214

D-22335 Hamburg

Germany

Orfiril 600

600 mg

gastro-resistant tablet

Oral Use

Czech Republic

| Desitin Arzneimittel GmbH, |
| --- |
| Weg beim Jäger 214 |
| D-22335 Hamburg |
| Germany |

Desitin Arzneimittel GmbH,

Weg beim Jäger 214

D-22335 Hamburg

Germany

Orfiril long 150 mg

150 mg

prolonged-release capsule, hard

Oral Use

Czech Republic

| Desitin Arzneimittel GmbH, |
| --- |
| Weg beim Jäger 214 |
| D-22335 Hamburg |
| Germany |

Desitin Arzneimittel GmbH,

Weg beim Jäger 214

D-22335 Hamburg

Germany

Orfiril long 300 mg

300 mg

prolonged-release capsule, hard

Oral Use

Czech Republic

| Desitin Arzneimittel GmbH, |
| --- |
| Weg beim Jäger 214 |
| D-22335 Hamburg |
| Germany |

Desitin Arzneimittel GmbH,

Weg beim Jäger 214

D-22335 Hamburg

Germany

Orfiril long 500 mg

500 mg

prolonged-release tablet

Oral Use

Czech Republic

| Desitin Arzneimittel GmbH, |
| --- |
| Weg beim Jäger 214 |
| D-22335 Hamburg |
| Germany |

Desitin Arzneimittel GmbH,

Weg beim Jäger 214

D-22335 Hamburg

Germany

Orfiril long 1 000 mg

1 000 mg

prolonged-release tablet

Oral Use

Czech Republic

| SANDOZ GmbH |
| --- |
| Biochemiestrasse 10 |
| A-6250 Kundl |
| Austria |

SANDOZ GmbH

Biochemiestrasse 10

A-6250 Kundl

Austria

Valproat Chrono Sandoz 300 mg

300 mg

(200 mg/87 mg)

prolonged-release tablet

Oral Use

Czech Republic

| SANDOZ GmbH |
| --- |
| Biochemiestrasse 10 |
| A-6250 Kundl |
| Austria |

SANDOZ GmbH

Biochemiestrasse 10

A-6250 Kundl

Austria

Valproat Chrono Sandoz 500 mg

500 mg

(333 mg/145 mg)

prolonged-release tablet

Oral Use

Czech Republic

| sanofi-aventis, s.r.o. |
| --- |
| Hadovka Office Park |
| Evropská 846/176a |
| 160 00 Praha 6 |
| Czech Republic |

sanofi-aventis, s.r.o.

Hadovka Office Park

Evropská 846/176a

160 00 Praha 6

Czech Republic

DEPAKINE CHRONOSPHERE 500 MG

500 mg

(333,30 mg/145,14 mg)

Modified-release granules

Oral Use

Czech Republic

| ratiopharm GmbH |
| --- |
| Graf-Arco-Straße 3 |
| 89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Straße 3

89079 Ulm

Germany

Valproat-ratiopharm Chrono 300 mg

300 mg

(200 mg/87 mg)

prolonged-release tablet

Oral Use

Czech Republic

| ratiopharm GmbH |
| --- |
| Graf-Arco-Straße 3 |
| 89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Straße 3

89079 Ulm

Germany

Valproat-ratiopharm Chrono 500 mg

500 mg

(333 mg/145 mg)

prolonged-release tablet

Oral Use

Denmark

| Sanofi-aventis Denmark A/S |
| --- |
| Slotsmarken 13 |
| DK-2970 Hørsholm |
| Denmark |

Sanofi-aventis Denmark A/S

Slotsmarken 13

DK-2970 Hørsholm

Denmark

Deprakine

100 mg

gastro-resistant tablet

Oral Use

Denmark

| Sanofi-aventis Denmark A/S |
| --- |
| Slotsmarken 13 |
| DK-2970 Hørsholm |
| Denmark |

Sanofi-aventis Denmark A/S

Slotsmarken 13

DK-2970 Hørsholm

Denmark

Deprakine

300 mg

gastro-resistant tablet

Oral Use

Denmark

| Sanofi-aventis Denmark A/S |
| --- |
| Slotsmarken 13 |
| DK-2970 Hørsholm |
| Denmark |

Sanofi-aventis Denmark A/S

Slotsmarken 13

DK-2970 Hørsholm

Denmark

Deprakine

500 mg

gastro-resistant tablet

Oral Use

Denmark

| Sanofi-aventis Denmark A/S |
| --- |
| Slotsmarken 13 |
| DK-2970 Hørsholm |
| Denmark |

Sanofi-aventis Denmark A/S

Slotsmarken 13

DK-2970 Hørsholm

Denmark

Deprakine

200 mg/ml

oral drops

Oral Use

Denmark

| Sanofi-aventis Denmark A/S |
| --- |
| Slotsmarken 13 |
| DK-2970 Hørsholm |
| Denmark |

Sanofi-aventis Denmark A/S

Slotsmarken 13

DK-2970 Hørsholm

Denmark

Deprakine

60 mg/ml

oral solution

Oral Use

Denmark

| Sanofi-aventis Denmark A/S |
| --- |
| Slotsmarken 13 |
| DK-2970 Hørsholm |
| Denmark |

Sanofi-aventis Denmark A/S

Slotsmarken 13

DK-2970 Hørsholm

Denmark

Deprakine Retard

300 mg

gastro-resistant tablet

Oral Use

Denmark

| Sanofi-aventis Denmark A/S |
| --- |
| Slotsmarken 13 |
| DK-2970 Hørsholm |
| Denmark |

Sanofi-aventis Denmark A/S

Slotsmarken 13

DK-2970 Hørsholm

Denmark

Deprakine Retard

500 mg

gastro-resistant tablet

Oral Use

Denmark

| Desitin Arzneimittel Gmbh |
| --- |
| Weg beim Jaeger 214 |
| DE-22335 Hamburg |
| Germany |

Desitin Arzneimittel Gmbh

Weg beim Jaeger 214

DE-22335 Hamburg

Germany

Orfiril

60 mg/ml

oral solution

Oral Use

Denmark

| Desitin Arzneimittel Gmbh |
| --- |
| Weg beim Jaeger 214 |
| DE-22335 Hamburg |
| Germany |

Desitin Arzneimittel Gmbh

Weg beim Jaeger 214

DE-22335 Hamburg

Germany

Orfiril

300 mg

gastro-resistant tablet

Oral Use

Denmark

| Desitin Arzneimittel Gmbh |
| --- |
| Weg beim Jaeger 214 |
| DE-22335 Hamburg |
| Germany |

Desitin Arzneimittel Gmbh

Weg beim Jaeger 214

DE-22335 Hamburg

Germany

Orfiril

600 mg

gastro-resistant tablet

Oral Use

Denmark

| Desitin Arzneimittel Gmbh |
| --- |
| Weg beim Jaeger 214 |
| DE-22335 Hamburg |
| Germany |

Desitin Arzneimittel Gmbh

Weg beim Jaeger 214

DE-22335 Hamburg

Germany

Orfiril Long

150 mg

prolonged-release capsule

Oral Use

Denmark

| Desitin Arzneimittel Gmbh |
| --- |
| Weg beim Jaeger 214 |
| DE-22335 Hamburg |
| Germany |

Desitin Arzneimittel Gmbh

Weg beim Jaeger 214

DE-22335 Hamburg

Germany

Orfiril Long

300 mg

prolonged-release capsule

Oral Use

Denmark

| Desitin Arzneimittel Gmbh |
| --- |
| Weg beim Jaeger 214 |
| DE-22335 Hamburg |
| Germany |

Desitin Arzneimittel Gmbh

Weg beim Jaeger 214

DE-22335 Hamburg

Germany

Orfiril Long

500 mg

prolonged-release granules

Oral Use

Denmark

| Desitin Arzneimittel Gmbh |
| --- |
| Weg beim Jaeger 214 |
| DE-22335 Hamburg |
| Germany |

Desitin Arzneimittel Gmbh

Weg beim Jaeger 214

DE-22335 Hamburg

Germany

Orfiril Long

1 000 mg

prolonged-release granules

Oral Use

Denmark

| Desitin Arzneimittel Gmbh |
| --- |
| Weg beim Jaeger 214 |
| DE-22335 Hamburg |
| Germany |

Desitin Arzneimittel Gmbh

Weg beim Jaeger 214

DE-22335 Hamburg

Germany

Orfiril Retard

300 mg

prolonged-release tablet

Oral Use

Denmark

| HEXAL A/S |
| --- |
| Kanalholmen 8-12 |
| DK-2650 Hvidovre |
| Denmark |

HEXAL A/S

Kanalholmen 8-12

DK-2650 Hvidovre

Denmark

Valproat ‘Hexal’

300 mg

prolonged-release tablet

Oral Use

Denmark

| HEXAL A/S |
| --- |
| Kanalholmen 8-12 |
| DK-2650 Hvidovre |
| Denmark |

HEXAL A/S

Kanalholmen 8-12

DK-2650 Hvidovre

Denmark

Valproat ‘Hexal’

500 mg

prolonged-release tablet

Oral Use

Denmark

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Valproat ‘Sandoz’

300 mg

prolonged-release tablet

Oral Use

Denmark

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Valproat ‘Sandoz’

500 mg

prolonged-release tablet

Oral Use

Denmark

| Orion Corporation Orion Pharma |
| --- |
| Orionintie 1 |
| FI-02200 Espoo |
| Finland |

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

Delepsine

300 mg

tablet

Oral Use

Denmark

| Orion Corporation Orion Pharma |
| --- |
| Orionintie 1 |
| FI-02200 Espoo |
| Finland |

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

Delepsine

100 mg

gastro-resistant tablet

Oral Use

Denmark

| Orion Corporation Orion Pharma |
| --- |
| Orionintie 1 |
| FI-02200 Espoo |
| Finland |

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

Delepsine

300 mg

gastro-resistant tablet

Oral Use

Denmark

| Orion Corporation Orion Pharma |
| --- |
| Orionintie 1 |
| FI-02200 Espoo |
| Finland |

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

Delepsine

500 mg

gastro-resistant tablet

Oral Use

Denmark

| Orion Corporation Orion Pharma |
| --- |
| Orionintie 1 |
| FI-02200 Espoo |
| Finland |

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

Delepsine

200 mg/ml

oral drops, solution

Oral Use

Denmark

| Orion Corporation Orion Pharma |
| --- |
| Orionintie 1 |
| FI-02200 Espoo |
| Finland |

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

Delepsine Retard

300 mg

prolonged-release tablet

Oral Use

Denmark

| Orion Corporation Orion Pharma |
| --- |
| Orionintie 1 |
| FI-02200 Espoo |
| Finland |

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

Delepsine Retard

500 mg

prolonged-release tablet

Oral Use

Denmark

| Orion Corporation Orion Pharma |
| --- |
| Orionintie 1 |
| FI-02200 Espoo |
| Finland |

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

Delepsine

60 mg/ml

oral solution

Oral Use

Estonia

| Orion Corporation |
| --- |
| Orion Pharma |
| Orionintie 1 |
| 02200 Espoo |
| Finland |

Orion Corporation

Orion Pharma

Orionintie 1

02200 Espoo

Finland

ABSENOR

500 mg

prolonged-release tablet

Oral Use

Estonia

| Orion Corporation |
| --- |
| Orion Pharma |
| Orionintie 1 |
| 02200 Espoo |
| Finland |

Orion Corporation

Orion Pharma

Orionintie 1

02200 Espoo

Finland

ABSENOR

300 mg

prolonged-release tablet

Oral Use

Estonia

| GEROT PHARMAZEUTIKA GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| Austria |

GEROT PHARMAZEUTIKA GmbH

Arnethgasse 3

A-1160 Wien

Austria

CONVULEX

50 mg/ml

syrup

Oral Use

Estonia

| GEROT PHARMAZEUTIKA GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| Austria |

GEROT PHARMAZEUTIKA GmbH

Arnethgasse 3

A-1160 Wien

Austria

CONVULEX 150 MG

150 mg

gastro-resistant capsule, soft

Oral Use

Estonia

| GEROT PHARMAZEUTIKA GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| Austria |

GEROT PHARMAZEUTIKA GmbH

Arnethgasse 3

A-1160 Wien

Austria

CONVULEX 300 MG

300 mg

gastro-resistant capsule, soft

Oral Use

Estonia

| GEROT PHARMAZEUTIKA GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| Austria |

GEROT PHARMAZEUTIKA GmbH

Arnethgasse 3

A-1160 Wien

Austria

CONVULEX 300 MG/ML

300 mg/ml

oral drops, solution

Oral Use

Estonia

| GEROT PHARMAZEUTIKA GmbH, |
| --- |
| Arnethgasse 3 |
| A-1160 Wien, |
| Austria |

GEROT PHARMAZEUTIKA GmbH,

Arnethgasse 3

A-1160 Wien,

Austria

CONVULEX 500 MG

500 mg

gastro-resistant capsule, soft

Oral Use

Estonia

| GEROT PHARMAZEUTIKA GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| Austria |

GEROT PHARMAZEUTIKA GmbH

Arnethgasse 3

A-1160 Wien

Austria

CONVULEX RETARD 300 MG

300 mg

prolonged-release tablet

Oral Use

Estonia

| GEROT PHARMAZEUTIKA GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| Austria |

GEROT PHARMAZEUTIKA GmbH

Arnethgasse 3

A-1160 Wien

Austria

CONVULEX RETARD 500 MG

500 mg

prolonged-release tablet

Oral Use

Estonia

| Sanofi-Aventis Estonia OÜ |
| --- |
| Pärnu mnt 139E/2 |
| 11317 Tallinn |
| Estonia |

Sanofi-Aventis Estonia OÜ

Pärnu mnt 139E/2

11317 Tallinn

Estonia

DEPAKINE

50 mg/1 ml

syrup

Oral Use

Estonia

| Sanofi-Aventis Estonia OÜ, |
| --- |
| Pärnu mnt 139E/2 |
| 11317 Tallinn |
| Estonia |

Sanofi-Aventis Estonia OÜ,

Pärnu mnt 139E/2

11317 Tallinn

Estonia

DEPAKINE CHRONO 300 mg

300 mg

prolonged-release tablet

Oral Use

Estonia

| Sanofi-Aventis Estonia OÜ |
| --- |
| Pärnu mnt 139E/2 |
| 11317 Tallinn |
| Estonia |

Sanofi-Aventis Estonia OÜ

Pärnu mnt 139E/2

11317 Tallinn

Estonia

DEPAKINE CHRONO 500 mg

500 mg

prolonged-release tablet

Oral Use

Estonia

| Sanofi-Aventis Estonia OÜ |
| --- |
| Pärnu mnt 139E/2 |
| 11317 Tallinn |
| Estonia |

Sanofi-Aventis Estonia OÜ

Pärnu mnt 139E/2

11317 Tallinn

Estonia

DEPAKINE CHRONOSPHERE

500 mg

modified-release granules

Oral Use

Estonia

| Sanofi-Aventis Estonia OÜ |
| --- |
| Pärnu mnt 139E/2 |
| 11317 Tallinn |
| Estonia |

Sanofi-Aventis Estonia OÜ

Pärnu mnt 139E/2

11317 Tallinn

Estonia

DEPAKINE CHRONOSPHERE

250 mg

modified-release granules

Oral Use

Estonia

| Sanofi-Aventis Estonia OÜ |
| --- |
| Pärnu mnt 139E/2 |
| 11317 Tallinn |
| Estonia |

Sanofi-Aventis Estonia OÜ

Pärnu mnt 139E/2

11317 Tallinn

Estonia

DEPAKINE CHRONOSPHERE

100 mg

modified-release granules

Oral Use

Estonia

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| D-22335 Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

D-22335 Hamburg

Germany

ORFIRIL 150

150 mg

gastro-resistant tablet

Oral Use

Estonia

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| D-22335 Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

D-22335 Hamburg

Germany

ORFIRIL 300

300 mg

gastro-resistant tablet

Oral Use

Estonia

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| D-22335 Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

D-22335 Hamburg

Germany

ORFIRIL 600

600 mg

gastro-resistant tablet

Oral Use

Estonia

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| D-22335 Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

D-22335 Hamburg

Germany

ORFIRIL LONG 1 000 MG

1 000 mg

prolonged-release granules

Oral Use

Estonia

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| D-22335 Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

D-22335 Hamburg

Germany

ORFIRIL LONG 150 MG

150 mg

prolonged-release capsule, hard

Oral Use

Estonia

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| D-22335 Hamburg, |
| Germany |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

D-22335 Hamburg,

Germany

ORFIRIL LONG 300 MG

300 mg

prolonged-release capsule, hard

Oral Use

Estonia

| Desitin Arzneimittel GmbH, |
| --- |
| Weg beim Jäger 214 |
| D-22335 Hamburg |
| Germany |

Desitin Arzneimittel GmbH,

Weg beim Jäger 214

D-22335 Hamburg

Germany

ORFIRIL LONG 500 MG

500 mg

prolonged-release granules

Oral Use

Estonia

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| D-22335 Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

D-22335 Hamburg

Germany

ORFIRIL SAFT

60 mg/ml

oral solution

Oral Use

Estonia

| STADA ARZNEIMITTEL AG |
| --- |
| Stadastr. 2-18 |
| D-61118 Bad Vilbel |
| Germany |

STADA ARZNEIMITTEL AG

Stadastr. 2-18

D-61118 Bad Vilbel

Germany

PRODEPA

500 mg

prolonged-release tablet

Oral Use

Estonia

| Sandoz d.d., |
| --- |
| Verovskova 57 |
| 1000 Ljubljana |
| Slovenia |

Sandoz d.d.,

Verovskova 57

1000 Ljubljana

Slovenia

VALPROATE SODIUM SANDOZ 300 MG

300 mg

prolonged-release tablet

Oral Use

Estonia

| Sandoz d.d., |
| --- |
| Verovskova 57 |
| 1000 Ljubljana |
| Slovenia |

Sandoz d.d.,

Verovskova 57

1000 Ljubljana

Slovenia

VALPROATE SODIUM SANDOZ 500 MG

500 mg

prolonged-release tablet

Oral Use

Finland

| sanofi-aventis Oy |
| --- |
| Huopalahdentie 24 |
| B.O. Box 22 |
| FI-00351 Helsinki |
| Finland |

sanofi-aventis Oy

Huopalahdentie 24

B.O. Box 22

FI-00351 Helsinki

Finland

DEPRAKINE

100 mg/dose

prolonged-release granules

Oral Use

Finland

| sanofi-aventis Oy |
| --- |
| Huopalahdentie 24 |
| B.O. Box 22 |
| FI-00351 Helsinki |
| Finland |

sanofi-aventis Oy

Huopalahdentie 24

B.O. Box 22

FI-00351 Helsinki

Finland

DEPRAKINE

1 000 mg/dose

prolonged-release granules

Oral Use

Finland

| sanofi-aventis Oy |
| --- |
| Huopalahdentie 24 |
| B.O. Box 22 |
| FI-00351 Helsinki |
| Finland |

sanofi-aventis Oy

Huopalahdentie 24

B.O. Box 22

FI-00351 Helsinki

Finland

DEPRAKINE

250 mg/dose

prolonged-release granules

Oral Use

Finland

| sanofi-aventis Oy |
| --- |
| Huopalahdentie 24 |
| B.O. Box 22 |
| FI-00351 Helsinki |
| Finland |

sanofi-aventis Oy

Huopalahdentie 24

B.O. Box 22

FI-00351 Helsinki

Finland

DEPRAKINE

300 mg

prolonged-release tablet

Oral Use

Finland

| sanofi-aventis Oy |
| --- |
| Huopalahdentie 24 |
| B.O. Box 22 |
| FI-00351 Helsinki |
| Finland |

sanofi-aventis Oy

Huopalahdentie 24

B.O. Box 22

FI-00351 Helsinki

Finland

DEPRAKINE

500 mg

prolonged-release tablet

Oral Use

Finland

| sanofi-aventis Oy |
| --- |
| Huopalahdentie 24 |
| B.O. Box 22 |
| FI-00351 Helsinki |
| Finland |

sanofi-aventis Oy

Huopalahdentie 24

B.O. Box 22

FI-00351 Helsinki

Finland

DEPRAKINE

500 mg/dose

prolonged-release granules

Oral Use

Finland

| sanofi-aventis Oy |
| --- |
| Huopalahdentie 24 |
| B.O. Box 22 |
| FI-00351 Helsinki |
| Finland |

sanofi-aventis Oy

Huopalahdentie 24

B.O. Box 22

FI-00351 Helsinki

Finland

DEPRAKINE

100 mg

gastro-resistant tablet

Oral Use

Finland

| sanofi-aventis Oy |
| --- |
| Huopalahdentie 24 |
| B.O. Box 22 |
| FI-00351 Helsinki |
| Finland |

sanofi-aventis Oy

Huopalahdentie 24

B.O. Box 22

FI-00351 Helsinki

Finland

DEPRAKINE

300 mg

gastro-resistant tablet

Oral Use

Finland

| sanofi-aventis Oy |
| --- |
| Huopalahdentie 24 |
| B.O. Box 22 |
| FI-00351 Helsinki |
| Finland |

sanofi-aventis Oy

Huopalahdentie 24

B.O. Box 22

FI-00351 Helsinki

Finland

DEPRAKINE

500 mg

gastro-resistant tablet

Oral Use

Finland

| sanofi-aventis Oy |
| --- |
| Huopalahdentie 24 |
| B.O. Box 22 |
| FI-00351 Helsinki |
| Finland |

sanofi-aventis Oy

Huopalahdentie 24

B.O. Box 22

FI-00351 Helsinki

Finland

DEPRAKINE

60 mg/ml

oral solution

Oral Use

Finland

| sanofi-aventis Oy |
| --- |
| Huopalahdentie 24 |
| B.O. Box 22 |
| FI-00351 Helsinki |
| Finland |

sanofi-aventis Oy

Huopalahdentie 24

B.O. Box 22

FI-00351 Helsinki

Finland

DEPRAKINE

200 mg/ml

oral drops, solution

Oral Use

Finland

| Orion Oyj |
| --- |
| Orionintie 1 |
| B.O. Box 65 |
| FI-02201 Espoo |
| Finland |

Orion Oyj

Orionintie 1

B.O. Box 65

FI-02201 Espoo

Finland

ABSENOR

300 mg

prolonged-release tablet

Oral Use

Finland

| Orion Oyj |
| --- |
| Orionintie 1 |
| B.O. Box 65 |
| FI-02201 Espoo |
| Finland |

Orion Oyj

Orionintie 1

B.O. Box 65

FI-02201 Espoo

Finland

ABSENOR

500 mg

prolonged-release tablet

Oral Use

Finland

| Orion Oyj |
| --- |
| Orionintie 1 |
| B.O. Box 65 |
| FI-02201 Espoo |
| Finland |

Orion Oyj

Orionintie 1

B.O. Box 65

FI-02201 Espoo

Finland

ABSENOR

100 mg

gastro-resistant tablet

Oral Use

Finland

| Orion Oyj |
| --- |
| Orionintie 1 |
| B.O. Box 65 |
| FI-02201 Espoo |
| Finland |

Orion Oyj

Orionintie 1

B.O. Box 65

FI-02201 Espoo

Finland

ABSENOR

300 mg

gastro-resistant tablet

Oral Use

Finland

| Orion Oyj |
| --- |
| Orionintie 1 |
| B.O. Box 65 |
| FI-02201 Espoo |
| Finland |

Orion Oyj

Orionintie 1

B.O. Box 65

FI-02201 Espoo

Finland

ABSENOR

500 mg

gastro-resistant tablet

Oral Use

Finland

| Orion Oyj |
| --- |
| Orionintie 1 |
| B.O. Box 65 |
| FI-02201 Espoo |
| Finland |

Orion Oyj

Orionintie 1

B.O. Box 65

FI-02201 Espoo

Finland

ABSENOR

60 mg/ml

oral solution

Oral Use

Finland

| Orion Oyj |
| --- |
| Orionintie 1 |
| B.O. Box 65 |
| FI-02201 Espoo |
| Finland |

Orion Oyj

Orionintie 1

B.O. Box 65

FI-02201 Espoo

Finland

ABSENOR

200 mg/ml

oral drops, solution

Oral Use

Finland

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Germany

NATRIUMVALPRO-AATTI LONG DESITIN

150 mg

prolonged-release capsule, hard

Oral Use

Finland

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Germany

NATRIUMVALPRO-AATTI LONG DESITIN

300 mg

prolonged-release capsule, hard

Oral Use

Finland

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Germany

NATRIUMVALPRO-AATTI LONG DESITIN

1 000 mg/dose

prolonged-release granules

Oral Use

Finland

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Germany

NATRIUMVALPRO-AATTI LONG DESITIN

500 mg/dose

prolonged-release granules

Oral Use

Finland

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Germany

ORFIRIL

60 mg/ml

oral solution

Oral Use

Finland

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Germany

ORFIRIL LONG

150 mg

prolonged-release capsule, hard

Oral Use

Finland

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Germany

ORFIRIL LONG

300 mg

prolonged-release capsule, hard

Oral Use

Finland

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Germany

ORFIRIL LONG

1 000 mg

prolonged-release granules

Oral Use

Finland

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Germany

ORFIRIL LONG

500 mg

prolonged-release granules

Oral Use

Finland

| Sandoz A/S |
| --- |
| C.F. Tietgens Boulevard 40, 5220 Odense SØ Denmark |

Sandoz A/S

C.F. Tietgens Boulevard 40, 5220 Odense SØ Denmark

VALPROAT SANDOZ

300 mg

prolonged-release tablet

Oral Use

Finland

| Sandoz A/S |
| --- |
| C.F. Tietgens Boulevard 40, 5220 Odense SØ Denmark |

Sandoz A/S

C.F. Tietgens Boulevard 40, 5220 Odense SØ Denmark

VALPROAT SANDOZ

500 mg

prolonged-release tablet

Oral Use

France

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

France

DEPAKINE

200 mg

gastro-resistant tablet

Oral Use

France

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

France

DEPAKINE

500 mg

gastro-resistant tablet

Oral Use

France

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

France

DEPAKINE

200 mg/ml

oral solution

Oral Use

France

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

France

DEPAKINE CHRONO

500 mg

prolonged-release film-coated tablet

Oral Use

France

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

France

DEPAKINE

57,64 mg/ml

syrup

Oral Use

France

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

France

DEPAMIDE

300 mg

gastro-resistant tablet

Oral Use

France

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

France

DEPAKOTE

125 mg

gastro-resistant tablet

Oral Use

France

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

France

DEPAKOTE

250 mg

gastro-resistant tablet

Oral Use

France

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

France

DEPAKOTE

500 mg

gastro-resistant tablet

Oral Use

France

| VENIPHARM |
| --- |
| 4, BUREAUX DE LA COLLINE |
| 92213 SAINT-CLOUD |
| France |

VENIPHARM

4, BUREAUX DE LA COLLINE

92213 SAINT-CLOUD

France

IMASLAV LP

500 mg

prolonged-release film-coated tablet

Oral Use

France

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

France

MICROPAKINE LP

100 mg

prolonged-release granules

Oral Use

France

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

France

MICROPAKINE LP

1 000 mg

prolonged-release granules

Oral Use

France

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

France

MICROPAKINE LP

250 mg

prolonged-release granules

Oral Use

France

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

France

MICROPAKINE LP

50 mg

prolonged-release granules

Oral Use

France

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

France

MICROPAKINE LP

500 mg

prolonged-release granules

Oral Use

France

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

France

MICROPAKINE LP

750 mg

prolonged-release granules

Oral Use

France

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

France

MICROPAKINE LP

0,33 g/g

prolonged-release granules

Oral Use

France

| ALTER |
| --- |
| 3, avenue de la Baltique |
| 91140 Villebon Sur Yvette |
| France |

ALTER

3, avenue de la Baltique

91140 Villebon Sur Yvette

France

VALPROATE DE SODIUM ALTER L.P.

500 mg

prolonged-release film-coated tablet

Oral Use

France

| ARROW GENERIQUES |
| --- |
| 26, avenue Tony Garnier |
| 69007 Lyon |
| France |

ARROW GENERIQUES

26, avenue Tony Garnier

69007 Lyon

France

VALPROATE DE SODIUM ARROW L.P.

500 mg

prolonged-release film-coated tablet

Oral Use

France

| BIOGARAN |
| --- |
| 15, boulevard Charles de Gaulle |
| 92700 Colombes |
| France |

BIOGARAN

15, boulevard Charles de Gaulle

92700 Colombes

France

VALPROATE DE SODIUM BIOGARAN L.P.

500 mg

prolonged-release film-coated tablet

Oral Use

France

| SANDOZ |
| --- |
| 49, avenue Georges Pompidou |
| 92300 Levallois-Perret FRANCE |

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret FRANCE

VALPROATE DE SODIUM GNR LP

500 mg

prolonged-release film-coated tablet

Oral Use

France

| EG LABO - LABORATOIRES EUROGENERICS |
| --- |
| ‘Le Quintet’ - bâtiment A |
| 12, rue Danjou |
| 92517 Boulogne Billancourt Cedex |
| France |

EG LABO - LABORATOIRES EUROGENERICS

‘Le Quintet’ - bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex

France

VALPROATE DE SODIUM EG L.P.

500 mg

prolonged-release film-coated tablet

Oral Use

France

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

France

VALPROATE DE SODIUM DAKOTA PHARM,

200 mg

gastro-resistant tablet

Oral Use

France

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

France

VALPROATE DE SODIUM DAKOTA PHARM,

500 mg

gastro-resistant tablet

Oral Use

France

| MYLAN SAS |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| France |

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

France

VALPROATE DE SODIUM MYLAN L.P.

500 mg

prolonged-release film-coated tablet

Oral Use

France

| QUALIMED (LYON) |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| France |

QUALIMED (LYON)

117, allée des Parcs

69800 Saint-Priest

France

VALPROATE DE SODIUM QUALIMED L.P.

500 mg

prolonged-release film-coated tablet

Oral Use

France

| RATIOPHARM (ALLEMAGNE) |
| --- |
| Graf Arco Strasse 3 |
| 89079 Ulm |
| Germany |

RATIOPHARM (ALLEMAGNE)

Graf Arco Strasse 3

89079 Ulm

Germany

VALPROATE DE SODIUM RATIOPHARM L.P.

500 mg

prolonged-release film-coated tablet

Oral Use

France

| RANBAXY PHARMACIE GENERIQUES |
| --- |
| 11-15 Quai Dion Bouton |
| 92800 Puteaux |
| France |

RANBAXY PHARMACIE GENERIQUES

11-15 Quai Dion Bouton

92800 Puteaux

France

VALPROATE DE SODIUM RPG L.P.

500 mg

prolonged-release film-coated tablet

Oral Use

France

| SANDOZ |
| --- |
| 49, avenue Georges Pompidou |
| 92300 Levallois-Perret |
| France |

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

France

VALPROATE DE SODIUM SANDOZ L.P.

500 mg

prolonged-release film-coated tablet

Oral Use

France

| TEVA CLASSICS |
| --- |
| Le Palatin 1 |
| 92936 Paris la Défense Cedex |
| France |

TEVA CLASSICS

Le Palatin 1

92936 Paris la Défense Cedex

France

VALPROATE DE SODIUM TEVA L.P.

500 mg

prolonged-release film-coated tablet

Oral Use

France

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

France

VALPROATE DE SODIUM WINTHROP

20 %

oral solution

Oral Use

France

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

France

VALPROATE DE SODIUM WINTHROP

200 mg

gastro-resistant tablet

Oral Use

France

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

France

VALPROATE DE SODIUM WINTHROP

500 mg

gastro-resistant tablet

Oral Use

France

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

France

VALPROATE DE SODIUM WINTHROP L.P.

500 mg

prolonged-release film-coated tablet

Oral Use

France

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

France

VALPROATE DE SODIUM-ACIDE VALPROIQUE DELALANDE L.P.

100 mg

prolonged-release granules

Oral Use

France

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

France

VALPROATE DE SODIUM-ACIDE VALPROIQUE DELALANDE L.P.

1 000 mg

prolonged-release granules

Oral Use

France

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

France

VALPROATE DE SODIUM-ACIDE VALPROIQUE DELALANDE L.P.

250 mg

prolonged-release granules

Oral Use

France

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

France

VALPROATE DE SODIUM-ACIDE VALPROIQUE DELALANDE L.P.

50 mg

prolonged-release granules

Oral Use

France

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

France

VALPROATE DE SODIUM-ACIDE VALPROIQUE DELALANDE L.P.

500 mg

prolonged-release granules

Oral Use

France

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

France

VALPROATE DE SODIUM-ACIDE VALPROIQUE DELALANDE L.P.

750 mg

prolonged-release granules

Oral Use

France

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

France

VALPROATE DE SODIUM-ACIDE VALPROIQUE SANOFI-SYNTHELABO FRANCE L.P.

100 mg

prolonged-release granules

Oral Use

France

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

France

VALPROATE DE SODIUM-ACIDE VALPROIQUE SANOFI-SYNTHELABO FRANCE L.P.

1 000 mg

prolonged-release granules

Oral Use

France

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

France

VALPROATE DE SODIUM-ACIDE VALPROIQUE SANOFI-SYNTHELABO FRANCE L.P.

250 mg

prolonged-release granules

Oral Use

France

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

France

VALPROATE DE SODIUM-ACIDE VALPROIQUE SANOFI-SYNTHELABO FRANCE L.P.

50 mg

prolonged-release granules

Oral Use

France

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

France

VALPROATE DE SODIUM-ACIDE VALPROIQUE SANOFI-SYNTHELABO FRANCE L.P.

500 mg

prolonged-release granules

Oral Use

France

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

France

VALPROATE DE SODIUM-ACIDE VALPROIQUE SANOFI-SYNTHELABO FRANCE L.P.

750 mg

prolonged-release granules

Oral Use

Germany

| Lundbeck GmbH |
| --- |
| Postfach 900662 |
| D-21046 Hamburg |
| Germany |

Lundbeck GmbH

Postfach 900662

D-21046 Hamburg

Germany

CONVULEX 150

150 mg

gastro-resistant capsule

Oral Use

Germany

| Lundbeck GmbH |
| --- |
| Postfach 900662 |
| D-21046 Hamburg |
| Germany |

Lundbeck GmbH

Postfach 900662

D-21046 Hamburg

Germany

Convulex 300

300 mg

gastro-resistant capsule

Oral Use

Germany

| Lundbeck GmbH |
| --- |
| Postfach 900662 |
| D-21046 Hamburg |
| Germany |

Lundbeck GmbH

Postfach 900662

D-21046 Hamburg

Germany

Convulex 300 mg Retardtabletten

300 mg

prolonged-release tablet

Oral Use

Germany

| Lundbeck GmbH |
| --- |
| Postfach 900662 |
| D-21046 Hamburg |
| Germany |

Lundbeck GmbH

Postfach 900662

D-21046 Hamburg

Germany

Convulex 500

500 mg

gastro-resistant capsule

Oral Use

Germany

| Lundbeck GmbH |
| --- |
| Postfach 900662 |
| D-21046 Hamburg |
| Germany |

Lundbeck GmbH

Postfach 900662

D-21046 Hamburg

Germany

Convulex 500 mg Retardtabletten

500 mg

prolonged-release tablet

Oral Use

Germany

| Lundbeck GmbH |
| --- |
| Postfach 900662 |
| D-21046 Hamburg |
| Germany |

Lundbeck GmbH

Postfach 900662

D-21046 Hamburg

Germany

Convulex Tropflösung

300 mg

oral solution

Oral Use

Germany

| AWD.pharma GmbH & Co. KG |
| --- |
| Wasastr. 50 |
| D-01445 Radebeul |
| Germany |

AWD.pharma GmbH & Co. KG

Wasastr. 50

D-01445 Radebeul

Germany

Convulsofin Tabletten

500 mg

tablet

Oral Use

Germany

| Steiner & Co. |
| --- |
| Ostpreussendamm 72-74 |
| D-12207 Berlin |
| Germany |

Steiner & Co.

Ostpreussendamm 72-74

D-12207 Berlin

Germany

Convulsofin-Tropfen

30 g

oral drops, solution

Oral Use

Germany

| Sanofi-Aventis Deutschland GmbH |
| --- |
| Industriepark Höchst, Gebäude K703 |
| D-65926 Frankfurt am Main |
| Germany |

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst, Gebäude K703

D-65926 Frankfurt am Main

Germany

Ergenyl 150 mg

150 mg

gastro-resistant tablet

Oral Use

Germany

| Sanofi-Aventis Deutschland GmbH |
| --- |
| Industriepark Höchst, Gebäude K703 |
| D-65926 Frankfurt am Main |
| Germany |

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst, Gebäude K703

D-65926 Frankfurt am Main

Germany

Ergenyl 300 mg

300 mg

gastro-resistant tablet

Oral Use

Germany

| Sanofi-Aventis Deutschland GmbH |
| --- |
| Industriepark Höchst, Gebäude K703 |
| D-65926 Frankfurt am Main |
| Germany |

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst, Gebäude K703

D-65926 Frankfurt am Main

Germany

Ergenyl 500 mg

500 mg

gastro-resistant tablet

Oral Use

Germany

| Sanofi-Aventis Deutschland GmbH |
| --- |
| Industriepark Höchst, Gebäude K703 |
| D-65926 Frankfurt am Main |
| Germany |

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst, Gebäude K703

D-65926 Frankfurt am Main

Germany

Ergenyl chrono 300 mg

300 mg

prolonged-release tablet

Oral Use

Germany

| Sanofi-Aventis Deutschland GmbH |
| --- |
| Industriepark Höchst, Gebäude K703 |
| D-65926 Frankfurt am Main |
| Germany |

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst, Gebäude K703

D-65926 Frankfurt am Main

Germany

Ergenyl chrono 500 mg

500 mg

prolonged-release tablet

Oral Use

Germany

| Sanofi-Aventis Deutschland GmbH |
| --- |
| Industriepark Höchst, Gebäude K703 |
| D-65926 Frankfurt am Main |
| Germany |

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst, Gebäude K703

D-65926 Frankfurt am Main

Germany

Ergenyl Chronosphere 100 mg Retardgranulat

100 mg

prolonged-release granules

Oral Use

Germany

| Sanofi-Aventis Deutschland GmbH |
| --- |
| Industriepark Höchst, Gebäude K703 |
| D-65926 Frankfurt am Main |
| Germany |

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst, Gebäude K703

D-65926 Frankfurt am Main

Germany

Ergenyl Chronosphere 1 000 mg Retardgranulat

1 000,6 mg

prolonged-release granules

Oral Use

Germany

| Sanofi-Aventis Deutschland GmbH |
| --- |
| Industriepark Höchst, Gebäude K703 |
| D-65926 Frankfurt am Main |
| Germany |

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst, Gebäude K703

D-65926 Frankfurt am Main

Germany

Ergenyl Chronosphere 250 mg Retardgranulat

250 mg

prolonged-release granules

Oral Use

Germany

| Sanofi-Aventis Deutschland GmbH |
| --- |
| Industriepark Höchst, Gebäude K703 |
| D-65926 Frankfurt am Main |
| Germany |

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst, Gebäude K703

D-65926 Frankfurt am Main

Germany

Ergenyl Chronosphere 50 mg Retardgranulat

50 mg

prolonged-release granules

Oral Use

Germany

| Sanofi-Aventis Deutschland GmbH |
| --- |
| Industriepark Höchst, Gebäude K703 |
| D-65926 Frankfurt am Main |
| Germany |

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst, Gebäude K703

D-65926 Frankfurt am Main

Germany

Ergenyl Chronosphere 500 mg Retardgranulat

500,3 mg

prolonged-release granules

Oral Use

Germany

| Sanofi-Aventis Deutschland GmbH |
| --- |
| Industriepark Höchst, Gebäude K703 |
| D-65926 Frankfurt am Main |
| Germany |

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst, Gebäude K703

D-65926 Frankfurt am Main

Germany

Ergenyl Chronosphere 750 mg Retardgranulat

750 mg

prolonged-release granules

Oral Use

Germany

| Sanofi-Aventis Deutschland GmbH |
| --- |
| Industriepark Höchst, Gebäude K703 |
| D-65926 Frankfurt am Main |
| Germany |

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst, Gebäude K703

D-65926 Frankfurt am Main

Germany

Ergenyl Lösung

300 mg

oral solution

Oral Use

Germany

| esparma GmbH |
| --- |
| Seepark 7 |
| D-39116 Magdeburg |
| Germany |

esparma GmbH

Seepark 7

D-39116 Magdeburg

Germany

espa-valept 150 mg

150 mg

gastro-resistant tablet

Oral Use

Germany

| esparma GmbH |
| --- |
| Seepark 7 |
| D-39116 Magdeburg |
| Germany |

esparma GmbH

Seepark 7

D-39116 Magdeburg

Germany

espa-valept 300 mg retard

300 mg

prolonged-release tablet

Oral Use

Germany

| esparma GmbH |
| --- |
| Seepark 7 |
| D-39116 Magdeburg |
| Germany |

esparma GmbH

Seepark 7

D-39116 Magdeburg

Germany

espa-valept 300 mg

300 mg

gastro-resistant tablet

Oral Use

Germany

| esparma GmbH |
| --- |
| Seepark 7 |
| D-39116 Magdeburg |
| Germany |

esparma GmbH

Seepark 7

D-39116 Magdeburg

Germany

espa-valept 500 mg retard

500 mg

prolonged-release tablet

Oral Use

Germany

| esparma GmbH |
| --- |
| Seepark 7 |
| D-39116 Magdeburg |
| Germany |

esparma GmbH

Seepark 7

D-39116 Magdeburg

Germany

espa-valept 600 mg

600 mg

gastro-resistant tablet

Oral Use

Germany

| Dolorgiet GmbH & Co. |
| --- |
| Postfach 1252 |
| D-53730 St.Augustin |
| Germany |

Dolorgiet GmbH & Co.

Postfach 1252

D-53730 St.Augustin

Germany

Leptilan 150 mg

150 mg

gastro-resistant tablet

Oral Use

Germany

| Dolorgiet GmbH & Co. |
| --- |
| Postfach 1252 |
| D-53730 St.Augustin |
| Germany |

Dolorgiet GmbH & Co.

Postfach 1252

D-53730 St.Augustin

Germany

Leptilan 300 mg

300 mg

gastro-resistant tablet

Oral Use

Germany

| Dolorgiet GmbH & Co. |
| --- |
| Postfach 1252 |
| D-53730 St.Augustin |
| Germany |

Dolorgiet GmbH & Co.

Postfach 1252

D-53730 St.Augustin

Germany

Leptilan 600 mg

600 mg

gastro-resistant tablet

Oral Use

Germany

| Desitin Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Germany

Natriumvalproat Desitin retard 1 000 mg

1 000 mg

prolonged-release tablet

Oral Use

Germany

| Desitin Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Germany

Natriumvalproat Desitin retard 150 mg

150 mg

prolonged-release capsule

Oral Use

Germany

| Desitin Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Germany

Natriumvalproat Desitin retard 300 mg

300 mg

prolonged-release capsule

Oral Use

Germany

| Desitin Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Germany

Natriumvalproat Desitin retard 500 mg

500 mg

prolonged-release tablet

Oral Use

Germany

| Desitin Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Germany

Orfiril 150

150 mg

gastro-resistant tablet

Oral Use

Germany

| Desitin Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Germany

Orfiril 200 mg

200 mg

gastro-resistant tablet

Oral Use

Germany

| Desitin Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Germany

Orfiril 300

300 mg

gastro-resistant tablet

Oral Use

Germany

| Desitin Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Germany

Orfiril 500 mg

500 mg

gastro-resistant tablet

Oral Use

Germany

| Desitin Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Germany

Orfiril 600

600 mg

gastro-resistant tablet

Oral Use

Germany

| Desitin Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Germany

Orfiril long 1 000 mg

1 000 mg

prolonged-release tablet

Oral Use

Germany

| Desitin Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Germany

Orfiril long 150 mg

150 mg

prolonged-release capsule

Oral Use

Germany

| Desitin Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Germany

Orfiril long 300 mg

300 mg

prolonged-release capsule

Oral Use

Germany

| Desitin Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Germany

Orfiril long 500 mg

500 mg

prolonged-release tablet

Oral Use

Germany

| Desitin Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Germany

Orfiril Saft

60 mg

oral solution

Oral Use

Germany

| IIP-Institut für industrielle Pharmazie |
| --- |
| Benzstr. 2 a |
| D-63741 Aschaffenburg |
| Germany |

IIP-Institut für industrielle Pharmazie

Benzstr. 2 a

D-63741 Aschaffenburg

Germany

Valberg PR 300 mg

300 mg

prolonged-release tablet

Oral Use

Germany

| IIP-Institut für industrielle Pharmazie |
| --- |
| Benzstr. 2 a |
| D-63741 Aschaffenburg |
| Germany |

IIP-Institut für industrielle Pharmazie

Benzstr. 2 a

D-63741 Aschaffenburg

Germany

Valberg PR 500 mg

500 mg

prolonged-release tablet

Oral Use

Germany

| IIP-Institut für industrielle Pharmazie |
| --- |
| Benzstr. 2 a |
| D-63741 Aschaffenburg |
| Germany |

IIP-Institut für industrielle Pharmazie

Benzstr. 2 a

D-63741 Aschaffenburg

Germany

Valdia PR 300 mg

300 mg

prolonged-release tablet

Oral Use

Germany

| IIP-Institut für industrielle Pharmazie |
| --- |
| Benzstr. 2 a |
| D-63741 Aschaffenburg |
| Germany |

IIP-Institut für industrielle Pharmazie

Benzstr. 2 a

D-63741 Aschaffenburg

Germany

Valdia PR 500 mg

500 mg

prolonged-release tablet

Oral Use

Germany

| IIP-Institut für industrielle Pharmazie |
| --- |
| Benzstr. 2 a |
| D-63741 Aschaffenburg |
| Germany |

IIP-Institut für industrielle Pharmazie

Benzstr. 2 a

D-63741 Aschaffenburg

Germany

Valhel PR 300 mg

300 mg

prolonged-release tablet

Oral Use

Germany

| IIP-Institut für industrielle Pharmazie |
| --- |
| Benzstr. 2 a |
| D-63741 Aschaffenburg |
| Germany |

IIP-Institut für industrielle Pharmazie

Benzstr. 2 a

D-63741 Aschaffenburg

Germany

Valhel PR 500 mg

500 mg

prolonged-release tablet

Oral Use

Germany

| ALIUD PHARMA GmbH |
| --- |
| Postfach 1380 |
| D-89146 Laichingen |
| Germany |

ALIUD PHARMA GmbH

Postfach 1380

D-89146 Laichingen

Germany

Valpro AL 300 mg Retardtabletten

300 mg

prolonged-release tablet

Oral Use

Germany

| ALIUD PHARMA GmbH |
| --- |
| Postfach 1380 |
| D-89146 Laichingen |
| Germany |

ALIUD PHARMA GmbH

Postfach 1380

D-89146 Laichingen

Germany

Valpro AL 500 mg Retardtabletten

500 mg

prolonged-release tablet

Oral Use

Germany

| betapharm Arzneimittel GmbH |
| --- |
| Kobelweg 95 |
| D-86156 Augsburg |
| Germany |

betapharm Arzneimittel GmbH

Kobelweg 95

D-86156 Augsburg

Germany

Valpro beta

300 mg

oral solution

Oral Use

Germany

| betapharm Arzneimittel GmbH |
| --- |
| Kobelweg 95 |
| D-86156 Augsburg |
| Germany |

betapharm Arzneimittel GmbH

Kobelweg 95

D-86156 Augsburg

Germany

Valpro beta 150

150 mg

gastro-resistant tablet

Oral Use

Germany

| betapharm Arzneimittel GmbH |
| --- |
| Kobelweg 95 |
| D-86156 Augsburg |
| Germany |

betapharm Arzneimittel GmbH

Kobelweg 95

D-86156 Augsburg

Germany

Valpro beta 300

300 mg

gastro-resistant tablet

Oral Use

Germany

| betapharm Arzneimittel GmbH |
| --- |
| Kobelweg 95 |
| D-86156 Augsburg |
| Germany |

betapharm Arzneimittel GmbH

Kobelweg 95

D-86156 Augsburg

Germany

Valpro beta 600

600 mg

gastro-resistant tablet

Oral Use

Germany

| betapharm Arzneimittel GmbH |
| --- |
| Kobelweg 95 |
| D-86156 Augsburg |
| Germany |

betapharm Arzneimittel GmbH

Kobelweg 95

D-86156 Augsburg

Germany

Valpro beta chrono 300 mg Retardtabletten

300 mg

prolonged-release tablet

Oral Use

Germany

| betapharm Arzneimittel GmbH |
| --- |
| Kobelweg 95 |
| D-86156 Augsburg |
| Germany |

betapharm Arzneimittel GmbH

Kobelweg 95

D-86156 Augsburg

Germany

Valpro beta chrono 500 mg Retardtabletten

500 mg

prolonged-release tablet

Oral Use

Germany

| TAD Pharma GmbH |
| --- |
| Postfach 720 |
| D-27457 Cuxhaven |
| Germany |

TAD Pharma GmbH

Postfach 720

D-27457 Cuxhaven

Germany

Valpro TAD 150 mg

150 mg

gastro-resistant tablet

Oral Use

Germany

| TAD Pharma GmbH |
| --- |
| Postfach 720 |
| D-27457 Cuxhaven |
| Germany |

TAD Pharma GmbH

Postfach 720

D-27457 Cuxhaven

Germany

Valpro TAD 300 mg

300 mg

gastro-resistant tablet

Oral Use

Germany

| TAD Pharma GmbH |
| --- |
| Postfach 720 |
| D-27457 Cuxhaven |
| Germany |

TAD Pharma GmbH

Postfach 720

D-27457 Cuxhaven

Germany

Valpro TAD 600 mg

600 mg

gastro-resistant tablet

Oral Use

Germany

| TAD Pharma GmbH |
| --- |
| Postfach 720 |
| D-27457 Cuxhaven |
| Germany |

TAD Pharma GmbH

Postfach 720

D-27457 Cuxhaven

Germany

Valpro TAD chrono 300 mg

300 mg

prolonged-release tablet

Oral Use

Germany

| TAD Pharma GmbH |
| --- |
| Postfach 720 |
| D-27457 Cuxhaven |
| Germany |

TAD Pharma GmbH

Postfach 720

D-27457 Cuxhaven

Germany

Valpro TAD chrono 500 mg

500 mg

prolonged-release tablet

Oral Use

Germany

| TAD Pharma GmbH |
| --- |
| Postfach 720 |
| D-27457 Cuxhaven |
| Germany |

TAD Pharma GmbH

Postfach 720

D-27457 Cuxhaven

Germany

Valpro TAD Lösung

300 mg

oral solution

Oral Use

Germany

| AbZ-Pharma GmbH |
| --- |
| Dr. Georg-Spohn-Str. 7 |
| D-89143 Blaubeuren |
| Germany |

AbZ-Pharma GmbH

Dr. Georg-Spohn-Str. 7

D-89143 Blaubeuren

Germany

Valproat AbZ 300 mg Retardtabletten

300 mg

prolonged-release tablet

Oral Use

Germany

| AbZ-Pharma GmbH |
| --- |
| Dr. Georg-Spohn-Str. 7 |
| D-89143 Blaubeuren |
| Germany |

AbZ-Pharma GmbH

Dr. Georg-Spohn-Str. 7

D-89143 Blaubeuren

Germany

Valproat AbZ 500 mg Retardtabletten

500 mg

prolonged-release tablet

Oral Use

Germany

| AWD.pharma GmbH & Co. KG |
| --- |
| Wasastr. 50 |
| D-01445 Radebeul |
| Germany |

AWD.pharma GmbH & Co. KG

Wasastr. 50

D-01445 Radebeul

Germany

Valproat AWD 300 mg Retardtabletten

300 mg

prolonged-release tablet

Oral Use

Germany

| AWD.pharma GmbH & Co. KG |
| --- |
| Wasastr. 50 |
| D-01445 Radebeul |
| Germany |

AWD.pharma GmbH & Co. KG

Wasastr. 50

D-01445 Radebeul

Germany

Valproat AWD 500 mg Retardtabletten

500 mg

prolonged-release tablet

Oral Use

Germany

| Desitin Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Germany

Valproat chrono Desitin 300 mg Retardtabletten

300 mg

prolonged-release tablet

Oral Use

Germany

| Desitin Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Germany

Valproat chrono Desitin 500 mg Retardtabletten

500 mg

prolonged-release tablet

Oral Use

Germany

| Winthrop Arzneimittel GmbH |
| --- |
| Potsdamer Str. 8 |
| 10785 Berlin |
| Germany |

Winthrop Arzneimittel GmbH

Potsdamer Str. 8

10785 Berlin

Germany

Valproat Chrono Winthrop 300 mg Retardtabletten

300 mg

prolonged-release tablet

Oral Use

Germany

| Winthrop Arzneimittel GmbH |
| --- |
| Potsdamer Str. 8 |
| 10785 Berlin |
| Germany |

Winthrop Arzneimittel GmbH

Potsdamer Str. 8

10785 Berlin

Germany

Valproat Chrono Winthrop 500 mg Retardtabletten

500 mg

prolonged-release tablet

Oral Use

Germany

| CT Arzneimittel GmbH |
| --- |
| Lengeder Str. 42 a |
| D-13407 Berlin |
| Germany |

CT Arzneimittel GmbH

Lengeder Str. 42 a

D-13407 Berlin

Germany

Valproat chrono-CT 300 mg Retardtabletten

300 mg

prolonged-release tablet

Oral Use

Germany

| CT Arzneimittel GmbH |
| --- |
| Lengeder Str. 42 a |
| D-13407 Berlin |
| Germany |

CT Arzneimittel GmbH

Lengeder Str. 42 a

D-13407 Berlin

Germany

Valproat chrono-CT 500 mg Retardtabletten

500 mg

prolonged-release tablet

Oral Use

Germany

| Heumann Pharma GmbH & Co. Generica KG |
| --- |
| Südwestpark 50 |
| D-90449 Nürnberg |
| Germany |

Heumann Pharma GmbH & Co. Generica KG

Südwestpark 50

D-90449 Nürnberg

Germany

Valproat Heumann chrono 300 mg Retardtabletten

300 mg

prolonged-release tablet

Oral Use

Germany

| Heumann Pharma GmbH & Co. Generica KG |
| --- |
| Südwestpark 50 |
| D-90449 Nürnberg |
| Germany |

Heumann Pharma GmbH & Co. Generica KG

Südwestpark 50

D-90449 Nürnberg

Germany

Valproat Heumann chrono 500 mg Retardtabletten

500 mg

prolonged-release tablet

Oral Use

Germany

| HEXAL AG |
| --- |
| Postfach 1263 |
| D-83602 Holzkirchen |
| Germany |

HEXAL AG

Postfach 1263

D-83602 Holzkirchen

Germany

Valproat HEXAL 150 mg Filmtabletten

150 mg

gastro-resistant tablet

Oral Use

Germany

| HEXAL AG |
| --- |
| Postfach 1263 |
| D-83602 Holzkirchen |
| Germany |

HEXAL AG

Postfach 1263

D-83602 Holzkirchen

Germany

Valproat HEXAL 300 mg Filmtabletten

300 mg

gastro-resistant tablet

Oral Use

Germany

| HEXAL AG |
| --- |
| Postfach 1263 |
| D-83602 Holzkirchen |
| Germany |

HEXAL AG

Postfach 1263

D-83602 Holzkirchen

Germany

Valproat HEXAL 300 mg/ml Lösung

300 mg

oral solution

Oral Use

Germany

| HEXAL AG |
| --- |
| Postfach 1263 |
| D-83602 Holzkirchen |
| Germany |

HEXAL AG

Postfach 1263

D-83602 Holzkirchen

Germany

Valproat HEXAL 600 mg Filmtabletten

600 mg

gastro-resistant tablet

Oral Use

Germany

| HEXAL AG |
| --- |
| Postfach 1263 |
| D-83602 Holzkirchen |
| Germany |

HEXAL AG

Postfach 1263

D-83602 Holzkirchen

Germany

Valproat HEXAL chrono 300 mg Retardtabletten

300 mg

prolonged-release tablet

Oral Use

Germany

| HEXAL AG |
| --- |
| Postfach 1263 |
| D-83602 Holzkirchen |
| Germany |

HEXAL AG

Postfach 1263

D-83602 Holzkirchen

Germany

Valproat HEXAL chrono 500 mg Retardtabletten

500 mg

prolonged-release tablet

Oral Use

Germany

| Orion Corporation |
| --- |
| Postfach P.O. Box 65 |
| FIN-02101 ESPOO |
| Finland |

Orion Corporation

Postfach P.O. Box 65

FIN-02101 ESPOO

Finland

Valproat Orion 300 mg Retardtabletten

300 mg

prolonged-release tablet

Oral Use

Germany

| Orion Corporation |
| --- |
| Postfach P.O. Box 65 |
| FIN-02101 ESPOO |
| Finland |

Orion Corporation

Postfach P.O. Box 65

FIN-02101 ESPOO

Finland

Valproat Orion 500 mg Retardtabletten

500 mg

prolonged-release tablet

Oral Use

Germany

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 11 |
| D-83607 Holzkirchen |
| Germany |

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

D-83607 Holzkirchen

Germany

Valproat Sandoz 150 mg magensaftresistente Filmtabletten

150 mg

gastro-resistant tablet

Oral Use

Germany

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 11 |
| D-83607 Holzkirchen |
| Germany |

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

D-83607 Holzkirchen

Germany

Valproat Sandoz 300 mg magensaftresistente Filmtabletten

300 mg

gastro-resistant tablet

Oral Use

Germany

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 11 |
| D-83607 Holzkirchen |
| Germany |

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

D-83607 Holzkirchen

Germany

Valproat Sandoz 600 mg magensaftresistente Filmtabletten

600 mg

gastro-resistant tablet

Oral Use

Germany

| Stadapharm GmbH |
| --- |
| Stadastr. 2-18 |
| D-61118 Bad Vilbel |
| Germany |

Stadapharm GmbH

Stadastr. 2-18

D-61118 Bad Vilbel

Germany

Valproat STADA 300 mg retard

300 mg

prolonged-release tablet

Oral Use

Germany

| Stadapharm GmbH |
| --- |
| Stadastr. 2-18 |
| D-61118 Bad Vilbel |
| Germany |

Stadapharm GmbH

Stadastr. 2-18

D-61118 Bad Vilbel

Germany

Valproat STADA 500 mg retard

500 mg

prolonged-release tablet

Oral Use

Germany

| Winthrop Arzneimittel GmbH |
| --- |
| Potsdamer Str. 8 |
| 10785 Berlin |
| Germany |

Winthrop Arzneimittel GmbH

Potsdamer Str. 8

10785 Berlin

Germany

Valproat Win 300 mg Retardtabletten

200 mg

prolonged-release tablet

Oral Use

Germany

| Winthrop Arzneimittel GmbH |
| --- |
| Potsdamer Str. 8 |
| 10785 Berlin |
| Germany |

Winthrop Arzneimittel GmbH

Potsdamer Str. 8

10785 Berlin

Germany

Valproat Win 500 mg Retardtabletten

500 mg

prolonged-release tablet

Oral Use

Germany

| CT Arzneimittel GmbH |
| --- |
| Lengeder Str. 42 a |
| D-13407 Berlin |
| Germany |

CT Arzneimittel GmbH

Lengeder Str. 42 a

D-13407 Berlin

Germany

Valproat-CT 150 mg Filmtabletten

150 mg

gastro-resistant tablet

Oral Use

Germany

| CT Arzneimittel GmbH |
| --- |
| Lengeder Str. 42 a |
| D-13407 Berlin |
| Germany |

CT Arzneimittel GmbH

Lengeder Str. 42 a

D-13407 Berlin

Germany

Valproat-CT 300 mg Filmtabletten

300 mg

gastro-resistant tablet

Oral Use

Germany

| CT Arzneimittel GmbH |
| --- |
| Lengeder Str. 42 a |
| D-13407 Berlin |
| Germany |

CT Arzneimittel GmbH

Lengeder Str. 42 a

D-13407 Berlin

Germany

Valproat-CT 600 mg Filmtabletten

600 mg

gastro-resistant tablet

Oral Use

Germany

| neuraxpharm Arzneimittel GmbH u. Co.KG |
| --- |
| Elisabeth-Selbert-Str. 23 |
| D-40764 Langenfeld |
| Germany |

neuraxpharm Arzneimittel GmbH u. Co.KG

Elisabeth-Selbert-Str. 23

D-40764 Langenfeld

Germany

Valproat-neuraxpharm

300 mg

oral solution

Oral Use

Germany

| neuraxpharm Arzneimittel GmbH u. Co.KG |
| --- |
| Elisabeth-Selbert-Str. 23 |
| D-40764 Langenfeld |
| Germany |

neuraxpharm Arzneimittel GmbH u. Co.KG

Elisabeth-Selbert-Str. 23

D-40764 Langenfeld

Germany

Valproat-neuraxpharm 150

150 mg

gastro-resistant tablet

Oral Use

Germany

| neuraxpharm Arzneimittel GmbH u. Co.KG |
| --- |
| Elisabeth-Selbert-Str. 23 |
| D-40764 Langenfeld |
| Germany |

neuraxpharm Arzneimittel GmbH u. Co.KG

Elisabeth-Selbert-Str. 23

D-40764 Langenfeld

Germany

Valproat-neuraxpharm 300

300 mg

gastro-resistant tablet

Oral Use

Germany

| neuraxpharm Arzneimittel GmbH u. Co.KG |
| --- |
| Elisabeth-Selbert-Str. 23 |
| D-40764 Langenfeld |
| Germany |

neuraxpharm Arzneimittel GmbH u. Co.KG

Elisabeth-Selbert-Str. 23

D-40764 Langenfeld

Germany

Valproat-neuraxpharm 600

600 mg

gastro-resistant tablet

Oral Use

Germany

| neuraxpharm Arzneimittel GmbH u. Co.KG |
| --- |
| Elisabeth-Selbert-Str. 23 |
| D-40764 Langenfeld |
| Germany |

neuraxpharm Arzneimittel GmbH u. Co.KG

Elisabeth-Selbert-Str. 23

D-40764 Langenfeld

Germany

Valproat-neuraxpharm chrono 300 mg

300 mg

prolonged-release tablet

Oral Use

Germany

| neuraxpharm Arzneimittel GmbH u. Co.KG |
| --- |
| Elisabeth-Selbert-Str. 23 |
| D-40764 Langenfeld |
| Germany |

neuraxpharm Arzneimittel GmbH u. Co.KG

Elisabeth-Selbert-Str. 23

D-40764 Langenfeld

Germany

Valproat-neuraxpharm chrono 500 mg

500 mg

prolonged-release tablet

Oral Use

Germany

| Dr. Lach Pharma Consulting |
| --- |
| Bahnhofstr. 6 |
| D-79359 Riegel |
| Germany |

Dr. Lach Pharma Consulting

Bahnhofstr. 6

D-79359 Riegel

Germany

Valproat-RPh 150 mg

150 mg

gastro-resistant tablet

Oral Use

Germany

| Dr. Lach Pharma Consulting |
| --- |
| Bahnhofstr. 6 |
| D-79359 Riegel |
| Germany |

Dr. Lach Pharma Consulting

Bahnhofstr. 6

D-79359 Riegel

Germany

Valproat-RPh 300 mg

300 mg

gastro-resistant tablet

Oral Use

Germany

| Dr. Lach Pharma Consulting |
| --- |
| Bahnhofstr. 6 |
| D-79359 Riegel |
| Germany |

Dr. Lach Pharma Consulting

Bahnhofstr. 6

D-79359 Riegel

Germany

Valproat-RPh 600 mg

600 mg

gastro-resistant tablet

Oral Use

Germany

| Dr. Lach Pharma Consulting |
| --- |
| Bahnhofstr. 6 |
| D-79359 Riegel |
| Germany |

Dr. Lach Pharma Consulting

Bahnhofstr. 6

D-79359 Riegel

Germany

Valproat-RPh Lösung

300 mg

oral solution

Oral Use

Germany

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 11 |
| D-83607 Holzkirchen |
| Germany |

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

D-83607 Holzkirchen

Germany

Valproat-Sandoz 300 mg Retardtabletten

300 mg

prolonged-release tablet

Oral Use

Germany

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 11 |
| D-83607 Holzkirchen |
| Germany |

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

D-83607 Holzkirchen

Germany

Valproat-Sandoz 500 mg Retardtabletten

500 mg

prolonged-release tablet

Oral Use

Germany

| Mylan dura GmbH |
| --- |
| Postfach 10 06 35 |
| D-64206 Darmstadt |
| Germany |

Mylan dura GmbH

Postfach 10 06 35

D-64206 Darmstadt

Germany

valprodura 150 mg

150 mg

gastro-resistant tablet

Oral Use

Germany

| Mylan dura GmbH |
| --- |
| Postfach 10 06 35 |
| D-64206 Darmstadt |
| Germany |

Mylan dura GmbH

Postfach 10 06 35

D-64206 Darmstadt

Germany

valprodura 300 mg

300 mg

gastro-resistant tablet

Oral Use

Germany

| Mylan dura GmbH |
| --- |
| Postfach 10 06 35 |
| D-64206 Darmstadt |
| Germany |

Mylan dura GmbH

Postfach 10 06 35

D-64206 Darmstadt

Germany

valprodura 600 mg

600 mg

gastro-resistant tablet

Oral Use

Germany

| MEDA Pharma GmbH & Co. KG |
| --- |
| Benzstrasse 1 |
| 61352 Bad Homburg |
| Germany |

MEDA Pharma GmbH & Co. KG

Benzstrasse 1

61352 Bad Homburg

Germany

Valproinsäure Valeant 300

300 mg

gastro-resistant tablet

Oral Use

Germany

| MEDA Pharma GmbH & Co. KG |
| --- |
| Benzstrasse 1 |
| 61352 Bad Homburg |
| Germany |

MEDA Pharma GmbH & Co. KG

Benzstrasse 1

61352 Bad Homburg

Germany

Valproinsäure Valeant 300 Retard

300 mg

prolonged-reclease tablet

Oral Use

Germany

| MEDA Pharma GmbH & Co. KG |
| --- |
| Benzstrasse 1 |
| 61352 Bad Homburg |
| Germany |

MEDA Pharma GmbH & Co. KG

Benzstrasse 1

61352 Bad Homburg

Germany

Valproinsäure Valeant 500 Retard

500 mg

prolonged-release tablet

Oral Use

Germany

| MEDA Pharma GmbH & Co. KG |
| --- |
| Benzstrasse 1 |
| 61352 Bad Homburg |
| Germany |

MEDA Pharma GmbH & Co. KG

Benzstrasse 1

61352 Bad Homburg

Germany

Valproinsäure Valeant 600

600 mg

gastro-resistant tablet

Oral Use

Germany

| ratiopharm GmbH |
| --- |
| D-89070 Ulm |
| Germany |

ratiopharm GmbH

D-89070 Ulm

Germany

Valproinsäure-ratiopharm 150

150 mg

gastro-resistant tablet

Oral Use

Germany

| ratiopharm GmbH |
| --- |
| D-89070 Ulm |
| Germany |

ratiopharm GmbH

D-89070 Ulm

Germany

Valproinsäure-ratiopharm 300 Filmtabletten

300 mg

gastro-resistant tablet

Oral Use

Germany

| ratiopharm GmbH |
| --- |
| D-89070 Ulm |
| Germany |

ratiopharm GmbH

D-89070 Ulm

Germany

Valproinsäure-ratiopharm 600

600 mg

gastro-resistant tablet

Oral Use

Germany

| ratiopharm GmbH |
| --- |
| D-89070 Ulm |
| Germany |

ratiopharm GmbH

D-89070 Ulm

Germany

Valproinsäure-ratiopharm chrono 300 Retardtabletten

300 mg

prolonged-release tablet

Oral Use

Germany

| ratiopharm GmbH |
| --- |
| D-89070 Ulm |
| Germany |

ratiopharm GmbH

D-89070 Ulm

Germany

Valproinsäure-ratiopharm chrono 500 Retardtabletten

500 mg

prolonged-release tablet

Oral Use

Germany

| ratiopharm GmbH |
| --- |
| D-89070 Ulm |
| Germany |

ratiopharm GmbH

D-89070 Ulm

Germany

Valproinsäure-ratiopharm Lösung

300 mg

oral solution

Oral Use

Germany

| IIP-Institut für industrielle Pharmazie |
| --- |
| Benzstr. 2 a |
| D-63741 Aschaffenburg |
| Germany |

IIP-Institut für industrielle Pharmazie

Benzstr. 2 a

D-63741 Aschaffenburg

Germany

Valsil PR 300 mg

199,8 mg

prolonged-release tablet

Oral Use

Germany

| IIP-Institut für industrielle Pharmazie |
| --- |
| Benzstr. 2 a |
| D-63741 Aschaffenburg |
| Germany |

IIP-Institut für industrielle Pharmazie

Benzstr. 2 a

D-63741 Aschaffenburg

Germany

Valsil PR 500 mg

333 mg

prolonged-release tablet

Oral Use

Greece

| SANOFI-AVENTIS AEBE |
| --- |
| 348 Syggrou Avenue, Building A’ |
| Kallithea 17674, Athens |
| Greece |

SANOFI-AVENTIS AEBE

348 Syggrou Avenue, Building A’

Kallithea 17674, Athens

Greece

DEPAKINE CHRONO

500 MG/TAB

prolonged-release tablet

Oral Use

Greece

| SANOFI-AVENTIS AEBE |
| --- |
| 348 Syggrou Avenue, Building A’ |
| Kallithea 17674 |
| Athens |
| Greece |

SANOFI-AVENTIS AEBE

348 Syggrou Avenue, Building A’

Kallithea 17674

Athens

Greece

DEPAKINE CHRONO

300 MG/TAB

prolonged-release tablet

Oral Use

Greece

| SANOFI-AVENTIS AEBE |
| --- |
| 348 Syggrou Avenue, Building A’ |
| Kallithea 17674 |
| Athens |
| Greece |

SANOFI-AVENTIS AEBE

348 Syggrou Avenue, Building A’

Kallithea 17674

Athens

Greece

DEPAKINE CHRONO (SPHERE)

50 MG/SACHET

modified-release granules

Oral Use

Greece

| SANOFI-AVENTIS AEBE |
| --- |
| 348 Syggrou Avenue, Building A’ |
| Kallithea 17674 |
| Athens |
| Greece |

SANOFI-AVENTIS AEBE

348 Syggrou Avenue, Building A’

Kallithea 17674

Athens

Greece

DEPAKINE CHRONO (SPHERE)

100 MG/SACHET

modified-release granules

Oral Use

Greece

| SANOFI-AVENTIS AEBE |
| --- |
| 348 Syggrou Avenue, Building A’ |
| Kallithea 17674 |
| Athens |
| Greece |

SANOFI-AVENTIS AEBE

348 Syggrou Avenue, Building A’

Kallithea 17674

Athens

Greece

DEPAKINE CHRONO (SPHERE)

250 MG/SACHET

modified-release granules

Oral Use

Greece

| SANOFI-AVENTIS AEBE |
| --- |
| 348 Syggrou Avenue, Building A’ |
| Kallithea 17674 |
| Athens |
| Greece |

SANOFI-AVENTIS AEBE

348 Syggrou Avenue, Building A’

Kallithea 17674

Athens

Greece

DEPAKINE CHRONO (SPHERE)

500 MG/SACHET

modified-release granules

Oral Use

Greece

| SANOFI-AVENTIS AEBE |
| --- |
| 348 Syggrou Avenue, Building A’ |
| Kallithea 17674 |
| Athens |
| Greece |

SANOFI-AVENTIS AEBE

348 Syggrou Avenue, Building A’

Kallithea 17674

Athens

Greece

DEPAKINE CHRONO (SPHERE)

750 MG/SACHET

modified-release granules

Oral Use

Greece

| SANOFI-AVENTIS AEBE |
| --- |
| 348 Syggrou Avenue, Building A’ |
| Kallithea 17674 |
| Athens |
| Greece |

SANOFI-AVENTIS AEBE

348 Syggrou Avenue, Building A’

Kallithea 17674

Athens

Greece

DEPAKINE CHRONO (SPHERE)

1 000 MG/SACHET

modified-release granules

Oral Use

Hungary

| Orion Corporation |
| --- |
| Orionintie 1A, FI-02200 Espoo P.O.Box 65, FI-02101 Espoo |
| Finland |

Orion Corporation

Orionintie 1A, FI-02200 Espoo P.O.Box 65, FI-02101 Espoo

Finland

ABSENOR

300 mg

modified-release tablet

Oral Use

Hungary

| Orion Corporation |
| --- |
| Orionintie 1A, FI-02200 Espoo P.O.Box 65, FI-02101 Espoo |
| Finland |

Orion Corporation

Orionintie 1A, FI-02200 Espoo P.O.Box 65, FI-02101 Espoo

Finland

ABSENOR

500 mg

modified-release tablet

Oral Use

Hungary

| Gerot Pharmazeutica GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| Austria |

Gerot Pharmazeutica GmbH

Arnethgasse 3

A-1160 Wien

Austria

CONVULEX

150 mg

capsule, hard

Oral Use

Hungary

| Gerot Pharmazeutica GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| Austria |

Gerot Pharmazeutica GmbH

Arnethgasse 3

A-1160 Wien

Austria

CONVULEX

300 mg

capsule, hard

Oral Use

Hungary

| Gerot Pharmazeutica GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| Austria |

Gerot Pharmazeutica GmbH

Arnethgasse 3

A-1160 Wien

Austria

CONVULEX

300 mg

film-coated tablet

Oral Use

Hungary

| Gerot Pharmazeutica GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| Austria |

Gerot Pharmazeutica GmbH

Arnethgasse 3

A-1160 Wien

Austria

CONVULEX

500 mg

capsule, hard

Oral Use

Hungary

| Gerot Pharmazeutica GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| Austria |

Gerot Pharmazeutica GmbH

Arnethgasse 3

A-1160 Wien

Austria

CONVULEX

500 mg

film-coated tablet

Oral Use

Hungary

| Gerot Pharmazeutica GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| Austria |

Gerot Pharmazeutica GmbH

Arnethgasse 3

A-1160 Wien

Austria

CONVULEX

43,38 mg/1 ml

syrup

Oral Use

Hungary

| Sanofi-aventis |
| --- |
| Tó u. 1-5 |
| HU-1045 Budapest |
| Hungary |

Sanofi-aventis

Tó u. 1-5

HU-1045 Budapest

Hungary

DEPAKINE CHRONO

300 mg

film-coated tablet

Oral Use

Hungary

| Sanofi-aventis |
| --- |
| Tó u. 1-5 |
| HU-1045 Budapest |
| Hungary |

Sanofi-aventis

Tó u. 1-5

HU-1045 Budapest

Hungary

DEPAKINE CHRONO

500 mg

film-coated tablet

Oral Use

Hungary

| Sanofi-aventis |
| --- |
| Tó u. 1-5 |
| HU-1045 Budapest |
| Hungary |

Sanofi-aventis

Tó u. 1-5

HU-1045 Budapest

Hungary

DEPAKINE CHRONOSPHERE

50 mg

(14,51 mg/33,33 mg)

modified-release granules

Oral Use

Hungary

| Sanofi-aventis |
| --- |
| Tó u. 1-5 |
| HU-1045 Budapest |
| Hungary |

Sanofi-aventis

Tó u. 1-5

HU-1045 Budapest

Hungary

DEPAKINE CHRONOSPHERE

100 mg

(29,03 mg/66,66 mg)

modified-release granules

Oral Use

Hungary

| Sanofi-aventis |
| --- |
| Tó u. 1-5 |
| HU-1045 Budapest |
| Hungary |

Sanofi-aventis

Tó u. 1-5

HU-1045 Budapest

Hungary

DEPAKINE CHRONOSPHERE

250 mg

(72,61 mg/166,76 mg)

modified-release granules

Oral Use

Hungary

| Sanofi-aventis |
| --- |
| Tó u. 1-5 |
| HU-1045 Budapest |
| Hungary |

Sanofi-aventis

Tó u. 1-5

HU-1045 Budapest

Hungary

DEPAKINE

7,50 g/150 ml

syrup

Oral Use

Hungary

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| D-22335, Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

D-22335, Hamburg

Germany

ORFIRIL

300 mg

gastro-resistant tablet

Oral Use

Hungary

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| D-22335, Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

D-22335, Hamburg

Germany

ORFIRIL

300 mg

coated tablet

Oral Use

Hungary

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| D-22335, Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

D-22335, Hamburg

Germany

ORFIRIL

600 mg

coated tablet

Oral Use

Iceland

| Sanofi-aventis Norge A/S |
| --- |
| Strandveien 15 |
| 1325 Lysaker |
| Norway |

Sanofi-aventis Norge A/S

Strandveien 15

1325 Lysaker

Norway

Depakine

200 mg/ml

oral solution

Oral Use

Iceland

| Sanofi-aventis Norge A/S |
| --- |
| Strandveien 15 |
| 1325 Lysaker |
| Norway |

Sanofi-aventis Norge A/S

Strandveien 15

1325 Lysaker

Norway

Depakine

200 mg

gastro-resistant tablet

Oral Use

Iceland

| Sanofi-aventis Norge A/S |
| --- |
| Strandveien 15 |
| 1325 Lysaker |
| Norway |

Sanofi-aventis Norge A/S

Strandveien 15

1325 Lysaker

Norway

Depakine

500 mg

gastro-resistant tablet

Oral Use

Iceland

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Germany

Orfiril

60 mg/ml

oral solution

Oral Use

Iceland

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Germany

Orfiril

150 mg

gastro-resistant tablet

Oral Use

Iceland

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Germany

Orfiril

300 mg

gastro-resistant tablet

Oral Use

Iceland

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Germany

Orfiril

600 mg

gastro-resistant tablet

Oral Use

Iceland

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Germany

Orfiril Retard

300 mg

tablet

Oral Use

Italy

| Biofutura Pharma S.p.A. |
| --- |
| Via Pontina Km 30,400 00040 |
| Pomezia - Roma Italy |

Biofutura Pharma S.p.A.

Via Pontina Km 30,400 00040

Pomezia - Roma Italy

ORFILEPT

300 mg

prolonged-release capsule, hard

Oral Use

Italy

| Biofutura Pharma S.p.A. |
| --- |
| Via Pontina Km 30,400 00040 |
| Pomezia - Roma Italy |

Biofutura Pharma S.p.A.

Via Pontina Km 30,400 00040

Pomezia - Roma Italy

ORFILEPT

500 mg

prolonged-release granules

Oral Use

Italy

| Biofutura Pharma S.p.A. |
| --- |
| Via Pontina Km 30,400 00040 |
| Pomezia - Roma Italy |

Biofutura Pharma S.p.A.

Via Pontina Km 30,400 00040

Pomezia - Roma Italy

ORFILEPT

1 000 mg

prolonged-release granules

Oral Use

Italy

| Sandoz S.p.A. |
| --- |
| Largo Boccioni, 1 |
| 21040 Origgio (VA) |
| Italy |

Sandoz S.p.A.

Largo Boccioni, 1

21040 Origgio (VA)

Italy

NAVALAC

300 mg

prolonged-release tablet

Oral Use

Italy

| Sandoz S.p.A. |
| --- |
| Largo Boccioni, 1 |
| 21040 Origgio (VA) |
| Italy |

Sandoz S.p.A.

Largo Boccioni, 1

21040 Origgio (VA)

Italy

NAVALAC

500 mg

prolonged-release tablet

Oral Use

Italy

| Sandoz S.p.A. |
| --- |
| Largo Boccioni, 1 |
| 21040 Origgio (VA) |
| Italy |

Sandoz S.p.A.

Largo Boccioni, 1

21040 Origgio (VA)

Italy

TOVAPROX

300 mg

prolonged-release tablet

Oral Use

Italy

| Sandoz S.p.A. |
| --- |
| Largo Boccioni, 1 |
| 21040 Origgio (VA) |
| Italy |

Sandoz S.p.A.

Largo Boccioni, 1

21040 Origgio (VA)

Italy

TOVAPROX

500 mg

prolonged-release tablet

Oral Use

Italy

| Sandoz S.p.A. |
| --- |
| Largo Boccioni, 1 |
| 21040 Origgio (VA) |
| Italy |

Sandoz S.p.A.

Largo Boccioni, 1

21040 Origgio (VA)

Italy

ACIDO VALPROICO SANDOZ

300 mg

prolonged-release tablet

Oral Use

Italy

| Sandoz S.p.A. |
| --- |
| Largo Boccioni, 1 |
| 21040 Origgio (VA) |
| Italy |

Sandoz S.p.A.

Largo Boccioni, 1

21040 Origgio (VA)

Italy

ACIDO VALPROICO SANDOZ

500 mg

prolonged-release tablet

Oral Use

Italy

| Sanofi-Aventis France S.A. |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

Sanofi-Aventis France S.A.

1-13, boulevard Romain Rolland

75014 Paris

France

DEPAKIN

200 mg

gastro-resistant tablet

Oral Use

Italy

| Sanofi-Aventis France S.A. |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

Sanofi-Aventis France S.A.

1-13, boulevard Romain Rolland

75014 Paris

France

DEPAKIN

500 mg

gastro-resistant tablet

Oral Use

Italy

| Sanofi-Aventis France S.A. |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

Sanofi-Aventis France S.A.

1-13, boulevard Romain Rolland

75014 Paris

France

DEPAKIN

200 mg/ml

oral solution

Oral Use

Italy

| Sanofi-Aventis France S.A. |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

Sanofi-Aventis France S.A.

1-13, boulevard Romain Rolland

75014 Paris

France

DEPAKIN CHRONO

300 mg

prolonged-release tablet

Oral Use

Italy

| Sanofi-Aventis France S.A. |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

Sanofi-Aventis France S.A.

1-13, boulevard Romain Rolland

75014 Paris

France

DEPAKIN CHRONO

500 mg

prolonged-release tablet

Oral use

Italy

| Sanofi-Aventis France S.A. |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

Sanofi-Aventis France S.A.

1-13, boulevard Romain Rolland

75014 Paris

France

DEPAKIN

1 000 mg

modified-release granules

Oral Use

Italy

| Sanofi-Aventis France S.A. |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

Sanofi-Aventis France S.A.

1-13, boulevard Romain Rolland

75014 Paris

France

DEPAKIN

100 mg

modified-release granules

Oral Use

Italy

| Sanofi-Aventis France S.A. |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

Sanofi-Aventis France S.A.

1-13, boulevard Romain Rolland

75014 Paris

France

DEPAKIN

250 mg

modified-release granules

Oral Use

Italy

| Sanofi-Aventis France S.A. |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |

Sanofi-Aventis France S.A.

1-13, boulevard Romain Rolland

75014 Paris

DEPAKIN

500 mg

modified-release granules

Oral Use

Italy

| Sanofi-Aventis France S.A. |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

Sanofi-Aventis France S.A.

1-13, boulevard Romain Rolland

75014 Paris

France

DEPAKIN

50 mg

modified-release granules

Oral Use

Italy

| Sanofi-Aventis France S.A. |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

Sanofi-Aventis France S.A.

1-13, boulevard Romain Rolland

75014 Paris

France

DEPAKIN

750 mg

modified-release granules

Oral Use

Italy

| Sanofi-Aventis spa |
| --- |
| Viale Luigi/Bodio, 37B |
| 20158 Milano |

Sanofi-Aventis spa

Viale Luigi/Bodio, 37B

20158 Milano

DEPAMIDE

300 mg

gastro-resistant tablet

Oral Use

Italy

| Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. |
| --- |
| Viale Shakespeare, 47 |
| 00144 Roma |
| Italy |

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.

Viale Shakespeare, 47

00144 Roma

Italy

DEPAMAG

200 mg

gastro-resistant tablet

Oral Use

Italy

| Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. |
| --- |
| Viale Shakespeare, 47 |
| 00144 Roma |
| Italy |

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.

Viale Shakespeare, 47

00144 Roma

Italy

DEPAMAG

500 mg

gastro-resistant tablet

Oral Use

Italy

| Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. |
| --- |
| Viale Shakespeare, 47 |
| 00144 Roma |
| Italy |

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.

Viale Shakespeare, 47

00144 Roma

Italy

DEPAMAG

100 mg/ml

oral solution

Oral Use

Italy

| Ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| 89079 Ulm |
| Germany |

Ratiopharm GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

ACIDO VALPROICO E SODIO VALPROATO RATIOPHARM

300 mg

prolonged-release tablet

Oral Use

Italy

| Ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| 89079 Ulm |
| Germany |

Ratiopharm GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

ACIDO VALPROICO E SODIO VALPROATO RATIOPHARM

500 mg

prolonged-release tablet

Oral Use

Italy

| EG Laboratori EuroGenerici S.P.A. |
| --- |
| Via Pavia, 6 |
| 20136 Milano |
| Italy |

EG Laboratori EuroGenerici S.P.A.

Via Pavia, 6

20136 Milano

Italy

ACIDO VALPROICO E SODIO VALPROATO EG

300 mg

prolonged-release tablet

Oral Use

Italy

| EG Laboratori EuroGenerici S.P.A. |
| --- |
| Via Pavia, 6 |
| 20136 Milano |
| Italy |

EG Laboratori EuroGenerici S.P.A.

Via Pavia, 6

20136 Milano

Italy

ACIDO VALPROICO E SODIO VALPROATO EG

500 mg

prolonged-release tablet

Oral Use

Italy

| Winthrop Pharmaceuticals Italia S.r.l. |
| --- |
| Viale Luigi Bodio, 37b |
| 20158 Milano |
| Italy |

Winthrop Pharmaceuticals Italia S.r.l.

Viale Luigi Bodio, 37b

20158 Milano

Italy

SODIO VALPROATO WINTHROP

500 mg

gastro-resistant tablet

Oral Use

Italy

| Winthrop Pharmaceuticals Italia S.r.l. |
| --- |
| Viale Luigi Bodio, 37b |
| 20158 Milano |
| Italy |

Winthrop Pharmaceuticals Italia S.r.l.

Viale Luigi Bodio, 37b

20158 Milano

Italy

SODIO VALPROATO WINTHROP

200 mg/ml

oral solution

Oral Use

Italy

| Winthrop Pharmaceuticals Italia S.r.l. |
| --- |
| Viale Luigi Bodio, 37b |
| 20158 Milano |
| Italy |

Winthrop Pharmaceuticals Italia S.r.l.

Viale Luigi Bodio, 37b

20158 Milano

Italy

SODIO VALPROATO WINTHROP

300 mg

prolonged-release tablet

Oral Use

Italy

| Winthrop Pharmaceuticals Italia S.r.l. |
| --- |
| Viale Luigi Bodio, 37b |
| 20158 Milano |
| Italy |

Winthrop Pharmaceuticals Italia S.r.l.

Viale Luigi Bodio, 37b

20158 Milano

Italy

SODIO VALPROATO WINTHROP

500 mg

prolonged-release tablet

Oral Use

Italy

| Winthrop Pharmaceuticals Italia S.r.l. |
| --- |
| Viale Luigi Bodio, 37b |
| 20158 Milano |
| Italy |

Winthrop Pharmaceuticals Italia S.r.l.

Viale Luigi Bodio, 37b

20158 Milano

Italy

SODIO VALPROATO WINTHROP

200 mg

gastro-resistant tablet

Oral Use

Ireland

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| Ireland |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

Ireland

Epi-Chrono

PA 540/149/1

200 mg

prolonged-release tablet

Oral Use

Ireland

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| Ireland |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

Ireland

Epi-Chrono

PA 540/149/2

300 mg

prolonged-release tablet

Oral Use

Ireland

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| Ireland |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

Ireland

Epi-Chrono

PA 540/149/3

500 mg

prolonged-release tablet

Oral Use

Ireland

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| Ireland |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

Ireland

Epilim Crushable

PA 540/150/1

100 mg

tablet

Oral Use

Ireland

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| Ireland |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

Ireland

Epilim Enteric

PA 540/150/2

200 mg

gastro-resistant coated tablet

Oral Use

Ireland

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| Ireland |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

Ireland

Epilim Enteric

PA 540/150/3

500 mg

gastro-resistant coated tablet

Oral Use

Ireland

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| Ireland |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

Ireland

Epilim Chronosphere

PA 540/150/4

50 mg

prolonged-release granules

Oral Use

Ireland

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| Ireland |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

Ireland

Epilim Chronosphere

PA 540/150/5

100 mg

prolonged-release granules

Oral Use

Ireland

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| Ireland |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

Ireland

Epilim Chronosphere

PA 540/150/6

250 mg

prolonged-release granules

Oral Use

Ireland

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| Ireland |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

Ireland

Epilim Chronosphere

PA 540/150/7

500 mg

prolonged-release granules

Oral Use

Ireland

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| Ireland |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

Ireland

Epilim Chronosphere

PA 540/150/8

750 mg

prolonged-release granules

Oral Use

Ireland

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| Ireland |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

Ireland

Epilim Chronosphere

PA 540/150/9

1 000 mg

prolonged-release granules

Oral Use

Ireland

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| Ireland |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

Ireland

Epilim Chrono

PA 540/150/10

200 mg

prolonged-release tablet

Oral Use

Ireland

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| Ireland |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

Ireland

Epilim Chrono

PA 540/150/11

300 mg

prolonged-release tablet

Oral Use

Ireland

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| Ireland |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

Ireland

Epilim Chrono

PA 540/150/12

500 mg

prolonged-release tablet

Oral Use

Ireland

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| Ireland |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

Ireland

Epilim Intravenous

PA 540/150/13

400 mg

powder and solvent for solution for infusion/injection

Intravenous

Ireland

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| Ireland |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

Ireland

Epilim Liquid

PA 540/150/14

200 mg/5 ml

oral solution

Oral Use

Ireland

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| Ireland |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

Ireland

Epilim Syrup

PA 540/150/15

200 mg/5 ml

syrup

Oral Use

Latvia

| Sandoz d.d. |
| --- |
| Verovškova 57 |
| 1000 Ljubljana |
| Slovenia |

Sandoz d.d.

Verovškova 57

1000 Ljubljana

Slovenia

Valproate sodium Sandoz 300 mg prolonged-release tablets

300 mg

prolonged-release tablet

Oral Use

Latvia

| Sandoz d.d. |
| --- |
| Verovškova 57 |
| 1000 Ljubljana |
| Slovenia |

Sandoz d.d.

Verovškova 57

1000 Ljubljana

Slovenia

Valproate sodium Sandoz 500 mg prolonged-release tablets

500 mg

prolonged-release tablet

Oral Use

Latvia

| Stada Arzneimittel AG |
| --- |
| Stadastraße 2-18 |
| D-61118 Bad Vilbel |
| Germany |

Stada Arzneimittel AG

Stadastraße 2-18

D-61118 Bad Vilbel

Germany

Convulex 150 mg gastro-resistant capsules, soft

150 mg

gastro-resistant capsule, soft

Oral Use

Latvia

| Gerot Pharmazeutika Ges.m.b.H |
| --- |
| Arnethgasse 3 |
| AT-1160 Wien |
| AUSTRIA |

Gerot Pharmazeutika Ges.m.b.H

Arnethgasse 3

AT-1160 Wien

AUSTRIA

Convulex 300 mg gastro-resistant capsules, soft

300 mg

gastro-resistant capsule, soft

Oral Use

Latvia

| Gerot Pharmazeutika Ges.m.b.H |
| --- |
| Arnethgasse 3 |
| AT-1160 Wien |
| AUSTRIA |

Gerot Pharmazeutika Ges.m.b.H

Arnethgasse 3

AT-1160 Wien

AUSTRIA

Convulex 500 mg gastro-resistant capsules, soft

500 mg

gastro-resistant capsule, soft

Oral Use

Latvia

| Gerot Pharmazeutika Ges.m.b.H |
| --- |
| Arnethgasse 3 |
| AT-1160 Wien |
| AUSTRIA |

Gerot Pharmazeutika Ges.m.b.H

Arnethgasse 3

AT-1160 Wien

AUSTRIA

Convulex 500 mg gastro-resistant capsules, soft

500 mg

gastro-resistant capsule, soft

Oral Use

Latvia

| Gerot Pharmazeutika Ges.m.b.H |
| --- |
| Arnethgasse 3 |
| AT-1160 Wien |
| AUSTRIA |

Gerot Pharmazeutika Ges.m.b.H

Arnethgasse 3

AT-1160 Wien

AUSTRIA

Convulex retard 300 mg prolonged release tablets

300 mg

prolonged-release tablet

Oral Use

Latvia

| Gerot Pharmazeutika Ges.m.b.H |
| --- |
| Arnethgasse 3 |
| AT-1160 Wien |
| AUSTRIA |

Gerot Pharmazeutika Ges.m.b.H

Arnethgasse 3

AT-1160 Wien

AUSTRIA

Convulex retard 500 mg prolonged release tablets

500 mg

prolonged-release tablet

Oral Use

Latvia

| Gerot Pharmazeutika Ges.m.b.H |
| --- |
| Arnethgasse 3 |
| AT-1160 Wien |
| AUSTRIA |

Gerot Pharmazeutika Ges.m.b.H

Arnethgasse 3

AT-1160 Wien

AUSTRIA

Convulex 50 mg/ml syrup

50 mg/ml

syrup

Oral Use

Latvia

| Gerot Pharmazeutika Ges.m.b.H |
| --- |
| Arnethgasse 3 |
| AT-1160 Wien |
| AUSTRIA |

Gerot Pharmazeutika Ges.m.b.H

Arnethgasse 3

AT-1160 Wien

AUSTRIA

Convulex 300 mg/ml oral solution

300 mg/ml

oral solution

Oral Use

Latvia

| Sanofi-aventis Latvia SIA |
| --- |
| Kr. Valdemāra iela 33 - 8 |
| LV - 1010 Riga |
| Latvia |

Sanofi-aventis Latvia SIA

Kr. Valdemāra iela 33 - 8

LV - 1010 Riga

Latvia

Depakine Chrono 300 mg prolonged release tablets

300 mg

prolonged-release tablet

Oral Use

Latvia

| Sanofi-aventis Latvia SIA |
| --- |
| Kr. Valdemāra iela 33 - 8 |
| LV - 1010 Riga |
| Latvia |

Sanofi-aventis Latvia SIA

Kr. Valdemāra iela 33 - 8

LV - 1010 Riga

Latvia

Depakine Chrono 500 mg prolonged release tablets

500 mg

prolonged-release tablet

Oral Use

Latvia

| Sanofi-aventis Latvia SIA |
| --- |
| Kr. Valdemāra iela 33 - 8 |
| LV - 1010 Riga |
| Latvia |

Sanofi-aventis Latvia SIA

Kr. Valdemāra iela 33 - 8

LV - 1010 Riga

Latvia

Depakine 57,64 mg/ml syrup

57,64 mg/ml

syrup

Oral Use

Latvia

| Orion Corporation |
| --- |
| Orionintie 1 |
| FI - 02200 Espoo |
| FINLAND |

Orion Corporation

Orionintie 1

FI - 02200 Espoo

FINLAND

Absenor 500 mg prolonged release tablets

500 mg

prolonged-release tablet

Oral Use

Latvia

| Orion Corporation |
| --- |
| Orionintie 1 |
| FI - 02200 Espoo |
| FINLAND |

Orion Corporation

Orionintie 1

FI - 02200 Espoo

FINLAND

Absenor 300 mg prolonged release tablets

300 mg

prolonged-release tablet

Oral Use

Lithuania

| Gerot Pharmazeutika Ges. m. b. H. Arnethgasse 3 |
| --- |
| A-1160 Vienna |
| Austria |

Gerot Pharmazeutika Ges. m. b. H. Arnethgasse 3

A-1160 Vienna

Austria

Convulex retard

500 mg

prolonged-release tablet

Oral Use

Lithuania

| Gerot Pharmazeutika Ges. m. b. H. Arnethgasse 3 |
| --- |
| A-1160 Vienna |
| Austria |

Gerot Pharmazeutika Ges. m. b. H. Arnethgasse 3

A-1160 Vienna

Austria

Convulex retard

300 mg

prolonged-release tablet

Oral Use

Lithuania

| Gerot Pharmazeutika Ges. m. b. H. Arnethgasse 3 |
| --- |
| A-1160 Vienna |
| Austria |

Gerot Pharmazeutika Ges. m. b. H. Arnethgasse 3

A-1160 Vienna

Austria

Convulex

50 mg/ml

syrup

Oral Use

Lithuania

| Gerot Pharmazeutika Ges. m. b. H. Arnethgasse 3 |
| --- |
| A-1160 Vienna |
| Austria |

Gerot Pharmazeutika Ges. m. b. H. Arnethgasse 3

A-1160 Vienna

Austria

Convulex

300 mg/ml

oral solution

Oral Use

Lithuania

| Gerot Pharmazeutika Ges. m. b. H. Arnethgasse 3 |
| --- |
| A-1160 Vienna |
| Austria |

Gerot Pharmazeutika Ges. m. b. H. Arnethgasse 3

A-1160 Vienna

Austria

Convulex

150 mg

gastro-resistant capsule, soft

Oral Use

Lithuania

| Gerot Pharmazeutika Ges. m. b. H. Arnethgasse 3 |
| --- |
| A-1160 Vienna |
| Austria |

Gerot Pharmazeutika Ges. m. b. H. Arnethgasse 3

A-1160 Vienna

Austria

Convulex

300 mg

gastro-resistant capsule, soft

Oral Use

Lithuania

| Gerot Pharmazeutika Ges. m. b. H. Arnethgasse 3 |
| --- |
| A-1160 Vienna |
| Austria |

Gerot Pharmazeutika Ges. m. b. H. Arnethgasse 3

A-1160 Vienna

Austria

Convulex

500 mg

gastro-resistant capsule, soft

Oral Use

Lithuania

| Orion Corporation |
| --- |
| Orionintie 1 |
| FI-02200 Espoo |
| Finland |

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Absenor

500 mg

prolonged-release tablet

Oral Use

Lithuania

| Orion Corporation |
| --- |
| Orionintie 1 |
| FI-02200 Espoo |
| Finland |

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Absenor

300 mg

prolonged-release tablet

Oral Use

Lithuania

| UAB „Sanofi Aventis“ Lietuva |
| --- |
| A. Juozapaviciaus 6/2 |
| LT-09310 Vilnius |
| Lithuania |

UAB „Sanofi Aventis“ Lietuva

A. Juozapaviciaus 6/2

LT-09310 Vilnius

Lithuania

Depakine

57,64 mg/ml

syrup

Oral Use

Lithuania

| UAB „Sanofi Aventis“ Lietuva |
| --- |
| A. Juozapaviciaus 6/2 |
| LT-09310 Vilnius |
| Lithuania |

UAB „Sanofi Aventis“ Lietuva

A. Juozapaviciaus 6/2

LT-09310 Vilnius

Lithuania

Depakine Chronosphere

50 mg

modified-release granules

Oral Use

Lithuania

| UAB „Sanofi Aventis“ Lietuva |
| --- |
| A. Juozapaviciaus 6/2 |
| LT-09310 Vilnius |
| Lithuania |

UAB „Sanofi Aventis“ Lietuva

A. Juozapaviciaus 6/2

LT-09310 Vilnius

Lithuania

Depakine Chronosphere

100 mg

modified-release granules

Oral Use

Lithuania

| UAB „Sanofi Aventis“ Lietuva |
| --- |
| A. Juozapaviciaus 6/2 |
| LT-09310 Vilnius |
| Lithuania |

UAB „Sanofi Aventis“ Lietuva

A. Juozapaviciaus 6/2

LT-09310 Vilnius

Lithuania

Depakine Chronosphere

250 mg

modified-release granules

Oral Use

Lithuania

| UAB „Sanofi Aventis“ Lietuva |
| --- |
| A. Juozapaviciaus 6/2 |
| LT-09310 Vilnius |
| Lithuania |

UAB „Sanofi Aventis“ Lietuva

A. Juozapaviciaus 6/2

LT-09310 Vilnius

Lithuania

Depakine Chronosphere

500 mg

modified-release granules

Oral Use

Lithuania

| UAB „Sanofi Aventis“ Lietuva |
| --- |
| A. Juozapaviciaus 6/2 |
| LT-09310 Vilnius |
| Lithuania |

UAB „Sanofi Aventis“ Lietuva

A. Juozapaviciaus 6/2

LT-09310 Vilnius

Lithuania

Depakine Chronosphere

750 mg

modified-release granules

Oral Use

Lithuania

| UAB „Sanofi Aventis“ Lietuva |
| --- |
| A. Juozapaviciaus 6/2 |
| LT-09310 Vilnius |
| Lithuania |

UAB „Sanofi Aventis“ Lietuva

A. Juozapaviciaus 6/2

LT-09310 Vilnius

Lithuania

Depakine Chronosphere

1 000 mg

modified-release granules

Oral Use

Lithuania

| UAB „Sanofi Aventis“ Lietuva |
| --- |
| A. Juozapaviciaus 6/2 |
| LT-09310 Vilnius |
| Lithuania |

UAB „Sanofi Aventis“ Lietuva

A. Juozapaviciaus 6/2

LT-09310 Vilnius

Lithuania

Depakine Chrono

500 mg

modified-release tablet

Oral Use

Lithuania

| UAB „Sanofi Aventis“ Lietuva |
| --- |
| A. Juozapaviciaus 6/2 |
| LT-09310 Vilnius |
| Lithuania |

UAB „Sanofi Aventis“ Lietuva

A. Juozapaviciaus 6/2

LT-09310 Vilnius

Lithuania

Depakine Chronosphere

300 mg

modified-release tablet

Oral Use

Lithuania

| Stada Arzneimittel AG |
| --- |
| Stadastrasse 2-18 |
| 61118 Bad Vilbel |
| Germany |

Stada Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Prodepa

500 mg

prolonged-release tablet

Oral Use

Lithuania

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| 1000 Ljubljana |
| Slovenia |

Sandoz d.d.

Verovskova 57

1000 Ljubljana

Slovenia

Valproate sodium Sandoz

300 mg

prolonged-release tablet

Oral Use

Lithuania

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| 1000 Ljubljana |
| Slovenia |

Sandoz d.d.

Verovskova 57

1000 Ljubljana

Slovenia

Valproate sodium Sandoz

500 mg

prolonged-release tablet

Oral Use

Luxembourg

| Sanofi-Aventis Belgium |
| --- |
| Culliganlaan 1C |
| B-1831 Diegem |
| Belgium |

Sanofi-Aventis Belgium

Culliganlaan 1C

B-1831 Diegem

Belgium

DEPAKINE

30 %

solution

Oral Use

Luxembourg

| Sanofi-Aventis Belgium |
| --- |
| Culliganlaan 1C |
| B-1831 Diegem |
| Belgium |

Sanofi-Aventis Belgium

Culliganlaan 1C

B-1831 Diegem

Belgium

DEPAKINE

6 %

syrup

Oral Use

Luxembourg

| Sanofi-Aventis Belgium |
| --- |
| Culliganlaan 1C |
| B-1831 Diegem |
| Belgium |

Sanofi-Aventis Belgium

Culliganlaan 1C

B-1831 Diegem

Belgium

DEPAKINE CHRONO

300 mg

tablet

Oral Use

Luxembourg

| Sanofi-Aventis Belgium |
| --- |
| Culliganlaan 1C |
| B-1831 Diegem |
| Belgium |

Sanofi-Aventis Belgium

Culliganlaan 1C

B-1831 Diegem

Belgium

DEPAKINE CHRONO

500 mg

tablet

Oral Use

Luxembourg

| Sanofi-Aventis Belgium |
| --- |
| Culliganlaan 1C |
| B-1831 Diegem |
| Belgium |

Sanofi-Aventis Belgium

Culliganlaan 1C

B-1831 Diegem

Belgium

DEPAKINE ENTERIC

150 mg

tablet

Oral Use

Luxembourg

| Sanofi-Aventis Belgium |
| --- |
| Culliganlaan 1C |
| B-1831 Diegem |
| Belgium |

Sanofi-Aventis Belgium

Culliganlaan 1C

B-1831 Diegem

Belgium

DEPAKINE ENTERIC

300 mg

tablet

Oral Use

Luxembourg

| Sanofi-Aventis Belgium |
| --- |
| Culliganlaan 1C |
| B-1831 Diegem |
| Belgium |

Sanofi-Aventis Belgium

Culliganlaan 1C

B-1831 Diegem

Belgium

DEPAKINE ENTERIC

500 mg

tablet

Oral Use

Luxembourg

| Gerot Pharmazeutika GmbH Arnethgasse 3 |
| --- |
| A-1160 Wien |
| Austria |

Gerot Pharmazeutika GmbH Arnethgasse 3

A-1160 Wien

Austria

CONVULEX

300 mg

prolonged-release tablet

Oral Use

Luxembourg

| Gerot Pharmazeutika GmbH Arnethgasse 3 |
| --- |
| A-1160 Wien |
| Austria |

Gerot Pharmazeutika GmbH Arnethgasse 3

A-1160 Wien

Austria

CONVULEX

500 mg

prolonged-release tablet

Oral Use

Luxembourg

| Gerot Pharmazeutika GmbH Arnethgasse 3 |
| --- |
| A-1160 Wien |
| Austria |

Gerot Pharmazeutika GmbH Arnethgasse 3

A-1160 Wien

Austria

CONVULEX

250 mg/5 ml

syrup

Oral Use

Luxembourg

| Gerot Pharmazeutika GmbH Arnethgasse 3 |
| --- |
| A-1160 Wien |
| Austria |

Gerot Pharmazeutika GmbH Arnethgasse 3

A-1160 Wien

Austria

CONVULEX

300 mg

capsule

Oral Use

Luxembourg

| Gerot Pharmazeutika GmbH Arnethgasse 3 |
| --- |
| A-1160 Wien |
| Austria |

Gerot Pharmazeutika GmbH Arnethgasse 3

A-1160 Wien

Austria

CONVULEX

500 mg

capsule

Oral Use

Luxembourg

| Ratiopharm GmbH Arzneimittel Postfach 3380 |
| --- |
| D-89070 Ulm |
| Germany |

Ratiopharm GmbH Arzneimittel Postfach 3380

D-89070 Ulm

Germany

Valproinsäure-Ratiopharm

300 mg

prolonged-release tablet

Oral Use

Luxembourg

| Ratiopharm GmbH Arzneimittel Postfach 3380 |
| --- |
| D-89070 Ulm |
| Germany |

Ratiopharm GmbH Arzneimittel Postfach 3380

D-89070 Ulm

Germany

Valproinsäure-Ratiopharm

500 mg

prolonged-release tablet

Oral Use

Luxembourg

| Hexal AG |
| --- |
| Industriestrasse 25 |
| D-83607 Holzkirchen |
| Germany |

Hexal AG

Industriestrasse 25

D-83607 Holzkirchen

Germany

Valproat-Hexal Chrono

300 mg

tablet

Oral Use

Luxembourg

| Hexal AG |
| --- |
| Industriestrasse 25 |
| D-83607 Holzkirchen |
| Germany |

Hexal AG

Industriestrasse 25

D-83607 Holzkirchen

Germany

Valproat-Hexal Chrono

500 mg

tablet

Oral Use

Luxembourg

| Eurogenerics s.a. |
| --- |
| Esplanade Heysel B.22 |
| B-1020 Bruxelles |
| Belgium |

Eurogenerics s.a.

Esplanade Heysel B.22

B-1020 Bruxelles

Belgium

Valproate Retard-EG

300 mg

prolonged-release tablet

Oral Use

Luxembourg

| Eurogenerics s.a. |
| --- |
| Esplanade Heysel |
| B.22 B-1020 Bruxelles |
| Belgium |

Eurogenerics s.a.

Esplanade Heysel

B.22 B-1020 Bruxelles

Belgium

Valproate Retard-EG

500 mg

prolonged-release tablet

Oral Use

Malta

| Norton Healthcare Limited |
| --- |
| Ivax Pharmaceuticals |
| Ivax Quays |
| Albert Basin, Royal Docks |
| London E16 2QJ |
| United Kingdom |

Norton Healthcare Limited

Ivax Pharmaceuticals

Ivax Quays

Albert Basin, Royal Docks

London E16 2QJ

United Kingdom

Sodium valproate oral solution BP

200 mg/5 ml

oral solution

Oral Use

Malta

| Sanofi-Aventis Malta Limited |
| --- |
| Triq Kanonku K. Pirotta |
| Birkirkara BKR 1114 |
| Malta |

Sanofi-Aventis Malta Limited

Triq Kanonku K. Pirotta

Birkirkara BKR 1114

Malta

Epilim liquid

200 mg/5 ml

oral liquid

Oral Use

Malta

| Sanofi-Aventis Malta Limited |
| --- |
| Triq Kanonku K. Pirotta |
| Birkirkara BKR 1114 |
| Malta |

Sanofi-Aventis Malta Limited

Triq Kanonku K. Pirotta

Birkirkara BKR 1114

Malta

Epilim Chrono 200 Controlled Release

200 mg

prolonged-release tablet

Oral Use

Malta

| Sanofi-Aventis Malta Limited |
| --- |
| Triq Kanonku K. Pirotta |
| Birkirkara BKR 1114 |
| Malta |

Sanofi-Aventis Malta Limited

Triq Kanonku K. Pirotta

Birkirkara BKR 1114

Malta

Epilim Chrono 300

Controlled release

300 mg

prolonged-release tablet

Oral Use

Malta

| Sanofi-Aventis Malta Limited |
| --- |
| Triq Kanonku K. Pirotta |
| Birkirkara BKR 1114 |
| Malta |

Sanofi-Aventis Malta Limited

Triq Kanonku K. Pirotta

Birkirkara BKR 1114

Malta

Epilim Chrono 500

Controlled release

500 mg

prolonged-release tablet

Oral Use

Malta

| Sanofi-Aventis Malta Limited |
| --- |
| Triq Kanonku K. Pirotta |
| Birkirkara BKR 1114 |
| Malta |

Sanofi-Aventis Malta Limited

Triq Kanonku K. Pirotta

Birkirkara BKR 1114

Malta

Epilim Chronosphere MR 50 mg

50 mg

modified-release granules

Oral Use

Malta

| Sanofi-Aventis Malta Limited |
| --- |
| Triq Kanonku K. Pirotta |
| Birkirkara BKR 1114 |
| Malta |

Sanofi-Aventis Malta Limited

Triq Kanonku K. Pirotta

Birkirkara BKR 1114

Malta

Epilim Chronosphere MR 100 mg

100 mg

modified-release granules

Oral Use

Malta

| Sanofi-Aventis Malta Limited |
| --- |
| Triq Kanonku K. Pirotta |
| Birkirkara BKR 1114 |

Sanofi-Aventis Malta Limited

Triq Kanonku K. Pirotta

Birkirkara BKR 1114

Epilim Chronosphere MR 250 mg

250 mg

modified-release granules

Oral Use

Malta

| Sanofi-Aventis Malta Limited |
| --- |
| Triq Kanonku K. Pirotta |
| Birkirkara BKR 1114 |
| Malta |

Sanofi-Aventis Malta Limited

Triq Kanonku K. Pirotta

Birkirkara BKR 1114

Malta

Epilim Chronosphere MR 500 mg

500 mg

modified-release granules

Oral Use

Malta

| Sanofi-Aventis Malta Limited |
| --- |
| Triq Kanonku K. Pirotta |
| Birkirkara BKR 1114 |
| Malta |

Sanofi-Aventis Malta Limited

Triq Kanonku K. Pirotta

Birkirkara BKR 1114

Malta

Epilim Chronosphere MR 750 mg

750 mg

modified-release granules

Oral Use

Malta

| Sanofi-Aventis Malta Limited |
| --- |
| Triq Kanonku K. Pirotta |
| Birkirkara BKR 1114 |
| Malta |

Sanofi-Aventis Malta Limited

Triq Kanonku K. Pirotta

Birkirkara BKR 1114

Malta

Epilim Chronosphere MR 1 000 mg

1 000 mg

modified-release granules

Oral Use

Norway

| Destin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Germany |

Destin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Germany

Orfiril Long

500 mg

prolonged-release granules

Oral Use

Norway

| Destin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Germany |

Destin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Germany

Orfiril Long

1 000 mg

prolonged-release granules

Oral Use

Norway

| Destin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Germany |

Destin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Germany

Orfiril Long

150 mg

prolonged-release capsule

Oral Use

Norway

| Destin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Germany |

Destin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Germany

Orfiril Long

300 mg

prolonged-release capsule

Oral Use

Norway

| Destin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Germany |

Destin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Germany

Orfiril Retard

300 mg

prolonged-release tablet

Oral Use

Norway

| Destin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Germany |

Destin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Germany

Orfiril

150 mg

gastro-resistant tablet

Oral Use

Norway

| Destin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Germany |

Destin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Germany

Orfiril

300 mg

gastro-resistant tablet

Oral Use

Norway

| Destin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Germany |

Destin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Germany

Orfiril

600 mg

gastro-resistant tablet

Oral Use

Norway

| Sanofi-Aventis Norge AS |
| --- |
| PB 133 |
| 1325 Lysaker |
| Norway |

Sanofi-Aventis Norge AS

PB 133

1325 Lysaker

Norway

Deprakine

100 mg

gastro-resistant tablet

Oral Use

Norway

| Sanofi-Aventis Norge AS |
| --- |
| PB 133 |
| 1325 Lysaker |
| Norway |

Sanofi-Aventis Norge AS

PB 133

1325 Lysaker

Norway

Deprakine

300 mg

gastro-resistant tablet

Oral Use

Norway

| Sanofi-Aventis Norge AS |
| --- |
| PB 133 |
| 1325 Lysaker |
| Norway |

Sanofi-Aventis Norge AS

PB 133

1325 Lysaker

Norway

Deprakine

500 mg

gastro-resistant tablet

Oral Use

Norway

| Destin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Germany |

Destin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Germany

Orfiril

60 mg/mL

oral solution

Oral Use

Norway

| Sanofi-Aventis Norge AS |
| --- |
| PB 133 |
| 1325 Lysaker |
| Norway |

Sanofi-Aventis Norge AS

PB 133

1325 Lysaker

Norway

Deprakine

60 mg/mL

oral solution

Oral Use

Poland

| G.L. Pharma GmbH |
| --- |
| Schloβplatz 1 |
| A-8502 Lannach |
| Austria |

G.L. Pharma GmbH

Schloβplatz 1

A-8502 Lannach

Austria

Convulex 150

150 mg

capsule, soft

Oral Use

Poland

| G.L. Pharma GmbH |
| --- |
| Schloβplatz 1 |
| A-8502 Lannach |
| Austria |

G.L. Pharma GmbH

Schloβplatz 1

A-8502 Lannach

Austria

Convulex 300

300 mg

capsule, soft

Oral Use

Poland

| G.L. Pharma GmbH |
| --- |
| Schloβplatz 1 |
| A-8502 Lannach |
| Austria |

G.L. Pharma GmbH

Schloβplatz 1

A-8502 Lannach

Austria

Convulex

500 mg

capsule, soft

Oral Use

Poland

| G.L. Pharma GmbH |
| --- |
| Schloβplatz 1 |
| A-8502 Lannach |
| Austria |

G.L. Pharma GmbH

Schloβplatz 1

A-8502 Lannach

Austria

Convulex

50 mg/ml

syrup

Oral Use

Poland

| Desitin Arznemittel GmbH |
| --- |
| Weg beim Jager 214 |
| Hamburg 22335 |
| Germany |

Desitin Arznemittel GmbH

Weg beim Jager 214

Hamburg 22335

Germany

Orfiril

300 mg/5 ml (60 mg/ml)

oral solution

Oral Use

Poland

| Desitin Arznemittel GmbH |
| --- |
| Weg beim Jager 214 |
| Hamburg 22335 |
| Germany |

Desitin Arznemittel GmbH

Weg beim Jager 214

Hamburg 22335

Germany

Orfiril 150

150 mg

gastro-resistant tablet

Oral Use

Poland

| Desitin Arznemittel GmbH |
| --- |
| Weg beim Jager 214 |
| Hamburg 22335 |
| Germany |

Desitin Arznemittel GmbH

Weg beim Jager 214

Hamburg 22335

Germany

Orfiril 300

300 mg

gastro-resistant tablet

Oral Use

Poland

| Desitin Arznemittel GmbH |
| --- |
| Weg beim Jager 214 |
| Hamburg 22335 |
| Germany |

Desitin Arznemittel GmbH

Weg beim Jager 214

Hamburg 22335

Germany

Orfiril 600

600 mg

gastro-resistant tablet

Oral Use

Poland

| Desitin Arznemittel GmbH |
| --- |
| Weg beim Jager 214 |
| Hamburg 22335 |
| Germany |

Desitin Arznemittel GmbH

Weg beim Jager 214

Hamburg 22335

Germany

Orfiril 300 retard

300 mg

prolonged-release gastro-resistant tablet

Oral Use

Poland

| Desitin Arznemittel GmbH |
| --- |
| Weg beim Jager 214 |
| Hamburg 22335 |
| Germany |

Desitin Arznemittel GmbH

Weg beim Jager 214

Hamburg 22335

Germany

Orfiril Long 150

150 mg

prolonged-release capsule

Oral Use

Poland

| Desitin Arznemittel GmbH |
| --- |
| Weg beim Jager 214 |
| Hamburg 22335 |
| Germany |

Desitin Arznemittel GmbH

Weg beim Jager 214

Hamburg 22335

Germany

Orfiril Long 300

300 mg

prolonged-release capsule

Oral Use

Poland

| Desitin Arznemittel GmbH |
| --- |
| Weg beim Jager 214 |
| Hamburg 22335 |
| Germany |

Desitin Arznemittel GmbH

Weg beim Jager 214

Hamburg 22335

Germany

Orfiril Long 500

500 mg

prolonged-release mini-tablet

Oral Use

Poland

| Desitin Arznemittel GmbH |
| --- |
| Weg beim Jager 214 |
| Hamburg 22335 |
| Germany |

Desitin Arznemittel GmbH

Weg beim Jager 214

Hamburg 22335

Germany

Orfiril Long 1 000

1 000 mg

prolonged-release mini-tablet

Oral Use

Poland

| ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| Ulm 89079 |
| Germany |

ratiopharm GmbH

Graf-Arco-Strasse 3

Ulm 89079

Germany

Valproic Acid ER-APC 300

300 mg

prolonged-release tablet

Oral Use

Poland

| ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| Ulm89079 |
| Germany |

ratiopharm GmbH

Graf-Arco-Strasse 3

Ulm89079

Germany

Valproic Acid ER-APC 500

500 mg

prolonged-release tablet

Oral Use

Poland

| ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| Ulm 89079 |
| Germany |

ratiopharm GmbH

Graf-Arco-Strasse 3

Ulm 89079

Germany

Valpro-ratiopharm Chrono 300 mg

199,8 mg + 87 mg

prolonged-release tablet

Oral Use

Poland

| ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| Ulm 89079 |
| Germany |

ratiopharm GmbH

Graf-Arco-Strasse 3

Ulm 89079

Germany

Valpro-ratiopharm Chrono 500 mg

333 mg + 145 mg

prolonged-release tablet

Oral Use

Poland

| Sanofi-Aventis Sp. z o.o. |
| --- |
| ul. Bonifraterska 17 |
| Warsaw 00-203 |
| Poland |

Sanofi-Aventis Sp. z o.o.

ul. Bonifraterska 17

Warsaw 00-203

Poland

Depakine Chrono 300

200 mg + 87 mg

prolonged-release film-coated tablet

Oral Use

Poland

| Sanofi-Aventis Sp. z o.o. |
| --- |
| ul. Bonifraterska 17 |
| 00.-203 Warsaw |
| Poland |

Sanofi-Aventis Sp. z o.o.

ul. Bonifraterska 17

00.-203 Warsaw

Poland

Depakine Chrono 500

333 mg + 145 mg

prolonged-release film-coated tablet

Oral Use

Poland

| Sanofi-Aventis Sp. z o.o. |
| --- |
| ul. Bonifraterska 17 |
| 00.-203 Warsaw |
| Poland |

Sanofi-Aventis Sp. z o.o.

ul. Bonifraterska 17

00.-203 Warsaw

Poland

Depakine Chronosphere 100

66,66 mg + 29,03 mg

prolonged-release granules

Oral Use

Poland

| Sanofi-Aventis Sp. z o.o. |
| --- |
| ul. Bonifraterska 17 |
| 00.-203 Warsaw |
| Poland |

Sanofi-Aventis Sp. z o.o.

ul. Bonifraterska 17

00.-203 Warsaw

Poland

Depakine Chronosphere 250

166,76 mg + 72,61 mg

prolonged-release granules

Oral Use

Poland

| Sanofi-Aventis Sp. z o.o. |
| --- |
| ul. Bonifraterska 17 |
| 00.-203 Warsaw |
| Poland |

Sanofi-Aventis Sp. z o.o.

ul. Bonifraterska 17

00.-203 Warsaw

Poland

Depakine Chronosphere 500

333,30 mg + 145,14 mg

prolonged-release granules

Oral Use

Poland

| Sanofi-Aventis Sp. z o.o. |
| --- |
| ul. Bonifraterska 17 |
| 00.-203 Warsaw |
| Poland |

Sanofi-Aventis Sp. z o.o.

ul. Bonifraterska 17

00.-203 Warsaw

Poland

Depakine Chronosphere 750

500,06 mg + 217,75 mg

prolonged-release granules

Oral Use

Poland

| Sanofi-Aventis Sp. z o.o. |
| --- |
| ul. Bonifraterska 17 |
| 00.-203 Warsaw |
| Poland |

Sanofi-Aventis Sp. z o.o.

ul. Bonifraterska 17

00.-203 Warsaw

Poland

Depakine Chronosphere 1 000

666,60 mg + 290,27 mg

prolonged-release granules

Oral Use

Poland

| Sanofi-Aventis France |
| --- |
| 1-13 bld Romain Rolland |
| 75014 Paris |
| France |

Sanofi-Aventis France

1-13 bld Romain Rolland

75014 Paris

France

Depakine

288,2 mg/5 ml

syrup

Oral Use

Poland

| Sanofi-Aventis France |
| --- |
| 1-13 bld Romain Rolland |
| 75014 Paris |
| France |

Sanofi-Aventis France

1-13 bld Romain Rolland

75014 Paris

France

Depakine 200

200 mg

film-coated tablet

Oral Use

Poland

| ICN Polfa Rzeszów S.A. |
| --- |
| Przemysłowa 2 st. |
| Rzeszów 35-959 |
| Poland |

ICN Polfa Rzeszów S.A.

Przemysłowa 2 st.

Rzeszów 35-959

Poland

Dipromal

200 mg

film-coated tablet

Oral Use

Poland

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10 |
| Kundl 6250 |
| Austria |

Sandoz GmbH

Biochemiestrasse 10

Kundl 6250

Austria

ValproLEK 300

300 mg

prolonged-release tablet

Oral Use

Poland

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10 |
| Kundl 6250 |
| Austria |

Sandoz GmbH

Biochemiestrasse 10

Kundl 6250

Austria

ValproLEK 500

500 mg

prolonged-release tablet

Oral Use

Poland

| Orion Corporation |
| --- |
| Orionintie 1 |
| Espoo 02200 |
| Finland |

Orion Corporation

Orionintie 1

Espoo 02200

Finland

Absenor

300 mg

modified-release tablet

Oral Use

Poland

| Orion Corporation |
| --- |
| Orionintie 1 |
| Espoo 02200 |
| Finland |

Orion Corporation

Orionintie 1

Espoo 02200

Finland

Absenor

500 mg

modified-release tablet

Oral Use

Portugal

| Sanofi-Aventis - Produtos Farmacêuticos, S.A. |
| --- |
| Empreendimento Lagoas Park |
| Edifício 7 - 3o |
| 2740-299 Porto Salvo |
| Portugal |

Sanofi-Aventis - Produtos Farmacêuticos, S.A.

Empreendimento Lagoas Park

Edifício 7 - 3o

2740-299 Porto Salvo

Portugal

Depakine

200 mg/ml

oral solution

Oral Use

Portugal

| Sanofi-Aventis - Produtos Farmacêuticos, S.A. |
| --- |
| Empreendimento Lagoas Park |
| Edifício 7 - 3o |
| 2740-299 Porto Salvo |
| Portugal |

Sanofi-Aventis - Produtos Farmacêuticos, S.A.

Empreendimento Lagoas Park

Edifício 7 - 3o

2740-299 Porto Salvo

Portugal

Depakine Chrono 300

300 mg

prolonged-release tablet

Oral Use

Portugal

| Sanofi-Aventis - Produtos Farmacêuticos, S.A. |
| --- |
| Empreendimento Lagoas Park |
| Edifício 7 - 3o |
| 2740-299 Porto Salvo |
| Portugal |

Sanofi-Aventis - Produtos Farmacêuticos, S.A.

Empreendimento Lagoas Park

Edifício 7 - 3o

2740-299 Porto Salvo

Portugal

Depakine Chrono 500

500 mg

prolonged-release tablet

Oral Use

Portugal

| Tecnifar - Indústria Técnica Farmacêutica, S.A. |
| --- |
| Rua Tierno Galvan - Amoreiras - Torre 3 - 12o |
| 1099-036 Lisboa |
| Portugal |

Tecnifar - Indústria Técnica Farmacêutica, S.A.

Rua Tierno Galvan - Amoreiras - Torre 3 - 12o

1099-036 Lisboa

Portugal

Diplexil

200 mg

coated tablet

Oral Use

Portugal

| Tecnifar - Indústria Técnica Farmacêutica, S.A. |
| --- |
| Rua Tierno Galvan - Amoreiras - Torre 3 - 12o |
| 1099-036 Lisboa |
| Portugal |

Tecnifar - Indústria Técnica Farmacêutica, S.A.

Rua Tierno Galvan - Amoreiras - Torre 3 - 12o

1099-036 Lisboa

Portugal

Diplexil

500 mg

gastro-resistant tablet

Oral Use

Portugal

| Tecnifar - Indústria Técnica Farmacêutica, S.A. |
| --- |
| Rua Tierno Galvan - Amoreiras - Torre 3 - 12o |
| 1099-036 Lisboa |
| Portugal |

Tecnifar - Indústria Técnica Farmacêutica, S.A.

Rua Tierno Galvan - Amoreiras - Torre 3 - 12o

1099-036 Lisboa

Portugal

Diplexil

200 mg/ml

oral solution

Oral Use

Portugal

| Tecnifar - Indústria Técnica Farmacêutica, S.A. |
| --- |
| Rua Tierno Galvan - Amoreiras - Torre 3 - 12o |
| 1099-036 Lisboa |
| Portugal |

Tecnifar - Indústria Técnica Farmacêutica, S.A.

Rua Tierno Galvan - Amoreiras - Torre 3 - 12o

1099-036 Lisboa

Portugal

Diplexil-R

250 mg

coated tablet

Oral Use

Portugal

| Tecnifar - Indústria Técnica Farmacêutica, S.A. |
| --- |
| Rua Tierno Galvan - Amoreiras - Torre 3 - 12o |
| 1099-036 Lisboa |
| Portugal |

Tecnifar - Indústria Técnica Farmacêutica, S.A.

Rua Tierno Galvan - Amoreiras - Torre 3 - 12o

1099-036 Lisboa

Portugal

Diplexil-R

500 mg

coated tablet

Oral Use

Portugal

| Sanofi-Aventis - Produtos Farmacêuticos, S.A. |
| --- |
| Empreendimento Lagoas Park, Edifício 7 - 3o |
| 2740-299 Porto Salvo |
| Portugal |

Sanofi-Aventis - Produtos Farmacêuticos, S.A.

Empreendimento Lagoas Park, Edifício 7 - 3o

2740-299 Porto Salvo

Portugal

Depakine

40 mg/ml

syrup

Oral Use

Portugal

| Tecnifar - Indústria Técnica Farmacêutica, S.A. |
| --- |
| Rua Tierno Galvan - Amoreiras - Torre 3 - 12o |
| 1099-036 Lisboa |
| Portugal |

Tecnifar - Indústria Técnica Farmacêutica, S.A.

Rua Tierno Galvan - Amoreiras - Torre 3 - 12o

1099-036 Lisboa

Portugal

Diplexil 150

150 mg

prolonged-release capsule

Oral Use

Portugal

| Tecnifar - Indústria Técnica Farmacêutica, S.A. |
| --- |
| Rua Tierno Galvan - Amoreiras - Torre 3 - 12o |
| 1099-036 Lisboa |
| Portugal |

Tecnifar - Indústria Técnica Farmacêutica, S.A.

Rua Tierno Galvan - Amoreiras - Torre 3 - 12o

1099-036 Lisboa

Portugal

Diplexil 300

300 mg

prolonged-release capsule

Oral Use

Portugal

| Tecnifar - Indústria Técnica Farmacêutica, S.A. |
| --- |
| Rua Tierno Galvan - Amoreiras - Torre 3 - 12o |
| 1099-036 Lisboa |
| Portugal |

Tecnifar - Indústria Técnica Farmacêutica, S.A.

Rua Tierno Galvan - Amoreiras - Torre 3 - 12o

1099-036 Lisboa

Portugal

Diplexil 500

500 mg

prolonged-release granules

Oral Use

Portugal

| Tecnifar - Indústria Técnica Farmacêutica, S.A. |
| --- |
| Rua Tierno Galvan - Amoreiras - Torre 3 - 12o |
| 1099-036 Lisboa |
| Portugal |

Tecnifar - Indústria Técnica Farmacêutica, S.A.

Rua Tierno Galvan - Amoreiras - Torre 3 - 12o

1099-036 Lisboa

Portugal

Diplexil 1 000

1 000 mg

prolonged-release granules

Oral Use

Portugal

| Sanofi-Aventis - Produtos Farmacêuticos, S.A. |
| --- |
| Empreendimento Lagoas Park, Edifício 7 - 3o |
| 2740-299 Porto Salvo |
| Portugal |

Sanofi-Aventis - Produtos Farmacêuticos, S.A.

Empreendimento Lagoas Park, Edifício 7 - 3o

2740-299 Porto Salvo

Portugal

Depakine Chronosphere 50/350

50 - 350 mg

modified-release granules

Oral Use

Portugal

| Sanofi-Aventis - Produtos Farmacêuticos, S.A. |
| --- |
| Empreendimento Lagoas Park, Edifício 7 - 3o |
| 2740-299 Porto Salvo |
| Portugal |

Sanofi-Aventis - Produtos Farmacêuticos, S.A.

Empreendimento Lagoas Park, Edifício 7 - 3o

2740-299 Porto Salvo

Portugal

Depakine Chronosphere 500/1 000

500 - 1 000 mg

modified-release granules

Oral Use

Portugal

| Sanofi-Aventis - Produtos Farmacêuticos, S.A. |
| --- |
| Empreendimento Lagoas Park, Edifício 7 - 3o |
| 2740-299 Porto Salvo |
| Portugal |

Sanofi-Aventis - Produtos Farmacêuticos, S.A.

Empreendimento Lagoas Park, Edifício 7 - 3o

2740-299 Porto Salvo

Portugal

Depakine Chronosphere 50 mg

50 mg

modified-release granules

Oral Use

Portugal

| Sanofi-Aventis - Produtos Farmacêuticos, S.A. |
| --- |
| Empreendimento Lagoas Park, Edifício 7 - 3o |
| 2740-299 Porto Salvo |
| Portugal |

Sanofi-Aventis - Produtos Farmacêuticos, S.A.

Empreendimento Lagoas Park, Edifício 7 - 3o

2740-299 Porto Salvo

Portugal

Depakine Chronosphere 100 mg

100 mg

modified-release granules

Oral Use

Portugal

| Sanofi-Aventis - Produtos Farmacêuticos, S.A. |
| --- |
| Empreendimento Lagoas Park, Edifício 7 - 3o |
| 2740-299 Porto Salvo |
| Portugal |

Sanofi-Aventis - Produtos Farmacêuticos, S.A.

Empreendimento Lagoas Park, Edifício 7 - 3o

2740-299 Porto Salvo

Portugal

Depakine Chronosphere 250 mg

250 mg

modified-release granules

Oral Use

Portugal

| Sanofi-Aventis - Produtos Farmacêuticos, S.A. |
| --- |
| Empreendimento Lagoas Park, Edifício 7 - 3o |
| 2740-299 Porto Salvo |
| Portugal |

Sanofi-Aventis - Produtos Farmacêuticos, S.A.

Empreendimento Lagoas Park, Edifício 7 - 3o

2740-299 Porto Salvo

Portugal

Depakine Chronosphere 500 mg

500 mg

modified-release granules

Oral Use

Portugal

| Sanofi-Aventis - Produtos Farmacêuticos, S.A. |
| --- |
| Empreendimento Lagoas Park, Edifício 7 - 3o |
| 2740-299 Porto Salvo |
| Portugal |

Sanofi-Aventis - Produtos Farmacêuticos, S.A.

Empreendimento Lagoas Park, Edifício 7 - 3o

2740-299 Porto Salvo

Portugal

Depakine Chronosphere 750 mg

750 mg

modified-release granules

Oral Use

Portugal

| Sanofi-Aventis - Produtos Farmacêuticos, S.A. |
| --- |
| Empreendimento Lagoas Park, Edifício 7 - 3o |
| 2740-299 Porto Salvo |
| Portugal |

Sanofi-Aventis - Produtos Farmacêuticos, S.A.

Empreendimento Lagoas Park, Edifício 7 - 3o

2740-299 Porto Salvo

Portugal

Depakine Chronosphere 1 000 mg

1 000 mg

modified-release granules

Oral Use

Portugal

| Sandoz Farmacêutica, Lda. |
| --- |
| Alameda da Beloura, Edifício 1, 2o - Escritório 15 |
| 2710-693 Sintra |
| Portugal |

Sandoz Farmacêutica, Lda.

Alameda da Beloura, Edifício 1, 2o - Escritório 15

2710-693 Sintra

Portugal

Ácido Valpróico Sandoz 300 mg Comprimidos de libertação prolongada

300 mg

prolonged-release tablet

Oral Use

Portugal

| Generis Farmacêutica, S.A. |
| --- |
| Office Park da Beloura, Edifício 4, Quinta da Beloura |
| 2710-444 Sintra |
| Portugal |

Generis Farmacêutica, S.A.

Office Park da Beloura, Edifício 4, Quinta da Beloura

2710-444 Sintra

Portugal

Ácido Valpróico Generis

500 mg

prolonged-release tablet

Oral Use

Portugal

| Generis Farmacêutica, S.A. |
| --- |
| Office Park da Beloura, Edifício 4, Quinta da Beloura |
| 2710-444 Sintra |
| Portugal |

Generis Farmacêutica, S.A.

Office Park da Beloura, Edifício 4, Quinta da Beloura

2710-444 Sintra

Portugal

Ácido Valpróico Generis

300 mg

prolonged-release tablet

Oral Use

Portugal

| Sandoz Farmacêutica, Lda. |
| --- |
| Alameda da Beloura, Edifício 1, 2o - Escritório 15 |
| 2710-693 Sintra |
| Portugal |

Sandoz Farmacêutica, Lda.

Alameda da Beloura, Edifício 1, 2o - Escritório 15

2710-693 Sintra

Portugal

Ácido Valpróico Sandoz 500 mg Comprimidos de libertação prolongada

500 mg

prolonged-release tablet

Oral Use

Portugal

| Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda. |
| --- |
| Rua Quinta do Pinheiro |
| Edifício Tejo - 6o Piso |
| 2790-143 Carnaxide |
| Portugal |

Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda.

Rua Quinta do Pinheiro

Edifício Tejo - 6o Piso

2790-143 Carnaxide

Portugal

Ácido Valpróico Ratiopharm 300 mg Comprimidos de libertação prolongada

300 mg

prolonged-release tablet

Oral Use

Portugal

| Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda. |
| --- |
| Rua Quinta do Pinheiro |
| Edifício Tejo - 6o Piso |
| 2790-143 Carnaxide |
| Portugal |

Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda.

Rua Quinta do Pinheiro

Edifício Tejo - 6o Piso

2790-143 Carnaxide

Portugal

Ácido Valpróico Ratiopharm 500 mg Comprimidos de libertação prolongada

500 mg

prolonged-release tablet

Oral Use

Romania

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13 boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS FRANCE

1-13 boulevard Romain Rolland

75014 Paris

France

DEPAKINE CHRONOSPHERE 100 mg

29,03 mg/66,66 mg

prolonged-release granules

Oral Use

Romania

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13 boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS FRANCE

1-13 boulevard Romain Rolland

75014 Paris

France

DEPAKINE CHRONOSPHERE 250 mg

72,61 mg/166,76 mg

prolonged-release granules

Oral Use

Romania

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13 boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS FRANCE

1-13 boulevard Romain Rolland

75014 Paris

France

DEPAKINE CHRONOSPHERE 500 mg

145,14 mg/333,3 mg

prolonged-release granules

Oral Use

Romania

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13 boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS FRANCE

1-13 boulevard Romain Rolland

75014 Paris

France

DEPAKINE CHRONOSPHERE 750 mg

217,75 mg/500,06 mg

prolonged-release granules

Oral Use

Romania

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13 boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS FRANCE

1-13 boulevard Romain Rolland

75014 Paris

France

DEPAKINE CHRONOSPHERE 1 000 mg

290,27 mg/666,60 mg

prolonged-release granules

Oral Use

Romania

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13 boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS FRANCE

1-13 boulevard Romain Rolland

75014 Paris

France

DEPAKINE

57,64 mg/ml

syrup

Oral Use

Romania

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13 boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS FRANCE

1-13 boulevard Romain Rolland

75014 Paris

France

DEPAKINE CHRONO 300 mg

87 mg/199,8 mg

prolonged – release tablet

Oral Use

Romania

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13 boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS FRANCE

1-13 boulevard Romain Rolland

75014 Paris

France

DEPAKINE CHRONO 500 mg

145 mg/333 mg

prolonged – release tablet

Oral Use

Romania

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13 boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS FRANCE

1-13 boulevard Romain Rolland

75014 Paris

France

DEPAKINE 200 mg

200 mg

gastro – resistant tablet

Oral Use

Romania

| DESITIN ARZNEIMITTEL GmbH |
| --- |
| Weg Beim Jäger 214 |
| 22335 Hamburg |
| Germany |

DESITIN ARZNEIMITTEL GmbH

Weg Beim Jäger 214

22335 Hamburg

Germany

ORFIRIL 150

150 mg

gastro - resistant tablet

Oral Use

Romania

| DESITIN ARZNEIMITTEL GmbH |
| --- |
| Weg Beim Jäger 214 |
| 22335 Hamburg |
| Germany |

DESITIN ARZNEIMITTEL GmbH

Weg Beim Jäger 214

22335 Hamburg

Germany

ORFIRIL 300

300 mg

gastro - resistant tablet

Oral Use

Romania

| DESITIN ARZNEIMITTEL GmbH |
| --- |
| Weg Beim Jäger 214 |
| 22335 Hamburg |
| Germany |

DESITIN ARZNEIMITTEL GmbH

Weg Beim Jäger 214

22335 Hamburg

Germany

ORFIRIL 600

600 mg

gastro - resistant tablet

Oral Use

Romania

| DESITIN ARZNEIMITTEL GmbH |
| --- |
| Weg Beim Jäger 214 |
| 22335 Hamburg |
| Germany |

DESITIN ARZNEIMITTEL GmbH

Weg Beim Jäger 214

22335 Hamburg

Germany

ORFIRIL LONG 150 mg

150 mg

prolonged-release capsule

Oral Use

Romania

| DESITIN ARZNEIMITTEL GmbH |
| --- |
| Weg Beim Jäger 214 |
| 22335 Hamburg |
| Germany |

DESITIN ARZNEIMITTEL GmbH

Weg Beim Jäger 214

22335 Hamburg

Germany

ORFIRIL LONG 300 mg

300 mg

prolonged-release capsule

Oral Use

Romania

| DESITIN ARZNEIMITTEL GmbH |
| --- |
| Weg Beim Jäger 214 |
| 22335 Hamburg |
| Germany |

DESITIN ARZNEIMITTEL GmbH

Weg Beim Jäger 214

22335 Hamburg

Germany

ORFIRIL LONG 500 mg

500 mg

prolonged-release granules

Oral Use

Romania

| DESITIN ARZNEIMITTEL GmbH |
| --- |
| Weg Beim Jäger 214 |
| 22335 Hamburg |
| Germany |

DESITIN ARZNEIMITTEL GmbH

Weg Beim Jäger 214

22335 Hamburg

Germany

ORFIRIL LONG 1 000 mg

1 000 mg

prolonged-release granules

Oral Use

Romania

| DESITIN ARZNEIMITTEL GmbH |
| --- |
| Weg Beim Jäger 214 |
| 22335 Hamburg |
| Germany |

DESITIN ARZNEIMITTEL GmbH

Weg Beim Jäger 214

22335 Hamburg

Germany

ORFIRIL SIROP

300 mg/5 ml

syrup

Oral Use

Romania

| GEROT PHARMAZEUTIKA Ges.m.b.H. |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| Austria |

GEROT PHARMAZEUTIKA Ges.m.b.H.

Arnethgasse 3

A-1160 Wien

Austria

CONVULEX 150 mg

150 mg

gastro-resistant capsule, soft

Oral Use

Romania

| GEROT PHARMAZEUTIKA Ges.m.b.H. |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| Austria |

GEROT PHARMAZEUTIKA Ges.m.b.H.

Arnethgasse 3

A-1160 Wien

Austria

CONVULEX 300 mg

300 mg

gastro-resistant capsule, soft

Oral Use

Romania

| GEROT PHARMAZEUTIKA Ges.m.b.H. |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| Austria |

GEROT PHARMAZEUTIKA Ges.m.b.H.

Arnethgasse 3

A-1160 Wien

Austria

CONVULEX 500 mg

500 mg

gastro-resistant capsule, soft

Oral Use

Romania

| GEROT PHARMAZEUTIKA Ges.m.b.H. |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| Austria |

GEROT PHARMAZEUTIKA Ges.m.b.H.

Arnethgasse 3

A-1160 Wien

Austria

CONVULEX RETARD 300 mg

300 mg

prolonged-release tablet

Oral Use

Romania

| GEROT PHARMAZEUTIKA Ges.m.b.H. |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| Austria |

GEROT PHARMAZEUTIKA Ges.m.b.H.

Arnethgasse 3

A-1160 Wien

Austria

CONVULEX RETARD 500 mg

500 mg

prolonged-release tablet

Oral Use

Romania

| GEROT PHARMAZEUTIKA Ges.m.b.H. |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| Austria |

GEROT PHARMAZEUTIKA Ges.m.b.H.

Arnethgasse 3

A-1160 Wien

Austria

CONVULEX 50 mg/ml

50 mg/ml

syrup

Oral Use

Romania

| REMEDICA Ltd. |
| --- |
| Limassol Industrial Estate |
| Aharnon P.O Box 51706 |
| 3508 Limassol |
| Cyprus |

REMEDICA Ltd.

Limassol Industrial Estate

Aharnon P.O Box 51706

3508 Limassol

Cyprus

PETILIN 200

200 mg

film-coated tablet

Oral Use

Romania

| S.C. ARENA GROUP S.A. |
| --- |
| Str. Ștefan Mihăileanu nr. 31 |
| Sector 2, București |
| România |

S.C. ARENA GROUP S.A.

Str. Ștefan Mihăileanu nr. 31

Sector 2, București

România

VALEPIL

200 mg/5 ml

syrup

Oral Use

The Netherlands

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| The Netherlands |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

Propymal Enteric 150 mg

150 mg

gastro-resistant capsule, soft

Oral Use

The Netherlands

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| The Netherlands |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

Propymal Enteric 300 mg

300 mg

gastro-resistant capsule, soft

Oral Use

The Netherlands

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| The Netherlands |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

Propymal Enteric 450 mg

450 mg

gastro-resistant capsule, soft

Oral Use

The Netherlands

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| The Netherlands |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

Propymal Enteric 600 mg

600 mg

gastro-resistant capsule, soft

Oral Use

The Netherlands

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| The Netherlands |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

The Netherlands

Depakine Zuur

125 mg

gastro-resistant capsule, soft

Oral Use

The Netherlands

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| The Netherlands |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

The Netherlands

Depakine Zuur

250 mg

gastro-resistant capsule, soft

Oral Use

The Netherlands

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| The Netherlands |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

The Netherlands

Depakine Zuur

500 mg

gastro-resistant capsule, soft

Oral Use

The Netherlands

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| The Netherlands |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

The Netherlands

Depakine

300 mg

tablet

Oral Use

The Netherlands

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| The Netherlands |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

The Netherlands

Depakine

300 mg/ml

oral drops, solution

Oral Use

The Netherlands

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| The Netherlands |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

The Netherlands

Depakine Retard

300 mg

modified-release tablet

Oral Use

The Netherlands

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| The Netherlands |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

The Netherlands

Depakine Enteric

150 mg

gastro-resistant tablet

Oral Use

The Netherlands

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| The Netherlands |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

The Netherlands

Depakine Enteric

300 mg

gastro-resistant tablet

Oral Use

The Netherlands

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| The Netherlands |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

The Netherlands

Depakine Enteric

500 mg

gastro-resistant tablet

Oral Use

The Netherlands

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| The Netherlands |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

The Netherlands

Depakine vloeistof voor kinderen

300 mg/ml

oral solution

Oral Use

The Netherlands

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| The Netherlands |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

The Netherlands

Depakine suikervrije stroop

40 mg/ml

syrup

Oral Use

The Netherlands

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| The Netherlands |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

The Netherlands

Natriumvalproaat Enteric Winthrop 150 mg

150 mg

gastro-resistant tablet

Oral Use

The Netherlands

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| The Netherlands |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

The Netherlands

Natriumvalproaat Enteric Winthrop 300 mg

300 mg

gastro-resistant tablet

Oral Use

The Netherlands

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| The Netherlands |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

The Netherlands

Natriumvalproaat Enteric Winthrop 500 mg

500 mg

gastro-resistant tablet

Oral Use

The Netherlands

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| The Netherlands |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

The Netherlands

Natrii Valproas

300 mg

gastro-resistant tablet

Oral Use

The Netherlands

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| The Netherlands |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

Natriumvalproaat Apotex 150 mg

150 mg

gastro-resistant tablet

Oral Use

The Netherlands

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| The Netherlands |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

Natriumvalproaat Apotex 300 mg

300 mg

gastro-resistant tablet

Oral Use

The Netherlands

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| The Netherlands |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

Natriumvalproaat Apotex 600 mg

600 mg

gastro-resistant tablet

Oral Use

The Netherlands

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| The Netherlands |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

Natriumvalproaat Apotex 300 mg/5 ml

60 mg/ml

oral solution

Oral Use

The Netherlands

| Pharmachemie BV |
| --- |
| Swensweg 5 |
| NL-2003 RN Haarlem |
| The Netherlands |

Pharmachemie BV

Swensweg 5

NL-2003 RN Haarlem

The Netherlands

Orfiril CR 150 mg

150 mg

modified-release capsule

Oral Use

The Netherlands

| Pharmachemie BV |
| --- |
| Swensweg 5 |
| NL-2003 RN Haarlem |
| The Netherlands |

Pharmachemie BV

Swensweg 5

NL-2003 RN Haarlem

The Netherlands

Orfiril CR 300 mg

300 mg

modified-release capsule

Oral Use

The Netherlands

| Pharmachemie BV |
| --- |
| Swensweg 5 |
| NL-2003 RN Haarlem |
| The Netherlands |

Pharmachemie BV

Swensweg 5

NL-2003 RN Haarlem

The Netherlands

Orfiril CR 500 mg

500 mg

modified-release granules

Oral Use

The Netherlands

| Pharmachemie BV |
| --- |
| Swensweg 5 |
| NL-2003 RN Haarlem |
| The Netherlands |

Pharmachemie BV

Swensweg 5

NL-2003 RN Haarlem

The Netherlands

Orfiril CR 1 000 mg

1 000 mg

modified-release granules

Oral Use

The Netherlands

| Ratiopharm Nederland B.V. |
| --- |
| Ronde Tocht 11 |
| NL-1507 CC Zaandam |
| The Netherlands |

Ratiopharm Nederland B.V.

Ronde Tocht 11

NL-1507 CC Zaandam

The Netherlands

Natriumvalproaat ratiopharm chrono 300 mg

300 mg

modified-release tablet

Oral Use

The Netherlands

| Ratiopharm Nederland B.V. |
| --- |
| Ronde Tocht 11 |
| NL-1507 CC Zaandam |
| The Netherlands |

Ratiopharm Nederland B.V.

Ronde Tocht 11

NL-1507 CC Zaandam

The Netherlands

Natriumvalproaat ratiopharm chrono 500 mg

500 mg

modified-release tablet

Oral Use

The Netherlands

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| The Netherlands |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

The Netherlands

Depakine Chrono 300

200 mg sodium valproate and 87 mg valproic acid

modified-release tablet

Oral Use

The Netherlands

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| The Netherlands |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

The Netherlands

Depakine Chrono 500

333 mg sodium valproate and 145 mg valproic acid

modified-release tablet

Oral Use

The Netherlands

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| The Netherlands |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

The Netherlands

Natriumvalproaat Chrono Winthrop 300 mg

200 mg sodium valproate and 87 mg valproic acid

modified-release tablet

Oral Use

The Netherlands

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| The Netherlands |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

The Netherlands

Natriumvalproaat Chrono Winthrop 500 mg

333 mg sodium valproate and 145 mg valproic acid

modified-release tablet

Oral Use

The Netherlands

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| The Netherlands |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

The Netherlands

Depakine Chronosphere

220 mg sodium valproate and 95,8 mg valproic acid per gram

modified-release granules

Oral Use

The Netherlands

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| The Netherlands |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

The Netherlands

Depakine Chronosphere 50 mg

33,33 sodium valproate and 14,51 mg valproic acid per sachet

modified-release granules

Oral Use

The Netherlands

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| The Netherlands |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

The Netherlands

Depakine Chronosphere 100 mg

66,66 sodium valproate and 29,03 mg valproic acid per sachet

modified-release granules

Oral Use

The Netherlands

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| The Netherlands |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

The Netherlands

Depakine Chronosphere 250 mg

166,76 sodium valproate and 72,61 mg valproic acid per sachet

modified-release granules

Oral Use

The Netherlands

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| The Netherlands |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

The Netherlands

Depakine Chronosphere 500 mg

333,30 sodium valproate and 145,14 mg valproic acid per sachet

modified-release granules

Oral Use

The Netherlands

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| The Netherlands |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

The Netherlands

Depakine Chronosphere 750 mg

500,06 sodium valproate and 217,75 mg valproic acid per sachet

modified-release granules

Oral Use

The Netherlands

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| The Netherlands |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

The Netherlands

Depakine Chronosphere 1 000 mg

666,60 sodium valproate and 290,27 mg valproic acid per sachet

modified-release granules

Oral Use

The Netherlands

| Ratiopharm Nederland B.V. |
| --- |
| Florapark 4 |
| 2012 HK Haarlem |
| The Netherlands |

Ratiopharm Nederland B.V.

Florapark 4

2012 HK Haarlem

The Netherlands

Natriumvalproaat ratiopharm chrono 300 mg

200 mg sodium valproate and 87 mg valproic acid

prolonged-release tablet

Oral Use

The Netherlands

| Ratiopharm Nederland B.V. |
| --- |
| Florapark 4 |
| 2012 HK Haarlem |
| The Netherlands |

Ratiopharm Nederland B.V.

Florapark 4

2012 HK Haarlem

The Netherlands

Natriumvalproaat ratiopharm chrono 500 mg

333 mg sodium valproate and 145 mg valproic acid

prolonged-release tablet

Oral Use

The Netherlands

| Centrafarm Services BV |
| --- |
| Nieuwe Donk 9 |
| 4879 AC Etten-Leur |
| The Netherlands |

Centrafarm Services BV

Nieuwe Donk 9

4879 AC Etten-Leur

The Netherlands

Natriumvalproaat Chrono CF 300 mg

200 mg sodium valproate and 87 mg valproic acid

prolonged-release tablet

Oral Use

The Netherlands

| Centrafarm Services BV |
| --- |
| Nieuwe Donk 9 |
| 4879 AC Etten-Leur |
| The Netherlands |

Centrafarm Services BV

Nieuwe Donk 9

4879 AC Etten-Leur

The Netherlands

Natriumvalproaat Chrono CF 500 mg

333 mg sodium valproate and 145 mg valproic acid

prolonged-release tablet

Oral Use

The Netherlands

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| NL-1327 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

NL-1327 AH Almere

The Netherlands

Natriumvalproaat Chrono Sandoz 300 mg

200 mg sodium valproate and 87 mg valproic acid

prolonged-release tablet

Oral Use

The Netherlands

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| NL-1327 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

NL-1327 AH Almere

The Netherlands

Natriumvalproaat Chrono Sandoz 500 mg

333 mg sodium valproate and 145 mg valproic acid

prolonged-release tablet

Oral Use

The Netherlands

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| NL-1327 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

NL-1327 AH Almere

The Netherlands

Natriumvalproaat Sandoz Chrono 300

200 mg sodium valproate and 87 mg valproic acid

prolonged-release tablet

Oral Use

The Netherlands

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| NL-1327 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

NL-1327 AH Almere

The Netherlands

Natriumvalproaat Sandoz Chrono 500

333 mg sodium valproate and 145 mg valproic acid

prolonged-release tablet

Oral Use

Slovakia

| Orion Corporation |
| --- |
| Orion Pharma |
| Orionintrie 1 |
| 02200 Espoo |
| Finland |

Orion Corporation

Orion Pharma

Orionintrie 1

02200 Espoo

Finland

Absenor 300 mg tablety s predĺženým uvoľňovaním

300 mg

prolonged-release tablet

Oral Use

Slovakia

| Orion Corporation |
| --- |
| Orion Pharma |
| Orionintrie 1 |
| 02200 Espoo |
| Finland |

Orion Corporation

Orion Pharma

Orionintrie 1

02200 Espoo

Finland

Absenor 500 mg tablety s predĺženým uvoľňovaním

500 mg

prolonged-release tablet

Oral Use

Slovakia

| G.L. Pharma GmbH Schlossplatz 1 |
| --- |
| 8502 Lannach |
| Austria |

G.L. Pharma GmbH Schlossplatz 1

8502 Lannach

Austria

Convulex 150 mg kapsuly

150 mg

capsule

Oral Use

Slovakia

| G.L. Pharma GmbH Schlossplatz 1 |
| --- |
| 8502 Lannach |
| Austria |

G.L. Pharma GmbH Schlossplatz 1

8502 Lannach

Austria

Convulex 300 mg kapsuly

300 mg

capsule

Oral Use

Slovakia

| G.L. Pharma GmbH Schlossplatz 1 |
| --- |
| 8502 Lannach |
| Austria |

G.L. Pharma GmbH Schlossplatz 1

8502 Lannach

Austria

Convulex 500 mg kapsuly

500 mg

capsule

Oral Use

Slovakia

| G.L. Pharma GmbH Schlossplatz 1 |
| --- |
| 8502 Lannach |
| Austria |

G.L. Pharma GmbH Schlossplatz 1

8502 Lannach

Austria

CONVULEX

50 mg/ml

syrup

Oral Use

Slovakia

| G.L. Pharma GmbH Schlossplatz 1 |
| --- |
| 8502 Lannach |
| Austria |

G.L. Pharma GmbH Schlossplatz 1

8502 Lannach

Austria

Convulex 300 mg/ml kvapky

300 mg/ml

oral drops

Oral Use

Slovakia

| Sanofi-aventis Slovakia, s.r.o., |
| --- |
| Žilinská 7-9 |
| 811 05 Bratislava |
| Slovakia |

Sanofi-aventis Slovakia, s.r.o.,

Žilinská 7-9

811 05 Bratislava

Slovakia

DEPAKINE

100 mg/ml

syrup

Oral Use

Slovakia

| Sanofi-aventis Slovakia, s.r.o., |
| --- |
| Žilinská 7-9 |
| 811 05 Bratislava |
| Slovakia |

Sanofi-aventis Slovakia, s.r.o.,

Žilinská 7-9

811 05 Bratislava

Slovakia

DEPAKINE CHRONO 500 mg

500 mg

film-coated prolonged release tablet

Oral Use

Slovakia

| Sanofi-aventis Slovakia, s.r.o., |
| --- |
| Žilinská 7-9 |
| 811 05 Bratislava |
| Slovakia |

Sanofi-aventis Slovakia, s.r.o.,

Žilinská 7-9

811 05 Bratislava

Slovakia

Depakine Chronosphere 50 mg

50 mg

modified-release granules

Oral Use

Slovakia

| Sanofi-aventis Slovakia, s.r.o., |
| --- |
| Žilinská 7-9 |
| 811 05 Bratislava |
| Slovakia |

Sanofi-aventis Slovakia, s.r.o.,

Žilinská 7-9

811 05 Bratislava

Slovakia

Depakine Chronosphere 100 mg

100 mg

modified-release granules

Oral Use

Slovakia

| Sanofi-aventis Slovakia, s.r.o., |
| --- |
| Žilinská 7-9 |
| 811 05 Bratislava |
| Slovakia |

Sanofi-aventis Slovakia, s.r.o.,

Žilinská 7-9

811 05 Bratislava

Slovakia

Depakine Chronosphere 250 mg

250 mg

modified-release granules

Oral Use

Slovakia

| Sanofi-aventis Slovakia, s.r.o., |
| --- |
| Žilinská 7-9 |
| 811 05 Bratislava |
| Slovakia |

Sanofi-aventis Slovakia, s.r.o.,

Žilinská 7-9

811 05 Bratislava

Slovakia

Depakine Chronosphere 500 mg

500 mg

modified-release granules

Oral Use

Slovakia

| Sanofi-aventis Slovakia, s.r.o., |
| --- |
| Žilinská 7-9 |
| 811 05 Bratislava |
| Slovakia |

Sanofi-aventis Slovakia, s.r.o.,

Žilinská 7-9

811 05 Bratislava

Slovakia

Depakine Chronosphere 750 mg

750 mg

modified-release granules

Oral Use

Slovakia

| Sanofi-aventis Slovakia, s.r.o., |
| --- |
| Žilinská 7-9 |
| 811 05 Bratislava |
| Slovakia |

Sanofi-aventis Slovakia, s.r.o.,

Žilinská 7-9

811 05 Bratislava

Slovakia

Depakine Chronosphere 1 000 mg

1 000 mg

modified-release granules

Oral Use

Slovakia

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Germany

Orfiril 150

150 mg

gastro-resistant tablet

Oral Use

Slovakia

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Germany

Orfiril 300

300 mg

gastro-resistant tablet

Oral Use

Slovakia

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Germany

Orfiril 600

600 mg

gastro-resistant tablet

Oral Use

Slovakia

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Germany

Orfiril long 150 mg

150 mg

prolonged-release capsule

Oral Use

Slovakia

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Germany

Orfiril long 300 mg

300 mg

prolonged-release capsule

Oral Use

Slovakia

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Germany

Orfiril long 500 mg

500 mg

prolonged-release tablet

Oral Use

Slovakia

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Germany

Orfiril long 1 000 mg

1 000 mg

prolonged-release tablet

Oral Use

Slovakia

| Ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| 89079 Ulm |
| Germany |

Ratiopharm GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Valpro-ratiopharm Chrono 500 mg

500 mg

prolonged-release tablet

Oral Use

Slovakia

| Sandoz Pharmaceuticals d.d., Verovškova 57 |
| --- |
| 1000 Ljubljana |
| Slovenia |

Sandoz Pharmaceuticals d.d., Verovškova 57

1000 Ljubljana

Slovenia

Valproát chrono Sandoz 300 mg tablety s predĺženým uvoľňovaním

300 mg

prolonged-release tablet

Oral Use

Slovakia

| Sandoz Pharmaceuticals d.d., Verovškova 57 |
| --- |
| 1000 Ljubljana |
| Slovenia |

Sandoz Pharmaceuticals d.d., Verovškova 57

1000 Ljubljana

Slovenia

Valproát chrono Sandoz 500 mg tablety s predľženým uvoľňovaním

500 mg

prolonged-release tablet

Oral Use

Slovenia

| Sanofi-Aventis d.o.o. |
| --- |
| Dunajska c. 119 |
| 1000 Ljubljana |
| Slovenia |

Sanofi-Aventis d.o.o.

Dunajska c. 119

1000 Ljubljana

Slovenia

Depakine chrono 500 mg filmsko obložene tablet s podaljšanim sproščanjem

500 mg

prolonged-release tablet

Oral Use

Slovenia

| Sanofi-Aventis d.o.o. |
| --- |
| Dunajska c. 119 |
| 1000 Ljubljana |
| Slovenia |

Sanofi-Aventis d.o.o.

Dunajska c. 119

1000 Ljubljana

Slovenia

Depakine chrono 300 mg filmsko obložene tablet s podaljšanim sproščanjem

300 mg

prolonged-release tablet

Oral Use

Spain

| SANOFI AVENTIS, S.A. |
| --- |
| Josep Plá, 2 |
| 08019 Barcelona |
| Spain |

SANOFI AVENTIS, S.A.

Josep Plá, 2

08019 Barcelona

Spain

DEPAKINE 200 mg comprimidos gastrorresistentes

200 mg

gastro-resistant tablet

Oral Use

Spain

| SANOFI AVENTIS, S.A. |
| --- |
| Josep Plá, 2 |
| 08019 Barcelona |
| Spain |

SANOFI AVENTIS, S.A.

Josep Plá, 2

08019 Barcelona

Spain

DEPAKINE solución oral

200 mg/ml

oral solution

Oral Use

Spain

| SANOFI AVENTIS, S.A. |
| --- |
| Josep Plá, 2 |
| 08019 Barcelona |
| Spain |

SANOFI AVENTIS, S.A.

Josep Plá, 2

08019 Barcelona

Spain

DEPAKINE CRONO 500 mg comprimidos recubiertos

500 mg

coated tablet

Oral Use

Spain

| SANOFI AVENTIS, S.A. |
| --- |
| Josep Plá, 2 |
| 08019 Barcelona |
| Spain |

SANOFI AVENTIS, S.A.

Josep Plá, 2

08019 Barcelona

Spain

DEPAKINE CRONO 300 mg comprimidos recubiertos

300 mg

coated tablet

Oral Use

Spain

| SANOFI AVENTIS, S.A. |
| --- |
| Josep Plá, 2 |
| 08019 Barcelona |
| Spain |

SANOFI AVENTIS, S.A.

Josep Plá, 2

08019 Barcelona

Spain

DEPAKINE 500 mg comprimidos gastrorresistentes

500 mg

gastro-resistant tablet

Oral Use

Spain

| SANOFI AVENTIS, S.A. |
| --- |
| Josep Plá, 2 |
| 08019 Barcelona |
| Spain |

SANOFI AVENTIS, S.A.

Josep Plá, 2

08019 Barcelona

Spain

DEPAKINE CHRONOSPHERE 100 MG Granulado de liberación modificada

100 mg

modified-release granules

Oral Use

Spain

| SANOFI AVENTIS, S.A. |
| --- |
| Josep Plá, 2 |
| 08019 Barcelona |
| Spain |

SANOFI AVENTIS, S.A.

Josep Plá, 2

08019 Barcelona

Spain

DEPAKINE CHRONOSPHERE 250 mg granulado de liberación modificada

250 mg

modified-release granules

Oral Use

Spain

| SANOFI AVENTIS, S.A. |
| --- |
| Josep Plá, 2 |
| 08019 Barcelona |
| Spain |

SANOFI AVENTIS, S.A.

Josep Plá, 2

08019 Barcelona

Spain

DEPAKINE CHRONOSPHERE 500 MG Granulado de liberación modificada

500 mg

modified-release granules

Oral Use

Spain

| SANOFI AVENTIS, S.A. |
| --- |
| Josep Plá, 2 |
| 08019 Barcelona |
| Spain |

SANOFI AVENTIS, S.A.

Josep Plá, 2

08019 Barcelona

Spain

DEPAKINE CHRONOSPHERE 750 MG Granulado de liberación modificada

750 mg

modified-release granules

Oral Use

Spain

| SANOFI AVENTIS, S.A. |
| --- |
| Josep Plá, 2 |
| 08019 Barcelona |
| Spain |

SANOFI AVENTIS, S.A.

Josep Plá, 2

08019 Barcelona

Spain

DEPAKINE CHRONOSPHERE 1 000 MG Granulado de liberación modificada

1 000 mg

modified-release granules

Oral Use

Spain

| WINTHROP PHARMA ESPAÑA, S.A. |
| --- |
| Josep Plá, 2 |
| 08019 Barcelona |
| Spain |

WINTHROP PHARMA ESPAÑA, S.A.

Josep Plá, 2

08019 Barcelona

Spain

VALPROATO SODICO CRONO WINTHROP 300 mg comprimidos de liberación prolongada

300 mg

prolonged-release tablet

Oral Use

Spain

| WINTHROP PHARMA ESPAÑA, S.A. |
| --- |
| Josep Plá, 2 |
| 08019 Barcelona |
| Spain |

WINTHROP PHARMA ESPAÑA, S.A.

Josep Plá, 2

08019 Barcelona

Spain

VALPROATO SODICO CRONO WINTHROP 500 mg comprimidos de liberación prolongada

500 mg

prolonged-release tablet

Oral Use

Spain

| DESITIN ARZNEIMITTEL GMBH |
| --- |
| Weg beim Jäger 214 |
| Hamburgo D-22335 |
| Germany |

DESITIN ARZNEIMITTEL GMBH

Weg beim Jäger 214

Hamburgo D-22335

Germany

MILZONE 300 MG CÁPSULAS DURAS DE LIBERACIÓN PROLONGADA

300 mg

prolonged-release capsule

Oral Use

Spain

| DESITIN ARZNEIMITTEL GMBH |
| --- |
| Weg beim Jäger 214 |
| Hamburgo D-22335 |
| Germany |

DESITIN ARZNEIMITTEL GMBH

Weg beim Jäger 214

Hamburgo D-22335

Germany

MILZONE 1 000 MG GRÁNULOS DE LIBERACIÓN PROLONGADA

1 000 mg

prolonged -release granules

Oral Use

Spain

| DESITIN ARZNEIMITTEL GMBH |
| --- |
| Weg beim Jäger 214 |
| Hamburgo D-22335 |
| Germany |

DESITIN ARZNEIMITTEL GMBH

Weg beim Jäger 214

Hamburgo D-22335

Germany

MILZONE 500 MG GRÁNULOS DE LIBERACIÓN PROLONGADA

500 mg

prolonged -release granules

Oral Use

Spain

| DESITIN ARZNEIMITTEL GMBH |
| --- |
| Weg beim Jäger 214 |
| Hamburgo D-22335 |
| Germany |

DESITIN ARZNEIMITTEL GMBH

Weg beim Jäger 214

Hamburgo D-22335

Germany

MILZONE 300 MG CÁPSULAS DURAS DE LIBERACIÓN PROLONGADA

300 mg

prolonged-release capsule

Oral Use

Sweden

| Orion Corporation |
| --- |
| Orionintie |
| FI-02200 Espoo |
| Finland |

Orion Corporation

Orionintie

FI-02200 Espoo

Finland

Absenor

200 mg/ml

oral drops, solution

Oral Use

Sweden

| Orion Corporation |
| --- |
| Orionintie |
| FI-02200 Espoo |
| Finland |

Orion Corporation

Orionintie

FI-02200 Espoo

Finland

Absenor

300 mg

tablet

Oral Use

Sweden

| Orion Corporation |
| --- |
| Orionintie |
| FI-02200 Espoo |
| Finland |

Orion Corporation

Orionintie

FI-02200 Espoo

Finland

Absenor

100 mg

gastro-resistant tablet

Oral Use

Sweden

| Orion Corporation |
| --- |
| Orionintie |
| FI-02200 Espoo |
| Finland |

Orion Corporation

Orionintie

FI-02200 Espoo

Finland

Absenor

300 mg

gastro-resistant tablet

Oral Use

Sweden

| Orion Corporation |
| --- |
| Orionintie |
| FI-02200 Espoo |
| Finland |

Orion Corporation

Orionintie

FI-02200 Espoo

Finland

Absenor

500 mg

gastro-resistant tablet

Oral Use

Sweden

| Orion Corporation |
| --- |
| Orionintie |
| FI-02200 Espoo |
| Finland |

Orion Corporation

Orionintie

FI-02200 Espoo

Finland

Absenor

60 mg/ml

oral solution

Oral Use

Sweden

| Orion Corporation |
| --- |
| Orionintie |
| FI-02200 Espoo |
| Finland |

Orion Corporation

Orionintie

FI-02200 Espoo

Finland

Absenor Depot

300 mg

prolonged-release tablet

Oral Use

Sweden

| Orion Corporation |
| --- |
| Orionintie |
| FI-02200 Espoo |
| Finland |

Orion Corporation

Orionintie

FI-02200 Espoo

Finland

Absenor Depot

500 mg

prolonged-release tablet

Oral Use

Sweden

| Sanofi-aventis AB |
| --- |
| Box 14142 |
| 167 14 Bromma |
| Sweden |

Sanofi-aventis AB

Box 14142

167 14 Bromma

Sweden

Ergenyl

200 mg/ml

oral drops, solution

Oral Use

Sweden

| Sanofi-aventis AB |
| --- |
| Box 14142 |
| 167 14 Bromma |
| Sweden |

Sanofi-aventis AB

Box 14142

167 14 Bromma

Sweden

Ergenyl

100 mg

gastro-resistant tablet

Oral Use

Sweden

| Sanofi-aventis AB |
| --- |
| Box 14142 |
| 167 14 Bromma |
| Sweden |

Sanofi-aventis AB

Box 14142

167 14 Bromma

Sweden

Ergenyl

300 mg

gastro-resistant tablet

Oral Use

Sweden

| Sanofi-aventis AB |
| --- |
| Box 14142 |
| 167 14 Bromma |
| Sweden |

Sanofi-aventis AB

Box 14142

167 14 Bromma

Sweden

Ergenyl

500 mg

gastro-resistant tablet

Oral Use

Sweden

| Sanofi-aventis AB |
| --- |
| Box 14142 |
| 167 14 Bromma |
| Sweden |

Sanofi-aventis AB

Box 14142

167 14 Bromma

Sweden

Ergenyl

60 mg/ml

oral solution

Oral Use

Sweden

| Sanofi-aventis AB |
| --- |
| Box 14142 |
| 167 14 Bromma |
| Sweden |

Sanofi-aventis AB

Box 14142

167 14 Bromma

Sweden

Ergenyl Retard

300 mg

prolonged-release tablet

Oral Use

Sweden

| Sanofi-aventis AB |
| --- |
| Box 14142 |
| 167 14 Bromma |
| Sweden |

Sanofi-aventis AB

Box 14142

167 14 Bromma

Sweden

Ergenyl Retard

500 mg

prolonged-release tablet

Oral Use

Sweden

| Sanofi-aventis AB |
| --- |
| Box 14142 |
| 167 14 Bromma |
| Sweden |

Sanofi-aventis AB

Box 14142

167 14 Bromma

Sweden

Ergenyl Retard

100 mg

prolonged-release granules

Oral Use

Sweden

| Sanofi-aventis AB |
| --- |
| Box 14142 |
| 167 14 Bromma |
| Sweden |

Sanofi-aventis AB

Box 14142

167 14 Bromma

Sweden

Ergenyl Retard

250 mg

prolonged-release granules

Oral Use

Sweden

| Sanofi-aventis AB |
| --- |
| Box 14142 |
| 167 14 Bromma |
| Sweden |

Sanofi-aventis AB

Box 14142

167 14 Bromma

Sweden

Ergenyl Retard

500 mg

prolonged-release granules

Oral Use

Sweden

| Sanofi-aventis AB |
| --- |
| Box 14142 |
| 167 14 Bromma |
| Sweden |

Sanofi-aventis AB

Box 14142

167 14 Bromma

Sweden

Ergenyl Retard

750 mg

prolonged-release granules

Oral Use

Sweden

| Sanofi-aventis AB |
| --- |
| Box 14142 |
| 167 14 Bromma |
| Sweden |

Sanofi-aventis AB

Box 14142

167 14 Bromma

Sweden

Ergenyl Retard

1 000 mg

prolonged-release granules

Oral Use

Sweden

| Desitin Arzneimittel GmbH |
| --- |
| Weg Beim Jäger 214 |
| 223 35 Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Weg Beim Jäger 214

223 35 Hamburg

Germany

Orfiril

150 mg

gastro-resistant tablet

Oral Use

Sweden

| Desitin Arzneimittel GmbH |
| --- |
| Weg Beim Jäger 214 |
| 223 35 Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Weg Beim Jäger 214

223 35 Hamburg

Germany

Orfiril

300 mg

gastro-resistant tablet

Oral Use

Sweden

| Desitin Arzneimittel GmbH |
| --- |
| Weg Beim Jäger 214 |
| 223 35 Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Weg Beim Jäger 214

223 35 Hamburg

Germany

Orfiri long

150 mg

prolonged-release capsule, hard

Oral Use

Sweden

| Desitin Arzneimittel GmbH |
| --- |
| Weg Beim Jäger 214 |
| 223 35 Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Weg Beim Jäger 214

223 35 Hamburg

Germany

Orfiril long

300 mg

prolonged-release capsule, hard

Oral Use

Sweden

| Desitin Arzneimittel GmbH |
| --- |
| Weg Beim Jäger 214 |
| 223 35 Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Weg Beim Jäger 214

223 35 Hamburg

Germany

Orfiril long

500 mg

prolonged-release granules

Oral Use

Sweden

| Desitin Arzneimittel GmbH |
| --- |
| Weg Beim Jäger 214 |
| 223 35 Hamburg |
| Germany |

Desitin Arzneimittel GmbH

Weg Beim Jäger 214

223 35 Hamburg

Germany

Orfiril long

1 000 mg

prolonged-release granules

Oral Use

United Kingdom

| Actavis UK Limited |
| --- |
| Whiddon Valley |
| Barnstaple |
| North Devon |
| EX32 8NS |
| United Kingdom |

Actavis UK Limited

Whiddon Valley

Barnstaple

North Devon

EX32 8NS

United Kingdom

SODIUM VALPROATE TABLETS BP 200 MG (E/C)

200 mg

gastro-resistant tablet

Oral Use

United Kingdom

| TEVA UK LIMITED |
| --- |
| Brampton Road |
| Hampden Park |
| Eastbourne |
| East Sussex |
| BN22 9AG |
| United Kingdom |

TEVA UK LIMITED

Brampton Road

Hampden Park

Eastbourne

East Sussex

BN22 9AG

United Kingdom

SODIUM VALPROATE ENTERIC COATED TABLETS 200 MG

200 mg

coated tablet

Oral Use

United Kingdom

| TEVA UK LIMITED |
| --- |
| Brampton Road |
| Hampden Park |
| Eastbourne |
| East Sussex |
| BN22 9AG |
| United Kingdom |

TEVA UK LIMITED

Brampton Road

Hampden Park

Eastbourne

East Sussex

BN22 9AG

United Kingdom

SODIUM VALPROATE ENTERIC COATED TABLETS 500 MG

500 mg

coated tablet

Oral Use

United Kingdom

| NORTON HEALTHCARE LIMITED |
| --- |
| Albert Basin, Royal Dock |
| Canning Town |
| London E16 2QJ |
| United Kingdom |

NORTON HEALTHCARE LIMITED

Albert Basin, Royal Dock

Canning Town

London E16 2QJ

United Kingdom

SODIUM VALPROATE ORAL SOLUTION BP 200 MG/5 ML

200 mg/5 ml

oral solution

Oral Use

United Kingdom

| AVENTIS PHARMA LIMITED |
| --- |
| 50 Kings Hill Avenue |
| Kings Hill |
| West Malling, Kent. ME194AH |
| United Kingdom |

AVENTIS PHARMA LIMITED

50 Kings Hill Avenue

Kings Hill

West Malling, Kent. ME194AH

United Kingdom

DEPAKOTE 250 MG TABLETS

250 mg

gastro-resistant tablet

Oral Use

United Kingdom

| AVENTIS PHARMA LIMITED |
| --- |
| 50 Kings Hill Avenue |
| Kings Hill |
| West Malling, Kent. ME194AH |
| United Kingdom |

AVENTIS PHARMA LIMITED

50 Kings Hill Avenue

Kings Hill

West Malling, Kent. ME194AH

United Kingdom

DEPAKOTE 500 MG TABLETS

500 mg

gastro-resistant tablet

Oral Use

United Kingdom

| AVENTIS PHARMA LIMITED |
| --- |
| 50 Kings Hill Avenue |
| Kings Hill |
| West Malling, Kent. ME194AH |
| United Kingdom |

AVENTIS PHARMA LIMITED

50 Kings Hill Avenue

Kings Hill

West Malling, Kent. ME194AH

United Kingdom

EPILIM CHRONOSPHERE MR 50 MG MODIFIED RELEASE GRANULES

50 mg

modified-release granules

Oral Use

United Kingdom

| AVENTIS PHARMA LIMITED |
| --- |
| 50 Kings Hill Avenue |
| Kings Hill |
| West Malling, Kent. ME194AH |
| United Kingdom |

AVENTIS PHARMA LIMITED

50 Kings Hill Avenue

Kings Hill

West Malling, Kent. ME194AH

United Kingdom

EPILIM CHRONOSPHERE MR 100 MG MODIFIED RELEASE GRANULES

100 mg

modified-release granules

Oral Use

United Kingdom

| AVENTIS PHARMA LIMITED |
| --- |
| 50 Kings Hill Avenue |
| Kings Hill |
| West Malling, Kent. ME194AH |
| United Kingdom |

AVENTIS PHARMA LIMITED

50 Kings Hill Avenue

Kings Hill

West Malling, Kent. ME194AH

United Kingdom

EPILIM CHRONOSPHERE MR 250 MG MODIFIED RELEASE GRANULES

250 mg

modified-release granules

Oral Use

United Kingdom

| AVENTIS PHARMA LIMITED |
| --- |
| 50 Kings Hill Avenue |
| Kings Hill |
| West Malling, Kent. ME194AH |
| United Kingdom |

AVENTIS PHARMA LIMITED

50 Kings Hill Avenue

Kings Hill

West Malling, Kent. ME194AH

United Kingdom

EPILIM CHRONOSPHERE MR 500 MG MODIFIED RELEASE GRANULES

500 mg

modified-release granules

Oral Use

United Kingdom

| AVENTIS PHARMA LIMITED |
| --- |
| 50 Kings Hill Avenue |
| Kings Hill |
| West Malling, Kent. ME194AH |
| United Kingdom |

AVENTIS PHARMA LIMITED

50 Kings Hill Avenue

Kings Hill

West Malling, Kent. ME194AH

United Kingdom

EPILIM CHRONOSPHERE MR 750 MG MODIFIED RELEASE GRANULES

750 mg

modified-release granules

Oral Use

United Kingdom

| AVENTIS PHARMA LIMITED |
| --- |
| 50 Kings Hill Avenue |
| Kings Hill |
| West Malling, Kent. ME194AH |
| United Kingdom |

AVENTIS PHARMA LIMITED

50 Kings Hill Avenue

Kings Hill

West Malling, Kent. ME194AH

United Kingdom

EPILIM CHRONOSPHERE MR 1 000 MG MODIFIED RELEASE GRANULES

1 000 mg

modified-release granules

Oral Use

United Kingdom

| GENERICS (UK) LIMITED |
| --- |
| Station Close |
| Potters Bar |
| Herts, EN6 1TL |
| United Kingdom |

GENERICS (UK) LIMITED

Station Close

Potters Bar

Herts, EN6 1TL

United Kingdom

SODIUM VALPROATE TABLETS BP 200 MG

200 mg

coated tablet

Oral Use

United Kingdom

| GENERICS (UK) LIMITED |
| --- |
| Station Close |
| Potters Bar |
| Herts, EN6 1TL |
| United Kingdom |

GENERICS (UK) LIMITED

Station Close

Potters Bar

Herts, EN6 1TL

United Kingdom

SODIUM VALPROATE TABLETS BP 500 MG EC

500 mg

coated tablet

Oral Use

United Kingdom

| GEROT PHARMAZEUTIKA GES.M.B.H |
| --- |
| Arnethgasse 3 |
| A-1160, Vienna |
| Austria |

GEROT PHARMAZEUTIKA GES.M.B.H

Arnethgasse 3

A-1160, Vienna

Austria

CONVULEX CAPSULES 300 MG

300 mg

gastro-resistant capsule

Oral Use

United Kingdom

| GEROT PHARMAZEUTIKA GES.M.B.H |
| --- |
| Arnethgasse 3 |
| A-1160, Vienna |
| Austria |

GEROT PHARMAZEUTIKA GES.M.B.H

Arnethgasse 3

A-1160, Vienna

Austria

CONVULEX CAPSULES 500 MG

500 mg

gastro-resistant capsule

Oral Use

United Kingdom

| GEROT PHARMAZEUTIKA GES.M.B.H |
| --- |
| Arnethgasse 3 |
| A-1160, Vienna |
| Austria |

GEROT PHARMAZEUTIKA GES.M.B.H

Arnethgasse 3

A-1160, Vienna

Austria

CONVULEX CAPSULES 150 MG

150 mg

gastro-resistant capsule

Oral Use

United Kingdom

| GEROT PHARMAZEUTIKA GES.M.B.H |
| --- |
| Arnethgasse 3 |
| A-1160, Vienna |
| Austria |

GEROT PHARMAZEUTIKA GES.M.B.H

Arnethgasse 3

A-1160, Vienna

Austria

CONVULEX CR 300 MG PROLONGED RELEASE TABLETS

300 mg

prolonged-release tablet

Oral Use

United Kingdom

| GEROT PHARMAZEUTIKA GES.M.B.H |
| --- |
| Arnethgasse 3, |
| A-1160, Vienna, |
| Austria |

GEROT PHARMAZEUTIKA GES.M.B.H

Arnethgasse 3,

A-1160, Vienna,

Austria

CONVULEX CR 500 MG PROLONGED RELEASE TABLETS

500 mg

modified-release tablet

Oral Use

United Kingdom

| GEROT PHARMAZEUTIKA GES.M.B.H |
| --- |
| Arnethgasse 3 |
| A-1160, Vienna |
| Austria |

GEROT PHARMAZEUTIKA GES.M.B.H

Arnethgasse 3

A-1160, Vienna

Austria

EPIVAL CR 500 MG PROLONGED RELEASE TABLETS

500 mg

prolonged-release tablet

Oral Use

United Kingdom

| GEROT PHARMAZEUTIKA GES.M.B.H |
| --- |
| Arnethgasse 3 |
| A-1160, Vienna |
| Austria |

GEROT PHARMAZEUTIKA GES.M.B.H

Arnethgasse 3

A-1160, Vienna

Austria

EPIVAL CR 300 MG PROLONGED RELEASE TABLETS

300 mg

prolonged-release tablet

Oral Use

United Kingdom

| SANOFI-SYNTHELABO LIMITED |
| --- |
| 1 Onslow Street |
| Guildford, Surrey |
| GU1 4YS |
| United Kingdom |

SANOFI-SYNTHELABO LIMITED

1 Onslow Street

Guildford, Surrey

GU1 4YS

United Kingdom

EPILIM 100 MG CRUSHABLE TABLET

100 mg

tablet

Oral Use

United Kingdom

| SANOFI-SYNTHELABO LIMITED |
| --- |
| 1 Onslow Street |
| Guildford, Surrey |
| GU1 4YS |
| United Kingdom |

SANOFI-SYNTHELABO LIMITED

1 Onslow Street

Guildford, Surrey

GU1 4YS

United Kingdom

EPILIM 200 EC TABLETS

200 mg

gastro-resistant tablet

Oral Use

United Kingdom

| SANOFI-SYNTHELABO LIMITED |
| --- |
| 1 Onslow Street |
| Guildford, Surrey |
| GU1 4YS |
| United Kingdom |

SANOFI-SYNTHELABO LIMITED

1 Onslow Street

Guildford, Surrey

GU1 4YS

United Kingdom

EPILIM 500 ENTERIC COATED TABLETS

500 mg

gastro-resistant tablet

Oral Use

United Kingdom

| SANOFI-SYNTHELABO LIMITED |
| --- |
| 1 Onslow Street |
| Guildford, Surrey |
| GU1 4YS |
| United Kingdom |

SANOFI-SYNTHELABO LIMITED

1 Onslow Street

Guildford, Surrey

GU1 4YS

United Kingdom

EPILIM CHRONO 300 CONTROLLED RELEASE

300 mg

modified-release tablet

Oral Use

United Kingdom

| SANOFI-SYNTHELABO LIMITED |
| --- |
| 1 Onslow Street |
| Guildford, Surrey |
| GU1 4YS |
| United Kingdom |

SANOFI-SYNTHELABO LIMITED

1 Onslow Street

Guildford, Surrey

GU1 4YS

United Kingdom

EPILIM LIQUID OR SODIUM VALPROATE 200 MG/5 ML LIQUID

200 mg/5 ml

oral solution

Oral Use

United Kingdom

| SANOFI-SYNTHELABO LIMITED |
| --- |
| 1 Onslow Street |
| Guildford, Surrey |
| GU1 4YS |
| United Kingdom |

SANOFI-SYNTHELABO LIMITED

1 Onslow Street

Guildford, Surrey

GU1 4YS

United Kingdom

EPILIM SYRUP 200 MG/5 ML

200 mg/5 ml

oral solution

Oral Use

United Kingdom

| SANOFI-SYNTHELABO LIMITED |
| --- |
| 1 Onslow Street |
| Guildford, Surrey |
| GU1 4YS |
| United Kingdom |

SANOFI-SYNTHELABO LIMITED

1 Onslow Street

Guildford, Surrey

GU1 4YS

United Kingdom

EPILIM CHRONO 200 CONTROLLED RELEASE TABLETS 200 MG

200 mg

modified-release tablet

Oral Use

United Kingdom

| SANOFI-SYNTHELABO LIMITED |
| --- |
| 1 Onslow Street |
| Guildford, Surrey |
| GU1 4YS |
| United Kingdom |

SANOFI-SYNTHELABO LIMITED

1 Onslow Street

Guildford, Surrey

GU1 4YS

United Kingdom

EPILIM CHRONO 500 CONTROLLED RELEASE TABLETS 500 MG

500 mg

modified-release tablet

Oral Use

United Kingdom

| WINTHROP PHARMACEUTICALS UK LIMITED |
| --- |
| 1 Onslow Street |
| Guildford Surrey, |
| GU1 4YS |
| United Kingdom |

WINTHROP PHARMACEUTICALS UK LIMITED

1 Onslow Street

Guildford Surrey,

GU1 4YS

United Kingdom

SODIUM VALPROATE 200 MG ENTERIC COATED TABLETS

200 mg

gastro-resistant tablet

Oral Use

United Kingdom

| WINTHROP PHARMACEUTICALS UK LIMITED |
| --- |
| 1 Onslow Street, |
| Guildford Surrey, |
| GU1 4YS |
| United Kingdom |

WINTHROP PHARMACEUTICALS UK LIMITED

1 Onslow Street,

Guildford Surrey,

GU1 4YS

United Kingdom

SODIUM VALPROATE 500 MG ENTERIC COATED TABLETS

500 mg

gastro-resistant tablet

Oral Use

United Kingdom

| RATIOPHARM GMBH |
| --- |
| Graff-Arco Strasse 3, Ulm, D-89079 |
| Germany |

RATIOPHARM GMBH

Graff-Arco Strasse 3, Ulm, D-89079

Germany

VALPROTEK CR 300 MG (PROLONGED RELEASE) TABLETS

300 mg

prolonged-release tablet

Oral Use

United Kingdom

| RATIOPHARM GMBH |
| --- |
| Graff-Arco Strasse 3, Ulm, D-89079 |
| Germany |

RATIOPHARM GMBH

Graff-Arco Strasse 3, Ulm, D-89079

Germany

VALPROTEK CR 500 MG (PROLONGED RELEASE) TABLETS

500 mg

prolonged-release tablet

Oral Use

United Kingdom

| WINTHROP PHARMACEUTICALS UK LIMITED |
| --- |
| 1 Onslow Street, Guildford |
| Surrey, GU1 4YS |
| United Kingdom |

WINTHROP PHARMACEUTICALS UK LIMITED

1 Onslow Street, Guildford

Surrey, GU1 4YS

United Kingdom

SODIUM VALPROATE LIQUID 200 MG/5 ML

200 mg

oral solution

Oral Use

United Kingdom

| WINTHROP PHARMACEUTICALS UK LIMITED |
| --- |
| 1 Onslow Street, Guildford |
| Surrey, GU1 4YS |
| United Kingdom |

WINTHROP PHARMACEUTICALS UK LIMITED

1 Onslow Street, Guildford

Surrey, GU1 4YS

United Kingdom

MAPHILEP 200 MG MR TABLETS

200 mg

prolonged-release tablet

Oral Use

United Kingdom

| WINTHROP PHARMACEUTICALS UK LIMITED |
| --- |
| 1 Onslow Street, Guildford |
| Surrey, GU1 4YS |
| United Kingdom |

WINTHROP PHARMACEUTICALS UK LIMITED

1 Onslow Street, Guildford

Surrey, GU1 4YS

United Kingdom

MAPHILEP 300 MG MR TABLETS

300 mg

modified release tablet

Oral Use

United Kingdom

| WINTHROP PHARMACEUTICALS UK LIMITED |
| --- |
| 1 Onslow Street, Guildford |
| Surrey, GU1 4YS |
| United Kingdom |

WINTHROP PHARMACEUTICALS UK LIMITED

1 Onslow Street, Guildford

Surrey, GU1 4YS

United Kingdom

MAPHILEP 500 MG MR TABLETS

500 mg

modified release tablet

Oral Use

United Kingdom

| BEACON PHARMACEUTICALS LIMITED |
| --- |
| 85 High Street |
| Tunbridge Wells, TN1 1YG |
| United Kingdom |

BEACON PHARMACEUTICALS LIMITED

85 High Street

Tunbridge Wells, TN1 1YG

United Kingdom

EPISENTA 150 MG PROLONGED-RELEASE CAPSULE

150 mg

prolonged-release capsule, hard

Oral Use

United Kingdom

| BEACON PHARMACEUTICALS LIMITED |
| --- |
| 85 High Street |
| Tunbridge Wells, TN1 1YG |
| United Kingdom |

BEACON PHARMACEUTICALS LIMITED

85 High Street

Tunbridge Wells, TN1 1YG

United Kingdom

EPISENTA 300 MG PROLONGED-RELEASE CAPSULE

300 mg

prolonged-release capsule, hard

Oral Use

United Kingdom

| BEACON PHARMACEUTICALS LIMITED |
| --- |
| 85 High Street |
| Tunbridge Wells, TN1 1YG |
| United Kingdom |

BEACON PHARMACEUTICALS LIMITED

85 High Street

Tunbridge Wells, TN1 1YG

United Kingdom

EPISENTA 500 MG PROLONGED-RELEASE GRANULES

500 mg

prolonged-release granules

Oral Use

United Kingdom

| BEACON PHARMACEUTICALS LIMITED |
| --- |
| 85 High Street |
| Tunbridge Wells, TN1 1YG |
| United Kingdom |

BEACON PHARMACEUTICALS LIMITED

85 High Street

Tunbridge Wells, TN1 1YG

United Kingdom

EPISENTA 1 000 MG PROLONGED-RELEASE GRANULES

1 000 mg

prolonged-release granules

Oral Use

United Kingdom

| WOCKHARDT UK LIMITED |
| --- |
| Ash Road North |
| Wrexham Industrial Estate |
| Wrexham, LL13 9UF |
| United Kingdom |

WOCKHARDT UK LIMITED

Ash Road North

Wrexham Industrial Estate

Wrexham, LL13 9UF

United Kingdom

ORLEPT (SF) LIQUID OR SODIUM VALPROATE 40 MG/ML ORAL SOLUTION

40 mg/ml

oral solution

Oral Use

United Kingdom

| WOCKHARDT UK LIMITED |
| --- |
| Ash Road North |
| Wrexham Industrial Estate |
| Wrexham, LL13 9UF |
| United Kingdom |

WOCKHARDT UK LIMITED

Ash Road North

Wrexham Industrial Estate

Wrexham, LL13 9UF

United Kingdom

ORLEPT 200 MG GASTRO-RESISTANT TABLETS

200 mg

gastro-resistant tablet

Oral Use

United Kingdom

| WOCKHARDT UK LIMITED |
| --- |
| Ash Road North |
| Wrexham Industrial Estate |
| Wrexham, LL13 9UF |
| United Kingdom |

WOCKHARDT UK LIMITED

Ash Road North

Wrexham Industrial Estate

Wrexham, LL13 9UF

United Kingdom

ORLEPT 500 MG GASTRO-RESISTANT TABLETS

500 mg

gastro-resistant tablet

Oral Use

---

ANNEX V

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State | Marketing Authorisation Holder | Product name | Strength | Pharmaceutical Form | Route of Administration |
| --- | --- | --- | --- | --- | --- |
| Austria | GUERBET |
| BP 57400 |
| 95943 Roissy Charles de Gaulle Cedex |
| France |

Member State

Marketing Authorisation Holder

Product name

Strength

Pharmaceutical Form

Route of Administration

Austria

GUERBET

BP 57400

95943 Roissy Charles de Gaulle Cedex

France

Dotarem - Injektionslösung

279,32 mg/ml

solution for injection

intravenous use

Austria

| Insight Agents GmbH |
| --- |
| Ringstrasse 19 B |
| 69115 Heidelberg |
| Germany |

Insight Agents GmbH

Ringstrasse 19 B

69115 Heidelberg

Germany

Gadopentetsäure Insight 500 Mikromol/ml Injektionslösung

469 mg/ml Gadopentetat-Dimeglumin (78,63 mg/ml Gadolinium)

solution for injection

intravenous use

Austria

| Bayer Austria GmbH |
| --- |
| Herbststrasse 6-10 |
| 1160 Wien |
| Austria |

Bayer Austria GmbH

Herbststrasse 6-10

1160 Wien

Austria

Gadovist 1,0 mmol/ml Injektionslösung in Fertigspritzen/Patronen

604,72 mg/ml Gadobutrol (157,25 mg/ml Gadolinium)

solution for injection

intravenous use

Austria

| Bayer Austria GmbH, |
| --- |
| Herbststrasse 6-10 |
| 1160 Wien |
| Austria |

Bayer Austria GmbH,

Herbststrasse 6-10

1160 Wien

Austria

Gadovist 1,0 mmol/ml - Injektionslösung

604,72 mg/ml Gadobutrol (157,25 mg/ml Gadolinium)

solution for injection

intravenous use

Austria

| Insight Agents GmbH |
| --- |
| Ringstrasse 19 B |
| 69115 Heidelberg |
| Germany |

Insight Agents GmbH

Ringstrasse 19 B

69115 Heidelberg

Germany

Magnegita 500 Mikromol/ml Injektionslösung

469 mg/ml Gadopentetat-Dimeglumin (78,63 mg/ml Gadolinium)

solution for injection

intravenous use

Austria

| Bayer Austria GmbH, |
| --- |
| Herbststrasse 6-10 |
| 1160 Wien |
| Austria |

Bayer Austria GmbH,

Herbststrasse 6-10

1160 Wien

Austria

Magnevist 0,5 mmol/ml - Injektionslösung

469 mg/ml Gadopentetsäure Dimeglumin

solution for injection/infusion

intravenous use

Austria

| Bracco S.p.A. |
| --- |
| Via Egidio Folli, 50 |
| 20134 Milano |
| Italy |

Bracco S.p.A.

Via Egidio Folli, 50

20134 Milano

Italy

MultiHance 0,5 M - Injektionslösung

334 mg/ml Gadobensäure Dimeglumin

solution for injection

intravenous use

Austria

| Bracco S.p.A. |
| --- |
| Via Egidio Folli, 50 |
| 20134 Milano |
| Italy |

Bracco S.p.A.

Via Egidio Folli, 50

20134 Milano

Italy

MultiHance 0,5 mmol/ml Injektionslösung in einer Fertigspritze

334 mg/ml Gadobensäure Dimeglumin

solution for injection

intravenous use

Austria

| GE Healthcare Handels GmbH |
| --- |
| Europlaza Gebäude E |
| Technologiestr. 10 |
| 1120 Wien |
| Austria |

GE Healthcare Handels GmbH

Europlaza Gebäude E

Technologiestr. 10

1120 Wien

Austria

Omniscan 0,5 mmol/ml - parenterale Kontrastmittellösung

287 mg/ml Gadodiamid

solution for injection

intravenous use

Austria

| Bayer Austria GmbH, |
| --- |
| Herbststrasse 6-10 |
| 1160 Wien |
| Austria |

Bayer Austria GmbH,

Herbststrasse 6-10

1160 Wien

Austria

Primovist 0,25 mmol/m Injektionslösung in einer Fertigspritze

181,43 mg/ml Gadoxetsäure-Dinatrium

solution for injection

intravenous use

Austria

| Bayer Austria GmbH, |
| --- |
| Herbststrasse 6-10 |
| 1160 Wien |
| Austria |

Bayer Austria GmbH,

Herbststrasse 6-10

1160 Wien

Austria

Primovist 0,25 mmol/ml Injektionslösung in einer Durchstechflasche

181,43 mg/ml Gadoxetsäure-Dinatrium

solution for injection

intravenous use

Austria

| Bracco S.p.A. |
| --- |
| Via Egidio Folli, 50 |
| 20134 Milano |
| Italy |

Bracco S.p.A.

Via Egidio Folli, 50

20134 Milano

Italy

Prohance - Injektionslösung

279,3 mg/ml Gadoteridol (78,61 mg/ml Gadolinium)

solution for injection

intravenous use

Belgium

| Codali S.A. |
| --- |
| Avenue Henri Dunant 31 |
| 1140 Bruxelles |
| Belgium |

Codali S.A.

Avenue Henri Dunant 31

1140 Bruxelles

Belgium

DOTAREM

0,5 mmol/ml

Solution for injection

intravenous use

Belgium

| Insight Agents GmbH |
| --- |
| Ringstrasse 19 B |
| 69115 Heidelberg |
| Germany |

Insight Agents GmbH

Ringstrasse 19 B

69115 Heidelberg

Germany

GADOPENTETATE CURAGITA 500 MICROMOL/ML

500 micromol/ml

Solution for injection

intravenous use

Belgium

| Bayer SA-NV |
| --- |
| J.E. Mommaertslaan 14 |
| 1831 Diegem |
| Belgium |

Bayer SA-NV

J.E. Mommaertslaan 14

1831 Diegem

Belgium

GADOVIST

1,0 mmol-ml

Solution for injection

intravenous use

Belgium

| Insight Agents GmbH |
| --- |
| Ringstraat 19 B |
| 69115 Heidelberg |
| Germany |

Insight Agents GmbH

Ringstraat 19 B

69115 Heidelberg

Germany

MAGNEGITA

500 micromol-ml

Solution for injection

intravenous use

Belgium

| Bayer SA-NV |
| --- |
| J.E. Mommaertslaan 14 |
| 1831 Diegem |
| Belgium |

Bayer SA-NV

J.E. Mommaertslaan 14

1831 Diegem

Belgium

MAGNEVIST

0,5 mmol-ml

Solution for injection

intravenous use

Belgium

| BRACCO Imaging Deutschland GmbH |
| --- |
| Max-Stromeyer-Strasse 116 |
| D - 78467 Konstanz |
| Germany |

BRACCO Imaging Deutschland GmbH

Max-Stromeyer-Strasse 116

D - 78467 Konstanz

Germany

MULTIHANCE

0,5 M

Solution for injection

intravenous use

Belgium

| GE HEALTHCARE BVBA |
| --- |
| Kouterveldstraat 20 |
| 1831 DIEGEM |
| Belgium |

GE HEALTHCARE BVBA

Kouterveldstraat 20

1831 DIEGEM

Belgium

OMNISCAN

0,5 mmol-ml

Solution for injection

intravenous use

Belgium

| Bayer SA-NV |
| --- |
| J.E. Mommaertslaan 14 |
| 1831 Diegem |
| Belgium |

Bayer SA-NV

J.E. Mommaertslaan 14

1831 Diegem

Belgium

PRIMOVIST

0,25 mmol-ml

Solution for injection

intravenous use

Belgium

| BRACCO Imaging Deutschland GmbH |
| --- |
| Max-Stromeyer-Strasse 116 |
| D - 78467 Konstanz |
| Germany |

BRACCO Imaging Deutschland GmbH

Max-Stromeyer-Strasse 116

D - 78467 Konstanz

Germany

PROHANCE

279,3 mg-ml

Solution for injection

intravenous use

Bulgaria

| Bayer Schering Pharma AG |
| --- |
| Muellerstrasse 178 |
| 13353 Berlin |
| Germany |

Bayer Schering Pharma AG

Muellerstrasse 178

13353 Berlin

Germany

Gadovist

604,72 mg/ml

solution for injection

intravenous use

Bulgaria

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

Primovist

181,43 mg/ml

solution for injection

intravenous use

Bulgaria

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

Magnevist

469 mg/ml

solution for injection

intravenous use

Bulgaria

| GE Healthcare AS |
| --- |
| Nycoveien 1-2 |
| P.O.Box 4220 Nydalen |
| N-0401 Oslo |
| Norway |

GE Healthcare AS

Nycoveien 1-2

P.O.Box 4220 Nydalen

N-0401 Oslo

Norway

Omniscan

287 mg/ml

solution for injection

intravenous use

Bulgaria

| Insight Agents GmbH |
| --- |
| Ringstrasse 19 B |
| D–69115, Heidellberg |
| Germany |

Insight Agents GmbH

Ringstrasse 19 B

D–69115, Heidellberg

Germany

Magnegita

500 micromol/ml

Solution for injection

Intravenous use

Cyprus

| PHADISCO LTD |
| --- |
| 185 YIANNOU GRANIDIOTI AVE, |
| 2235 LATSIA |
| CYPRUS |

PHADISCO LTD

185 YIANNOU GRANIDIOTI AVE,

2235 LATSIA

CYPRUS

OMNISCAN

0,5 MMOL/ML

solution for injection

intravenous use

Cyprus

| BAYER HELLAS ABEE |
| --- |
| SOROU 18-20 |
| 151 25 MAROUSI, ATHENS, |
| GREECE |

BAYER HELLAS ABEE

SOROU 18-20

151 25 MAROUSI, ATHENS,

GREECE

PRIMOVIST PFS

0,25 MMOL/ML

solution for injection in prefilled syringes

intravenous use

Cyprus

| BAYER HELLAS ABEE |
| --- |
| SOROU 18-20 |
| 151 25 MAROUSI, ATHENS, |
| GREECE |

BAYER HELLAS ABEE

SOROU 18-20

151 25 MAROUSI, ATHENS,

GREECE

PRIMOVIST

0,25 MMOL/ML

solution for injection

intravenous use

Czech Republic

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

GADOVIST 1,0 m mol/ml

1 mmol/l

solution for injection

intravenous use

Czech Republic

| Insight Agents GmbH |
| --- |
| Ringstrasse 19 B |
| 69115 Heidelberg |
| Germany |

Insight Agents GmbH

Ringstrasse 19 B

69115 Heidelberg

Germany

Magnegita 500 mikromol/ml injekční roztok

0,5 mmo/ml

solution for injection

intravenous use

Czech Republic

| Bracco Imaging Deutschland GmbH |
| --- |
| Max-Stromeyer-Strasse 116 |
| D-78467 Konstanz |
| Germany |

Bracco Imaging Deutschland GmbH

Max-Stromeyer-Strasse 116

D-78467 Konstanz

Germany

ProHance

279,3 mg-ml

solution for injection

intravenous use

Czech Republic

| Bracco Imaging Deutschland GmbH |
| --- |
| Max-Stromeyer-Strasse 116 |
| D-78467 Konstanz |
| Germany |

Bracco Imaging Deutschland GmbH

Max-Stromeyer-Strasse 116

D-78467 Konstanz

Germany

MultiHance

529 mg/ml

solution for injection

intravenous use

Czech Republic

| GE Healthcare AS |
| --- |
| Nycoveien 1-2, |
| P.O.Box 4220 |
| Nydalen |
| N-0401 Oslo |
| Norway |

GE Healthcare AS

Nycoveien 1-2,

P.O.Box 4220

Nydalen

N-0401 Oslo

Norway

Omniscan 0,5 mmol/l

287 mg/ml

solution for injection

intravenous use

Czech Republic

| Guerbet |
| --- |
| BP 57400 |
| 95943 Roissy CdG cedex |
| France |

Guerbet

BP 57400

95943 Roissy CdG cedex

France

Dotarem

279,32 mg/ml

solution for injection

intravenous use

Czech Republic

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

Primovist 0,25 mmol/ml

0,25 mmol/ml

solution for injection

intravenous use

Germany

| BRACCO Imaging Deutschland GmbH |
| --- |
| Max-Stromeyer-Strasse 116 |
| D - 78467 Konstanz |
| Germany |

BRACCO Imaging Deutschland GmbH

Max-Stromeyer-Strasse 116

D - 78467 Konstanz

Germany

MultiHance

529 mg/ml

solution for injection

intravenous use

Germany

| BRACCO Imaging Deutschland GmbH |
| --- |
| Max-Stromeyer-Strasse 116 |
| D - 78467 Konstanz |
| Germany |

BRACCO Imaging Deutschland GmbH

Max-Stromeyer-Strasse 116

D - 78467 Konstanz

Germany

MultiHance

0,5 mmol/ml

solution for injection, prefilled syringe

intravenous use

Germany

| BRACCO Imaging Deutschland GmbH |
| --- |
| Max-Stromeyer-Strasse 116 |
| D - 78467 Konstanz |
| Germany |

BRACCO Imaging Deutschland GmbH

Max-Stromeyer-Strasse 116

D - 78467 Konstanz

Germany

MultiHance XL

529 mg/ml

solution for injection

intravenous use

Germany

| Bayer Vital GmbH |
| --- |
| D-51368 Leverkusen |
| Germany |

Bayer Vital GmbH

D-51368 Leverkusen

Germany

Gadovist 1,0 mmol/ml Injektioslösung

604,72 mg/ml

solution for injection

intravenous use

Germany

| Bayer Vital GmbH |
| --- |
| D-51368 Leverkusen |
| Germany |

Bayer Vital GmbH

D-51368 Leverkusen

Germany

Gadovist 1,0 mmol/ml Injektioslösung in Fertigspritzen/Patronen

604,72 mg/ml

solution for injection

intravenous use

Germany

| Marotrast GmbH |
| --- |
| Otto-Schott-Str. 15 |
| D-07745 Jena |
| Germany |

Marotrast GmbH

Otto-Schott-Str. 15

D-07745 Jena

Germany

Gadograf 1,0 mmol/ml Injektionslösung in Fertigspritzen

604,72 mg/ml

solution for injection

intravenous use

Germany

| Marotrast GmbH |
| --- |
| Otto-Schott-Str. 15 |
| D-07745 Jena |
| Germany |

Marotrast GmbH

Otto-Schott-Str. 15

D-07745 Jena

Germany

Gadograf 1,0 mmol/ml

604,72 mg/ml

solution for injection

intravenous use

Germany

| GE Healthcare Buchler GmbH & Co.KG |
| --- |
| Gieselweg 1 |
| D-38110 Braunschweig |
| Germany |

GE Healthcare Buchler GmbH & Co.KG

Gieselweg 1

D-38110 Braunschweig

Germany

Omniscan 0,5 mmol/ml Injektioslösung

287 mg/ml

solution for injection

intravenous use

Germany

| GE Healthcare Buchler GmbH & Co.KG |
| --- |
| Gieselweg 1 |
| D-38110 Braunschweig |
| Germany |

GE Healthcare Buchler GmbH & Co.KG

Gieselweg 1

D-38110 Braunschweig

Germany

Omniscan 0,5 mmol/ml Injektioslösung in Fertigspritzen

287 mg/ml

solution for injection

intravenous use

Germany

| Guerbet |
| --- |
| 15 rue des Vanesses |
| Zone Paris Nord II |
| F-83420 VILLEPINTE |
| France |

Guerbet

15 rue des Vanesses

Zone Paris Nord II

F-83420 VILLEPINTE

France

Dotarem 0,5 mmol/ml Injektionslösung in Fertigspritzen

279,32 mg/ml

solution for injection

intravenous use

Germany

| Guerbet |
| --- |
| 15 rue des Vanesses |
| Zone Paris Nord II |
| F-83420 VILLEPINTE |
| France |

Guerbet

15 rue des Vanesses

Zone Paris Nord II

F-83420 VILLEPINTE

France

Dotarem 0,5 mmol/ml Injektionslösung in Durchstechflaschen (für Mehrfachentnahme)

279,32 mg/ml

solution for injection

intravenous use

Germany

| Guerbet |
| --- |
| 15 rue des Vanesses |
| Zone Paris Nord II |
| F-83420 VILLEPINTE |
| France |

Guerbet

15 rue des Vanesses

Zone Paris Nord II

F-83420 VILLEPINTE

France

Dotarem 0,5 mmol/ml Injektionslösung in Durchstechflaschen

279,32 mg/ml

solution for injection

intravenous use

Germany

| Bayer Vital GmbH |
| --- |
| D-51368 Leverkusen |
| Germany |

Bayer Vital GmbH

D-51368 Leverkusen

Germany

Magnevist 0,5 mmol/ml, Injektionslösung

469,01 mg/ml

solution for injection

intravenous use

Germany

| Bayer Vital GmbH |
| --- |
| D-51368 Leverkusen |
| Germany |

Bayer Vital GmbH

D-51368 Leverkusen

Germany

Gadopentetat-Dimeglumin 0,5 mmol/ml, Injektionslösung

469,01 mg/ml

solution for injection

intravenous use

Germany

| be imaging GmbH |
| --- |
| Dr.-Rudolf-Eberle-Str. 8-10 |
| D-76534 Baden-Baden |
| Germany |

be imaging GmbH

Dr.-Rudolf-Eberle-Str. 8-10

D-76534 Baden-Baden

Germany

Magnevision 0,5 mmol/ml Injektionslösung

469 mg/ml

solution for injection

intravenous use

Germany

| Covidien Deutschland GmbH |
| --- |
| Gewerbepark 1 |
| D-93333 Neustadt |
| Germany |

Covidien Deutschland GmbH

Gewerbepark 1

D-93333 Neustadt

Germany

Marktiv 500 Mikromol/ml Injektionslösung

469 mg/ml

solution for injection

intravenous use

Germany

| be imaging GmbH |
| --- |
| Dr.-Rudolf-Eberle-Str. 8-10 |
| D-76534 Baden-Baden |
| Germany |

be imaging GmbH

Dr.-Rudolf-Eberle-Str. 8-10

D-76534 Baden-Baden

Germany

Magnevision b.e. 0,5 mmol/ml Injektionslösung

469 mg/ml

solution for injection

intravenous use

Germany

| Helm AG |
| --- |
| Nordkanalstr. 28 |
| D-20097 Hamburg |
| Germany |

Helm AG

Nordkanalstr. 28

D-20097 Hamburg

Germany

Gadopentetat Dimeglumin Helm AG Injektionslösung

469 mg/ml

solution for injection

intravenous use

Germany

| Insight Agents GmbH |
| --- |
| Ringstr. 19 B |
| D-69115 Heidelberg |
| Germany |

Insight Agents GmbH

Ringstr. 19 B

D-69115 Heidelberg

Germany

Magnegita 500 Mikromol/ml Injektionslösung

469,01 mg/ml

solution for injection

intravenous use

Germany

| Insight Agents GmbH |
| --- |
| Ringstr. 19 B |
| D-69115 Heidelberg |
| Germany |

Insight Agents GmbH

Ringstr. 19 B

D-69115 Heidelberg

Germany

Gadopentetat Insight 500 Mikromol/ml Injektionslösung

469,01 mg/ml

solution for injection

intravenous use

Germany

| Marotrast GmbH |
| --- |
| Otto-Schott-Str. 15 |
| D-07745 Jena |
| Germany |

Marotrast GmbH

Otto-Schott-Str. 15

D-07745 Jena

Germany

Magnograf 0,5 mmol/ml, Injektionslösung

469,01 mg/ml

solution for injection

intravenous use

Germany

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Germany

Gadopentetat-MRT-ratiopharm

469 mg/ml

solution for injection

intravenous use

Germany

| Sanochemia Diagnostics Deutschland GmbH |
| --- |
| Stresemannallee 4 c |
| D-41460 Neuss |
| Germany |

Sanochemia Diagnostics Deutschland GmbH

Stresemannallee 4 c

D-41460 Neuss

Germany

MR-Lux

469 mg/ml

solution for injection

intravenous use

Germany

| Bracco IMAGING Deutschland GmbH |
| --- |
| Max-Stromexer-Str. 116 |
| D-78467 Konstanz |
| Germany |

Bracco IMAGING Deutschland GmbH

Max-Stromexer-Str. 116

D-78467 Konstanz

Germany

ProHance

279,3 mg/ml

solution for injection

intravenous use

Germany

| Bayer Vital GmbH |
| --- |
| D-51368 Leverkusen |
| Germany |

Bayer Vital GmbH

D-51368 Leverkusen

Germany

Primovist 0,25 mml/ml Injektionslösung, Fertigspritze

181,43 mg/ml

solution for injection

intravenous use

Germany

| Bayer Vital GmbH |
| --- |
| D-51368 Leverkusen |
| Germany |

Bayer Vital GmbH

D-51368 Leverkusen

Germany

Primovist 0,25 mml/ml Injektionslösung, Durchstechflasche

181,43 mg/ml

solution for injection

intravenous use

Denmark

| GUERBET |
| --- |
| BP 57400 |
| 95943 Roissy Charles de Gaulle Cedex |
| France |

GUERBET

BP 57400

95943 Roissy Charles de Gaulle Cedex

France

Dotarem

279,3 mg/mL

solution for injection

intravenous use

Denmark

| GUERBET |
| --- |
| BP 57400 |
| 95943 Roissy Charles de Gaulle Cedex |
| France |

GUERBET

BP 57400

95943 Roissy Charles de Gaulle Cedex

France

Dotarem

279,3 mg/mL

Solution for injection, prefilled syringe

intravenous use

Denmark

| GE Healthcare AS |
| --- |
| Nycoveien 1-2, 4220 Nydalen, |
| Oslo N-0401 |
| Norway |

GE Healthcare AS

Nycoveien 1-2, 4220 Nydalen,

Oslo N-0401

Norway

Omniscan

0,5 mmol/mL

solution for injection

intravenous use

Denmark

| Insight Agents GmbH |
| --- |
| Ringstr. 19 B |
| D-69115 Heidelberg |
| Germany |

Insight Agents GmbH

Ringstr. 19 B

D-69115 Heidelberg

Germany

Magnegita

0,5 mmol/mL

solution for injection

intravenous use

Denmark

| Insight Agents GmbH |
| --- |
| Ringstr. 19 B |
| D-69115 Heidelberg |
| Germany |

Insight Agents GmbH

Ringstr. 19 B

D-69115 Heidelberg

Germany

Gadopentetat ‘Insight’

0,5 mmol/mL

solution for injection

intravenous use

Denmark

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

Gadovist

1 mmol/mL

solution for injection

intravenous use

Denmark

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

Gadovist PFS

1 mmol/mL

solution for injection, prefilled syringe

intravenous use

Denmark

| Bracco International B.V |
| --- |
| Strawinskylaan 3051 |
| NL-1077 ZX Amsterdam |
| Netherlands |

Bracco International B.V

Strawinskylaan 3051

NL-1077 ZX Amsterdam

Netherlands

Prohance

279,3 mg/mL

solution for injection

intravenous use

Denmark

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

Magnevist

469 mg/mL

solution for injection

intravenous use

Denmark

| Bracco S.p.A. |
| --- |
| Via Emilio Folli, 50 |
| 20134 Milano |
| Italy |

Bracco S.p.A.

Via Emilio Folli, 50

20134 Milano

Italy

Multihance

334 mg/ml

solution for injection

intravenous use

Denmark

| Bracco S.p.A. |
| --- |
| Via Emilio Folli, 50 |
| 20134 Milano |
| Italy |

Bracco S.p.A.

Via Emilio Folli, 50

20134 Milano

Italy

Multihance

334 mg

Solution for injection, prefilled syringe

intravenous use

Estonia

| Bayer Schering Pharma AG |
| --- |
| DE-13342 Berlin- |
| Germany |

Bayer Schering Pharma AG

DE-13342 Berlin-

Germany

MAGNEVIST

469 mg/ml

solution for injection

intravenous use

Estonia

| GE Healthcare AS |
| --- |
| PO 4220, Nycoveien 1-2 |
| NO-0401 Nydalen |
| Norway |

GE Healthcare AS

PO 4220, Nycoveien 1-2

NO-0401 Nydalen

Norway

OMNISCAN

0,5 mmol/ml

solution for injection

intravenous use

Estonia

| Bayer Schering Pharma AG |
| --- |
| DE-13342 Berlin- |
| Germany |

Bayer Schering Pharma AG

DE-13342 Berlin-

Germany

GADOVIST

1 mmol/ml

solution for injection

intravenous use

Estonia

| Bayer Schering Pharma AG |
| --- |
| DE-13342 Berlin- |
| Germany |

Bayer Schering Pharma AG

DE-13342 Berlin-

Germany

PRIMOVIST

0,25 mmol/ml

solution for injection

intravenous use

Estonia

| Bayer Schering Pharma AG |
| --- |
| DE-13342 Berlin- |
| Germany |

Bayer Schering Pharma AG

DE-13342 Berlin-

Germany

PRIMOVIST

0,25 mmol/ml

solution for injection inpre-filled syringe

intravenous use

Estonia

| Insight Agents GmbH |
| --- |
| Ringstr. 19 B |
| D-69115 Heidelberg |
| Germany |

Insight Agents GmbH

Ringstr. 19 B

D-69115 Heidelberg

Germany

MAGNEGITA

469 mg/ml

solution for injection

intravenous use

Spain

| GE HEALTHCARE BIO-SCIENCES S.A. |
| --- |
| Avda. de Europa |
| 22 Alcobendas 28108 Madrid |
| Spain |

GE HEALTHCARE BIO-SCIENCES S.A.

Avda. de Europa

22 Alcobendas 28108 Madrid

Spain

OMNISCAN

0,5 mmol/ml

solution for injection syringe

intravenous use

Spain

| GE HEALTHCARE BIO-SCIENCES S.A. |
| --- |
| Avda. de Europa |
| 22 Alcobendas 28108 Madrid |
| Spain |

GE HEALTHCARE BIO-SCIENCES S.A.

Avda. de Europa

22 Alcobendas 28108 Madrid

Spain

OMNISCAN

0,5 mmol/ml

solution for injection

intravenous use

Spain

| Bracco S.p.A. |
| --- |
| Via Egido Folli, 50 |
| 20134 Milano |
| Italy |

Bracco S.p.A.

Via Egido Folli, 50

20134 Milano

Italy

MULTIHANCE

0,5 M

solution for injection

intravenous use

Spain

| QUIMICA FARMACEUTICA BAYER S.L. |
| --- |
| Av. Baix Llobregat |
| 3-5 Sant Joan Despi |
| Barcelona 08970 |
| Spain |

QUIMICA FARMACEUTICA BAYER S.L.

Av. Baix Llobregat

3-5 Sant Joan Despi

Barcelona 08970

Spain

PRIMOVIST

0,25 mmol/ml

solution for injection

intravenous use

Spain

| QUIMICA FARMACEUTICA BAYER S.L. |
| --- |
| Av. Baix Llobregat |
| 3-5 Sant Joan Despi |
| Barcelona 08970 |
| Spain |

QUIMICA FARMACEUTICA BAYER S.L.

Av. Baix Llobregat

3-5 Sant Joan Despi

Barcelona 08970

Spain

PRIMOVIST

0,25 mmol/ml

solution for injection (syringe)

intravenous use

Spain

| Bracco International B.V |
| --- |
| Strawinskylaan 3051 |
| NL-1077 ZX Amsterdam |
| Netherlands |

Bracco International B.V

Strawinskylaan 3051

NL-1077 ZX Amsterdam

Netherlands

PROHANCE

(0,5 M)

solution for injection (syringe)

intravenous use

Spain

| Bracco International B.V |
| --- |
| Strawinskylaan 3051 |
| NL-1077 ZX Amsterdam |
| Netherlands |

Bracco International B.V

Strawinskylaan 3051

NL-1077 ZX Amsterdam

Netherlands

PROHANCE

(0,5 M)

solution for injection (vial)

intravenous use

Spain

| QUIMICA FARMACEUTICA BAYER S.L. |
| --- |
| Av. Baix Llobregat |
| 3-5 Sant Joan Despi |
| Barcelona 08970 |
| Spain |

QUIMICA FARMACEUTICA BAYER S.L.

Av. Baix Llobregat

3-5 Sant Joan Despi

Barcelona 08970

Spain

GADOVIST

1,0 mmol/ml

solution for injection (vial)

intravenous use

Spain

| QUIMICA FARMACEUTICA BAYER S.L. |
| --- |
| Av. Baix Llobregat |
| 3-5 Sant Joan Despi |
| Barcelona 08970 |
| Spain |

QUIMICA FARMACEUTICA BAYER S.L.

Av. Baix Llobregat

3-5 Sant Joan Despi

Barcelona 08970

Spain

GADOVIST

1,0 mmol/ml

solution for injection (syringe and cartridge)

intravenous use

Spain

| QUIMICA FARMACEUTICA BAYER S.L. |
| --- |
| Av. Baix Llobregat |
| 3-5 Sant Joan Despi |
| Barcelona 08970 |
| Spain |

QUIMICA FARMACEUTICA BAYER S.L.

Av. Baix Llobregat

3-5 Sant Joan Despi

Barcelona 08970

Spain

MAGNEVIST

0,5 mmol/ml

solution for injection

intravenous use

Spain

| QUIMICA FARMACEUTICA BAYER S.L. |
| --- |
| Av. Baix Llobregat |
| 3-5 Sant Joan Despi |
| Barcelona 08970 |
| Spain |

QUIMICA FARMACEUTICA BAYER S.L.

Av. Baix Llobregat

3-5 Sant Joan Despi

Barcelona 08970

Spain

MAGNEVIST

0,5 mmol/ml

solution for injection (syringe)

intravenous use

Spain

| QUIMICA FARMACEUTICA BAYER S.L. |
| --- |
| Av. Baix Llobregat |
| 3-5 Sant Joan Despi |
| Barcelona 08970 |
| Spain |

QUIMICA FARMACEUTICA BAYER S.L.

Av. Baix Llobregat

3-5 Sant Joan Despi

Barcelona 08970

Spain

MAGNOGRAF

0,5 mmol/ml

solution for injection

intravenous use

Spain

| QUIMICA FARMACEUTICA BAYER S.L. |
| --- |
| Av. Baix Llobregat |
| 3-5 Sant Joan Despi |
| Barcelona 08970 |
| Spain |

QUIMICA FARMACEUTICA BAYER S.L.

Av. Baix Llobregat

3-5 Sant Joan Despi

Barcelona 08970

Spain

MAGNOGRAF

0,5 mmol/ml

solution for injection (syringe)

intravenous use

Spain

| Guerbet |
| --- |
| BP 57400 |
| 95493 Roissy CdG cedex |
| France |

Guerbet

BP 57400

95493 Roissy CdG cedex

France

Dotarem

0,5 mmol/ml

solution for injection

intravenous use

Spain

| Guerbet |
| --- |
| BP 57400 |
| 95493 Roissy CdG cedex |
| France |

Guerbet

BP 57400

95493 Roissy CdG cedex

France

Dotarem

0,5 mmol/ml

solution for injection (syringe)

intravenous use

Finland

| GE Healthcare AS |
| --- |
| Nycoveien 1-2 |
| 4220 Nydalen, |
| Oslo N-0401 |
| Norway |

GE Healthcare AS

Nycoveien 1-2

4220 Nydalen,

Oslo N-0401

Norway

OMNISCAN

0,5 mmol/ml

Solution for injection

intravenous use

Finland

| Bayer Schering Pharma Oy |
| --- |
| Pansiontie 47 |
| 20210 Turku |
| Finland |

Bayer Schering Pharma Oy

Pansiontie 47

20210 Turku

Finland

MAGNEVIST

0,5 mmol/ml

solution for injection

intravenous use

Finland

| Insight Agents GmbH |
| --- |
| Ringstr. 19 B, |
| 69115 HEIDELBERG |
| Germany |

Insight Agents GmbH

Ringstr. 19 B,

69115 HEIDELBERG

Germany

MAGNEGITA

500 micromol/ml

solution for injection

intravenous use

Finland

| Insight Agents GmbH |
| --- |
| Ringstr. 19 B, |
| 69115 HEIDELBERG |
| Germany |

Insight Agents GmbH

Ringstr. 19 B,

69115 HEIDELBERG

Germany

GADOPENTETATE INSIGHT

500 micromol/ml

solution for injection

intravenous use

Finland

| Bracco S.p.A. |
| --- |
| Via Emilio Folli, 50 |
| 20134 Milano |
| Italy |

Bracco S.p.A.

Via Emilio Folli, 50

20134 Milano

Italy

MULTIHANCE

334 mg/ml

solution for injection

intravenous use

Finland

| Bracco S.p.A. |
| --- |
| Via Emilio Folli, 50 |
| 20134 Milano |
| Italy |

Bracco S.p.A.

Via Emilio Folli, 50

20134 Milano

Italy

MULTIHANCE

334 mg/ml

Solution for injection, pre-filled syringe

intravenous use

Finland

| Bayer Schering Pharma Oy |
| --- |
| Pansiontie 47, |
| 20210 Turku |
| Finland |

Bayer Schering Pharma Oy

Pansiontie 47,

20210 Turku

Finland

PRIMOVIST

0,25 mmol/ml

solution for injection

intravenous use

Finland

| Bayer Schering Pharma Oy |
| --- |
| Pansiontie 47, |
| 20210 Turku |
| Finland |

Bayer Schering Pharma Oy

Pansiontie 47,

20210 Turku

Finland

PRIMOVIST

0,25 mmol/ml

Solution for injection, pre-filled syringe

intravenous use

Finland

| Bracco International B.V |
| --- |
| Strawinskylaan 3051, |
| NL-1077 ZX Amsterdam |
| Netherlands |

Bracco International B.V

Strawinskylaan 3051,

NL-1077 ZX Amsterdam

Netherlands

PROHANCE

279,3 mg/ml

solution for injection

intravenous use

Finland

| Bayer Schering Pharma Oy |
| --- |
| Pansiontie 47, |
| 20210 Turku |
| Finland |

Bayer Schering Pharma Oy

Pansiontie 47,

20210 Turku

Finland

GADOVIST

1 mmol/ml

solution for injection

intravenous use

Finland

| Bayer Schering Pharma Oy |
| --- |
| Pansiontie 47, |
| 20210 Turku |
| Finland |

Bayer Schering Pharma Oy

Pansiontie 47,

20210 Turku

Finland

GADOVIST

1 mmol/ml

Solution for injection (syringe)

intravenous use

Finland

| GUERBET |
| --- |
| BP 57400 |
| 95943 Roissy Charles de Gaulle Cedex |
| France |

GUERBET

BP 57400

95943 Roissy Charles de Gaulle Cedex

France

DOTAREM

279,3 mg/ml

solution for injection

intravenous use

France

| GE HEALTHCARE |
| --- |
| 11, avenue Morane Saulnier |
| 78140 Vélizy Villacoublay |
| France |

GE HEALTHCARE

11, avenue Morane Saulnier

78140 Vélizy Villacoublay

France

OMNISCAN 0,5 mmol/ml, solution injectable

28,7 g/1,0 ml

solution for injection

intravenous use

France

| GE HEALTHCARE |
| --- |
| 11, avenue Morane Saulnier |
| 78140 Vélizy Villacoublay |
| France |

GE HEALTHCARE

11, avenue Morane Saulnier

78140 Vélizy Villacoublay

France

OMNISCAN 0,5 mmol/ml, solution injectable en seringue pré-remplie

287 mg/1 ml

Solution for injection (pre-filled syringe)

intravenous use

France

| BRACCO IMAGING France |
| --- |
| 7, place Copernic |
| 91080 Courcouronnes |
| France |

BRACCO IMAGING France

7, place Copernic

91080 Courcouronnes

France

MULTIHANCE 0,5 mmol/ml, solution injectable (IV)

529 mg/1 ml

solution for injection

intravenous use

France

| BRACCO IMAGING France |
| --- |
| 7, place Copernic |
| 91080 Courcouronnes |
| France |

BRACCO IMAGING France

7, place Copernic

91080 Courcouronnes

France

MULTIHANCE 0,5 mmol/ml, solution injectable en seringue pré-remplie

529 mg/1 ml

solution for injection

intravenous use

France

| BAYER SANTE |
| --- |
| 220, avenue de la Recherche |
| 59120 Loos |
| France |

BAYER SANTE

220, avenue de la Recherche

59120 Loos

France

MAGNEVIST, solution injectable (IV)

46,901 g/1,0 ml

solution for injection

intravenous use

France

| BAYER SANTE |
| --- |
| 220, avenue de la Recherche |
| 59120 Loos |
| France |

BAYER SANTE

220, avenue de la Recherche

59120 Loos

France

MAGNEVIST, solution injectable en seringue pré-remplie (IV)

46,901 g/1,0 ml

Solution for injection (pre-filled syringe)

intravenous use

France

| BRACCO IMAGING France |
| --- |
| 7, place Copernic |
| 91080 Courcouronnes |
| France |

BRACCO IMAGING France

7, place Copernic

91080 Courcouronnes

France

PROHANCE 1 396,5 mg/5 ml, solution injectable

1 396,50 mg/5 ml

solution for injection

intravenous use

France

| BRACCO IMAGING France |
| --- |
| 7, place Copernic |
| 91080 Courcouronnes |
| France |

BRACCO IMAGING France

7, place Copernic

91080 Courcouronnes

France

PROHANCE 1 396,5 mg/5 ml, solution injectable en seringue pré-remplie

1 396,5 mg/5ml

Solution for injection (pre-filled syringe)

intravenous use

France

| BRACCO IMAGING France |
| --- |
| 7, place Copernic |
| 91080 Courcouronnes |
| France |

BRACCO IMAGING France

7, place Copernic

91080 Courcouronnes

France

PROHANCE 2 793 mg/10 ml, solution injectable

2 793 mg/10 ml

solution for injection

intravenous use

France

| BRACCO IMAGING France |
| --- |
| 7, place Copernic |
| 91080 Courcouronnes |
| France |

BRACCO IMAGING France

7, place Copernic

91080 Courcouronnes

France

PROHANCE 2 793 mg/10 ml, solution injectable en seringue pré-remplie

2 793 mg/10 ml

Solution for injection (pre-filled syringe)

intravenous use

France

| BRACCO IMAGING France |
| --- |
| 7, place Copernic |
| 91080 Courcouronnes |
| France |

BRACCO IMAGING France

7, place Copernic

91080 Courcouronnes

France

PROHANCE 4 189,5 mg/15 ml, solution injectable

4 189,50 mg/15 ml

solution for injection

intravenous use

France

| BRACCO IMAGING France |
| --- |
| 7, place Copernic |
| 91080 Courcouronnes |
| France |

BRACCO IMAGING France

7, place Copernic

91080 Courcouronnes

France

PROHANCE 4 189,5 mg/15 ml, solution injectable en seringue pré-remplie

4 189,50 mg/15 ml

Solution for injection (pre-filled syringe)

intravenous use

France

| BRACCO IMAGING France |
| --- |
| 7, place Copernic |
| 91080 Courcouronnes |
| France |

BRACCO IMAGING France

7, place Copernic

91080 Courcouronnes

France

PROHANCE 4 748,10 mg/17 ml, solution injectable en seringue pré-remplie

4 748,1 mg/17 ml

Solution for injection (pre-filled syringe)

intravenous use

France

| BRACCO IMAGING France |
| --- |
| 7, place Copernic |
| 91080 Courcouronnes |
| France |

BRACCO IMAGING France

7, place Copernic

91080 Courcouronnes

France

PROHANCE 5 586 mg/20 ml, solution injectable

5 586 mg/20 ml

solution for injection

intravenous use

France

| BAYER SANTE |
| --- |
| 220, avenue de la Recherche |
| 59120 Loos |
| France |

BAYER SANTE

220, avenue de la Recherche

59120 Loos

France

GADOVIST 1,0 mmol/mL, solution injectable

604,72 mg/1 ml

solution for injection

intravenous use

France

| BAYER SANTE |
| --- |
| 220, avenue de la Recherche |
| 59120 Loos |
| France |

BAYER SANTE

220, avenue de la Recherche

59120 Loos

France

GADOVIST 1,0 mmol/mL, solution injectable en seringue préremplie

604,72 mg/1 ml

Solution for injection (pre-filled syringe)

intravenous use

France

| GUERBET |
| --- |
| BP 57400 |
| 95943 Roissy Charles de Gaulle Cedex |
| France |

GUERBET

BP 57400

95943 Roissy Charles de Gaulle Cedex

France

DOTAREM 0,5 mmol/ml, solution injectable en flacon

27,932 g/1,0 ml

solution for injection

intravenous use

France

| GUERBET |
| --- |
| BP 57400 |
| 95943 Roissy Charles de Gaulle Cedex |
| France |

GUERBET

BP 57400

95943 Roissy Charles de Gaulle Cedex

France

DOTAREM 0,5 mmol/ml, solution injectable en seringue pré-remplie

27,932 g/1,0 ml

Solution for injection (pre-filled syringe)

intravenous use

Greece

| GE HEALTHCARE |
| --- |
| PLAPOUTA 139 & LAMIAS ST |
| NEO IRAKLEIO 14121 |
| GREECE |

GE HEALTHCARE

PLAPOUTA 139 & LAMIAS ST

NEO IRAKLEIO 14121

GREECE

OMNISCAN

287 mg/ml

solution for injection

intravenous use

Greece

| BAYER HELLAS ABEE |
| --- |
| SOROU 18-20, |
| 151 25 MAROUSI, ATHENS, GREECE |

BAYER HELLAS ABEE

SOROU 18-20,

151 25 MAROUSI, ATHENS, GREECE

MAGNEVIST

469,01 mg/ml

solution for injection

intravenous use

Greece

| GEROLYMATOS P.G.N. AEBE |
| --- |
| ASKLIPIOU ST KRYONERI |
| ATTICA |
| GREECE |

GEROLYMATOS P.G.N. AEBE

ASKLIPIOU ST KRYONERI

ATTICA

GREECE

MULTIHANCE

529 mg/mlm

solution for injection

intravenous use

Greece

| GEROLYMATOS P.G.N. AEBE |
| --- |
| ASKLIPIOU ST KRYONERI |
| ATTICA |
| GREECE |

GEROLYMATOS P.G.N. AEBE

ASKLIPIOU ST KRYONERI

ATTICA

GREECE

MULTIHANCE

529 mg/mlm

Solution for injection prefilled syringe

intravenous use

Greece

| BAYER HELLAS ABEE |
| --- |
| SOROU 18-20, |
| 151 25 MAROUSI, ATHENS, |
| GREECE |

BAYER HELLAS ABEE

SOROU 18-20,

151 25 MAROUSI, ATHENS,

GREECE

PRIMOVIST

0,25 mmol/ml

Solution for injection

intravenous use

Greece

| BAYER HELLAS ABEE |
| --- |
| SOROU 18-20, |
| 151 25 MAROUSI, ATHENS, |
| GREECE |

BAYER HELLAS ABEE

SOROU 18-20,

151 25 MAROUSI, ATHENS,

GREECE

PRIMOVIST ‘PFS’

0,25 mmol/ml

Solution for injection prefilled syringe

intravenous use

Greece

| BAYER HELLAS ABEE |
| --- |
| SOROU 18-20, |
| 151 25 MAROUSI, ATHENS, |
| GREECE |

BAYER HELLAS ABEE

SOROU 18-20,

151 25 MAROUSI, ATHENS,

GREECE

GADOVIST

1 mmol/ml

solution for injection

intravenous use

Greece

| BAYER HELLAS ABEE |
| --- |
| SOROU 18-20, |
| 151 25 MAROUSI, ATHENS, |
| GREECE |

BAYER HELLAS ABEE

SOROU 18-20,

151 25 MAROUSI, ATHENS,

GREECE

GADOVIST PFS

1 mmol/ml

Solution for injection prefilled syringe

intravenous use

Greece

| Hospital Line SA |
| --- |
| K. Palama 36 |
| GR-143 43, N. Chalkidona, Athens |
| Greece |

Hospital Line SA

K. Palama 36

GR-143 43, N. Chalkidona, Athens

Greece

Dotarem

1,4 mg/ml

solution for injection

intravenous use

Greece

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

VASOVIST

0,25 mmol/ml

solution for injection

intravenous use

Hungary

| GUERBET |
| --- |
| BP 57400 |
| 95943 Roissy Charles de Gaulle Cedex |
| France |

GUERBET

BP 57400

95943 Roissy Charles de Gaulle Cedex

France

DOTAREM 0,5 mmol/ml injection 15ml

0,5 mmol/ml

injection

intravenous use

Hungary

| GUERBET |
| --- |
| BP 57400 |
| 95943 Roissy Charles de Gaulle Cedex |
| France |

GUERBET

BP 57400

95943 Roissy Charles de Gaulle Cedex

France

DOTAREM 0,5 mmol/ml injection 20ml

0,5 mmol/ml

injection

intravenous use

Hungary

| GUERBET |
| --- |
| BP 57400 |
| 95943 Roissy Charles de Gaulle Cedex |
| France |

GUERBET

BP 57400

95943 Roissy Charles de Gaulle Cedex

France

DOTAREM 0,5 mmol/ml injection 60ml

0,5 mmol/ml

injection

intravenous use

Hungary

| GUERBET |
| --- |
| BP 57400 |
| 95943 Roissy Charles de Gaulle Cedex |
| France |

GUERBET

BP 57400

95943 Roissy Charles de Gaulle Cedex

France

DOTAREM 0,5 mmol/ml injection 1,0ml

0,5 mmol/ml

injection

intravenous use

Hungary

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

GADOVIST 1,0 mmol/ml solution for injection

1 mmol/ml

solution for injection

intravenous use

Hungary

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

GADOVIST

1 mmol/ml

solution for injection, prefilled syringe

intravenous use

Hungary

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

MAGNEVIST

0,5 mmol/ml

solution for injection

intravenous use

Hungary

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

MAGNEVIST

0,5 mmol/ml

injection in a pre-filled syringe

intravenous use

Hungary

| Bracco S.p.A. |
| --- |
| Via Emilio Folli, 50 |
| 20134 Milano |
| Italy |

Bracco S.p.A.

Via Emilio Folli, 50

20134 Milano

Italy

MULTIHANCE

0,5 M

solution for injection

intravenous use

Hungary

| GE Healthcare AS |
| --- |
| Nycoveien 1-2 |
| 4220 Nydalen, |
| Oslo N-0401 |
| Norway |

GE Healthcare AS

Nycoveien 1-2

4220 Nydalen,

Oslo N-0401

Norway

OMNISCAN 0,5 mmol/ml injection

0,5 mmol/ml

solution for injection

intravenous use

Hungary

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

PRIMOVIST

0,25 mmol/ml

solution for injection

intravenous use

Hungary

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

PRIMOVIST

0,25 mmol/ml

solution for injection, pre-filled syringe

intravenous use

Ireland

| GE Healthcare AS |
| --- |
| Nycoveien 1-2 |
| 4220 Nydalen, |
| Oslo N-0401 |
| Norway |

GE Healthcare AS

Nycoveien 1-2

4220 Nydalen,

Oslo N-0401

Norway

Omniscan 0,5 mmol/ml solution for injection, glass vial/bottle

0,5 mmol/ml

solution for injection

intravenous use

Ireland

| GE Healthcare AS |
| --- |
| Nycoveien 1-2 |
| 4220 Nydalen, |
| Oslo N-0401 |
| Norway |

GE Healthcare AS

Nycoveien 1-2

4220 Nydalen,

Oslo N-0401

Norway

Omniscan 0,5 mmol/ml solution for injection, polypropylene bottles

0,5 mmol/ml

solution for injection

intravenous use

Ireland

| GE Healthcare AS |
| --- |
| Nycoveien 1-2 |
| 4220 Nydalen, |
| Oslo N-0401 |
| Norway |

GE Healthcare AS

Nycoveien 1-2

4220 Nydalen,

Oslo N-0401

Norway

Omniscan 0,5 mmol/ml solution for injection, prefilled syringe

0,5 mmol/ml

solution for injection, prefilled syringe

intravenous use

Ireland

| Bayer Limited |
| --- |
| The Atrium |
| Blackthorn Road |
| Dublin 18 |
| Ireland |

Bayer Limited

The Atrium

Blackthorn Road

Dublin 18

Ireland

Primovist 0,25 mmol/ml Sol for Injection

0,25 mmol/ml

solution for injection

intravenous use

Ireland

| Bayer Limited |
| --- |
| The Atrium |
| Blackthorn Road |
| Dublin 18 |
| Ireland |

Bayer Limited

The Atrium

Blackthorn Road

Dublin 18

Ireland

Primovist 0,25 mmol/ml Sol for Injection, prefilled syringe

0,25 mmol/ml

solution for injection, prefilled syringe

intravenous use

Ireland

| Bayer Limited |
| --- |
| The Atrium |
| Blackthorn Road |
| Dublin 18 |
| Ireland |

Bayer Limited

The Atrium

Blackthorn Road

Dublin 18

Ireland

Gadovist 1,0 mmol/ml Solution for Injection

1,0 mmol/ml

solution for injection

intravenous use

Ireland

| Bayer Limited |
| --- |
| The Atrium |
| Blackthorn Road |
| Dublin 18 |
| Ireland |

Bayer Limited

The Atrium

Blackthorn Road

Dublin 18

Ireland

Gadovist 1,0 mmol/ml Solution for Injection in prefilled syringe

1,0 mmol/ml

solution for injection, in prefilled syringe

intravenous use

Ireland

| Bayer Limited |
| --- |
| The Atrium |
| Blackthorn Road |
| Dublin 18 |
| Ireland |

Bayer Limited

The Atrium

Blackthorn Road

Dublin 18

Ireland

Gadovist 1,0 mmol/ml Solution for Injection in prefilled cartridge

1,0 mmol/ml

solution for injection, in prefilled cartridge

intravenous use

Ireland

| Bracco International B.V |
| --- |
| Strawinskylaan 3051 |
| NL-1077 ZX Amsterdam |
| Netherlands |

Bracco International B.V

Strawinskylaan 3051

NL-1077 ZX Amsterdam

Netherlands

Prohance 279,3 mg/ml Solution for Injection, 5 ml vial

279,3 mg/ml

solution for injection

intravenous use

Ireland

| Bracco International B.V |
| --- |
| Strawinskylaan 3051 |
| NL-1077 ZX Amsterdam |
| Netherlands |

Bracco International B.V

Strawinskylaan 3051

NL-1077 ZX Amsterdam

Netherlands

Prohance 279,3 mg/ml Solution for Injection, 10 ml vial

279,3 mg/ml

solution for injection

intravenous use

Ireland

| Bracco International B.V |
| --- |
| Strawinskylaan 3051 |
| NL-1077 ZX Amsterdam |
| Netherlands |

Bracco International B.V

Strawinskylaan 3051

NL-1077 ZX Amsterdam

Netherlands

Prohance 279,3 mg/ml Solution for Injection, 15 ml vial

279,3 mg/ml

solution for injection

intravenous use

Ireland

| Bracco International B.V |
| --- |
| Strawinskylaan 3051 |
| NL-1077 ZX Amsterdam |
| Netherlands |

Bracco International B.V

Strawinskylaan 3051

NL-1077 ZX Amsterdam

Netherlands

Prohance 279,3 mg/ml Solution for Injection, 20 ml vial

279,3 mg/ml

solution for injection

intravenous use

Ireland

| GUERBET |
| --- |
| BP 57400 |
| 95943 Roissy Charles de Gaulle Cedex |
| France |

GUERBET

BP 57400

95943 Roissy Charles de Gaulle Cedex

France

Dotarem 279,32 mg/ml Solution for Injection, glass pre-filled syringes

279,32 mg/ml

solution for injection

intravenous use

Ireland

| GUERBET |
| --- |
| BP 57400 |
| 95943 Roissy Charles de Gaulle Cedex |
| France |

GUERBET

BP 57400

95943 Roissy Charles de Gaulle Cedex

France

Dotarem 279,32 mg/ml Solution for Injection, glass vials

279,32 mg/ml

solution for injection

intravenous use

Ireland

| Bracco SpA |
| --- |
| Via Egidio Folli 50 |
| I-20134 Milan |
| Italy |

Bracco SpA

Via Egidio Folli 50

I-20134 Milan

Italy

Multihance 0,5 M solution for injection

529 mg/ml

solution for injection

intravenous use

Ireland

| Bracco SpA |
| --- |
| Via Egidio Folli 50 |
| I-20134 Milan |
| Italy |

Bracco SpA

Via Egidio Folli 50

I-20134 Milan

Italy

Multihance 529 mg/ml solution for injection in prefiled syringe

529 mg/ml

solution for injection in prefilled syringe

intravenous use

Ireland

| Insights Agents GmbH |
| --- |
| Ringstrasse 19B |
| D-69115 Heidelberg |
| Germany |

Insights Agents GmbH

Ringstrasse 19B

D-69115 Heidelberg

Germany

Magnegita 500 micromol/ml solution for injection

500 mmol/ml

solution for injection

intravenous use

Ireland

| Bayer Limited |
| --- |
| The Atrium |
| Blackthorn Road |
| Dublin 18 |
| Ireland |

Bayer Limited

The Atrium

Blackthorn Road

Dublin 18

Ireland

Magnevist 0,5 mmol/ml Solution for Injection

0,5 mmol/ml

solution for injection

intravenous use

Ireland

| Bayer Limited |
| --- |
| The Atrium |
| Blackthorn Road |
| Dublin 18 |
| Ireland |

Bayer Limited

The Atrium

Blackthorn Road

Dublin 18

Ireland

Magnevist 0,5 mmol/ml Solution for Injection in pre-filled syringe.

0,5 mmol/ml

solution for Injection in pre-filled syringe

intravenous use

Iceland

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

Magnevist

469 mg/ml

solution for injection

intravenous use

Iceland

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

Magnevist

469 mg/ml

solution for injection, prefilled syringe

intravenous use

Iceland

| GE Healthcare AS |
| --- |
| Nycoveien 1-2 |
| 4220 Nydalen, |
| Oslo N-0401 |
| Norway |

GE Healthcare AS

Nycoveien 1-2

4220 Nydalen,

Oslo N-0401

Norway

Omniscan

0,5 mmol/ml

solution for injection

intravenous use

Iceland

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

Gadovist

1,0 mmol/ml

Solution for injection

Intravenous use

Italy

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178, |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178,

DE-13342 Berlin-Wedding

Germany

Magnevist

469 mg/ml

solution for injection

intravenous use

Italy

| GUERBET |
| --- |
| BP 57400 |
| 95943 Roissy Charles de Gaulle Cedex |
| France |

GUERBET

BP 57400

95943 Roissy Charles de Gaulle Cedex

France

Dotarem

0,5 mmol/ml

solution for injection

intravenous use

Italy

| GUERBET |
| --- |
| BP 57400 |
| 95943 Roissy Charles de Gaulle Cedex |
| France |

GUERBET

BP 57400

95943 Roissy Charles de Gaulle Cedex

France

Dotarem

0,0025 mmol/ml

solution for injection

intravenous use

Italy

| GE Healthcare |
| --- |
| Via Galeno 36, |
| 20126 Milano |
| Italy |

GE Healthcare

Via Galeno 36,

20126 Milano

Italy

Omniscan

287 mg/ml (0,5 mmol/ml)

solution for injection

intravenous use

Italy

| Bracco Imaging Italia |
| --- |
| Via Egidio Folli, 50 |
| 20134 Milano |
| Italy |

Bracco Imaging Italia

Via Egidio Folli, 50

20134 Milano

Italy

ProHance

279,3 mg/ml (0,5 M)

solution for infusion

intravenous use

Italy

| Bracco Imaging Italia |
| --- |
| Via Egidio Folli, 50 |
| 20134 Milano |
| Italy |

Bracco Imaging Italia

Via Egidio Folli, 50

20134 Milano

Italy

MultiHance

334 mg/ml (0,5 M)

solution for injection

intravenous use

Italy

| Bayer SpA |
| --- |
| Viale Certosa, 130 |
| 20156 Milano |
| Italy |

Bayer SpA

Viale Certosa, 130

20156 Milano

Italy

Gadovist

604,72 mg/ml

solution for injection

intravenous use

Italy

| Bayer SpA |
| --- |
| Viale Certosa, 130 |
| 20156 Milano |
| Italy |

Bayer SpA

Viale Certosa, 130

20156 Milano

Italy

Primovist

0,25 mmol/ml

solution for injection

intravenous use

Lithuania

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 178 |
| DE-13353 Berlin |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 178

DE-13353 Berlin

Germany

Gadovist

1 mmol/ml

solution for injection (pre- filled syringe)

intravenous use

Lithuania

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 178 |
| DE-13353 Berlin |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 178

DE-13353 Berlin

Germany

Primovist

0,25 mmol/ml

solution for injection

intravenous use

Lithuania

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 178 |
| DE-13353 Berlin |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 178

DE-13353 Berlin

Germany

Primovist

0,25 mmol/ml

solution for injection (pre-filled syringe)

intravenous use

Lithuania

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 178 |
| DE-13353 Berlin |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 178

DE-13353 Berlin

Germany

Magnevist

0,5 mmol/ml

solution for injection/infusion

intravenous use

Lithuania

| Insight Agents GmbH |
| --- |
| Ringstr. 19 B |
| D-69115 Heidelberg |
| Germany |

Insight Agents GmbH

Ringstr. 19 B

D-69115 Heidelberg

Germany

Magnegita

500 micromol/ml

solution for injection

intravenous use

Lithuania

| GE Healthcare AS |
| --- |
| Nycoveien 1-2 |
| P.O. Box 4220 Nydalen, |
| Oslo N-0401 |
| Norway |

GE Healthcare AS

Nycoveien 1-2

P.O. Box 4220 Nydalen,

Oslo N-0401

Norway

Omniscan

0,5 mmol/ml

solution for injection

intravenous use

Luxembourg

| Codali S.A. |
| --- |
| Avenue Henri Dunant 31 |
| 1140 Bruxelles |
| Belgium |

Codali S.A.

Avenue Henri Dunant 31

1140 Bruxelles

Belgium

DOTAREM

37,7 G

solution for injection

intravenous use

Luxembourg

| Insight Agents GmbH |
| --- |
| Ringstr. 19 B |
| D-69115 Heidelberg |
| Germany |

Insight Agents GmbH

Ringstr. 19 B

D-69115 Heidelberg

Germany

GADOPENTETATE INSIGHT

469 MG/ML

solution for injection

intravenous use

Luxembourg

| Bayer SA-NV |
| --- |
| J.E. Mommaertslaan 14 |
| 1831 Diegem |
| Belgium |

Bayer SA-NV

J.E. Mommaertslaan 14

1831 Diegem

Belgium

GADOVIST 1

604,72 mg

solution for injection

intravenous use

Luxembourg

| Bayer SA-NV |
| --- |
| J.E. Mommaertslaan 14 |
| 1831 Diegem |
| Belgium |

Bayer SA-NV

J.E. Mommaertslaan 14

1831 Diegem

Belgium

GADOVIST PFS-1

604,72 mg/1 ml

solution for injection

intravenous use

Luxembourg

| Insight Agents GmbH |
| --- |
| Ringstr. 19 B |
| D-69115 Heidelberg |
| Germany |

Insight Agents GmbH

Ringstr. 19 B

D-69115 Heidelberg

Germany

MAGNEGITA

78,63 MG/1 ML

solution for injection

intravenous use

Luxembourg

| Bayer SA-NV |
| --- |
| J.E. Mommaertslaan 14 |
| 1831 Diegem |
| Belgium |

Bayer SA-NV

J.E. Mommaertslaan 14

1831 Diegem

Belgium

MAGNEVIST

4,69 G/10 ML

solution for injection

intravenous use

Luxembourg

| Bracco IMAGING Deutschland GmbH |
| --- |
| Max-Stromeyer-Str. 116 |
| D-78467 Konstanz |
| Germany |

Bracco IMAGING Deutschland GmbH

Max-Stromeyer-Str. 116

D-78467 Konstanz

Germany

MULTIHANCE

529 mg/1 ml

solution for injection

intravenous use

Luxembourg

| GE HEALTHCARE BVBA |
| --- |
| Kouterveldstraat 20 |
| 1831 DIEGEM |
| Belgium |

GE HEALTHCARE BVBA

Kouterveldstraat 20

1831 DIEGEM

Belgium

OMNISCAN

287 MG/1 ML

solution for injection

intravenous use

Luxembourg

| Bracco IMAGING Deutschland GmbH |
| --- |
| Max-Stromeyer-Str. 116 |
| D-78467 Konstanz |
| Germany |

Bracco IMAGING Deutschland GmbH

Max-Stromeyer-Str. 116

D-78467 Konstanz

Germany

PROHANCE

279,3 MG/1 ML

solution for injection

intravenous use

Latvia

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

Gadovist 1,0 mmol/ml solution for injections

1,0 mmol/ml

solution for injection

intravenous use

Latvia

| Insight Agents GmbH |
| --- |
| Ringstr. 19 B |
| D-69115 Heidelberg |
| Germany |

Insight Agents GmbH

Ringstr. 19 B

D-69115 Heidelberg

Germany

Magnegita 500 micromol/ml solution for injection

500 micromol/ml

solution for injection

intravenous use

Latvia

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

Magnevist 0,5 mmol/ml solution for injection

0,5 mmol/ml

solution for injection

intravenous use

Latvia

| GE Healthcare AS |
| --- |
| Nycoveien 1-2, 4220 Nydalen, |
| Oslo N-0401 |
| Norway |

GE Healthcare AS

Nycoveien 1-2, 4220 Nydalen,

Oslo N-0401

Norway

Omniscan 0,5 mmmol/ml solution for injection

0,5 mmol/ml

solution for injection

intravenous use

Latvia

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

Primovist 0,25 mmol/ ml solution for injection

0,25 mmol/ml

solution for injection

intravenous use

Latvia

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

Primovist 0,25 mmol/ml solution for injection pre-filled syringe

0,25 mmol/ml

Solution for injection, pre-filled syringe

intravenous use

Malta

| GE Healthcare AS |
| --- |
| Nycoveien 1-2, 4220 Nydalen, |
| Oslo N-0401 |
| Norway |

GE Healthcare AS

Nycoveien 1-2, 4220 Nydalen,

Oslo N-0401

Norway

Omniscan

0,5 mMol/ml (287 mg equiv. 0,5 mmol)

solution for injection

intravenous use

Malta

| Bayer plc |
| --- |
| Bayer House, Strawberry Hill, |
| Newbury, Berkshire, RG14 1JA |
| UK |

Bayer plc

Bayer House, Strawberry Hill,

Newbury, Berkshire, RG14 1JA

UK

Magnevist

469,01 mg

Solution for injection

intravenous use

Malta

| Bayer plc |
| --- |
| Bayer House, Strawberry Hill, |
| Newbury, Berkshire, RG14 1JA |
| UK |

Bayer plc

Bayer House, Strawberry Hill,

Newbury, Berkshire, RG14 1JA

UK

Primovist

PFS 0,25 mmol/ml

Solution for injection, prefilled syringe

intravenous use

Netherlands

| Guerbet Nederland B.V. |
| --- |
| Avelingen-West 3A |
| 4202 MS GORINCHEM |
| Netherlands |

Guerbet Nederland B.V.

Avelingen-West 3A

4202 MS GORINCHEM

Netherlands

Dotarem

0,5 mmol/ml

solution for injection

intravenous use

Netherlands

| Bayer B.V. |
| --- |
| Energieweg 1 |
| 3641 RT MIJDRECHT |
| Netherlands |

Bayer B.V.

Energieweg 1

3641 RT MIJDRECHT

Netherlands

Gadovisit

1,0 mmol/ml

solution for injection

intravenous use

Netherlands

| Bayer B.V. |
| --- |
| Energieweg 1 |
| 3641 RT MIJDRECHT |
| Netherlands |

Bayer B.V.

Energieweg 1

3641 RT MIJDRECHT

Netherlands

Magnevist

0,5 mmol/ml

solution for injection

intravenous use

Netherlands

| Bracco IMAGING Deutschland GmbH |
| --- |
| Max-Stromeyer-Str. 116 |
| D-78467 Konstanz |
| Germany |

Bracco IMAGING Deutschland GmbH

Max-Stromeyer-Str. 116

D-78467 Konstanz

Germany

Multihance

0,5 mmol/ml

solution for injection

intravenous use

Netherlands

| GE Healthcare B.V. |
| --- |
| Cygne Centre De Rondom 8 |
| 5612 AP EINDHOVEN |
| Netherlands |

GE Healthcare B.V.

Cygne Centre De Rondom 8

5612 AP EINDHOVEN

Netherlands

Omniscan

0,5 mmol/ml

solution for injection

intravenous use

Netherlands

| Bayer B.V. |
| --- |
| Energieweg 1 |
| 3641 RT MIJDRECHT |
| Netherlands |

Bayer B.V.

Energieweg 1

3641 RT MIJDRECHT

Netherlands

Primovist

0,25 mmol/ml

solution for injection

intravenous use

Netherlands

| Bracco IMAGING Deutschland GmbH |
| --- |
| Max-Stromeyer-Str. 116 |
| D-78467 Konstanz |
| Germany |

Bracco IMAGING Deutschland GmbH

Max-Stromeyer-Str. 116

D-78467 Konstanz

Germany

Prohance

0,5 mmol/ml

solution for injection

intravenous use

Netherlands

| Insight Agents GmbH |
| --- |
| Ringstr. 19 B |
| D-69115 Heidelberg |
| Germany |

Insight Agents GmbH

Ringstr. 19 B

D-69115 Heidelberg

Germany

Magnegita

0,5 mmol/ml

solution for injection

intravenous use

Netherlands

| Insight Agents GmbH |
| --- |
| Ringstr. 19 B |
| D-69115 Heidelberg |
| Germany |

Insight Agents GmbH

Ringstr. 19 B

D-69115 Heidelberg

Germany

Gadopentetate Insight

0,5 mmol/ml

solution for injection

intravenous use

Norway

| GUERBET |
| --- |
| BP 57400 |
| 95943 Roissy Charles de Gaulle Cedex |
| France |

GUERBET

BP 57400

95943 Roissy Charles de Gaulle Cedex

France

Dotarem

279,3 mg/ml

solution for injection

intravenous use

Norway

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

Magnevist

469 mg/ml

solution for injection

intravenous use

Norway

| Bracco S.p.A. |
| --- |
| Via Emilio Folli, 50 |
| 20134 Milano |
| Italy |

Bracco S.p.A.

Via Emilio Folli, 50

20134 Milano

Italy

MultiHance

334 mg/ml

solution for injection

intravenous use

Norway

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

Primovist

0,25 mmol/ml

solution for injection

intravenous use

Norway

| Bracco International B.V |
| --- |
| Strawinskylaan 3051 |
| NL-1077 ZX Amsterdam |
| Netherlands |

Bracco International B.V

Strawinskylaan 3051

NL-1077 ZX Amsterdam

Netherlands

Prohance

279,3 mg/ml

solution for injection

intravenous use

Norway

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

Gadovist

1 mmol/ml

solution for injection

intravenous use

Norway

| GE Healthcare AS |
| --- |
| Nycoveien 1-2 |
| 4220 Nydalen, |
| Oslo N-0401 |
| Norway |

GE Healthcare AS

Nycoveien 1-2

4220 Nydalen,

Oslo N-0401

Norway

Omniscan

0,5 mmol/ml

solution for injection

intravenous use

Poland

| GE Healthcare AS |
| --- |
| Nycoveien 1-2 |
| P.O. Box 4220 Nydalen, |
| Oslo NO-0401 |
| Norway |

GE Healthcare AS

Nycoveien 1-2

P.O. Box 4220 Nydalen,

Oslo NO-0401

Norway

Omniscan

0,5 mmol/ml

solution for injection

intravenous use

Poland

| Bracco Imaging Deutschland GmbH |
| --- |
| Max-Stromeyer-Str. 116 |
| D-78467 Konstanz |
| Germany |

Bracco Imaging Deutschland GmbH

Max-Stromeyer-Str. 116

D-78467 Konstanz

Germany

ProHance

279,3 mg/ml

solution for injection

intravenous use

Poland

| Bayer Schering Pharma AG |
| --- |
| D-13342 Berlin |
| Germany |

Bayer Schering Pharma AG

D-13342 Berlin

Germany

Gadovist 1,0

604,72 mg/ml

solution for injection

intravenous use

Poland

| Bayer Schering Pharma AG |
| --- |
| D-13342 Berlin |
| Germany |

Bayer Schering Pharma AG

D-13342 Berlin

Germany

Magnevist

469 mg/ml

solution for injection

intravenous use

Poland

| Bracco ALTANA Pharma GmbH |
| --- |
| Max-Stromeyer-Str. 116 |
| 78467 Konstanz |
| Germany |

Bracco ALTANA Pharma GmbH

Max-Stromeyer-Str. 116

78467 Konstanz

Germany

Multihance

529 mg/ml

solution for injection

intravenous use

Poland

| Bayer Schering Pharma AG |
| --- |
| D-13342 Berlin |
| Germany |

Bayer Schering Pharma AG

D-13342 Berlin

Germany

Primovist

0,25 mmol/ml

solution for injection

intravenous use

Portugal

| Bayer Portugal S.A. |
| --- |
| Rua Quinta do Pinheiro, 5 |
| 2794-003 Carnaxide |
| Portugal |

Bayer Portugal S.A.

Rua Quinta do Pinheiro, 5

2794-003 Carnaxide

Portugal

Primovist

0,25 mmol/ml

solution for injection

intravenous use

Portugal

| Bayer Portugal S.A. |
| --- |
| Rua Quinta Pinheiro, 5, |
| 2794-003 Carnaxide |
| Portugal |

Bayer Portugal S.A.

Rua Quinta Pinheiro, 5,

2794-003 Carnaxide

Portugal

Primovist

0,25 mmol/ml

solution for injection (pre-filled syringe)

intravenous use

Portugal

| Lusal - Produção Químico-Farmacêutica Luso-Alemã Lda. |
| --- |
| Rua Quinta Pinheiro, 5, Outurela 2794-003 Carnaxide |
| Portugal |

Lusal - Produção Químico-Farmacêutica Luso-Alemã Lda.

Rua Quinta Pinheiro, 5, Outurela 2794-003 Carnaxide

Portugal

Gadovist

1 mmol/ml

solution for injection

intravenous use

Portugal

| Lusal - Produção Químico-Farmacêutica Luso-Alemã Lda. |
| --- |
| Rua Quinta Pinheiro, 5, Outurela 2794-003 Carnaxide |
| Portugal |

Lusal - Produção Químico-Farmacêutica Luso-Alemã Lda.

Rua Quinta Pinheiro, 5, Outurela 2794-003 Carnaxide

Portugal

Gadovist

1 mmol/ml

solution for injection (pre-filled syringe)

intravenous use

Portugal

| A. Martins & Fernandes S.A. |
| --- |
| Rua Raúl Mesnier du Ponsard, |
| 4 B 1750-243 Lisboa |
| Portugal |

A. Martins & Fernandes S.A.

Rua Raúl Mesnier du Ponsard,

4 B 1750-243 Lisboa

Portugal

Dotarem

377 mg/ml

solution for injection

intravenous use

Portugal

| Satis-Radioisótopos e Protecções Contra Sobretensões Eléctricas Unipessoal Lda. |
| --- |
| Edifício Ramazzotti, Av. do Forte, |
| n.o 6 - 6A, 2790-502 Carnaxide |
| Portugal |

Satis-Radioisótopos e Protecções Contra Sobretensões Eléctricas Unipessoal Lda.

Edifício Ramazzotti, Av. do Forte,

n.o 6 - 6A, 2790-502 Carnaxide

Portugal

Omniscan

287 mg/ml

solution for injection

intravenous use

Romania

| Bracco S.p.A. |
| --- |
| Via Egidio Folli, 50 |
| 20134 Milano |
| Italy |

Bracco S.p.A.

Via Egidio Folli, 50

20134 Milano

Italy

MULTIHANCE 0,5M

0,529 g (0,334 g + 0,195 g )/ml

solution for injection

intravenous use

Romania

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 178 |
| DE-13342 Berlin- |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 178

DE-13342 Berlin-

Germany

MAGNEVIST

469,01 mg/ml

solution for injection

intravenous use

Romania

| INSIGHT AGENTS GmbH |
| --- |
| Ringstrasse. 19B |
| 69115 Heidelberg |
| Germany |

INSIGHT AGENTS GmbH

Ringstrasse. 19B

69115 Heidelberg

Germany

MAGNEGITA 500 micromol/ml, soluție injectabilă

500 micromol/ml (469,01 mg/ml)

solution for injection

intravenous use

Romania

| GUERBET |
| --- |
| BP 57400 |
| 95943 Roissy Charles de Gaulle Cedex |
| France |

GUERBET

BP 57400

95943 Roissy Charles de Gaulle Cedex

France

DOTAREM 0,5 mmol/ml soluție injectabilă în seringă preumplută

27,932 g/ml

solution for injection, pre-filled syringe

intravenous use

Romania

| GUERBET |
| --- |
| BP 57400 |
| 95943 Roissy Charles de Gaulle Cedex |
| France |

GUERBET

BP 57400

95943 Roissy Charles de Gaulle Cedex

France

DOTAREM 0,5 mmol/ml soluție injectabilă unidoză

27,932 g/ml

solution for injection

intravenous use

Romania

| GUERBET |
| --- |
| BP 57400 |
| 95943 Roissy Charles de Gaulle Cedex |
| France |

GUERBET

BP 57400

95943 Roissy Charles de Gaulle Cedex

France

DOTAREM 0,5 mmol/ml soluție injectabilă multidoză

27,932 g/ml

solution for injection

intravenous use

Romania

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 178 |
| DE-13342 Berlin- |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 178

DE-13342 Berlin-

Germany

PRIMOVIST 0,25 mmol/ml, soluție injectabilă în seringă preumplută

181,430 mg/ml

solution for injection, pre-filled syringe

intravenous use

Romania

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 178 |
| DE-13342 Berlin- |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 178

DE-13342 Berlin-

Germany

GADOVIST 1,0 mmol/ml, soluție injectabilă

604,720 mg/ml

solution for injection

intravenous use

Romania

| GE Healthcare AS |
| --- |
| Nycoveien 1-2 |
| P.O. Box 4220 Nydalen, |
| N-0401 Oslo |
| Norway |

GE Healthcare AS

Nycoveien 1-2

P.O. Box 4220 Nydalen,

N-0401 Oslo

Norway

OMNISCAN, soluție injectabilă

287,000 mg/ml

solution for injection

intravenous use

Sweden

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 178

DE-13342 Berlin-Wedding

Germany

Magnevist

0,5 mmol/m

solution for injection

intravenous use

Sweden

| Bracco SpA |
| --- |
| Via Egidio Folli 50 |
| I-20134 Milan |
| Italy |

Bracco SpA

Via Egidio Folli 50

I-20134 Milan

Italy

Multihance

334 mg/ml

solution for injection

intravenous use

Sweden

| Bracco SpA |
| --- |
| Via Egidio. Folli 50 |
| I-20134 Milan |
| Italy |

Bracco SpA

Via Egidio. Folli 50

I-20134 Milan

Italy

Multihance

334 mg/ml

solution for injection, pre-filled syringe

intravenous use

Sweden

| Bracco International BV |
| --- |
| Stravinskylaan 3051 |
| NL-1077 ZX Amsterdam |
| The Netherlands |

Bracco International BV

Stravinskylaan 3051

NL-1077 ZX Amsterdam

The Netherlands

Prohance

279,3 mg/ml

solution for injection

intravenous use

Sweden

| GE Healthcare AS |
| --- |
| P.O.Box 4220 |
| Nydalen |
| N-0401 Oslo |
| Norway |

GE Healthcare AS

P.O.Box 4220

Nydalen

N-0401 Oslo

Norway

Omniscan

0,5 mmol/ml

solution for injection

intravenous use

Sweden

| GE Healthcare AS |
| --- |
| P.O.Box 4220 |
| Nydalen |
| N-0401 Oslo |
| Norway |

GE Healthcare AS

P.O.Box 4220

Nydalen

N-0401 Oslo

Norway

Omniscan

0,5 mmol/ml

solution for injection, pre-filled syringe

intravenous use

Sweden

| Bayer Schering Pharma AG, |
| --- |
| Müllerstrasse 178 |
| DE-133 42 Berlin |
| Germany |

Bayer Schering Pharma AG,

Müllerstrasse 178

DE-133 42 Berlin

Germany

Primovist

0,25 mmol/ml

solution for injection

intravenous use

Sweden

| Bayer Schering Pharma AG, |
| --- |
| Müllerstrasse 178 |
| DE-133 42 Berlin |
| Germany |

Bayer Schering Pharma AG,

Müllerstrasse 178

DE-133 42 Berlin

Germany

Primovist

0,25 mmol/ml

solution for injection, pre-filled syringe

intravenous use

Sweden

| GUERBET |
| --- |
| BP 57400 |
| 95943 Roissy Charles de Gaulle Cedex |
| France |

GUERBET

BP 57400

95943 Roissy Charles de Gaulle Cedex

France

Dotarem

279,3 mg/ml

solution for injection

intravenous use

Sweden

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 178, |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 178,

DE-13342 Berlin-Wedding

Germany

Gadovist

1,0 mmol/ml

solution for injection

intravenous use

Sweden

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 178, |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 178,

DE-13342 Berlin-Wedding

Germany

Gadovist

1,0 mmol/ml

solution for injection, pre-filled syringe

intravenous use

Sweden

| Insight Agents GmbH |
| --- |
| Ringstr.19 B |
| D-69115 Heidelberg |
| Germany |

Insight Agents GmbH

Ringstr.19 B

D-69115 Heidelberg

Germany

Magnegita

500 mikromol/ml

solution for injection

intravenous use

Sweden

| Insight Agents GmbH |
| --- |
| Ringstr.19 B |
| D-69115 Heidelberg |
| Germany |

Insight Agents GmbH

Ringstr.19 B

D-69115 Heidelberg

Germany

Gadopentetsyrad imegluminat Insight

500 mikromol/ml

solution for injection

intravenous use

Sweden

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 178

DE-13342 Berlin-Wedding

Germany

Magnograf

0,5 mmol/ml

solution for injection

intravenous use

Sweden

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 178

DE-13342 Berlin-Wedding

Germany

Magnograf

0,5 mmol/ml

solution for injection pre-filled syringe

intravenous use

Slovenia

| Higieia d.o.o. |
| --- |
| Zastopstva in trgovina, Blatnica 10, |
| 1236 Trzin, |
| Slovenia |

Higieia d.o.o.

Zastopstva in trgovina, Blatnica 10,

1236 Trzin,

Slovenia

Omniscan 0,5 mmol/ml raztopina za injiciranje

0,5 mmol/ml

solution for injection

intravenous use

Slovenia

| Insight Agents GmbH |
| --- |
| Ringstr. 19 B |
| D-69115 Heidelberg |
| Germany |

Insight Agents GmbH

Ringstr. 19 B

D-69115 Heidelberg

Germany

Magnetita 500 mikromolov/ml raztopina za injiciranje

500 micromol/ml

solution for injection

intravenous use

Slovenia

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

Magnevist

0,5 mmol/ml

solution for injection

intravenous use

Slovenia

| Auremiana |
| --- |
| izvozno uvozno trgovsko podjetje, d.o.o., Sežana, Partizanska 109, 6210 Sežana |

Auremiana

izvozno uvozno trgovsko podjetje, d.o.o., Sežana, Partizanska 109, 6210 Sežana

Multihance 0,5 mmol/ml raztopina za injiciranje

334 mg/ml

solution for injection

intravenous use

Slovenia

| Emporio Medical |
| --- |
| d.o.o., Prešernova 5, 1,00 Ljubljana, |
| Slovenia |

Emporio Medical

d.o.o., Prešernova 5, 1,00 Ljubljana,

Slovenia

Dotarem 0,5 mmol/ml raztopina za injiciranje

27,93 g/ml

solution for injection

intravenous use

Slovenia

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178, DE-13342 |
| Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178, DE-13342

Berlin-Wedding

Germany

Gadovist 1,0 mmol/ml raztopina za injiciranje

1,0 mmol/ml

solution for injection

intravenous use

Slovenia

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178, DE-13342 |
| Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178, DE-13342

Berlin-Wedding

Germany

Primovist 0,25 mmol/ml raztopina za injiciranje v napolnjeni injekcijski brizgi

0,25 mmol/ml

solution for injection

intravenous use

Slovakia

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178, DE-13342 |
| Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178, DE-13342

Berlin-Wedding

Germany

Gadovist 1,0 mmol/ml

604,72 mg/ml

solution for injection

intravenous use

Slovakia

| GE Healthcare AS |
| --- |
| Nycoveien 1-2, 4220 Nydalen, |
| Oslo N-0401 |
| Norway |

GE Healthcare AS

Nycoveien 1-2, 4220 Nydalen,

Oslo N-0401

Norway

OMNISCAN

0,5 mmol/ml

solution for injection

intravenous use

Slovakia

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178, DE-13342 |
| Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178, DE-13342

Berlin-Wedding

Germany

Primovist 0,25 mmol/ml, injekčný roztok

0,25 mmol/ml

solution for injection

intravenous use

Slovakia

| Bracco IMAGING Deutschland GmbH |
| --- |
| Max-Stromexer-Str. 116 |
| D-78467 Konstanz |
| Germany |

Bracco IMAGING Deutschland GmbH

Max-Stromexer-Str. 116

D-78467 Konstanz

Germany

PROHANCE

279,3 mg/ml

solution for injection

intravenous use

Slovakia

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178, |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178,

DE-13342 Berlin-Wedding

Germany

Magnevist

469 mg/ml

solution for injection

intravenous use

United Kingdom

| GE Healthcare AS |
| --- |
| Nycoveien 1-2, 4220 Nydalen, |
| Oslo N-0401 |
| Norway |

GE Healthcare AS

Nycoveien 1-2, 4220 Nydalen,

Oslo N-0401

Norway

Omniscan injection

0,5 mmol/ml and 0,5 mmol/litre

solution for injection

intravenous use

United Kingdom

| Bayer plc |
| --- |
| Bayer House, Strawberry Hill, |
| Newbury, Berkshire, RG14 1JA |
| UK |

Bayer plc

Bayer House, Strawberry Hill,

Newbury, Berkshire, RG14 1JA

UK

Magnevist

0,5 mmol/ml

solution for injection

intravenous use

United Kingdom

| Bracco S.p.A. |
| --- |
| Via Emilio Folli, 50 |
| 20134 Milano |
| Italy |

Bracco S.p.A.

Via Emilio Folli, 50

20134 Milano

Italy

Multihance

0,5 M/ml

solution for injection

intravenous use

United Kingdom

| Bayer plc |
| --- |
| Bayer House, Strawberry Hill, |
| Newbury, Berkshire, RG14 1JA |
| UK |

Bayer plc

Bayer House, Strawberry Hill,

Newbury, Berkshire, RG14 1JA

UK

Primovist solution for injection

0,25 mmol/ml

solution for injection

intravenous use

United Kingdom

| Bracco International B.V., |
| --- |
| Strawinskylaan 3051 |
| Amsterdam 107 zx |
| Netherlands |

Bracco International B.V.,

Strawinskylaan 3051

Amsterdam 107 zx

Netherlands

Prohance

0,5 M/ml

solution for injection

intravenous use

United Kingdom

| Bayer plc |
| --- |
| Bayer House, Strawberry Hill, Newbury, |
| Berkshire, RG14 1JA |
| UK |

Bayer plc

Bayer House, Strawberry Hill, Newbury,

Berkshire, RG14 1JA

UK

Gadovist

1,0 mmol/ml

solution for injection

intravenous use

United Kingdom

| GUERBET |
| --- |
| BP 57400 |
| 95943 Roissy Charles de Gaulle Cedex |
| France |

GUERBET

BP 57400

95943 Roissy Charles de Gaulle Cedex

France

Dotarem solution for injection

0,5 mmol/ml

solution for injection

intravenous use

---

ANNEX VI

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State EU/EEA | Marketing Authorisation Holder | (Invented) name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6, |
| A-1140 Wien, |
| Austria |

Member State EU/EEA

Marketing Authorisation Holder

(Invented) name

Strength

Pharmaceutical Form

Route of administration

Austria

GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6,

A-1140 Wien,

Austria

Valtrex 1 000 mg - Filmtabletten

1 000 mg

film – coated tablet

Oral use

Austria

| Sandoz GmbH |
| --- |
| Biochemiestraße 10, |
| 6250 Kundl |
| Austria |

Sandoz GmbH

Biochemiestraße 10,

6250 Kundl

Austria

Valaciclovir Sandoz 1 000 mg - Filmtabletten

1 000 mg

film – coated tablet

Oral use

Austria

| GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6, |
| --- |
| A-1140 Wien |
| Austria |

GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6,

A-1140 Wien

Austria

Valtrex 500 mg - Filmtabletten

500 mg

film – coated tablet

Oral use

Austria

| Sandoz GmbH |
| --- |
| Biochemiestraße 10, |
| 6250 Kundl |
| Austria |

Sandoz GmbH

Biochemiestraße 10,

6250 Kundl

Austria

Valaciclovir Sandoz 500 mg - Filmtabletten

500 mg

film – coated tablet

Oral use

Austria

| GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6, |
| --- |
| A-1140 Wien, |
| Austria |

GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6,

A-1140 Wien,

Austria

Valtrex 250 mg - Filmtabletten

250 mg

film – coated tablet

Oral use

Austria

| Sandoz GmbH |
| --- |
| Biochemiestraße 10, |
| 6250 Kundl |
| Austria |

Sandoz GmbH

Biochemiestraße 10,

6250 Kundl

Austria

Valaciclovir Sandoz 250 mg - Filmtabletten

250 mg

film – coated tablet

Oral use

Belgium

GlaxoSmithKline s.a. /n.v., rue du Tilleul 13, B-1332 Genval, Belgium

Zelitrex

500 mg

film – coated tablet

Oral use

Belgium

GlaxoSmithKline s.a. /n.v., rue du Tilleul 13, B-1332 Genval, Belgium

Zelitrex

250 mg

film – coated tablet

Oral use

Bulgaria

| Glaxo Group Ltd |
| --- |
| Greenford Road |
| Greenford |
| Middlesex UB6 0NN |
| United Kingdom |

Glaxo Group Ltd

Greenford Road

Greenford

Middlesex UB6 0NN

United Kingdom

Valtrex

500 mg

film – coated tablet

Oral use

Cyprus

| Glaxo Group Limited |
| --- |
| Berkeley Avenue |
| Greenford |
| Middlesex, UB6 0NN, |
| United Kingdom |

Glaxo Group Limited

Berkeley Avenue

Greenford

Middlesex, UB6 0NN,

United Kingdom

Valtrex

500 mg

film – coated tablet

Oral use

Czech Republic

| The Wellcome Foundation Ltd., Glaxo Wellcome House |
| --- |
| Berkeley Avenue |
| Greenford |
| Middlesex |
| UB6 0NN, |
| United Kingdom |

The Wellcome Foundation Ltd., Glaxo Wellcome House

Berkeley Avenue

Greenford

Middlesex

UB6 0NN,

United Kingdom

Valtrex 500 mg

500 mg

film – coated tablet

Oral use

Denmark

| GlaxoSmithKline Pharma A/S, Nykaer 68 |
| --- |
| 2605 Broendby, |
| Denmark |

GlaxoSmithKline Pharma A/S, Nykaer 68

2605 Broendby,

Denmark

Zelitrex

1 000 mg

film – coated tablet

Oral use

Denmark

| GlaxoSmithKline Pharma A/S, Nykaer 68 |
| --- |
| 2605 Broendby, |
| Denmark |

GlaxoSmithKline Pharma A/S, Nykaer 68

2605 Broendby,

Denmark

Zelitrex

500 mg

film – coated tablet

Oral use

Denmark

| GlaxoSmithKline Pharma A/S, Nykaer 68 |
| --- |
| 2605 Broendby, |
| Denmark |

GlaxoSmithKline Pharma A/S, Nykaer 68

2605 Broendby,

Denmark

Zelitrex

250 mg

film – coated tablet

Oral use

Estonia

| Glaxo Wellcome Operations |
| --- |
| Glaxo Wellcome House, |
| Berkeley Avenue, Greenford, |
| Middlesex UB6 0NN, |
| United Kingdom |

Glaxo Wellcome Operations

Glaxo Wellcome House,

Berkeley Avenue, Greenford,

Middlesex UB6 0NN,

United Kingdom

Valtrex

500 mg

film – coated tablet

Oral use

Finland

| The Wellcome Foundation Ltd. Greenford, |
| --- |
| Middlesex, |
| United Kingdom |

The Wellcome Foundation Ltd. Greenford,

Middlesex,

United Kingdom

Valtrex

500 mg

film – coated tablet

Oral use

Finland

| Orion Corporation |
| --- |
| Orionintie 1 |
| FI-02200 Espoo, |
| Finland |

Orion Corporation

Orionintie 1

FI-02200 Espoo,

Finland

Valavir

500 mg

film – coated tablet

Oral use

Finland

| GlaxoSmithKline Oy |
| --- |
| Piispansilta 9 A, |
| 02230 Espoo, |
| Finland |

GlaxoSmithKline Oy

Piispansilta 9 A,

02230 Espoo,

Finland

Valtrex

250 mg

film – coated tablet

Oral use

France

| Laboratoire GlaxoSmithKline |
| --- |
| 100 route de Versailles |
| 78163 Marly-le-Roi cedex, France |

Laboratoire GlaxoSmithKline

100 route de Versailles

78163 Marly-le-Roi cedex, France

Zelitrex 500 mg, comprimé enrobé

500 mg

film – coated tablet

Oral use

France

| Laboratoire GlaxoSmithKline |
| --- |
| 100 route de Versailles |
| 78163 Marly-le-Roi cedex, France |

Laboratoire GlaxoSmithKline

100 route de Versailles

78163 Marly-le-Roi cedex, France

Zelitrex 1 000 mg, comprimé enrobé

1 000 mg

film – coated tablet

Oral use

France

| Laboratoires BIOGARAN 15, boulevard Charles de Gaulle |
| --- |
| 92707 COLOMBES Cedex |
| France |

Laboratoires BIOGARAN 15, boulevard Charles de Gaulle

92707 COLOMBES Cedex

France

Valaciclovir Biogaran 500 mg, comprimé enrobé

500 mg

film – coated tablet

Oral use

France

| Laboratoire GlaxoSmithKline |
| --- |
| 100 route de Versailles |
| 78163 Marly-le-Roi cedex, France |

Laboratoire GlaxoSmithKline

100 route de Versailles

78163 Marly-le-Roi cedex, France

Valaciclovir GSK 500 mg, comprimé enrobé

500 mg

film – coated tablet

Oral use

France

| sanofi-aventis France |
| --- |
| 1 – 13 boulevard Romain Rolland |
| 75014 PARIS |
| France |

sanofi-aventis France

1 – 13 boulevard Romain Rolland

75014 PARIS

France

Valaciclovir Winthrop 500 mg, comprimé enrobé

500 mg

film – coated tablet

Oral use

Germany

| GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11, |
| --- |
| 80339 München, |
| Germany |

GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11,

80339 München,

Germany

Valtrex

500 mg

film – coated tablet

Oral use

Germany

| GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11, |
| --- |
| 80339 München, |
| Germany |

GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11,

80339 München,

Germany

Valtrex S

500 mg

film – coated tablet

Oral use

Germany

| GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11, |
| --- |
| 80339 München, |
| Germany |

GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11,

80339 München,

Germany

Valtrex S 250 mg

250 mg

film – coated tablet

Oral use

Greece

| GlaxoSmithKline a.e.b.e, Leof. Kifissias 266, |
| --- |
| 152 32 Halandri, Athens, |
| Greece |

GlaxoSmithKline a.e.b.e, Leof. Kifissias 266,

152 32 Halandri, Athens,

Greece

Valtrex

1 000 mg

film – coated tablet

Oral use

Greece

| GlaxoSmithKline a.e.b.e, Leof. Kifissias 266, |
| --- |
| 152 32 Halandri, Athens, |
| Greece |

GlaxoSmithKline a.e.b.e, Leof. Kifissias 266,

152 32 Halandri, Athens,

Greece

Valtrex

500 mg

film – coated tablet

Oral use

Greece

| GlaxoSmithKline a.e.b.e, Leof. Kifissias 266, |
| --- |
| 152 32 Halandri, Athens, |
| Greece |

GlaxoSmithKline a.e.b.e, Leof. Kifissias 266,

152 32 Halandri, Athens,

Greece

Valtrex

250 mg

film – coated tablet

Oral use

Iceland

| GlaxoSmithKline ehf. |
| --- |
| Þverholt 14 |
| 105 Reykjavík, |
| Iceland |

GlaxoSmithKline ehf.

Þverholt 14

105 Reykjavík,

Iceland

Valtrex

500 mg

film – coated tablet

Oral use

Iceland

| GlaxoSmithKline ehf. |
| --- |
| Þverholt 14 |
| 105 Reykjavík, |
| Iceland |

GlaxoSmithKline ehf.

Þverholt 14

105 Reykjavík,

Iceland

Valtrex

250 mg

film – coated tablet

Oral use

Ireland

GlaxoSmithKline (Ireland) Ltd., Stonemasons Way, Rathfarnham, Dublin 16, Ireland

Valtrex 500 mg Film-coated Tablet

500 mg

film – coated tablet

Oral use

Ireland

GlaxoSmithKline (Ireland) Ltd., Stonemasons Way, Rathfarnham, Dublin 16, Ireland

Valtrex 250 mg Film-coated Tablet

250 mg

film – coated tablet

Oral use

Italy

| GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – |
| --- |
| 37135 Verona, |
| Italy |

GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –

37135 Verona,

Italy

Zelitrex

1 000 mg

film – coated tablet

Oral use

Italy

| Sigma Tau Industrie Farmaceutiche Riunite S.p.A |
| --- |
| Viale Shakespeare, 47 – 00144 Roma, |
| Italy |

Sigma Tau Industrie Farmaceutiche Riunite S.p.A

Viale Shakespeare, 47 – 00144 Roma,

Italy

Talavir

1 000 mg

film – coated tablet

Oral use

Italy

| GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – |
| --- |
| 37135 Verona, |
| Italy |

GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –

37135 Verona,

Italy

Zelitrex

500 mg

film – coated tablet

Oral use

Italy

| Sigma Tau Industrie Farmaceutiche Riunite S.p.A |
| --- |
| Viale Shakespeare, 47 – 00144 Roma, |
| Italy |

Sigma Tau Industrie Farmaceutiche Riunite S.p.A

Viale Shakespeare, 47 – 00144 Roma,

Italy

Talavir

500 mg

film – coated tablet

Oral use

Italy

| GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – |
| --- |
| 37135 Verona, |
| Italy |

GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –

37135 Verona,

Italy

Zelitrex

250 mg

film – coated tablet

Oral use

Italy

| Sigma Tau Industrie Farmaceutiche Riunite S.p.A |
| --- |
| Viale Shakespeare, 47 – 00144 Roma, |
| Italy |

Sigma Tau Industrie Farmaceutiche Riunite S.p.A

Viale Shakespeare, 47 – 00144 Roma,

Italy

Talavir

250 mg

film – coated tablet

Oral use

Latvia

| GlaxoSmithKline Latvia SIA, Bruņinieku iela 5, |
| --- |
| Riga, LV-1001 |
| Latria |

GlaxoSmithKline Latvia SIA, Bruņinieku iela 5,

Riga, LV-1001

Latria

Valtrex 500 mg film-coated tablets

500 mg

film – coated tablet

Oral use

Lithuania

| The Wellcome Foundation Ltd, |
| --- |
| Glaxo Wellcome House, Berkeley Avenue, |
| Greenford, |
| Middlesex UB6 0NN, |
| United Kingdom |

The Wellcome Foundation Ltd,

Glaxo Wellcome House, Berkeley Avenue,

Greenford,

Middlesex UB6 0NN,

United Kingdom

Valtrex

500 mg

film – coated tablet

Oral use

Luxembourg

GlaxoSmithKline s.a. /n.v., rue du Tilleul 13, B-1332 Genval, Belgium

Zelitrex

500 mg

film – coated tablet

Oral use

Luxembourg

GlaxoSmithKline s.a. /n.v., rue du Tilleul 13, B-1332 Genval, Belgium

Zelitrex

250 mg

film – coated tablet

Oral use

Malta

| The Wellcome Foundation Limited Glaxo Wellcome House, Berkeley Avenue, Greenford, |
| --- |
| Middlesex, UB6 ONN, |
| United Kingdom |

The Wellcome Foundation Limited Glaxo Wellcome House, Berkeley Avenue, Greenford,

Middlesex, UB6 ONN,

United Kingdom

Valtrex

500 mg

film – coated tablet

Oral use

Netherlands

| GlaxoSmithKline BV |
| --- |
| Huis ter Heideweg 62 |
| 3705 LZ Zeist, |
| Netherlands |

GlaxoSmithKline BV

Huis ter Heideweg 62

3705 LZ Zeist,

Netherlands

Zelitrex 500 mg

500 mg

film – coated tablet

Oral use

Netherlands

| GlaxoSmithKline BV |
| --- |
| Huis ter Heideweg 62 |
| 3705 LZ Zeist, |
| Netherlands |

GlaxoSmithKline BV

Huis ter Heideweg 62

3705 LZ Zeist,

Netherlands

Zelitrex 250 mg

250 mg

film – coated tablet

Oral use

Norway

| GlaxoSmithKline AS |
| --- |
| Forskningsveien 2A |
| Postboks 180 Vinderen |
| 0319 Oslo, |
| Norway |

GlaxoSmithKline AS

Forskningsveien 2A

Postboks 180 Vinderen

0319 Oslo,

Norway

Valtrex

1 000 mg

film – coated tablet

Oral use

Norway

| GlaxoSmithKline AS |
| --- |
| Forskningsveien 2A |
| Postboks 180 Vinderen |
| 0319 Oslo, |
| Norway |

GlaxoSmithKline AS

Forskningsveien 2A

Postboks 180 Vinderen

0319 Oslo,

Norway

Valtrex

500 mg

film – coated tablet

Oral use

Norway

| GlaxoSmithKline AS |
| --- |
| Forskningsveien 2A |
| Postboks 180 Vinderen |
| 0319 Oslo, |
| Norway |

GlaxoSmithKline AS

Forskningsveien 2A

Postboks 180 Vinderen

0319 Oslo,

Norway

Valtrex

250 mg

film – coated tablet

Oral use

Poland

| GlaxoSmithKline Export Ltd, 980 Great West Road, Brentford, Middlesex, |
| --- |
| TW8 9GS |
| United Kingdom |

GlaxoSmithKline Export Ltd, 980 Great West Road, Brentford, Middlesex,

TW8 9GS

United Kingdom

Valtrex

500 mg

film – coated tablet

Oral use

Portugal

| Laboratórios Wellcome de Portugal, Lda, Rua Dr António Loureiro Borges, no3 |
| --- |
| Arquiparque - Miraflores |
| 1495-131 Algés |
| Portugal |

Laboratórios Wellcome de Portugal, Lda, Rua Dr António Loureiro Borges, no3

Arquiparque - Miraflores

1495-131 Algés

Portugal

Valtrex

1 000 mg

film – coated tablet

Oral use

Portugal

| Alter, SAEstrada Marco do Grilo |
| --- |
| Zemouto - Coina |
| 2830 Barreiro |
| Portugal |

Alter, SAEstrada Marco do Grilo

Zemouto - Coina

2830 Barreiro

Portugal

Valavir

1 000 mg

film – coated tablet

Oral use

Portugal

| Laboratórios Wellcome de Portugal, Lda, Rua Dr António Loureiro Borges, no3 |
| --- |
| Arquiparque - Miraflores |
| 1495-131 Algés |
| Portugal |

Laboratórios Wellcome de Portugal, Lda, Rua Dr António Loureiro Borges, no3

Arquiparque - Miraflores

1495-131 Algés

Portugal

Valtrex

500 mg

film – coated tablet

Oral use

Portugal

| Alter, SAEstrada Marco do Grilo |
| --- |
| Zemouto - Coina |
| 2830 Barreiro |
| Portugal |

Alter, SAEstrada Marco do Grilo

Zemouto - Coina

2830 Barreiro

Portugal

Valavir

500 mg

film – coated tablet

Oral use

Portugal

| Laboratórios Wellcome de Portugal, Lda, Rua Dr António Loureiro Borges, no3 |
| --- |
| Arquiparque - Miraflores |
| 1495-131 Algés |
| Portugal |

Laboratórios Wellcome de Portugal, Lda, Rua Dr António Loureiro Borges, no3

Arquiparque - Miraflores

1495-131 Algés

Portugal

Valtrex

250 mg

film – coated tablet

Oral use

Portugal

| Alter, SAEstrada Marco do Grilo |
| --- |
| Zemouto - Coina |
| 2830 Barreiro |
| Portugal |

Alter, SAEstrada Marco do Grilo

Zemouto - Coina

2830 Barreiro

Portugal

Valavir

250 mg

film – coated tablet

Oral use

Romania

| The Wellcome Foundation Limited, Glaxo Wellcome House, Berkeley Avenue, |
| --- |
| Greenford, |
| Middlesex UB6 0NN, |
| United Kingdom |

The Wellcome Foundation Limited, Glaxo Wellcome House, Berkeley Avenue,

Greenford,

Middlesex UB6 0NN,

United Kingdom

Valtrex

500 mg

film – coated tablet

Oral use

Slovak Republic

| GlaxoSmithKline Slovakia s.r.o., |
| --- |
| Galvaniho 7/A, |
| 82104 Bratislava |
| Slovak Republic |

GlaxoSmithKline Slovakia s.r.o.,

Galvaniho 7/A,

82104 Bratislava

Slovak Republic

Valtrex

500 mg

film – coated tablet

Oral use

Slovenia

| GSK do.o., Ljubljana |
| --- |
| Knezov štradon 90 |
| 1001 Ljubljana |
| Slovenija |

GSK do.o., Ljubljana

Knezov štradon 90

1001 Ljubljana

Slovenija

Valtrex

500 mg

film – coated tablet

Oral use

Spain

| GlaxoSmithKline, S.A |
| --- |
| Severo Ochoa, 2, 28760, |
| Tres Cantos Madrid |
| Spain |

GlaxoSmithKline, S.A

Severo Ochoa, 2, 28760,

Tres Cantos Madrid

Spain

Valtrex

1 000 mg

film – coated tablet

Oral use

Spain

| GlaxoSmithKline, S.A |
| --- |
| Severo Ochoa, 2, 28760, |
| Tres Cantos Madrid |
| Spain |

GlaxoSmithKline, S.A

Severo Ochoa, 2, 28760,

Tres Cantos Madrid

Spain

Virval

1 000 mg

film – coated tablet

Oral use

Spain

| Allen Farmacéutica S.A. |
| --- |
| Severo Ochoa, 2, 28760, |
| Tres Cantos Madrid |
| Spain |

Allen Farmacéutica S.A.

Severo Ochoa, 2, 28760,

Tres Cantos Madrid

Spain

Valaciclovir Allen

1 000 mg

film – coated tablet

Oral use

Spain

| Smithkline Beecham Farma S.A. |
| --- |
| Severo Ochoa, 2, 28760, |
| Tres Cantos Madrid |
| Spain |

Smithkline Beecham Farma S.A.

Severo Ochoa, 2, 28760,

Tres Cantos Madrid

Spain

Valherpes

1 000 mg

film – coated tablet

Oral use

Spain

| GlaxoSmithKline, S.A |
| --- |
| Severo Ochoa, 2, 28760, |
| Tres Cantos Madrid |
| Spain |

GlaxoSmithKline, S.A

Severo Ochoa, 2, 28760,

Tres Cantos Madrid

Spain

Valtrex

500 mg

film – coated tablet

Oral use

Spain

| GlaxoSmithKline, S.A Severo Ochoa, 2, 28760, |
| --- |
| Tres Cantos Madrid |
| Spain |

GlaxoSmithKline, S.A Severo Ochoa, 2, 28760,

Tres Cantos Madrid

Spain

Virval

500 mg

film – coated tablet

Oral use

Spain

| Allen Farmacéutica S.A. |
| --- |
| Severo Ochoa, 2, 28760, |
| Tres Cantos Madrid |
| Spain |

Allen Farmacéutica S.A.

Severo Ochoa, 2, 28760,

Tres Cantos Madrid

Spain

Valaciclovir Allen

500 mg

film – coated tablet

Oral use

Spain

| Smithkline Beecham Farma S.A. |
| --- |
| Severo Ochoa, 2, 28760, |
| Tres Cantos Madrid |
| Spain |

Smithkline Beecham Farma S.A.

Severo Ochoa, 2, 28760,

Tres Cantos Madrid

Spain

Valherpes

500 mg

film – coated tablet

Oral use

Sweden

| GlaxoSmithKline AB |
| --- |
| Box 516 |
| 169 29 Solna, |
| Sweden |

GlaxoSmithKline AB

Box 516

169 29 Solna,

Sweden

Valtrex

1 g

film – coated tablet

Oral use

Sweden

| GlaxoSmithKline AB |
| --- |
| Box 516 |
| 169 29 Solna, |
| Sweden |

GlaxoSmithKline AB

Box 516

169 29 Solna,

Sweden

Valtrex

500 mg

film – coated tablet

Oral use

Sweden

| GlaxoSmithKline AB |
| --- |
| Box 516 |
| 169 29 Solna, |
| Sweden |

GlaxoSmithKline AB

Box 516

169 29 Solna,

Sweden

Valtrex

250 mg

film – coated tablet

Oral use

United Kingdom

| The Wellcome Foundation Ltd |
| --- |
| Glaxo Wellcome House |
| Berkeley Avenue |
| Greenford |
| Middlesex |
| UB6 0NN, |
| United Kingdom |

The Wellcome Foundation Ltd

Glaxo Wellcome House

Berkeley Avenue

Greenford

Middlesex

UB6 0NN,

United Kingdom

Trading as;

| GlaxoSmithKline UK |
| --- |
| Stockley Park West |
| Uxbridge |
| Middlesex |
| UB11 1BT |
| United Kingdom |

GlaxoSmithKline UK

Stockley Park West

Uxbridge

Middlesex

UB11 1BT

United Kingdom

Valtrex

500 mg

film – coated tablet

Oral use

United Kingdom

| The Wellcome Foundation Ltd |
| --- |
| Glaxo Wellcome House |
| Berkeley Avenue |
| Greenford |
| Middlesex |
| UB6 0NN, |
| United Kingdom |

The Wellcome Foundation Ltd

Glaxo Wellcome House

Berkeley Avenue

Greenford

Middlesex

UB6 0NN,

United Kingdom

Trading as;

| GlaxoSmithKline UK |
| --- |
| Stockley Park West |
| Uxbridge |
| Middlesex |
| UB11 1BT |
| United Kingdom |

GlaxoSmithKline UK

Stockley Park West

Uxbridge

Middlesex

UB11 1BT

United Kingdom

Valtrex

250 mg

film – coated tablet

Oral use

---

ANNEX VII

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State EU/EEA | Marketing Authorisation Holder | Invented name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Novartis Pharma GmbH |
| Brunner Strasse 59 |
| 1235 Wien |
| Austria |

Member State EU/EEA

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Austria

Novartis Pharma GmbH

Brunner Strasse 59

1235 Wien

Austria

Famvir 125 mg – Filmtabletten

125 mg

Film-coated tablets

Oral use

Austria

| Novartis Pharma GmbH |
| --- |
| Brunner Strasse 59 |
| 1235 Wien |
| Austria |

Novartis Pharma GmbH

Brunner Strasse 59

1235 Wien

Austria

Famvir 250 mg – Filmtabletten

250 mg

Film-coated tablets

Oral use

Austria

| Novartis Pharma GmbH |
| --- |
| Brunner Strasse 59 |
| 1235 Wien |
| Austria |

Novartis Pharma GmbH

Brunner Strasse 59

1235 Wien

Austria

Famvir 500 mg – Filmtabletten

500 mg

Film-coated tablets

Oral use

Cyprus

| Demetriades & Papaellinas Ltd |
| --- |
| 21 Kasou P.O. Box 23490 |
| Nicosia |
| Cyprus |

Demetriades & Papaellinas Ltd

21 Kasou P.O. Box 23490

Nicosia

Cyprus

Famvir

125 mg

Film-coated tablets

Oral use

Cyprus

| Demetriades & Papaellinas Ltd |
| --- |
| 21 Kasou P.O. Box 23490 |
| Nicosia |
| Cyprus |

Demetriades & Papaellinas Ltd

21 Kasou P.O. Box 23490

Nicosia

Cyprus

Famvir

250 mg

Film-coated tablets

Oral use

Denmark

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| 2100 Kopenhagen Ø |
| Denmark |

Novartis Healthcare A/S

Lyngbyvej 172

2100 Kopenhagen Ø

Denmark

Famvir

125 mg

Film-coated tablets

Oral use

Denmark

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| 2100 Kopenhagen Ø |
| Denmark |

Novartis Healthcare A/S

Lyngbyvej 172

2100 Kopenhagen Ø

Denmark

Famvir

500 mg

Film-coated tablets

Oral use

Finland

| Novartis Finland Oy |
| --- |
| Metsänneidonkuja 10 |
| FI-02130 Espoo |
| Finland |

Novartis Finland Oy

Metsänneidonkuja 10

FI-02130 Espoo

Finland

Famvir

125 mg

Film-coated tablets

Oral use

Finland

| Novartis Finland Oy |
| --- |
| Metsänneidonkuja 10 |
| FI-02130 Espoo |
| Finland |

Novartis Finland Oy

Metsänneidonkuja 10

FI-02130 Espoo

Finland

Famvir

250 mg

Film-coated tablets

Oral use

Finland

| Novartis Finland Oy |
| --- |
| Metsänneidonkuja 10 |
| FI-02130 Espoo |
| Finland |

Novartis Finland Oy

Metsänneidonkuja 10

FI-02130 Espoo

Finland

Famvir

500 mg

Film-coated tablets

Oral use

France

| Novartis Pharma S.A.S. |
| --- |
| 2 - 4, rue Lionel Terray |
| 92500 Rueil-Malmaison |
| France |

Novartis Pharma S.A.S.

2 - 4, rue Lionel Terray

92500 Rueil-Malmaison

France

Oravir

125 mg

Film-coated tablets

Oral use

France

| Novartis Pharma S.A.S. |
| --- |
| 2 - 4, rue Lionel Terray |
| 92500 Rueil-Malmaison |
| France |

Novartis Pharma S.A.S.

2 - 4, rue Lionel Terray

92500 Rueil-Malmaison

France

Oravir

500 mg

Film-coated tablets

Oral use

Germany

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90429 Nürnberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

Germany

Famvir 125 mg Filmtabletten

125 mg

Film-coated tablets

Oral use

Germany

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90429 Nürnberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

Germany

Famvir 250 mg Filmtabletten

250 mg

Film-coated tablets

Oral use

Germany

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90429 Nürnberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

Germany

Famvir Zoster 250 mg Filmtabletten

250 mg

Film-coated tablets

Oral use

Germany

| Grünwalder Gesundheitsprodukte GmbH |
| --- |
| Ruhlandstr. 5 |
| 83646 Bad Tölz |
| Germany |

Grünwalder Gesundheitsprodukte GmbH

Ruhlandstr. 5

83646 Bad Tölz

Germany

Famciclovir-Sandoz 250 mg Filmtabletten

250 mg

Film-coated tablets

Oral use

Germany

| Grünwalder Gesundheitsprodukte GmbH |
| --- |
| Ruhlandstr. 5 |
| 83646 Bad Tölz |
| Germany |

Grünwalder Gesundheitsprodukte GmbH

Ruhlandstr. 5

83646 Bad Tölz

Germany

Famciclovir-Sandoz 500 mg Filmtabletten

500 mg

Film-coated tablets

Oral use

Germany

| Grünwalder Gesundheitsprodukte GmbH |
| --- |
| Ruhlandstr. 5 |
| 83646 Bad Tölz |
| Germany |

Grünwalder Gesundheitsprodukte GmbH

Ruhlandstr. 5

83646 Bad Tölz

Germany

Famciclovir-SB 250 mg Filmtabletten

250 mg

Film-coated tablets

Oral use

Germany

| Grünwalder Gesundheitsprodukte GmbH |
| --- |
| Ruhlandstr. 5 |
| 83646 Bad Tölz |
| Germany |

Grünwalder Gesundheitsprodukte GmbH

Ruhlandstr. 5

83646 Bad Tölz

Germany

Famciclovir-SB Zoster 250 mg Filmtabletten

250 mg

Film-coated tablets

Oral use

Greece

| Novartis (Hellas) S.A.C.I. |
| --- |
| 12th Km National Road No. 1 |
| GR-144 51 Metamorphosis |
| Greece |

Novartis (Hellas) S.A.C.I.

12th Km National Road No. 1

GR-144 51 Metamorphosis

Greece

Famvir

125 mg

Film-coated tablets

Oral use

Greece

| Novartis (Hellas) S.A.C.I. |
| --- |
| 12th Km National Road No. 1 |
| GR-144 51 Metamorphosis |
| Greece |

Novartis (Hellas) S.A.C.I.

12th Km National Road No. 1

GR-144 51 Metamorphosis

Greece

Famvir

250 mg

Film-coated tablets

Oral use

Greece

| Novartis (Hellas) S.A.C.I. |
| --- |
| 12th Km National Road No. 1 |
| GR-144 51 Metamorphosis |
| Greece |

Novartis (Hellas) S.A.C.I.

12th Km National Road No. 1

GR-144 51 Metamorphosis

Greece

Famvir

500 mg

Film-coated tablets

Oral use

Hungary

| Novartis Hungaria Kft. |
| --- |
| Bartók Béla út 43-47 |
| H-1114 Budapest |
| Hungary |

Novartis Hungaria Kft.

Bartók Béla út 43-47

H-1114 Budapest

Hungary

Famvir

125 mg

Film-coated tablets

Oral use

Hungary

| Novartis Hungaria Kft. |
| --- |
| Bartók Béla út 43-47 |
| H-1114 Budapest |
| Hungary |

Novartis Hungaria Kft.

Bartók Béla út 43-47

H-1114 Budapest

Hungary

Famvir

250 mg

Film-coated tablets

Oral use

Iceland

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| 2100 Kopenhagen Ø |
| Denmark |

Novartis Healthcare A/S

Lyngbyvej 172

2100 Kopenhagen Ø

Denmark

Famvir

125 mg

Film-coated tablets

Oral use

Iceland

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| 2100 Kopenhagen Ø |
| Denmark |

Novartis Healthcare A/S

Lyngbyvej 172

2100 Kopenhagen Ø

Denmark

Famvir

500 mg

Film-coated tablets

Oral use

Ireland

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Famvir

125 mg

Film-coated tablets

Oral use

Ireland

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Famvir

250 mg

Film-coated tablets

Oral use

Ireland

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Famvir

750 mg

Film-coated tablets

Oral use

Italy

| Novartis Farma S.p.A. |
| --- |
| Largo Umberto Boccioni 1 |
| I-21040 Origgio |
| Italy |

Novartis Farma S.p.A.

Largo Umberto Boccioni 1

I-21040 Origgio

Italy

Famvir

125 mg

Film-coated tablets

Oral use

Italy

| Novartis Farma S.p.A. |
| --- |
| Largo Umberto Boccioni 1 |
| I-21040 Origgio |
| Italy |

Novartis Farma S.p.A.

Largo Umberto Boccioni 1

I-21040 Origgio

Italy

Famvir

250 mg

Film-coated tablets

Oral use

Italy

| Novartis Farma S.p.A. |
| --- |
| Largo Umberto Boccioni 1 |
| I-21040 Origgio |
| Italy |

Novartis Farma S.p.A.

Largo Umberto Boccioni 1

I-21040 Origgio

Italy

Famvir

500 mg

Film-coated tablets

Oral use

Italy

| Sandoz S.p.A. |
| --- |
| Largo Umberto Boccioni 1 |
| I-21040 Origgio |
| Italy |

Sandoz S.p.A.

Largo Umberto Boccioni 1

I-21040 Origgio

Italy

Famciclovir Sandoz

125 mg

Film-coated tablets

Oral use

Italy

| Sandoz S.p.A. |
| --- |
| Largo Umberto Boccioni 1 |
| I-21040 Origgio |
| Italy |

Sandoz S.p.A.

Largo Umberto Boccioni 1

I-21040 Origgio

Italy

Famciclovir Sandoz

250 mg

Film-coated tablets

Oral use

Italy

| Sandoz S.p.A. |
| --- |
| Largo Umberto Boccioni 1 |
| I-21040 Origgio |
| Italy |

Sandoz S.p.A.

Largo Umberto Boccioni 1

I-21040 Origgio

Italy

Famciclovir Sandoz

500 mg

Film-coated tablets

Oral use

Luxembourg

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| D-90429 Nürnberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Famvir 125 mg Filmtabletten

125 mg

Film-coated tablets

Oral use

Luxembourg

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| D-90429 Nürnberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Famvir 250 mg Filmtabletten

250 mg

Film-coated tablets

Oral use

Luxembourg

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| D-90429 Nürnberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Famvir Zoster 250 mg Filmtabletten

250 mg

Film-coated tablets

Oral use

Malta

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Famvir

125 mg

Film-coated tablets

Oral use

Malta

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Famvir

250 mg

Film-coated tablets

Oral use

Netherlands

| Novartis Pharma B.V. |
| --- |
| P.O. Box 241 |
| 6800 LZ Arnhem |
| The Netherlands |

Novartis Pharma B.V.

P.O. Box 241

6800 LZ Arnhem

The Netherlands

Famvir

125 mg

Film-coated tablets

Oral use

Netherlands

| Novartis Pharma B.V. |
| --- |
| P.O. Box 241 |
| 6800 LZ Arnhem |
| The Netherlands |

Novartis Pharma B.V.

P.O. Box 241

6800 LZ Arnhem

The Netherlands

Famvir

250 mg

Film-coated tablets

Oral use

Netherlands

| Novartis Pharma B.V. |
| --- |
| P.O. Box 241 |
| 6800 LZ Arnhem |
| The Netherlands |

Novartis Pharma B.V.

P.O. Box 241

6800 LZ Arnhem

The Netherlands

Famvir

500 mg

Film-coated tablets

Oral use

Spain

| Novartis Farmacéutica S.A. |
| --- |
| Gran Via de les Corts Catalanes 764. |
| E-08013 Barcelona |
| Spain |

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes 764.

E-08013 Barcelona

Spain

Famvir

125 mg

Film-coated tablets

Oral use

Spain

| Novartis Farmacéutica S.A. |
| --- |
| Gran Via de les Corts Catalanes 764. |
| E-08013 Barcelona |
| Spain |

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes 764.

E-08013 Barcelona

Spain

Famvir

250 mg

Film-coated tablets

Oral use

Spain

| Novartis Farmacéutica S.A. |
| --- |
| Gran Via de les Corts Catalanes 764. |
| E-08013 Barcelona |
| Spain |

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes 764.

E-08013 Barcelona

Spain

Famvir

500 mg

Film-coated tablets

Oral use

Spain

| Novartis Farmacéutica S.A. |
| --- |
| Gran Via de les Corts Catalanes 764. |
| E-08013 Barcelona |
| Spain |

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes 764.

E-08013 Barcelona

Spain

Famvir

750 mg

Film-coated tablets

Oral use

Sweden

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sweden |

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

Famvir

125 mg

Film-coated tablets

Oral use

Sweden

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sweden |

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

Famvir

250 mg

Film-coated tablets

Oral use

Sweden

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sweden |

Novartis Sverige AB

Box 1150

183 11 Täby

Sweden

Famvir

500 mg

Film-coated tablets

Oral use

United Kingdom

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Famvir

125 mg

Film-coated tablets

Oral use

United Kingdom

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Famvir

250 mg

Film-coated tablets

Oral use

United Kingdom

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Famvir

500 mg

Film-coated tablets

Oral use

United Kingdom

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Famvir

750 mg

Film-coated tablets

Oral use

---

ANNEX VIII

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State EU | Marketing Authorisation Holder | (Invented) name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Roche Austria GmbH, |
| Engelhorngasse 3, |
| A - 1211 Vienna |
| Austria |

Member State EU

Marketing Authorisation Holder

(Invented) name

Strength

Pharmaceutical Form

Route of administration

Austria

Roche Austria GmbH,

Engelhorngasse 3,

A - 1211 Vienna

Austria

Inhibace ‘Roche’ 0,5 mg - Filmtabletten

0,5 mg

Film-coated tablets

Oral use

Austria

| Roche Austria GmbH, |
| --- |
| Engelhorngasse 3, |
| A - 1211 Vienna |
| Austria |

Roche Austria GmbH,

Engelhorngasse 3,

A - 1211 Vienna

Austria

Inhibace ‘Roche’ 2,5 mg - Filmtabletten

2,5 mg

Film-coated tablets

Oral use

Austria

| Roche Austria GmbH, |
| --- |
| Engelhorngasse 3, |
| A - 1211 Vienna |
| Austria |

Roche Austria GmbH,

Engelhorngasse 3,

A - 1211 Vienna

Austria

Inhibace ‘Roche’ 5 mg - Filmtabletten

5 mg

Film-coated tablets

Oral use

Belgium

| N.V. Roche S.A. |
| --- |
| Rue Dante 75 |
| 1070 Bruxelles |
| Belgium |

N.V. Roche S.A.

Rue Dante 75

1070 Bruxelles

Belgium

Inhibace

0,5 mg

Film-coated tablets

Oral use

Belgium

| N.V. Roche S.A. |
| --- |
| Rue Dante 75 |
| 1070 Bruxelles |
| Belgium |

N.V. Roche S.A.

Rue Dante 75

1070 Bruxelles

Belgium

Inhibace

5 mg

Film-coated tablets

Oral use

Bulgaria

| Roche Bulgaria EOOD |
| --- |
| 16, Bvalo pole Str. |
| 1618 / Sofia |
| Bulgaria |

Roche Bulgaria EOOD

16, Bvalo pole Str.

1618 / Sofia

Bulgaria

Inhibace

1 mg

Film-coated tablets

Oral use

Bulgaria

| Roche Bulgaria EOOD |
| --- |
| 16, Bvalo pole Str. |
| 1618 / Sofia |
| Bulgaria |

Roche Bulgaria EOOD

16, Bvalo pole Str.

1618 / Sofia

Bulgaria

Inhibace

2,5 mg

Film-coated tablets

Oral use

Bulgaria

| Roche Bulgaria EOOD |
| --- |
| 16, Bvalo pole Str. |
| 1618 / Sofia |
| Bulgaria |

Roche Bulgaria EOOD

16, Bvalo pole Str.

1618 / Sofia

Bulgaria

Inhibace

5 mg

Film-coated tablets

Oral use

Czech Republic

| Roche s.r.o. |
| --- |
| Dukelskych hrdinu 567/52 |
| 170 00 / Praha 7 |
| Czech Republic |

Roche s.r.o.

Dukelskych hrdinu 567/52

170 00 / Praha 7

Czech Republic

Inhibace 2,5 mg

2,5 mg

Film-coated tablets

Oral use

Czech Republic

| Roche s.r.o. |
| --- |
| Dukelskych hrdinu 567/52 |
| 170 00 / Praha 7 |
| Czech Republic |

Roche s.r.o.

Dukelskych hrdinu 567/52

170 00 / Praha 7

Czech Republic

Inhibace 5 mg

5 mg

Film-coated tablets

Oral use

France

| Chiesi SA |
| --- |
| Immeuble le Doublon, bâtiment B |
| 11 avenue Dubonnet |
| 92 400 Courbevoie |
| France |

Chiesi SA

Immeuble le Doublon, bâtiment B

11 avenue Dubonnet

92 400 Courbevoie

France

Justor 0,5 mg

0,5 mg

Film-coated tablets

Oral use

France

| Chiesi SA |
| --- |
| Immeuble le Doublon, bâtiment B |
| 11 avenue Dubonnet |
| 92 400 Courbevoie |
| France |

Chiesi SA

Immeuble le Doublon, bâtiment B

11 avenue Dubonnet

92 400 Courbevoie

France

Justor 1 mg

1 mg

Film-coated tablets

Oral use

France

| Chiesi SA |
| --- |
| Immeuble le Doublon, bâtiment B |
| 11 avenue Dubonnet |
| 92 400 Courbevoie |
| France |

Chiesi SA

Immeuble le Doublon, bâtiment B

11 avenue Dubonnet

92 400 Courbevoie

France

Justor 2,5 mg

2,5 mg

Film-coated tablets

Oral use

Germany

| Roche Pharma AG |
| --- |
| Emil-Barell-Strasse 1 |
| 79639/Grenzach |
| Germany |

Roche Pharma AG

Emil-Barell-Strasse 1

79639/Grenzach

Germany

Dynorm 0,5

0,5 mg

Film-coated tablets

Oral use

Germany

| Roche Pharma AG |
| --- |
| Emil-Barell-Strasse 1 |
| 79639/Grenzach |
| Germany |

Roche Pharma AG

Emil-Barell-Strasse 1

79639/Grenzach

Germany

Dynorm 1,0

1 mg

Film-coated tablets

Oral use

Germany

| Roche Pharma AG |
| --- |
| Emil-Barell-Strasse 1 |
| 79639/Grenzach |
| Germany |

Roche Pharma AG

Emil-Barell-Strasse 1

79639/Grenzach

Germany

Dynorm 2,5

2,5 mg

Film-coated tablets

Oral use

Germany

| Roche Pharma AG |
| --- |
| Emil-Barell-Strasse 1 |
| 79639/Grenzach |
| Germany |

Roche Pharma AG

Emil-Barell-Strasse 1

79639/Grenzach

Germany

Dynorm 5,0

5 mg

Film-coated tablets

Oral use

Greece

| Roche (Hellas) SA |
| --- |
| 4, Alamanas & Delfon Str. |
| Maroussi 15125 |
| Attiki |
| Greece |

Roche (Hellas) SA

4, Alamanas & Delfon Str.

Maroussi 15125

Attiki

Greece

Vascace

0,5 mg

Film-coated tablets

Oral use

Greece

| Roche (Hellas) SA |
| --- |
| 4, Alamanas & Delfon Str. |
| Maroussi 15125 |
| Attiki |
| Greece |

Roche (Hellas) SA

4, Alamanas & Delfon Str.

Maroussi 15125

Attiki

Greece

Vascace

1 mg

Film-coated tablets

Oral use

Greece

| Roche (Hellas) SA |
| --- |
| 4, Alamanas & Delfon Str. |
| Maroussi 15125 |
| Attiki |
| Greece |

Roche (Hellas) SA

4, Alamanas & Delfon Str.

Maroussi 15125

Attiki

Greece

Vascace

2,5 mg

Film-coated tablets

Oral use

Greece

| Roche (Hellas) SA |
| --- |
| 4, Alamanas & Delfon Str. |
| Maroussi 15125 |
| Attiki |
| Greece |

Roche (Hellas) SA

4, Alamanas & Delfon Str.

Maroussi 15125

Attiki

Greece

Vascace

5 mg

Film-coated tablets

Oral use

Hungary

| Roche Hungary Ltd |
| --- |
| Edison ut 1 |
| 2040 / Budaörs |
| Hungary |

Roche Hungary Ltd

Edison ut 1

2040 / Budaörs

Hungary

Inhibace

1 mg

Film-coated tablets

Oral use

Hungary

| Roche Hungary Ltd |
| --- |
| Edison ut 1 |
| 2040 / Budaörs |
| Hungary |

Roche Hungary Ltd

Edison ut 1

2040 / Budaörs

Hungary

Inhibace

2,5 mg

Film-coated tablets

Oral use

Hungary

| Roche Hungary Ltd |
| --- |
| Edison ut 1 |
| 2040 / Budaörs |
| Hungary |

Roche Hungary Ltd

Edison ut 1

2040 / Budaörs

Hungary

Inhibace

5 mg

Film-coated tablets

Oral use

Ireland

| Roche Products Ltd |
| --- |
| 6 Falcon Way, Shire Park |
| Welwyn Garden City / AL7 1TW |
| United Kingdom |

Roche Products Ltd

6 Falcon Way, Shire Park

Welwyn Garden City / AL7 1TW

United Kingdom

Vascace

0,5 mg

Film-coated tablets

Oral use

Ireland

| Roche Products Ltd |
| --- |
| 6 Falcon Way, Shire Park |
| Welwyn Garden City / AL7 1TW |
| United Kingdom |

Roche Products Ltd

6 Falcon Way, Shire Park

Welwyn Garden City / AL7 1TW

United Kingdom

Vascace

1 mg

Film-coated tablets

Oral use

Ireland

| Roche Products Ltd |
| --- |
| 6 Falcon Way, Shire Park |
| Welwyn Garden City / AL7 1TW |
| United Kingdom |

Roche Products Ltd

6 Falcon Way, Shire Park

Welwyn Garden City / AL7 1TW

United Kingdom

Vascace

2,5 mg

Film-coated tablets

Oral use

Ireland

| Roche Products Ltd |
| --- |
| 6 Falcon Way, Shire Park |
| Welwyn Garden City / AL7 1TW |
| United Kingdom |

Roche Products Ltd

6 Falcon Way, Shire Park

Welwyn Garden City / AL7 1TW

United Kingdom

Vascace

5 mg

Film-coated tablets

Oral use

Italy

| Roche S.p.A |
| --- |
| Via G.B Stucchi 110 |
| 20052/Monza |
| Italy |

Roche S.p.A

Via G.B Stucchi 110

20052/Monza

Italy

Inibace

1 mg

Film-coated tablets

Oral use

Italy

| Roche S.p.A |
| --- |
| Via G.B Stucchi 110 |
| 20052/Monza |
| Italy |

Roche S.p.A

Via G.B Stucchi 110

20052/Monza

Italy

Inibace

5 mg

Film-coated tablets

Oral use

Luxembourg

| N.V. Roche S.A. |
| --- |
| Rue Dante 75 |
| 1070 Bruxelles |
| Belgium |

N.V. Roche S.A.

Rue Dante 75

1070 Bruxelles

Belgium

Inhibace

0,5 mg

Film-coated tablets

Oral use

Luxembourg

| N.V. Roche S.A. |
| --- |
| Rue Dante 75 |
| 1070 Bruxelles |
| Belgium |

N.V. Roche S.A.

Rue Dante 75

1070 Bruxelles

Belgium

Inhibace

5 mg

Film-coated tablets

Oral use

Netherlands

| Roche Nederland BV |
| --- |
| Beneluxlaan 2A |
| 3446 GG Woerden |
| Netherlands |

Roche Nederland BV

Beneluxlaan 2A

3446 GG Woerden

Netherlands

Vascase 0,5

0,5 mg

Film-coated tablets

Oral use

Netherlands

| Roche Nederland BV |
| --- |
| Beneluxlaan 2A |
| 3446 GG Woerden |
| Netherlands |

Roche Nederland BV

Beneluxlaan 2A

3446 GG Woerden

Netherlands

Vascase 2,5

2,5 mg

Film-coated tablets

Oral use

Netherlands

| Roche Nederland BV |
| --- |
| Beneluxlaan 2A |
| 3446 GG Woerden |
| Netherlands |

Roche Nederland BV

Beneluxlaan 2A

3446 GG Woerden

Netherlands

Vascase 5

5 mg

Film-coated tablets

Oral use

Poland

| Roche Polska Sp.z.o.o. |
| --- |
| Ul. Domaniewska 39B |
| 02-672 / Warsaw |
| Poland |

Roche Polska Sp.z.o.o.

Ul. Domaniewska 39B

02-672 / Warsaw

Poland

Inhibace

0,5 mg

Film-coated tablets

Oral use

Poland

| Roche Polska Sp.z.o.o. |
| --- |
| Ul. Domaniewska 39B |
| 02-672 / Warsaw |
| Poland |

Roche Polska Sp.z.o.o.

Ul. Domaniewska 39B

02-672 / Warsaw

Poland

Inhibace

1 mg

Film-coated tablets

Oral use

Poland

| Roche Polska Sp.z.o.o. |
| --- |
| Ul. Domaniewska 39B |
| 02-672 / Warsaw |
| Poland |

Roche Polska Sp.z.o.o.

Ul. Domaniewska 39B

02-672 / Warsaw

Poland

Inhibace

2,5 mg

Film-coated tablets

Oral use

Poland

| Roche Polska Sp.z.o.o. |
| --- |
| Ul. Domaniewska 39B |
| 02-672 / Warsaw |
| Poland |

Roche Polska Sp.z.o.o.

Ul. Domaniewska 39B

02-672 / Warsaw

Poland

Inhibace

5 mg

Film-coated tablets

Oral use

Portugal

| Roche Farmacêutica Química, Lda. |
| --- |
| Estrada Nacional 249-1 |
| 2720-413 / Amadora |
| Portugal |

Roche Farmacêutica Química, Lda.

Estrada Nacional 249-1

2720-413 / Amadora

Portugal

Inibace

1 mg

Film-coated tablets

Oral use

Portugal

| Roche Farmacêutica Química, Lda. |
| --- |
| Estrada Nacional 249-1 |
| 2720-413 / Amadora |
| Portugal |

Roche Farmacêutica Química, Lda.

Estrada Nacional 249-1

2720-413 / Amadora

Portugal

Inibace

2,5 mg

Film-coated tablets

Oral use

Portugal

| Roche Farmacêutica Química, Lda. |
| --- |
| Estrada Nacional 249-1 |
| 2720-413 / Amadora |
| Portugal |

Roche Farmacêutica Química, Lda.

Estrada Nacional 249-1

2720-413 / Amadora

Portugal

Inibace

5 mg

Film-coated tablets

Oral use

Spain

| Roche Farma S.A. |
| --- |
| Eucalipto no 33 |
| 28016 / Madrid |
| Spain |

Roche Farma S.A.

Eucalipto no 33

28016 / Madrid

Spain

Inhibace

1 mg

Film-coated tablets

Oral use

Spain

| Roche Farma S.A. |
| --- |
| Eucalipto no 33 |
| 28016 / Madrid |
| Spain |

Roche Farma S.A.

Eucalipto no 33

28016 / Madrid

Spain

Inhibace

2,5 mg

Film-coated tablets

Oral use

Spain

| Roche Farma S.A. |
| --- |
| Eucalipto no 33 |
| 28016 / Madrid |
| Spain |

Roche Farma S.A.

Eucalipto no 33

28016 / Madrid

Spain

Inhibace

5 mg

Film-coated tablets

Oral use

United Kingdom

| Roche Products Ltd |
| --- |
| 6 Falcon Way, Shire Park |
| Welwyn Garden City / AL7 1TW |
| United Kingdom |

Roche Products Ltd

6 Falcon Way, Shire Park

Welwyn Garden City / AL7 1TW

United Kingdom

Vascace

0,5 mg

Film-coated tablets

Oral use

United Kingdom

| Roche Products Ltd |
| --- |
| 6 Falcon Way, Shire Park |
| Welwyn Garden City / AL7 1TW |
| United Kingdom |

Roche Products Ltd

6 Falcon Way, Shire Park

Welwyn Garden City / AL7 1TW

United Kingdom

Vascace

1 mg

Film-coated tablets

Oral use

United Kingdom

| Roche Products Ltd |
| --- |
| 6 Falcon Way, Shire Park |
| Welwyn Garden City / AL7 1TW |
| United Kingdom |

Roche Products Ltd

6 Falcon Way, Shire Park

Welwyn Garden City / AL7 1TW

United Kingdom

Vascace

2,5 mg

Film-coated tablets

Oral use

United Kingdom

| Roche Products Ltd |
| --- |
| 6 Falcon Way, Shire Park |
| Welwyn Garden City / AL7 1TW |
| United Kingdom |

Roche Products Ltd

6 Falcon Way, Shire Park

Welwyn Garden City / AL7 1TW

United Kingdom

Vascace

5 mg

Film-coated tablets

Oral use

---

ANNEX IX

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State EU/EEA | Marketing Authorisation Holder | Invented name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | AstraZeneca Österreich GmbH., |
| Schwarzenbergplatz 7, |
| A-1037 Wien, Austria |

Member State EU/EEA

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Austria

AstraZeneca Österreich GmbH.,

Schwarzenbergplatz 7,

A-1037 Wien, Austria

Atacand 2 mg - Tabletten

2 mg

Tablet

Oral use

Austria

| AstraZeneca Österreich GmbH., |
| --- |
| Schwarzenbergplatz 7, |
| A-1037 Wien, Austria |

AstraZeneca Österreich GmbH.,

Schwarzenbergplatz 7,

A-1037 Wien, Austria

Atacand 4 mg - Tabletten

4 mg

Tablet

Oral use

Austria

| AstraZeneca Österreich GmbH., |
| --- |
| Schwarzenbergplatz 7, |
| A-1037 Wien, Austria |

AstraZeneca Österreich GmbH.,

Schwarzenbergplatz 7,

A-1037 Wien, Austria

Atacand 8 mg - Tabletten

8 mg

Tablet

Oral use

Austria

| AstraZeneca Österreich GmbH., |
| --- |
| Schwarzenbergplatz 7, |
| A-1037 Wien, Austria |

AstraZeneca Österreich GmbH.,

Schwarzenbergplatz 7,

A-1037 Wien, Austria

Atacand 16 mg - Tabletten

16 mg

Tablet

Oral use

Austria

| AstraZeneca Österreich GmbH., |
| --- |
| Schwarzenbergplatz 7, |
| A-1037 Wien, Austria |

AstraZeneca Österreich GmbH.,

Schwarzenbergplatz 7,

A-1037 Wien, Austria

Atacand 32 mg - Tabletten

32 mg

Tablet

Oral use

Austria

| Takeda Pharma Ges.m.b.H. |
| --- |
| Seidengasse 33-35 |
| 1070 Wien |
| Austria |

Takeda Pharma Ges.m.b.H.

Seidengasse 33-35

1070 Wien

Austria

Blopress 4 mg – Tabletten

4 mg

Tablet

Oral use

Austria

| Takeda Pharma Ges.m.b.H. |
| --- |
| Seidengasse 33-35 |
| 1070 Wien |
| Austria |

Takeda Pharma Ges.m.b.H.

Seidengasse 33-35

1070 Wien

Austria

Blopress 8 mg – Tabletten

8 mg

Tablet

Oral use

Austria

| Takeda Pharma Ges.m.b.H. |
| --- |
| Seidengasse 33-35 |
| 1070 Wien |
| Austria |

Takeda Pharma Ges.m.b.H.

Seidengasse 33-35

1070 Wien

Austria

Blopress 16 mg – Tabletten

16 mg

Tablet

Oral use

Austria

| Takeda Pharma Ges.m.b.H. |
| --- |
| Seidengasse 33-35 |
| 1070 Wien |
| Austria |

Takeda Pharma Ges.m.b.H.

Seidengasse 33-35

1070 Wien

Austria

Blopress 32 mg – Tabletten

32 mg

Tablet

Oral use

Belgium

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussels |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels

Belgium

Atacand

2 mg

Tablet

Oral use

Belgium

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussels |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels

Belgium

Atacand

4 mg

Tablet

Oral use

Belgium

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussels |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels

Belgium

Atacand

8 mg

Tablet

Oral use

Belgium

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussels |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels

Belgium

Atacand

16 mg

Tablet

Oral use

Belgium

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussels |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels

Belgium

Atacand

32 mg

Tablet

Oral use

Bulgaria

| AstraZeneca AB, |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB,

S-151 85 Södertälje, Sweden

Atacand

8 mg

Tablet

Oral use

Bulgaria

| AstraZeneca AB, |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB,

S-151 85 Södertälje, Sweden

Atacand

16 mg

Tablet

Oral use

Bulgaria

| AstraZeneca AB, |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB,

S-151 85 Södertälje, Sweden

Atacand

32 mg

Tablet

Oral use

Cyprus

| AstraZeneca AB, |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB,

S-151 85 Södertälje, Sweden

Atacand

4 mg

Tablet

Oral use

Cyprus

| AstraZeneca AB, |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB,

S-151 85 Södertälje, Sweden

Atacand

8 mg

Tablet

Oral use

Cyprus

| AstraZeneca AB, |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB,

S-151 85 Södertälje, Sweden

Atacand

16 mg

Tablet

Oral use

Cyprus

| AstraZeneca AB, |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB,

S-151 85 Södertälje, Sweden

Atacand

32 mg

Tablet

Oral use

Czech Republic

| AstraZeneca UK Ltd., Macclesfield, |
| --- |
| Cheshire, United Kingdom |

AstraZeneca UK Ltd., Macclesfield,

Cheshire, United Kingdom

Atacand 4 mg

4 mg

Tablet

Oral use

Czech Republic

| AstraZeneca UK Ltd., Macclesfield, |
| --- |
| Cheshire, United Kingdom |

AstraZeneca UK Ltd., Macclesfield,

Cheshire, United Kingdom

Atacand 8 mg

8 mg

Tablet

Oral use

Czech Republic

| AstraZeneca UK Ltd., Macclesfield, |
| --- |
| Cheshire, United Kingdom |

AstraZeneca UK Ltd., Macclesfield,

Cheshire, United Kingdom

Atacand 16 mg

16 mg

Tablet

Oral use

Denmark

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| DK-2620 Albertslund, |
| Denmark |

AstraZeneca A/S

Roskildevej 22

DK-2620 Albertslund,

Denmark

Atacand

4 mg

Tablet

Oral use

Denmark

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| DK-2620 Albertslund, |
| Denmark |

AstraZeneca A/S

Roskildevej 22

DK-2620 Albertslund,

Denmark

Atacand

8 mg

Tablet

Oral use

Denmark

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| DK-2620 Albertslund, |
| Denmark |

AstraZeneca A/S

Roskildevej 22

DK-2620 Albertslund,

Denmark

Atacand

16 mg

Tablet

Oral use

Denmark

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| DK-2620 Albertslund, |
| Denmark |

AstraZeneca A/S

Roskildevej 22

DK-2620 Albertslund,

Denmark

Atacand

32 mg

Tablet

Oral use

Estonia

| AstraZeneca AB, Strängnäsvägen 44, |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB, Strängnäsvägen 44,

S-151 85 Södertälje, Sweden

Atacand

8 mg

Tablet

Oral use

Estonia

| AstraZeneca AB, Strängnäsvägen 44, |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB, Strängnäsvägen 44,

S-151 85 Södertälje, Sweden

Atacand

16 mg

Tablet

Oral use

Estonia

| AstraZeneca AB, Strängnäsvägen 44, |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB, Strängnäsvägen 44,

S-151 85 Södertälje, Sweden

Atacand

32 mg

Tablet

Oral use

Finland

| AstraZeneca Oy |
| --- |
| Luomanportti 3 |
| FI-02200 Espoo |
| Finland |

AstraZeneca Oy

Luomanportti 3

FI-02200 Espoo

Finland

Atacand

2 mg

Tablet

Oral use

Finland

| AstraZeneca Oy |
| --- |
| Luomanportti 3 |
| FI-02200 Espoo |
| Finland |

AstraZeneca Oy

Luomanportti 3

FI-02200 Espoo

Finland

Atacand

4 mg

Tablet

Oral use

Finland

| AstraZeneca Oy |
| --- |
| Luomanportti 3 |
| FI-02200 Espoo |
| Finland |

AstraZeneca Oy

Luomanportti 3

FI-02200 Espoo

Finland

Atacand

8 mg

Tablet

Oral use

Finland

| AstraZeneca Oy |
| --- |
| Luomanportti 3 |
| FI-02200 Espoo |
| Finland |

AstraZeneca Oy

Luomanportti 3

FI-02200 Espoo

Finland

Atacand

16 mg

Tablet

Oral use

Finland

| AstraZeneca Oy |
| --- |
| Luomanportti 3 |
| FI-02200 Espoo |
| Finland |

AstraZeneca Oy

Luomanportti 3

FI-02200 Espoo

Finland

Atacand

32 mg

Tablet

Oral use

France

| AstraZeneca |
| --- |
| 1, Place Renault |
| 92844 Rueil- |
| Malmaison Cedex |
| France |

AstraZeneca

1, Place Renault

92844 Rueil-

Malmaison Cedex

France

Atacand 4 mg, comprimé sécable

4 mg

Tablet

Oral use

France

| AstraZeneca |
| --- |
| 1, Place Renault |
| 92844 Rueil- |
| Malmaison Cedex |
| France |

AstraZeneca

1, Place Renault

92844 Rueil-

Malmaison Cedex

France

Atacand 8 mg, comprimé sécable

8 mg

Tablet

Oral use

France

| AstraZeneca |
| --- |
| 1, Place Renault |
| 92844 Rueil- |
| Malmaison Cedex |
| France |

AstraZeneca

1, Place Renault

92844 Rueil-

Malmaison Cedex

France

Atacand 16 mg, comprimé sécable

16 mg

Tablet

Oral use

France

| AstraZeneca |
| --- |
| 1, Place Renault |
| 92844 Rueil- |
| Malmaison Cedex |
| France |

AstraZeneca

1, Place Renault

92844 Rueil-

Malmaison Cedex

France

Atacand 32 mg, comprimé sécable

32 mg

Tablet

Oral use

France

| Laboratoires Takeda |
| --- |
| 11-15, quai de Dion Bouton |
| 92816 Puteaux Cedex |
| France |

Laboratoires Takeda

11-15, quai de Dion Bouton

92816 Puteaux Cedex

France

Kenzen 4 mg, comprimé sécable

4 mg

Tablet

Oral use

France

| Laboratoires Takeda |
| --- |
| 11-15, quai de Dion Bouton |
| 92816 Puteaux Cedex |
| France |

Laboratoires Takeda

11-15, quai de Dion Bouton

92816 Puteaux Cedex

France

Kenzen 8 mg, comprimé sécable

8 mg

Tablet

Oral use

France

| Laboratoires Takeda |
| --- |
| 11-15, quai de Dion Bouton |
| 92816 Puteaux Cedex |
| France |

Laboratoires Takeda

11-15, quai de Dion Bouton

92816 Puteaux Cedex

France

Kenzen 16 mg, comprimé sécable

16 mg

Tablet

Oral use

France

| Laboratoires Takeda |
| --- |
| 11-15, quai de Dion Bouton |
| 92816 Puteaux Cedex |
| France |

Laboratoires Takeda

11-15, quai de Dion Bouton

92816 Puteaux Cedex

France

Kenzen 32 mg, comprimé sécable

32 mg

Tablet

Oral use

Germany

| AstraZeneca GmbH |
| --- |
| 22876 Wedel, Germany |

AstraZeneca GmbH

22876 Wedel, Germany

Atacand 4 mg

4 mg

Tablet

Oral use

Germany

| AstraZeneca GmbH |
| --- |
| 22876 Wedel, Germany |

AstraZeneca GmbH

22876 Wedel, Germany

Atacand 8 mg

8 mg

Tablet

Oral use

Germany

| AstraZeneca GmbH |
| --- |
| 22876 Wedel, Germany |

AstraZeneca GmbH

22876 Wedel, Germany

Atacand 16 mg

16 mg

Tablet

Oral use

Germany

| AstraZeneca GmbH |
| --- |
| 22876 Wedel, Germany |

AstraZeneca GmbH

22876 Wedel, Germany

Atacand PROTECT 32 mg Tabletten

32 mg

Tablet

Oral use

Germany

| Takeda Pharma GmbH |
| --- |
| Viktoriaallee 3-5 |
| 52066 Aachen |
| Germany |

Takeda Pharma GmbH

Viktoriaallee 3-5

52066 Aachen

Germany

Blopress 2 mg Tabletten

2 mg

Tablet

Oral use

Germany

| Takeda Pharma GmbH |
| --- |
| Viktoriaallee 3-5 |
| 52066 Aachen |
| Germany |

Takeda Pharma GmbH

Viktoriaallee 3-5

52066 Aachen

Germany

Blopress 4 mg Tabletten

4 mg

Tablet

Oral use

Germany

| Takeda Pharma GmbH |
| --- |
| Viktoriaallee 3-5 |
| 52066 Aachen |
| Germany |

Takeda Pharma GmbH

Viktoriaallee 3-5

52066 Aachen

Germany

Blopress 8 mg Tabletten

8 mg

Tablet

Oral use

Germany

| Takeda Pharma GmbH |
| --- |
| Viktoriaallee 3-5 |
| 52066 Aachen |
| Germany |

Takeda Pharma GmbH

Viktoriaallee 3-5

52066 Aachen

Germany

Blopress 16 mg Tabletten

16 mg

Tablet

Oral use

Germany

| Takeda Pharma GmbH |
| --- |
| Viktoriaallee 3-5 |
| 52066 Aachen |
| Germany |

Takeda Pharma GmbH

Viktoriaallee 3-5

52066 Aachen

Germany

Blopress 32 mg Tabletten

32 mg

Tablet

Oral use

Greece

| AstraZeneca SA |
| --- |
| Theotokopoulou 4 & Astrnafton |
| 151 25 Maroussi |
| Greece |

AstraZeneca SA

Theotokopoulou 4 & Astrnafton

151 25 Maroussi

Greece

Atacand

2 mg

Tablet

Oral use

Greece

| AstraZeneca SA |
| --- |
| Theotokopoulou 4 & Astronafton |
| 151 25 Maroussi |
| Greece |

AstraZeneca SA

Theotokopoulou 4 & Astronafton

151 25 Maroussi

Greece

Atacand

4 mg

Tablet

Oral use

Greece

| AstraZeneca SA |
| --- |
| Theotokopoulou 4 & Astronafton |
| 151 25 Maroussi |
| Greece |

AstraZeneca SA

Theotokopoulou 4 & Astronafton

151 25 Maroussi

Greece

Atacand

8 mg

Tablet

Oral use

Greece

| AstraZeneca SA |
| --- |
| Theotokopoulou 4 & Astronafton |
| 151 25 Maroussi |
| Greece |

AstraZeneca SA

Theotokopoulou 4 & Astronafton

151 25 Maroussi

Greece

Atacand

16 mg

Tablet

Oral use

Greece

| AstraZeneca SA |
| --- |
| Theotokopoulou 4 & Astronafton |
| 151 25 Maroussi |
| Greece |

AstraZeneca SA

Theotokopoulou 4 & Astronafton

151 25 Maroussi

Greece

Atacand

32 mg

Tablet

Oral use

Hungary

| AstraZeneca Kft. |
| --- |
| 1113 Budapest, |
| Bocskai út 134-146 |
| Hungary |

AstraZeneca Kft.

1113 Budapest,

Bocskai út 134-146

Hungary

Atacand

8 mg

Tablet

Oral use

Hungary

| AstraZeneca Kft. |
| --- |
| 1113 Budapest, |
| Bocskai út 134-146 |
| Hungary |

AstraZeneca Kft.

1113 Budapest,

Bocskai út 134-146

Hungary

Atacand

16 mg

Tablet

Oral use

Iceland

| AstraZeneca A/S |
| --- |
| Roskildevej 22, |
| DK-2620 Albertslund, |
| Denmark |

AstraZeneca A/S

Roskildevej 22,

DK-2620 Albertslund,

Denmark

Atacand

4 mg

Tablet

Oral use

Iceland

| AstraZeneca A/S |
| --- |
| Roskildevej 22, |
| DK-2620 Albertslund, |
| Denmark |

AstraZeneca A/S

Roskildevej 22,

DK-2620 Albertslund,

Denmark

Atacand

8 mg

Tablet

Oral use

Iceland

| AstraZeneca A/S |
| --- |
| Roskildevej 22, |
| DK-2620 Albertslund, |
| Denmark |

AstraZeneca A/S

Roskildevej 22,

DK-2620 Albertslund,

Denmark

Atacand

16 mg

Tablet

Oral use

Iceland

| AstraZeneca A/S |
| --- |
| Roskildevej 22, |
| DK-2620 Albertslund, |
| Denmark |

AstraZeneca A/S

Roskildevej 22,

DK-2620 Albertslund,

Denmark

Atacand

32 mg

Tablet

Oral use

Ireland

| AstraZeneca UK Limited, |
| --- |
| 600 Capability Green, Luton, |
| LU1 3LU, United Kingdom |

AstraZeneca UK Limited,

600 Capability Green, Luton,

LU1 3LU, United Kingdom

Atacand

2 mg

Tablet

Oral use

Ireland

| AstraZeneca UK Limited, |
| --- |
| 600 Capability Green, Luton, |
| LU1 3LU, United Kingdom |

AstraZeneca UK Limited,

600 Capability Green, Luton,

LU1 3LU, United Kingdom

Atacand

4 mg

Tablet

Oral use

Ireland

| AstraZeneca UK Limited, |
| --- |
| 600 Capability Green, Luton, |
| LU1 3LU, United Kingdom |

AstraZeneca UK Limited,

600 Capability Green, Luton,

LU1 3LU, United Kingdom

Atacand

8 mg

Tablet

Oral use

Ireland

| AstraZeneca UK Limited, |
| --- |
| 600 Capability Green, Luton, |
| LU1 3LU, United Kingdom |

AstraZeneca UK Limited,

600 Capability Green, Luton,

LU1 3LU, United Kingdom

Atacand

16 mg

Tablet

Oral use

Ireland

| AstraZeneca UK Limited, |
| --- |
| 600 Capability Green, Luton, |
| LU1 3LU, United Kingdom |

AstraZeneca UK Limited,

600 Capability Green, Luton,

LU1 3LU, United Kingdom

Atacand

32 mg

Tablet

Oral use

Ireland

| Takeda UK Limited |
| --- |
| Takeda House, Mercury Park, |
| Wycombe Lane, Wooburn Green, |
| High Wycombe, |
| Buckinghamshire |
| HP10 OHH |
| United Kingdom |

Takeda UK Limited

Takeda House, Mercury Park,

Wycombe Lane, Wooburn Green,

High Wycombe,

Buckinghamshire

HP10 OHH

United Kingdom

Blopress 2 mg

2 mg

Tablet

Oral use

Ireland

| Takeda UK Limited |
| --- |
| Takeda House, Mercury Park, |
| Wycombe Lane, Wooburn Green, |
| High Wycombe, |
| Buckinghamshire |
| HP10 OHH |
| United Kingdom |

Takeda UK Limited

Takeda House, Mercury Park,

Wycombe Lane, Wooburn Green,

High Wycombe,

Buckinghamshire

HP10 OHH

United Kingdom

Blopress 4 mg

4 mg

Tablet

Oral use

Ireland

| Takeda UK Limited |
| --- |
| Takeda House, Mercury Park, |
| Wycombe Lane, Wooburn Green, |
| High Wycombe, |
| Buckinghamshire |
| HP10 OHH |
| United Kingdom |

Takeda UK Limited

Takeda House, Mercury Park,

Wycombe Lane, Wooburn Green,

High Wycombe,

Buckinghamshire

HP10 OHH

United Kingdom

Blopress 8 mg

8 mg

Tablet

Oral use

Ireland

| Takeda UK Limited |
| --- |
| Takeda House, Mercury Park, |
| Wycombe Lane, Wooburn Green, |
| High Wycombe, |
| Buckinghamshire |
| HP10 OHH |
| United Kingdom |

Takeda UK Limited

Takeda House, Mercury Park,

Wycombe Lane, Wooburn Green,

High Wycombe,

Buckinghamshire

HP10 OHH

United Kingdom

Blopress 16 mg

16 mg

Tablet

Oral use

Ireland

| Takeda UK Limited |
| --- |
| Takeda House, Mercury Park, |
| Wycombe Lane, Wooburn Green, |
| High Wycombe, |
| Buckinghamshire |
| HP10 OHH |
| United Kingdom |

Takeda UK Limited

Takeda House, Mercury Park,

Wycombe Lane, Wooburn Green,

High Wycombe,

Buckinghamshire

HP10 OHH

United Kingdom

Blopress 32 mg

32 mg

Tablet

Oral use

Italy

| AstraZeneca SpA |
| --- |
| Palazzo Volta, via F.Sforza – 20080 |
| Basiglio (MI) –Italy |

AstraZeneca SpA

Palazzo Volta, via F.Sforza – 20080

Basiglio (MI) –Italy

Ratacand

2 mg

Tablet

Oral use

Italy

| AstraZeneca SpA |
| --- |
| Palazzo Volta, via F.Sforza – 20080 |
| Basiglio (MI) –Italy |

AstraZeneca SpA

Palazzo Volta, via F.Sforza – 20080

Basiglio (MI) –Italy

Ratacand

4 mg

Tablet

Oral use

Italy

| AstraZeneca SpA |
| --- |
| Palazzo Volta, via F.Sforza – 20080 |
| Basiglio (MI) –Italy |

AstraZeneca SpA

Palazzo Volta, via F.Sforza – 20080

Basiglio (MI) –Italy

Ratacand

8 mg

Tablet

Oral use

Italy

| AstraZeneca SpA |
| --- |
| Palazzo Volta, via F.Sforza – 20080 |
| Basiglio (MI) –Italy |

AstraZeneca SpA

Palazzo Volta, via F.Sforza – 20080

Basiglio (MI) –Italy

Ratacand

16 mg

Tablet

Oral use

Italy

| AstraZeneca SpA |
| --- |
| Palazzo Volta, via F.Sforza – 20080 |
| Basiglio (MI) –Italy |

AstraZeneca SpA

Palazzo Volta, via F.Sforza – 20080

Basiglio (MI) –Italy

Ratacand

32 mg

Tablet

Oral use

Italy

| Takeda Italia Farmaceutici S.p.A. |
| --- |
| Via Elio Vittorini, 129 |
| 00144 Roma |
| Italy |

Takeda Italia Farmaceutici S.p.A.

Via Elio Vittorini, 129

00144 Roma

Italy

Blopress 2 mg

2 mg

Tablet

Oral use

Italy

| Takeda Italia Farmaceutici S.p.A. |
| --- |
| Via Elio Vittorini, 129 |
| 00144 Roma |
| Italy |

Takeda Italia Farmaceutici S.p.A.

Via Elio Vittorini, 129

00144 Roma

Italy

Blopress 4 mg

4 mg

Tablet

Oral use

Italy

| Takeda Italia Farmaceutici S.p.A. |
| --- |
| Via Elio Vittorini, 129 |
| 00144 Roma |
| Italy |

Takeda Italia Farmaceutici S.p.A.

Via Elio Vittorini, 129

00144 Roma

Italy

Blopress 8 mg

8 mg

Tablet

Oral use

Italy

| Takeda Italia Farmaceutici S.p.A. |
| --- |
| Via Elio Vittorini, 129 |
| 00144 Roma |
| Italy |

Takeda Italia Farmaceutici S.p.A.

Via Elio Vittorini, 129

00144 Roma

Italy

Blopress 16 mg

16 mg

Tablet

Oral use

Italy

| Takeda Italia Farmaceutici S.p.A. |
| --- |
| Via Elio Vittorini, 129 |
| 00144 Roma |
| Italy |

Takeda Italia Farmaceutici S.p.A.

Via Elio Vittorini, 129

00144 Roma

Italy

Blopress 32 mg

32 mg

Tablet

Oral use

Latvia

| AstraZeneca AB |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB

S-151 85 Södertälje, Sweden

Atacand

8 mg

Tablet

Oral use

Latvia

| AstraZeneca AB |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB

S-151 85 Södertälje, Sweden

Atacand

16 mg

Tablet

Oral use

Lithuania

| AstraZeneca AB |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB

S-151 85 Södertälje, Sweden

Atacand

4 mg

Tablet

Oral use

Lithuania

| AstraZeneca AB |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB

S-151 85 Södertälje, Sweden

Atacand

8 mg

Tablet

Oral use

Lithuania

| AstraZeneca AB |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB

S-151 85 Södertälje, Sweden

Atacand

16 mg

Tablet

Oral use

Lithuania

| AstraZeneca AB |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB

S-151 85 Södertälje, Sweden

Atacand

32 mg

Tablet

Oral use

Luxembourg

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussels |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels

Belgium

Atacand

2 mg

Tablet

Oral use

Luxembourg

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussels |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels

Belgium

Atacand

4 mg

Tablet

Oral use

Luxembourg

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussels |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels

Belgium

Atacand

8 mg

Tablet

Oral use

Luxembourg

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussels |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels

Belgium

Atacand

16 mg

Tablet

Oral use

Luxembourg

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussels |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels

Belgium

Atacand

32 mg

Tablet

Oral use

Malta

| AstraZeneca AB, Gärtunavägen, |
| --- |
| S-15185, Södertälje, Sweden |

AstraZeneca AB, Gärtunavägen,

S-15185, Södertälje, Sweden

Atacand

8 mg

Tablet

Oral use

Malta

| AstraZeneca AB, Gärtunavägen, |
| --- |
| S-15185, Södertälje, Sweden |

AstraZeneca AB, Gärtunavägen,

S-15185, Södertälje, Sweden

Atacand

16 mg

Tablet

Oral use

Netherlands

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE Zoetermeer |
| The Netherlands |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Atacand 2, tabletten 2 mg

2 mg

Tablet

Oral use

Netherlands

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE Zoetermeer |
| The Netherlands |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Atacand 4, tabletten 4 mg

4 mg

Tablet

Oral use

Netherlands

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE Zoetermeer |
| The Netherlands |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Atacand 8, tabletten 8 mg

8 mg

Tablet

Oral use

Netherlands

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE Zoetermeer |
| The Netherlands |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Atacand 16, tabletten 16 mg

16 mg

Tablet

Oral use

Netherlands

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE Zoetermeer |
| The Netherlands |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Atacand 32, tabletten 32 mg

32 mg

Tablet

Oral use

Norway

| AstraZeneca AS |
| --- |
| Boks 200 Vinderen |
| NO-0319 Oslo, Norway |

AstraZeneca AS

Boks 200 Vinderen

NO-0319 Oslo, Norway

Atacand

4 mg

Tablet

Oral use

Norway

| AstraZeneca AS |
| --- |
| Boks 200 Vinderen |
| NO-0319 Oslo, Norway |

AstraZeneca AS

Boks 200 Vinderen

NO-0319 Oslo, Norway

Atacand

8 mg

Tablet

Oral use

Norway

| AstraZeneca AS |
| --- |
| Boks 200 Vinderen |
| NO-0319 Oslo, Norway |

AstraZeneca AS

Boks 200 Vinderen

NO-0319 Oslo, Norway

Atacand

16 mg

Tablet

Oral use

Norway

| AstraZeneca AS |
| --- |
| Boks 200 Vinderen |
| NO-0319 Oslo, Norway |

AstraZeneca AS

Boks 200 Vinderen

NO-0319 Oslo, Norway

Atacand

32 mg

Tablet

Oral use

Poland

| AstraZeneca AB, S-151 85 Södertälje, |
| --- |
| Gärtunavägen, Sweden |

AstraZeneca AB, S-151 85 Södertälje,

Gärtunavägen, Sweden

Atacand

4 mg

Tablet

Oral use

Poland

| AstraZeneca AB, S-151 85 Södertälje, |
| --- |
| Gärtunavägen, Sweden |

AstraZeneca AB, S-151 85 Södertälje,

Gärtunavägen, Sweden

Atacand

8 mg

Tablet

Oral use

Poland

| AstraZeneca AB, S-151 85 Södertälje, |
| --- |
| Gärtunavägen, Sweden |

AstraZeneca AB, S-151 85 Södertälje,

Gärtunavägen, Sweden

Atacand

16 mg

Tablet

Oral use

Poland

| AstraZeneca AB, S-151 85 Södertälje, |
| --- |
| Gärtunavägen, Sweden |

AstraZeneca AB, S-151 85 Södertälje,

Gärtunavägen, Sweden

Atacand

32 mg

Tablet

Oral use

Portugal

| AstraZeneca Produtos Farmacêuticos, Lda. |
| --- |
| Rua Humberto Madeira, 7, |
| Valejas 2745-663 Barcarena, Portugal |

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, 7,

Valejas 2745-663 Barcarena, Portugal

Atacand

2 mg

Tablet

Oral use

Portugal

| AstraZeneca Produtos Farmacêuticos, Lda. |
| --- |
| Rua Humberto Madeira, 7, |
| Valejas 2745-663 Barcarena, Portugal |

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, 7,

Valejas 2745-663 Barcarena, Portugal

Atacand

4 mg

Tablet

Oral use

Portugal

| AstraZeneca Produtos Farmacêuticos, Lda. |
| --- |
| Rua Humberto Madeira, 7, |
| Valejas 2745-663 Barcarena, Portugal |

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, 7,

Valejas 2745-663 Barcarena, Portugal

Atacand

8 mg

Tablet

Oral use

Portugal

| AstraZeneca Produtos Farmacêuticos, Lda. |
| --- |
| Rua Humberto Madeira, 7, |
| Valejas 2745-663 Barcarena, Portugal |

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, 7,

Valejas 2745-663 Barcarena, Portugal

Atacand

16 mg

Tablet

Oral use

Portugal

| AstraZeneca Produtos Farmacêuticos, Lda. |
| --- |
| Rua Humberto Madeira, 7, |
| Valejas 2745-663 Barcarena, Portugal |

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, 7,

Valejas 2745-663 Barcarena, Portugal

Atacand 32 mg

32 mg

Tablet

Oral use

Portugal

| Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A. |
| --- |
| Estrada Consiglieri Pedroso, 69 B - Queluz de Baixo |
| 2730-055 Barcarena |
| Portugal |

Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A.

Estrada Consiglieri Pedroso, 69 B - Queluz de Baixo

2730-055 Barcarena

Portugal

Blopress

2 mg

Tablet

Oral use

Portugal

| Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A. |
| --- |
| Estrada Consiglieri Pedroso, 69 B - Queluz de Baixo |
| 2730-055 Barcarena |
| Portugal |

Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A.

Estrada Consiglieri Pedroso, 69 B - Queluz de Baixo

2730-055 Barcarena

Portugal

Blopress

4 mg

Tablet

Oral use

Portugal

| Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A. |
| --- |
| Estrada Consiglieri Pedroso, 69 B - Queluz de Baixo |
| 2730-055 Barcarena |
| Portugal |

Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A.

Estrada Consiglieri Pedroso, 69 B - Queluz de Baixo

2730-055 Barcarena

Portugal

Blopress

8 mg

Tablet

Oral use

Portugal

| Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A. |
| --- |
| Estrada Consiglieri Pedroso, 69 B - Queluz de Baixo |
| 2730-055 Barcarena |
| Portugal |

Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A.

Estrada Consiglieri Pedroso, 69 B - Queluz de Baixo

2730-055 Barcarena

Portugal

Blopress

16 mg

Tablet

Oral use

Portugal

| Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A. |
| --- |
| Estrada Consiglieri Pedroso, 69 B - Queluz de Baixo |
| 2730-055 Barcarena |
| Portugal |

Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A.

Estrada Consiglieri Pedroso, 69 B - Queluz de Baixo

2730-055 Barcarena

Portugal

Blopress

32 mg

Tablet

Oral use

Romania

| AstraZeneca AB, |
| --- |
| S 151 85, Södertälje, Sweden |

AstraZeneca AB,

S 151 85, Södertälje, Sweden

Atacand 8 mg

8 mg

Tablet

Oral use

Romania

| AstraZeneca AB, |
| --- |
| S 151 85, Södertälje, Sweden |

AstraZeneca AB,

S 151 85, Södertälje, Sweden

Atacand 16 mg

16 mg

Tablet

Oral use

Romania

| AstraZeneca AB, |
| --- |
| S 151 85, Södertälje, Sweden |

AstraZeneca AB,

S 151 85, Södertälje, Sweden

Atacand 32 mg

32 mg

Tablet

Oral use

Slovak Republic

| AstraZeneca AB, |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB,

S-151 85 Södertälje, Sweden

Atacand 8 mg

8 mg

Tablet

Oral use

Slovak Republic

| AstraZeneca AB, |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB,

S-151 85 Södertälje, Sweden

Atacand 16 mg

16 mg

Tablet

Oral use

Slovak Republic

| AstraZeneca AB, |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB,

S-151 85 Södertälje, Sweden

Atacand 32 mg

32 mg

Tablet

Oral use

Slovenia

| AstraZeneca UK Limited |
| --- |
| 15 Stanhope Gate |
| London W1K 1LN |
| United Kingdom |

AstraZeneca UK Limited

15 Stanhope Gate

London W1K 1LN

United Kingdom

Atacand 4 mg

4 mg

Tablet

Oral use

Slovenia

| AstraZeneca UK Limited |
| --- |
| 15 Stanhope Gate |
| London W1K 1LN |
| United Kingdom |

AstraZeneca UK Limited

15 Stanhope Gate

London W1K 1LN

United Kingdom

Atacand 8 mg

8 mg

Tablet

Oral use

Slovenia

| AstraZeneca UK Limited |
| --- |
| 15 Stanhope Gate |
| London W1K 1LN |
| United Kingdom |

AstraZeneca UK Limited

15 Stanhope Gate

London W1K 1LN

United Kingdom

Atacand 16 mg

16 mg

Tablet

Oral use

Slovenia

| AstraZeneca UK Limited |
| --- |
| 15 Stanhope Gate |
| London W1K 1LN |
| United Kingdom |

AstraZeneca UK Limited

15 Stanhope Gate

London W1K 1LN

United Kingdom

Atacand 32 mg

32 mg

Tablet

Oral use

Spain

| AstraZeneca Farmacéutica Spain, S.A. |
| --- |
| Parque Norte.Edificio Roble. |
| C/ Serrano Galvache 56 |
| 28033 Madrid, Spain |

AstraZeneca Farmacéutica Spain, S.A.

Parque Norte.Edificio Roble.

C/ Serrano Galvache 56

28033 Madrid, Spain

Atacand 4 mg comprimidos

4 mg

Tablet

Oral use

Spain

| AstraZeneca Farmacéutica Spain, S.A. |
| --- |
| Parque Norte.Edificio Roble. |
| C/ Serrano Galvache 56 |
| 28033 Madrid, Spain |

AstraZeneca Farmacéutica Spain, S.A.

Parque Norte.Edificio Roble.

C/ Serrano Galvache 56

28033 Madrid, Spain

Atacand 8 mg comprimidos

8 mg

Tablet

Oral use

Spain

| AstraZeneca Farmacéutica Spain, S.A. |
| --- |
| Parque Norte.Edificio Roble. |
| C/ Serrano Galvache 56 |
| 28033 Madrid, Spain |

AstraZeneca Farmacéutica Spain, S.A.

Parque Norte.Edificio Roble.

C/ Serrano Galvache 56

28033 Madrid, Spain

Atacand 16 mg comprimidos

16 mg

Tablet

Oral use

Spain

| AstraZeneca Farmacéutica Spain, S.A. |
| --- |
| Parque Norte.Edificio Roble. |
| C/ Serrano Galvache 56 |
| 28033 Madrid, Spain |

AstraZeneca Farmacéutica Spain, S.A.

Parque Norte.Edificio Roble.

C/ Serrano Galvache 56

28033 Madrid, Spain

Atacand 32 mg comprimidos

32 mg

Tablet

Oral use

Spain

| Takeda Global Research and Development Centre (Europe) Ltd |
| --- |
| 61 Aldwych |
| London |
| WC2B 4AE |
| United Kingdom |

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych

London

WC2B 4AE

United Kingdom

Blopress 4 mg comprimidos

4 mg

Tablet

Oral use

Spain

| Takeda Global Research and Development Centre (Europe) Ltd |
| --- |
| 61 Aldwych |
| London |
| WC2B 4AE |
| United Kingdom |

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych

London

WC2B 4AE

United Kingdom

Blopress 8 mg comprimidos

8 mg

Tablet

Oral use

Spain

| Takeda Global Research and Development Centre (Europe) Ltd |
| --- |
| 61 Aldwych |
| London |
| WC2B 4AE |
| United Kingdom |

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych

London

WC2B 4AE

United Kingdom

Blopress 16 mg comprimidos

16 mg

Tablet

Oral use

Spain

| Takeda Global Research and Development Centre (Europe) Ltd |
| --- |
| 61 Aldwych |
| London |
| WC2B 4AE |
| United Kingdom |

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych

London

WC2B 4AE

United Kingdom

Blopress 32 mg comprimidos

32 mg

Tablet

Oral use

Spain

| Almirall, S.A. Ronda General Mitre, 151 |
| --- |
| 08022 Barcelona |
| Spain |

Almirall, S.A. Ronda General Mitre, 151

08022 Barcelona

Spain

Parapres 4 mg comprimidos

4 mg

Tablet

Oral use

Spain

| Almirall, S.A. Ronda General Mitre, 151 |
| --- |
| 08022 Barcelona |
| Spain |

Almirall, S.A. Ronda General Mitre, 151

08022 Barcelona

Spain

Parapres 8 mg comprimidos

8 mg

Tablet

Oral use

Spain

| Almirall, S.A. Ronda General Mitre, 151 |
| --- |
| 08022 Barcelona |
| Spain |

Almirall, S.A. Ronda General Mitre, 151

08022 Barcelona

Spain

Parapres 16 mg comprimidos

16 mg

Tablet

Oral use

Spain

| Almirall, S.A. Ronda General Mitre, 151 |
| --- |
| 08022 Barcelona |
| Spain |

Almirall, S.A. Ronda General Mitre, 151

08022 Barcelona

Spain

Parapres 32 mg comprimidos

32 mg

Tablet

Oral use

Sweden

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, Sweden |

AstraZeneca AB

151 85 Södertälje, Sweden

Atacand

2 mg

Tablet

Oral use

Sweden

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, Sweden |

AstraZeneca AB

151 85 Södertälje, Sweden

Atacand

4 mg

Tablet

Oral use

Sweden

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, Sweden |

AstraZeneca AB

151 85 Södertälje, Sweden

Atacand

8 mg

Tablet

Oral use

Sweden

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, Sweden |

AstraZeneca AB

151 85 Södertälje, Sweden

Atacand

16 mg

Tablet

Oral use

Sweden

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, Sweden |

AstraZeneca AB

151 85 Södertälje, Sweden

Atacand

32 mg

Tablet

Oral use

Sweden

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, Sweden |

AstraZeneca AB

151 85 Södertälje, Sweden

Racanda

4 mg

Tablet

Oral use

Sweden

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, Sweden |

AstraZeneca AB

151 85 Södertälje, Sweden

Racanda

8 mg

Tablet

Oral use

Sweden

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, Sweden |

AstraZeneca AB

151 85 Södertälje, Sweden

Racanda

16 mg

Tablet

Oral use

Sweden

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, Sweden |

AstraZeneca AB

151 85 Södertälje, Sweden

Racanda

32 mg

Tablet

Oral use

United Kingdom

| AstraZeneca UK Limited, |
| --- |
| 600 Capability Green, Luton, |
| LU1 3LU, United Kingdom |

AstraZeneca UK Limited,

600 Capability Green, Luton,

LU1 3LU, United Kingdom

Atacand

2 mg

Tablet

Oral use

United Kingdom

| AstraZeneca UK Limited, |
| --- |
| 600 Capability Green, Luton, |
| LU1 3LU, United Kingdom |

AstraZeneca UK Limited,

600 Capability Green, Luton,

LU1 3LU, United Kingdom

Atacand

4 mg

Tablet

Oral use

United Kingdom

| AstraZeneca UK Limited, |
| --- |
| 600 Capability Green, Luton, |
| LU1 3LU, United Kingdom |

AstraZeneca UK Limited,

600 Capability Green, Luton,

LU1 3LU, United Kingdom

Atacand

8 mg

Tablet

Oral use

United Kingdom

| AstraZeneca UK Limited, |
| --- |
| 600 Capability Green, Luton, |
| LU1 3LU, United Kingdom |

AstraZeneca UK Limited,

600 Capability Green, Luton,

LU1 3LU, United Kingdom

Atacand

16 mg

Tablet

Oral use

United Kingdom

| AstraZeneca UK Limited, |
| --- |
| 600 Capability Green, Luton, |
| LU1 3LU, United Kingdom |

AstraZeneca UK Limited,

600 Capability Green, Luton,

LU1 3LU, United Kingdom

Atacand

32 mg

Tablet

Oral use

United Kingdom

| Takeda Global Research and Development Centre (Europe) Ltd |
| --- |
| 61 Aldwych |
| London |
| WC2B 4AE |
| United Kingdom |

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych

London

WC2B 4AE

United Kingdom

Blopress 2 mg

2 mg

Tablet

Oral use

United Kingdom

| Takeda Global Research and Development Centre (Europe) Ltd |
| --- |
| 61 Aldwych |
| London |
| WC2B 4AE |
| United Kingdom |

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych

London

WC2B 4AE

United Kingdom

Blopress 4 mg

4 mg

Tablet

Oral use

United Kingdom

| Takeda Global Research and Development Centre (Europe) Ltd |
| --- |
| 61 Aldwych |
| London |
| WC2B 4AE |
| United Kingdom |

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych

London

WC2B 4AE

United Kingdom

Blopress 8 mg

8 mg

Tablet

Oral use

United Kingdom

| Takeda Global Research and Development Centre (Europe) Ltd |
| --- |
| 61 Aldwych |
| London |
| WC2B 4AE |
| United Kingdom |

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych

London

WC2B 4AE

United Kingdom

Blopress 16 mg

16 mg

Tablet

Oral use

United Kingdom

| Takeda Global Research and Development Centre (Europe) Ltd |
| --- |
| 61 Aldwych |
| London |
| WC2B 4AE |
| United Kingdom |

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych

London

WC2B 4AE

United Kingdom

Blopress 32 mg

32 mg

Tablet

Oral use

United Kingdom

| Takeda UK Limited |
| --- |
| Takeda House, Mercury Park, |
| Wycombe Lane, Wooburn Green, |
| High Wycombe, |
| Buckinghamshire |
| HP10 OHH |
| United Kingdom |

Takeda UK Limited

Takeda House, Mercury Park,

Wycombe Lane, Wooburn Green,

High Wycombe,

Buckinghamshire

HP10 OHH

United Kingdom

Amias 2 mg

2 mg

Tablet

Oral use

United Kingdom

| Takeda UK Limited |
| --- |
| Takeda House, Mercury Park, |
| Wycombe Lane, Wooburn Green, |
| High Wycombe, |
| Buckinghamshire |
| HP10 OHH |
| United Kingdom |

Takeda UK Limited

Takeda House, Mercury Park,

Wycombe Lane, Wooburn Green,

High Wycombe,

Buckinghamshire

HP10 OHH

United Kingdom

Amias 4 mg

4 mg

Tablet

Oral use

United Kingdom

| Takeda UK Limited |
| --- |
| Takeda House, Mercury Park, |
| Wycombe Lane, Wooburn Green, |
| High Wycombe, |
| Buckinghamshire |
| HP10 OHH |
| United Kingdom |

Takeda UK Limited

Takeda House, Mercury Park,

Wycombe Lane, Wooburn Green,

High Wycombe,

Buckinghamshire

HP10 OHH

United Kingdom

Amias 8 mg

8 mg

Tablet

Oral use

United Kingdom

| Takeda UK Limited |
| --- |
| Takeda House, Mercury Park, |
| Wycombe Lane, Wooburn Green, |
| High Wycombe, |
| Buckinghamshire |
| HP10 OHH |
| United Kingdom |

Takeda UK Limited

Takeda House, Mercury Park,

Wycombe Lane, Wooburn Green,

High Wycombe,

Buckinghamshire

HP10 OHH

United Kingdom

Amias 16 mg

16 mg

Tablet

Oral use

United Kingdom

| Takeda UK Limited |
| --- |
| Takeda House, Mercury Park, |
| Wycombe Lane, Wooburn Green, |
| High Wycombe, |
| Buckinghamshire |
| HP10 OHH |
| United Kingdom |

Takeda UK Limited

Takeda House, Mercury Park,

Wycombe Lane, Wooburn Green,

High Wycombe,

Buckinghamshire

HP10 OHH

United Kingdom

Amias 32 mg

32 mg

Tablet

Oral use

---

ANNEX X

LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, APPLICANT(S)/MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES

| Member State EU/EEA | Marketing Authorisation Holder | Invented name
  Name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Pfizer Corporation Austria Ges.m.b.H. |
| Floridsdorfer Hauptstraße 1 |
| A - 1210 Wien Austria |

Member State EU/EEA

Marketing Authorisation Holder

Invented name

Name

Strength

Pharmaceutical Form

Route of administration

Austria

Pfizer Corporation Austria Ges.m.b.H.

Floridsdorfer Hauptstraße 1

A - 1210 Wien Austria

Sortis 10 mg - Filmtabletten

10 mg

Film-coated tablet

Oral use

Austria

| Pfizer Corporation Austria Ges.m.b.H. |
| --- |
| Floridsdorfer Hauptstraße 1 |
| A - 1210 Wien Austria |

Pfizer Corporation Austria Ges.m.b.H.

Floridsdorfer Hauptstraße 1

A - 1210 Wien Austria

Sortis 20 mg - Filmtabletten

20 mg

Film-coated tablet

Oral use

Austria

| Pfizer Corporation Austria Ges.m.b.H. |
| --- |
| Floridsdorfer Hauptstraße 1 |
| A - 1210 Wien Austria |

Pfizer Corporation Austria Ges.m.b.H.

Floridsdorfer Hauptstraße 1

A - 1210 Wien Austria

Sortis 40 mg - Filmtabletten

40 mg

Film-coated tablet

Oral use

Austria

| Pfizer Corporation Austria Ges.m.b.H. |
| --- |
| Floridsdorfer Hauptstraße 1 |
| A - 1210 Wien Austria |

Pfizer Corporation Austria Ges.m.b.H.

Floridsdorfer Hauptstraße 1

A - 1210 Wien Austria

Sortis 80 mg - Filmtabletten

80 mg

Film-coated tablet

Oral use

Belgium

| Pfizer SA |
| --- |
| Boulevard de la Plaine 17 |
| B-1050 Brussels, Belgium |

Pfizer SA

Boulevard de la Plaine 17

B-1050 Brussels, Belgium

Lipitor

10 mg

Film-coated tablet

Oral use

Belgium

| Pfizer SA |
| --- |
| Boulevard de la Plaine 17 |
| B-1050 Brussels, Belgium |

Pfizer SA

Boulevard de la Plaine 17

B-1050 Brussels, Belgium

Lipitor

20 mg

Film-coated tablet

Oral use

Belgium

| Pfizer SA |
| --- |
| Boulevard de la Plaine 17 |
| B-1050 Brussels, Belgium |

Pfizer SA

Boulevard de la Plaine 17

B-1050 Brussels, Belgium

Lipitor

40 mg

Film-coated tablet

Oral use

Belgium

| Pfizer SA |
| --- |
| Boulevard de la Plaine 17 |
| B-1050 Brussels, Belgium |

Pfizer SA

Boulevard de la Plaine 17

B-1050 Brussels, Belgium

Lipitor

80 mg

Film-coated tablet

Oral use

Bulgaria

| Pfizer Europe MA EEIG, Ramsgate Road, |
| --- |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG, Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Sortis

10 mg

Film-coated tablet

Oral use

Bulgaria

| Pfizer Europe MA EEIG, Ramsgate Road, |
| --- |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG, Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Sortis

20 mg

Film-coated tablet

Oral use

Bulgaria

| Pfizer Europe MA EEIG, Ramsgate Road, |
| --- |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG, Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Sortis

40 mg

Film-coated tablet

Oral use

Bulgaria

| Pfizer Europe MA EEIG, Ramsgate Road, |
| --- |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG, Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Sortis

80 mg

Film-coated tablet

Oral use

Cyprus

| Pfizer Hellas A. E. |
| --- |
| 243, Messoghion Ave., |
| 154 51 Νeo Psychiko, Athens, Greece |

Pfizer Hellas A. E.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens, Greece

Lipitor

10 mg

Film-coated tablet

Oral use

Cyprus

| Pfizer Hellas A. E. |
| --- |
| 243, Messoghion Ave., |
| 154 51 Νeo Psychiko, Athens, Greece |

Pfizer Hellas A. E.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens, Greece

Lipitor

20 mg

Film-coated tablet

Oral use

Cyprus

| Pfizer Hellas A. E. |
| --- |
| 243, Messoghion Ave., |
| 154 51 Νeo Psychiko, Athens, Greece |

Pfizer Hellas A. E.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens, Greece

Lipitor

40 mg

Film-coated tablet

Oral use

Czech Republic

| Pfizer, spol. s r.o., |
| --- |
| Stroupežnického 17, 150 00 Prague 5, |
| Czech Republic |

Pfizer, spol. s r.o.,

Stroupežnického 17, 150 00 Prague 5,

Czech Republic

Sortis

10 mg

Film-coated tablet

Oral use

Czech Republic

| Pfizer, spol. s r.o., |
| --- |
| Stroupežnického 17, 150 00 Prague 5, |
| Czech Republic |

Pfizer, spol. s r.o.,

Stroupežnického 17, 150 00 Prague 5,

Czech Republic

Sortis

20 mg

Film-coated tablet

Oral use

Czech Republic

| Pfizer, spol. s r.o., |
| --- |
| Stroupežnického 17, 150 00 Prague 5, |
| Czech Republic |

Pfizer, spol. s r.o.,

Stroupežnického 17, 150 00 Prague 5,

Czech Republic

Sortis

40 mg

Film-coated tablet

Oral use

Czech Republic

| Pfizer, spol. s r.o., |
| --- |
| Stroupežnického 17, 150 00 Prague 5, |
| Czech Republic |

Pfizer, spol. s r.o.,

Stroupežnického 17, 150 00 Prague 5,

Czech Republic

Sortis

80 mg

Film-coated tablet

Oral use

Denmark

| Pfizer ApS, |
| --- |
| Lautrupvang 8, |
| 2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8,

2750 Ballerup,

Denmark

Zarator

10 mg

Film-coated tablet

Oral use

Denmark

| Pfizer ApS, |
| --- |
| Lautrupvang 8, |
| 2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8,

2750 Ballerup,

Denmark

Zarator

20 mg

Film-coated tablet

Oral use

Denmark

| Pfizer ApS, |
| --- |
| Lautrupvang 8, 2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8, 2750 Ballerup,

Denmark

Zarator

40 mg

Film-coated tablet

Oral use

Denmark

| Pfizer ApS, |
| --- |
| Lautrupvang 8, 2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8, 2750 Ballerup,

Denmark

Zarator

80 mg

Film-coated tablet

Oral use

Estonia

| Pfizer Europe MA EEIG, Ramsgate Road, |
| --- |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG, Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Sortis

10 mg

Film-coated tablet

Oral use

Estonia

| Pfizer Europe MA EEIG, Ramsgate Road, |
| --- |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG, Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Sortis

20 mg

Film-coated tablet

Oral use

Estonia

| Pfizer Europe MA EEIG, Ramsgate Road, |
| --- |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG, Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Sortis

40 mg

Film-coated tablet

Oral use

Estonia

| Pfizer Europe MA EEIG, Ramsgate Road, |
| --- |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG, Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Sortis 80 mg

80 mg

Film-coated tablet

Oral use

Finland

| Pfizer Oy, |
| --- |
| Tietokuja 4, 00330 |
| Helsinki, Finland |

Pfizer Oy,

Tietokuja 4, 00330

Helsinki, Finland

Lipitor

10 mg

Film-coated tablet

Oral use

Finland

| Pfizer Oy, |
| --- |
| Tietokuja 4, 00330 |
| Helsinki, Finland |

Pfizer Oy,

Tietokuja 4, 00330

Helsinki, Finland

Lipitor

20 mg

Film-coated tablet

Oral use

Finland

| Pfizer Oy, |
| --- |
| Tietokuja 4, 00330 |
| Helsinki, Finland |

Pfizer Oy,

Tietokuja 4, 00330

Helsinki, Finland

Lipitor

40 mg

Film-coated tablet

Oral use

Finland

| Pfizer Oy, |
| --- |
| Tietokuja 4, 00330 |
| Helsinki, Finland |

Pfizer Oy,

Tietokuja 4, 00330

Helsinki, Finland

Lipitor

80 mg

Film-coated tablet

Oral use

Finland

| Pfizer Oy, |
| --- |
| Tietokuja 4, 00330 |
| Helsinki, Finland |

Pfizer Oy,

Tietokuja 4, 00330

Helsinki, Finland

Orbeos

10 mg

Film-coated tablet

Oral use

Finland

| Pfizer Oy, |
| --- |
| Tietokuja 4, 00330 |
| Helsinki, Finland |

Pfizer Oy,

Tietokuja 4, 00330

Helsinki, Finland

Orbeos

20 mg

Film-coated tablet

Oral use

Finland

| Pfizer Oy, |
| --- |
| Tietokuja 4, 00330 |
| Helsinki, Finland |

Pfizer Oy,

Tietokuja 4, 00330

Helsinki, Finland

Orbeos

40 mg

Film-coated tablet

Oral use

Finland

| Pfizer Oy, |
| --- |
| Tietokuja 4, 00330 |
| Helsinki, Finland |

Pfizer Oy,

Tietokuja 4, 00330

Helsinki, Finland

Orbeos

80 mg

Film-coated tablet

Oral use

France

| Pfizer Holding France |
| --- |
| 23-25 Avenue du Docteur Lannelongue |
| 75668 Paris Cedex 14 |
| France |

Pfizer Holding France

23-25 Avenue du Docteur Lannelongue

75668 Paris Cedex 14

France

Tahor

10 mg

Film-coated tablet

Oral use

France

| Pfizer Holding France |
| --- |
| 23-25 Avenue du Docteur Lannelongue |
| 75668 Paris Cedex 14 |
| France |

Pfizer Holding France

23-25 Avenue du Docteur Lannelongue

75668 Paris Cedex 14

France

Tahor

20 mg

Film-coated tablet

Oral use

France

| Pfizer Holding France |
| --- |
| 23-25 Avenue du Docteur Lannelongue |
| 75668 Paris Cedex 14 |
| France |

Pfizer Holding France

23-25 Avenue du Docteur Lannelongue

75668 Paris Cedex 14

France

Tahor

40 mg

Film-coated tablet

Oral use

France

| Pfizer Holding France |
| --- |
| 23-25 Avenue du Docteur Lannelongue |
| 75668 Paris Cedex 14 |
| France |

Pfizer Holding France

23-25 Avenue du Docteur Lannelongue

75668 Paris Cedex 14

France

Tahor

80 mg

Film-coated tablet

Oral use

Germany

| Pfizer Pharma GmbH, |
| --- |
| Linkstraße 10 10785 Berlin, |
| Germany |

Pfizer Pharma GmbH,

Linkstraße 10 10785 Berlin,

Germany

Sortis 10 mg

10 mg

Film-coated tablet

Oral use

Germany

| Pfizer Pharma GmbH, |
| --- |
| Linkstraße 10 10785 Berlin, |
| Germany |

Pfizer Pharma GmbH,

Linkstraße 10 10785 Berlin,

Germany

Sortis 20 mg

20 mg

Film-coated tablet

Oral use

Germany

| Pfizer Pharma GmbH, |
| --- |
| Linkstraße 10 10785 Berlin, |
| Germany |

Pfizer Pharma GmbH,

Linkstraße 10 10785 Berlin,

Germany

Sortis 40 mg

40 mg

Film-coated tablet

Oral use

Germany

| Pfizer Pharma GmbH, |
| --- |
| Linkstraße 10 10785 Berlin, |
| Germany |

Pfizer Pharma GmbH,

Linkstraße 10 10785 Berlin,

Germany

Sortis 80 mg

80 mg

Film-coated tablet

Oral use

Germany

| Pfizer Pharma GmbH, |
| --- |
| Linkstraße 10 10785 Berlin, |
| Germany |

Pfizer Pharma GmbH,

Linkstraße 10 10785 Berlin,

Germany

Liprimar 10 mg

10 mg

Film-coated tablet

Oral use

Germany

| Pfizer Pharma GmbH, |
| --- |
| Linkstraße 10 10785 Berlin, |
| Germany |

Pfizer Pharma GmbH,

Linkstraße 10 10785 Berlin,

Germany

Liprimar 20 mg

20 mg

Film-coated tablet

Oral use

Germany

| Pfizer Pharma GmbH, |
| --- |
| Linkstraße 10 10785 Berlin, |
| Germany |

Pfizer Pharma GmbH,

Linkstraße 10 10785 Berlin,

Germany

Liprimar 40 mg

40 mg

Film-coated tablet

Oral use

Germany

| Pfizer Pharma GmbH, |
| --- |
| Linkstraße 10 10785 Berlin, |
| Germany |

Pfizer Pharma GmbH,

Linkstraße 10 10785 Berlin,

Germany

Liprimar 80 mg

80 mg

Film-coated tablet

Oral use

Germany

| Pfizer Pharma GmbH, |
| --- |
| Linkstraße 10 10785 Berlin, |
| Germany |

Pfizer Pharma GmbH,

Linkstraße 10 10785 Berlin,

Germany

Atorvastatin 10 mg PD

10 mg

Film-coated tablet

Oral use

Germany

| Pfizer Pharma GmbH, |
| --- |
| Linkstraße 10 10785 Berlin, |
| Germany |

Pfizer Pharma GmbH,

Linkstraße 10 10785 Berlin,

Germany

Atorvastatin 20 mg PD

20 mg

Film-coated tablet

Oral use

Germany

| Pfizer Pharma GmbH, |
| --- |
| Linkstraße 10 10785 Berlin, |
| Germany |

Pfizer Pharma GmbH,

Linkstraße 10 10785 Berlin,

Germany

Atorvastatin 40 mg PD

40 mg

Film-coated tablet

Oral use

Germany

| Pfizer Pharma GmbH, |
| --- |
| Linkstraße 10 10785 Berlin, |
| Germany |

Pfizer Pharma GmbH,

Linkstraße 10 10785 Berlin,

Germany

Atorvastatin 80 mg PD

80 mg

Film-coated tablet

Oral use

Greece

| Pfizer Hellas A. E. |
| --- |
| 243, Messoghion Ave., |
| 154 51 Νeo Psychiko, Athens, Greece |

Pfizer Hellas A. E.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens, Greece

Lipitor

10 mg

Film-coated tablet

Oral use

Greece

| Pfizer Hellas A. E. |
| --- |
| 243, Messoghion Ave., |
| 154 51 Νeo Psychiko, Athens, Greece |

Pfizer Hellas A. E.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens, Greece

Lipitor

20 mg

Film-coated tablet

Oral use

Greece

| Pfizer Hellas A. E. |
| --- |
| 243, Messoghion Ave., |
| 154 51 Νeo Psychiko, Athens, Greece |

Pfizer Hellas A. E.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens, Greece

Lipitor

40 mg

Film-coated tablet

Oral use

Greece

| Pfizer Hellas A. E. |
| --- |
| 243, Messoghion Ave., |
| 154 51 Νeo Psychiko, Athens, Greece |

Pfizer Hellas A. E.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens, Greece

Lipitor

80 mg

Film-coated tablet

Oral use

Greece

| WIN MEDICA Ltd |
| --- |
| 41 Papadiamantopoulou |
| Street |
| 115 28 Ilisia |
| Athens, Greece |

WIN MEDICA Ltd

41 Papadiamantopoulou

Street

115 28 Ilisia

Athens, Greece

Zarator

10 mg

Film-coated tablet

Oral use

Greece

| WIN MEDICA Ltd |
| --- |
| 41 Papadiamantopoulou |
| Street |
| 115 28 Ilisia |
| Athens, Greece |

WIN MEDICA Ltd

41 Papadiamantopoulou

Street

115 28 Ilisia

Athens, Greece

Zarator

20 mg

Film-coated tablet

Oral use

Greece

| WIN MEDICA Ltd |
| --- |
| 41 Papadiamantopoulou |
| Street |
| 115 28 Ilisia |
| Athens, Greece |

WIN MEDICA Ltd

41 Papadiamantopoulou

Street

115 28 Ilisia

Athens, Greece

Zarator

40 mg

Film-coated tablet

Oral use

Greece

| Pfizer Hellas A. E. |
| --- |
| 243, Messoghion Ave., |
| 154 51 Νeo Psychiko, Athens, Greece |

Pfizer Hellas A. E.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens, Greece

Edovin

10 mg

Film-coated tablet

Oral use

Greece

| Pfizer Hellas A. E. |
| --- |
| 243, Messoghion Ave., |
| 154 51 Νeo Psychiko, Athens, Greece |

Pfizer Hellas A. E.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens, Greece

Edovin

20 mg

Film-coated tablet

Oral use

Greece

| Pfizer Hellas A. E. |
| --- |
| 243, Messoghion Ave., |
| 154 51 Νeo Psychiko, Athens, Greece |

Pfizer Hellas A. E.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens, Greece

Edovin

40 mg

Film-coated tablet

Oral use

Hungary

| Pfizer KFT, |
| --- |
| 1123 Budapest, |
| Alkotás u. 53. MOM Park ‘F’ Ép., |
| Hungary |

Pfizer KFT,

1123 Budapest,

Alkotás u. 53. MOM Park ‘F’ Ép.,

Hungary

Sortis

10 mg

Film-coated tablet

Oral use

Hungary

| Pfizer KFT, |
| --- |
| 1123 Budapest, |
| Alkotás u. 53. MOM Park ‘F’ Ép., |
| Hungary |

Pfizer KFT,

1123 Budapest,

Alkotás u. 53. MOM Park ‘F’ Ép.,

Hungary

Sortis

20 mg

Film-coated tablet

Oral use

Hungary

| Pfizer KFT, |
| --- |
| 1123 Budapest, |
| Alkotás u. 53. MOM Park ‘F’ Ép., |
| Hungary |

Pfizer KFT,

1123 Budapest,

Alkotás u. 53. MOM Park ‘F’ Ép.,

Hungary

Sortis

40 mg

Film-coated tablet

Oral use

Hungary

| Pfizer KFT, |
| --- |
| 1123 Budapest, |
| Alkotás u. 53. MOM Park ‘F’ Ép., |
| Hungary |

Pfizer KFT,

1123 Budapest,

Alkotás u. 53. MOM Park ‘F’ Ép.,

Hungary

Sortis

80 mg

Film-coated tablet

Oral use

Hungary

| C.P. Pharma Gyógyszerkereskedelmi Kft. |
| --- |
| 2040 Budaörs |
| Vasút u. 11. |
| Hungary |

C.P. Pharma Gyógyszerkereskedelmi Kft.

2040 Budaörs

Vasút u. 11.

Hungary

Obradon

10 mg

Film-coated tablet

Oral use

Hungary

| C.P. Pharma Gyógyszerkereskedelmi Kft. |
| --- |
| 2040 Budaörs |
| Vasút u. 11. |
| Hungary |

C.P. Pharma Gyógyszerkereskedelmi Kft.

2040 Budaörs

Vasút u. 11.

Hungary

Obradon

20 mg

Film-coated tablet

Oral use

Hungary

| C.P. Pharma Gyógyszerkereskedelmi Kft. |
| --- |
| 2040 Budaörs |
| Vasút u. 11. |
| Hungary |

C.P. Pharma Gyógyszerkereskedelmi Kft.

2040 Budaörs

Vasút u. 11.

Hungary

Obradon

40 mg

Film-coated tablet

Oral use

Hungary

| C.P. Pharma Gyógyszerkereskedelmi Kft. |
| --- |
| 2040 Budaörs |
| Vasút u. 11. |
| Hungary |

C.P. Pharma Gyógyszerkereskedelmi Kft.

2040 Budaörs

Vasút u. 11.

Hungary

Obradon

80 mg

Film-coated tablet

Oral use

Iceland

| Pfizer ApS, |
| --- |
| Lautrupvang 8, 2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8, 2750 Ballerup,

Denmark

Zarator

10 mg

Film-coated tablet

Oral use

Iceland

| Pfizer ApS, |
| --- |
| Lautrupvang 8, 2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8, 2750 Ballerup,

Denmark

Zarator

20 mg

Film-coated tablet

Oral use

Iceland

| Pfizer ApS, |
| --- |
| Lautrupvang 8, 2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8, 2750 Ballerup,

Denmark

Zarator

40 mg

Film-coated tablet

Oral use

Iceland

| Pfizer ApS, |
| --- |
| Lautrupvang 8, 2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8, 2750 Ballerup,

Denmark

Zarator

80 mg

Film-coated tablet

Oral use

Ireland

| Pfizer Ireland Pharmaceuticals, |
| --- |
| Pottery Road, Dun Laoghaire, Co Dublin |
| Ireland |

Pfizer Ireland Pharmaceuticals,

Pottery Road, Dun Laoghaire, Co Dublin

Ireland

Lipitor

10 mg

Film-coated tablet

Oral use

Ireland

| Pfizer Ireland Pharmaceuticals, |
| --- |
| Pottery Road, Dun Laoghaire, Co Dublin |
| Ireland |

Pfizer Ireland Pharmaceuticals,

Pottery Road, Dun Laoghaire, Co Dublin

Ireland

Lipitor

20 mg

Film-coated tablet

Oral use

Ireland

| Pfizer Ireland Pharmaceuticals, |
| --- |
| Pottery Road, Dun Laoghaire, Co Dublin |
| Ireland |

Pfizer Ireland Pharmaceuticals,

Pottery Road, Dun Laoghaire, Co Dublin

Ireland

Lipitor

40 mg

Film-coated tablet

Oral use

Ireland

| Pfizer Ireland Pharmaceuticals, |
| --- |
| Pottery Road, Dun Laoghaire, Co Dublin |
| Ireland |

Pfizer Ireland Pharmaceuticals,

Pottery Road, Dun Laoghaire, Co Dublin

Ireland

Lipitor

80 mg

Film-coated tablet

Oral use

Italy

| Pfizer Italia S.r.l. |
| --- |
| Via Isonzo, 71 |
| 04100 Latina – Italy |

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina – Italy

Xarator

10 mg

Film-coated tablet

Oral use

Italy

| Pfizer Italia S.r.l. Via Isonzo, 71 |
| --- |
| 04100 Latina – Italy |

Pfizer Italia S.r.l. Via Isonzo, 71

04100 Latina – Italy

Xarator

20 mg

Film-coated tablet

Oral use

Italy

| Pfizer Italia S.r.l. |
| --- |
| Via Isonzo, 71 |
| 04100 Latina – Italy |

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina – Italy

Xarator

40 mg

Film-coated tablet

Oral use

Italy

| Pfizer Italia S.r.l. |
| --- |
| Via Isonzo, 71 |
| 04100 Latina – Italy |

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina – Italy

Xarator

80 mg

Film-coated tablet

Oral use

Italy

| Bioindustria Farmaceutici S.r.l |
| --- |
| Via Isonzo, 71 |
| 04100 Latina – Italy |

Bioindustria Farmaceutici S.r.l

Via Isonzo, 71

04100 Latina – Italy

Lipitor

10 mg

Film-coated tablet

Oral use

Italy

| Bioindustria Farmaceutici S.r.l. |
| --- |
| Via Isonzo, 71 |
| 04100 Latina – Italy |

Bioindustria Farmaceutici S.r.l.

Via Isonzo, 71

04100 Latina – Italy

Lipitor

20 mg

Film-coated tablet

Oral use

Italy

| Bioindustria Farmaceutici S.r.l. |
| --- |
| Via Isonzo, 71 |
| 04100 Latina – Italy |

Bioindustria Farmaceutici S.r.l.

Via Isonzo, 71

04100 Latina – Italy

Lipitor

40 mg

Film-coated tablet

Oral use

Italy

| Bioindustria Farmaceutici S.r.l. |
| --- |
| Via Isonzo, 71 |
| 04100 Latina – Italy |

Bioindustria Farmaceutici S.r.l.

Via Isonzo, 71

04100 Latina – Italy

Lipitor

80 mg

Film-coated tablet

Oral use

Italy

| Pfizer Italia S.r.l. |
| --- |
| Via Isonzo, 71 |
| 04100 Latina – Italy |

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina – Italy

Torvast

10 mg

Film-coated tablet

Oral use

Italy

| Pfizer Italia S.r.l. |
| --- |
| Via Isonzo, 71 |
| 04100 Latina – Italy |

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina – Italy

Torvast

20 mg

Film-coated tablet

Oral use

Italy

| Pfizer Italia S.r.l. |
| --- |
| Via Isonzo, 71 |
| 04100 Latina – Italy |

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina – Italy

Torvast

40 mg

Film-coated tablet

Oral use

Italy

| Pfizer Italia S.r.l. |
| --- |
| Via Isonzo, 71 |
| 04100 Latina – Italy |

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina – Italy

Torvast

80 mg

Film-coated tablet

Oral use

Italy

| Laboratori Guidotti S.p.A. |
| --- |
| Via Livornese, 897 - La Vettola |
| 56010 Pisa – Italy |

Laboratori Guidotti S.p.A.

Via Livornese, 897 - La Vettola

56010 Pisa – Italy

Totalip

10 mg

Film-coated tablet

Oral use

Italy

| Laboratori Guidotti S.p.A. |
| --- |
| Via Livornese, 897 - La Vettola |
| 56010 Pisa – Italy |

Laboratori Guidotti S.p.A.

Via Livornese, 897 - La Vettola

56010 Pisa – Italy

Totalip

20 mg

Film-coated tablet

Oral use

Italy

| Laboratori Guidotti S.p.A. |
| --- |
| Via Livornese, 897 - La Vettola |
| 56010 Pisa – Italy |

Laboratori Guidotti S.p.A.

Via Livornese, 897 - La Vettola

56010 Pisa – Italy

Totalip

40 mg

Film-coated tablet

Oral use

Italy

| Laboratori Guidotti S.p.A. |
| --- |
| Via Livornese, 897 - La Vettola |
| 56010 Pisa – Italy |

Laboratori Guidotti S.p.A.

Via Livornese, 897 - La Vettola

56010 Pisa – Italy

Totalip

80 mg

Film-coated tablet

Oral use

Latvia

| Pfizer Limited, |
| --- |
| Ramsgate Road, |
| Sandwich, Kent CT13 9NJ, United Kingdom |

Pfizer Limited,

Ramsgate Road,

Sandwich, Kent CT13 9NJ, United Kingdom

Sortis

10 mg

Film-coated tablet

Oral use

Latvia

| Pfizer Limited, |
| --- |
| Ramsgate Road, |
| Sandwich, Kent CT13 9NJ, United Kingdom |

Pfizer Limited,

Ramsgate Road,

Sandwich, Kent CT13 9NJ, United Kingdom

Sortis

20 mg

Film-coated tablet

Oral use

Latvia

| Pfizer Limited, |
| --- |
| Ramsgate Road, |
| Sandwich, Kent CT13 9NJ, United Kingdom |

Pfizer Limited,

Ramsgate Road,

Sandwich, Kent CT13 9NJ, United Kingdom

Sortis

40 mg

Film-coated tablet

Oral use

Latvia

| Pfizer Limited, |
| --- |
| Ramsgate Road, |
| Sandwich, Kent CT 13 9NJ, United Kingdom |

Pfizer Limited,

Ramsgate Road,

Sandwich, Kent CT 13 9NJ, United Kingdom

Sortis

80 mg

Film-coated tablet

Oral use

Lithuania

| Pfizer Limited, |
| --- |
| Ramsgate Road, |
| Sandwich, Kent, CT13 9NJ, United Kingdom |

Pfizer Limited,

Ramsgate Road,

Sandwich, Kent, CT13 9NJ, United Kingdom

Sortis

10 mg

Film-coated tablet

Oral use

Lithuania

| Pfizer Limited, |
| --- |
| Ramsgate Road, |
| Sandwich, Kent, CT13 9NJ, United Kingdom |

Pfizer Limited,

Ramsgate Road,

Sandwich, Kent, CT13 9NJ, United Kingdom

Sortis

20 mg

Film-coated tablet

Oral use

Lithuania

| Pfizer Limited, |
| --- |
| Ramsgate Road, |
| Sandwich, Kent, CT13 9NJ, United Kingdom |

Pfizer Limited,

Ramsgate Road,

Sandwich, Kent, CT13 9NJ, United Kingdom

Sortis

40 mg

Film-coated tablet

Oral use

Lithuania

| Pfizer Limited, |
| --- |
| Ramsgate Road, |
| Sandwich, Kent, CT13 9NJ, United Kingdom |

Pfizer Limited,

Ramsgate Road,

Sandwich, Kent, CT13 9NJ, United Kingdom

Sortis

80 mg

Film-coated tablet

Oral use

Luxembourg

| Pfizer SA |
| --- |
| Boulevard de la Plaine 17 |
| B-1050 Brussels, |
| Belgium |

Pfizer SA

Boulevard de la Plaine 17

B-1050 Brussels,

Belgium

Lipitor

10 mg

Film-coated tablet

Oral use

Luxembourg

| Pfizer SA |
| --- |
| Boulevard de la Plaine 17 |
| B-1050 Brussels, |
| Belgium |

Pfizer SA

Boulevard de la Plaine 17

B-1050 Brussels,

Belgium

Lipitor

20 mg

Film-coated tablet

Oral use

Luxembourg

| Pfizer SA |
| --- |
| Boulevard de la Plaine 17 |
| B-1050 Brussels, |
| Belgium |

Pfizer SA

Boulevard de la Plaine 17

B-1050 Brussels,

Belgium

Lipitor

40 mg

Film-coated tablet

Oral use

Luxembourg

| Pfizer SA |
| --- |
| Boulevard de la Plaine 17 |
| B-1050 Brussels, |
| Belgium |

Pfizer SA

Boulevard de la Plaine 17

B-1050 Brussels,

Belgium

Lipitor

80 mg

Film-coated tablet

Oral use

Malta

| Pfizer Hellas S.A. |
| --- |
| 243, Messoghion Ave., |
| 154 51 Νeo Psychiko, Athens, |
| Greece |

Pfizer Hellas S.A.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens,

Greece

Lipitor

10 mg

Film-coated tablet

Oral use

Malta

| Pfizer Hellas S.A. |
| --- |
| 243, Messoghion Ave., |
| 154 51 Νeo Psychiko, Athens, |
| Greece |

Pfizer Hellas S.A.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens,

Greece

Lipitor

20 mg

Film-coated tablet

Oral use

Malta

| Pfizer Hellas S.A. |
| --- |
| 243, Messoghion Ave., |
| 154 51 Νeo Psychiko, Athens, |
| Greece |

Pfizer Hellas S.A.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens,

Greece

Lipitor

40 mg

Film-coated tablet

Oral use

Malta

| Pfizer Hellas S.A. |
| --- |
| 243, Messoghion Ave., |
| 154 51 Νeo Psychiko, Athens, |
| Greece |

Pfizer Hellas S.A.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens,

Greece

Lipitor

80 mg

Film-coated tablet

Oral use

Netherlands

| Pfizer bv |
| --- |
| Rivium Westlaan 142 |
| 2909 LD Capelle a/d IJssel |
| The Netherlands |

Pfizer bv

Rivium Westlaan 142

2909 LD Capelle a/d IJssel

The Netherlands

Lipitor

10 mg

Film-coated tablet

Oral use

Netherlands

| Pfizer bv |
| --- |
| Rivium Westlaan 142 |
| 2909 LD Capelle a/d IJssel |
| The Netherlands |

Pfizer bv

Rivium Westlaan 142

2909 LD Capelle a/d IJssel

The Netherlands

Lipitor

20 mg

Film-coated tablet

Oral use

Netherlands

| Pfizer bv |
| --- |
| Rivium Westlaan 142 |
| 2909 LD Capelle a/d IJssel |
| The Netherlands |

Pfizer bv

Rivium Westlaan 142

2909 LD Capelle a/d IJssel

The Netherlands

Lipitor

40 mg

Film-coated tablet

Oral use

Netherlands

| Pfizer bv |
| --- |
| Rivium Westlaan 142 |
| 2909 LD Capelle a/d IJssel |
| The Netherlands |

Pfizer bv

Rivium Westlaan 142

2909 LD Capelle a/d IJssel

The Netherlands

Lipitor

80 mg

Film-coated tablet

Oral use

Norway

| Pfizer AS |
| --- |
| Pb. 3 |
| 1324 Lysaker |
| Norway |

Pfizer AS

Pb. 3

1324 Lysaker

Norway

Lipitor

10 mg

Film-coated tablet

Oral use

Norway

| Pfizer AS |
| --- |
| Pb. 3 |
| 1324 Lysaker |
| Norway |

Pfizer AS

Pb. 3

1324 Lysaker

Norway

Lipitor

20 mg

Film-coated tablet

Oral use

Norway

| Pfizer AS |
| --- |
| Pb. 3 |
| 1324 Lysaker |
| Norway |

Pfizer AS

Pb. 3

1324 Lysaker

Norway

Lipitor

40 mg

Film-coated tablet

Oral use

Norway

| Pfizer AS |
| --- |
| Pb. 3 |
| 1324 Lysaker |
| Norway |

Pfizer AS

Pb. 3

1324 Lysaker

Norway

Lipitor

80 mg

Film-coated tablet

Oral use

Poland

| Parke-Davis GmbH, |
| --- |
| Pfizerstrasse 1, |
| 76 139 Karlsruhe, |
| Germany |

Parke-Davis GmbH,

Pfizerstrasse 1,

76 139 Karlsruhe,

Germany

Sortis 10

10 mg

Film-coated tablet

Oral use

Poland

| Parke-Davis GmbH, |
| --- |
| Pfizerstrasse 1, |
| 76 139 Karlsruhe, |
| Germany |

Parke-Davis GmbH,

Pfizerstrasse 1,

76 139 Karlsruhe,

Germany

Sortis 20

20 mg

Film-coated tablet

Oral use

Poland

| Parke-Davis GmbH, |
| --- |
| Pfizerstrasse 1, |
| 76 139 Karlsruhe, |
| Germany |

Parke-Davis GmbH,

Pfizerstrasse 1,

76 139 Karlsruhe,

Germany

Sortis 40

40 mg

Film-coated tablet

Oral use

Poland

| Pfizer Polska Sp.z o.o. |
| --- |
| ul. Rzymowskiego 28 |
| 02-697 Warszawa |
| Poland |

Pfizer Polska Sp.z o.o.

ul. Rzymowskiego 28

02-697 Warszawa

Poland

Sortis 80

80 mg

Film-coated tablet

Oral use

Portugal

| Laboratorios Pfizer, Lda., |
| --- |
| Lagoas Park, Edifício 10, |
| 2740-271 Porto Salvo, Portugal |

Laboratorios Pfizer, Lda.,

Lagoas Park, Edifício 10,

2740-271 Porto Salvo, Portugal

Zarator

10 mg

Film-coated tablet

Oral use

Portugal

| Laboratorios Pfizer, Lda., |
| --- |
| Lagoas Park, Edifício 10, |
| 2740-271 Porto Salvo, Portugal |

Laboratorios Pfizer, Lda.,

Lagoas Park, Edifício 10,

2740-271 Porto Salvo, Portugal

Zarator

20 mg

Film-coated tablet

Oral use

Portugal

| Laboratorios Pfizer, Lda., |
| --- |
| Lagoas Park, Edifício 10, |
| 2740-271 Porto Salvo, Portugal |

Laboratorios Pfizer, Lda.,

Lagoas Park, Edifício 10,

2740-271 Porto Salvo, Portugal

Zarator

40 mg

Film-coated tablet

Oral use

Portugal

| Laboratorios Pfizer, Lda., |
| --- |
| Lagoas Park, Edifício 10, |
| 2740-271 Porto Salvo, Portugal |

Laboratorios Pfizer, Lda.,

Lagoas Park, Edifício 10,

2740-271 Porto Salvo, Portugal

Zarator

80 mg

Film-coated tablet

Oral use

Portugal

| Parke-Davis - Produtos Farmaceuticos, Lda., |
| --- |
| Lagoas Park, Edifício 10, 2740-271 Porto Salvo, |
| Portugal |

Parke-Davis - Produtos Farmaceuticos, Lda.,

Lagoas Park, Edifício 10, 2740-271 Porto Salvo,

Portugal

Atorvastatina Parke-Davis

10 mg

Film-coated tablet

Oral use

Portugal

| Parke-Davis - Produtos Farmaceuticos, Lda., |
| --- |
| Lagoas Park, Edifício 10, 2740-271 Porto Salvo, |
| Portugal |

Parke-Davis - Produtos Farmaceuticos, Lda.,

Lagoas Park, Edifício 10, 2740-271 Porto Salvo,

Portugal

Atorvastatina Parke-Davis

20 mg

Film-coated tablet

Oral use

Portugal

| Parke-Davis - Produtos Farmaceuticos, Lda., |
| --- |
| Lagoas Park, Edifício 10, 2740-271 Porto Salvo, |
| Portugal |

Parke-Davis - Produtos Farmaceuticos, Lda.,

Lagoas Park, Edifício 10, 2740-271 Porto Salvo,

Portugal

Atorvastatina Parke-Davis

40 mg

Film-coated tablet

Oral use

Portugal

| Parke-Davis - Produtos Farmaceuticos, Lda., |
| --- |
| Lagoas Park, Edifício 10, 2740-271 Porto Salvo, |
| Portugal |

Parke-Davis - Produtos Farmaceuticos, Lda.,

Lagoas Park, Edifício 10, 2740-271 Porto Salvo,

Portugal

Atorvastatina Parke-Davis

80 mg

Film-coated tablet

Oral use

Portugal

| Farmogene - Produtos Farmacêuticos, Lda, |
| --- |
| Lagoas Park, Edifício 10, 2740-271 Porto Salvo, |
| Portugal |

Farmogene - Produtos Farmacêuticos, Lda,

Lagoas Park, Edifício 10, 2740-271 Porto Salvo,

Portugal

Texzor

10 mg

Film-coated tablet

Oral use

Portugal

| Farmogene - Produtos Farmacêuticos, Lda, |
| --- |
| Lagoas Park, Edifício 10, 2740-271 Porto Salvo, |
| Portugal |

Farmogene - Produtos Farmacêuticos, Lda,

Lagoas Park, Edifício 10, 2740-271 Porto Salvo,

Portugal

Texzor

20 mg

Film-coated tablet

Oral use

Portugal

| Farmogene - Produtos Farmacêuticos, Lda, |
| --- |
| Lagoas Park, Edifício 10, 2740-271 Porto Salvo, |
| Portugal |

Farmogene - Produtos Farmacêuticos, Lda,

Lagoas Park, Edifício 10, 2740-271 Porto Salvo,

Portugal

Texzor

40 mg

Film-coated tablet

Oral use

Portugal

| Farmogene - Produtos Farmacêuticos, Lda, |
| --- |
| Lagoas Park, Edifício 10, 2740-271 Porto Salvo, |
| Portugal |

Farmogene - Produtos Farmacêuticos, Lda,

Lagoas Park, Edifício 10, 2740-271 Porto Salvo,

Portugal

Texzor

80 mg

Film-coated tablet

Oral use

Romania

| Pfizer Europe MA EEIG, Ramsgate Road, |
| --- |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG, Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Sortis

10 mg

Film-coated tablet

Oral use

Romania

| Pfizer Europe MA EEIG, Ramsgate Road, |
| --- |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG, Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Sortis

20 mg

Film-coated tablet

Oral use

Romania

| Pfizer Europe MA EEIG, Ramsgate Road, |
| --- |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG, Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Sortis

40 mg

Film-coated tablet

Oral use

Romania

| Pfizer Europe MA EEIG, Ramsgate Road, |
| --- |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG, Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Sortis

80 mg

Film-coated tablet

Oral use

Slovak Republic

| Pfizer Europe MA EEIG, Ramsgate Road, |
| --- |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG, Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Sortis

10 mg

Film-coated tablet

Oral use

Slovak Republic

| Pfizer Europe MA EEIG, Ramsgate Road, |
| --- |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG, Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Sortis

20 mg

Film-coated tablet

Oral use

Slovak Republic

| Pfizer Europe MA EEIG, Ramsgate Road, |
| --- |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG, Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Sortis

40 mg

Film-coated tablet

Oral use

Slovak Republic

| Pfizer Europe MA EEIG, Ramsgate Road, |
| --- |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG, Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Sortis

80 mg

Film-coated tablet

Oral use

Slovenia

| Pfizer Luxembourg SARL, |
| --- |
| 51, Avenue J. F. Kennedy, L-1855 Luxembourg, |
| Luxembourg |

Pfizer Luxembourg SARL,

51, Avenue J. F. Kennedy, L-1855 Luxembourg,

Luxembourg

Sortis 10 mg filmsko obložene tablete

10 mg

Film-coated tablet

Oral use

Slovenia

| Pfizer Luxembourg SARL, |
| --- |
| 51, Avenue J. F. Kennedy, L-1855 Luxembourg, |
| Luxembourg |

Pfizer Luxembourg SARL,

51, Avenue J. F. Kennedy, L-1855 Luxembourg,

Luxembourg

Sortis 20 mg filmsko obložene tablete

20 mg

Film-coated tablet

Oral use

Slovenia

| Pfizer Luxembourg SARL, |
| --- |
| 51, Avenue J. F. Kennedy, L-1855 Luxembourg, |
| Luxembourg |

Pfizer Luxembourg SARL,

51, Avenue J. F. Kennedy, L-1855 Luxembourg,

Luxembourg

Sortis 40 mg filmsko obložene tablete

40 mg

Film-coated tablet

Oral use

Slovenia

| Pfizer Luxembourg SARL, |
| --- |
| 51, Avenue J. F. Kennedy, L-1855 Luxembourg, |
| Luxembourg |

Pfizer Luxembourg SARL,

51, Avenue J. F. Kennedy, L-1855 Luxembourg,

Luxembourg

Sortis 80 mg filmsko obložene tablete

80 mg

Film-coated tablet

Oral use

Spain

| Parke Davis. S.L. |
| --- |
| Avda. de Europa 20B |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Spain |

Parke Davis. S.L.

Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Zarator

10 mg

Film-coated tablet

Oral use

Spain

| Parke Davis. S.L. |
| --- |
| Avda. de Europa 20B |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Spain |

Parke Davis. S.L.

Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Zarator

20 mg

Film-coated tablet

Oral use

Spain

| Parke Davis. S.L. |
| --- |
| Avda. de Europa 20B |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Spain |

Parke Davis. S.L.

Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Zarator

40 mg

Film-coated tablet

Oral use

Spain

| Parke Davis. S.L. |
| --- |
| Avda. de Europa 20B |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Spain |

Parke Davis. S.L.

Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Zarator

80 mg

Film-coated tablet

Oral use

Spain

| Pfizer, S.A. |
| --- |
| Avda. de Europa 20B |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Spain |

Pfizer, S.A.

Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Cardyl

10 mg

Film-coated tablet

Oral use

Spain

| Pfizer, S.A. |
| --- |
| Avda. de Europa 20B |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Spain |

Pfizer, S.A.

Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Cardyl

20 mg

Film-coated tablet

Oral use

Spain

| Pfizer, S.A. |
| --- |
| Avda. de Europa 20B |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Spain |

Pfizer, S.A.

Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Cardyl

40 mg

Film-coated tablet

Oral use

Spain

| Pfizer, S.A. |
| --- |
| Avda. de Europa 20B |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Spain |

Pfizer, S.A.

Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Cardyl

80 mg

Film-coated tablet

Oral use

Spain

| Nostrum Farma, S.A., Avda. de Europa 20B |
| --- |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Spain |

Nostrum Farma, S.A., Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Atorvastatina Nostrum

10 mg

Film-coated tablet

Oral use

Spain

| Nostrum Farma, S.A., Avda. de Europa 20B |
| --- |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Spain |

Nostrum Farma, S.A., Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Atorvastatina Nostrum

20 mg

Film-coated tablet

Oral use

Spain

| Nostrum Farma, S.A., Avda. de Europa 20B |
| --- |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Spain |

Nostrum Farma, S.A., Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Atorvastatina Nostrum

40 mg

Film-coated tablet

Oral use

Spain

| Nostrum Farma, S.A., Avda. de Europa 20B |
| --- |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Spain |

Nostrum Farma, S.A., Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Atorvastatina Nostrum

80 mg

Film-coated tablet

Oral use

Spain

| PHARMACIA GRUPO PFIZER, S.L. |
| --- |
| Avda. de Europa 20B |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Spain |

PHARMACIA GRUPO PFIZER, S.L.

Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Atorvastatina Pharmacia

10 mg

Film-coated tablet

Oral use

Spain

| PHARMACIA GRUPO PFIZER, S.L. |
| --- |
| Avda. de Europa 20B |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Spain |

PHARMACIA GRUPO PFIZER, S.L.

Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Atorvastatina Pharmacia

20 mg

Film-coated tablet

Oral use

Spain

| PHARMACIA GRUPO PFIZER, S.L. |
| --- |
| Avda. de Europa 20B |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Spain |

PHARMACIA GRUPO PFIZER, S.L.

Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Atorvastatina Pharmacia

40 mg

Film-coated tablet

Oral use

Spain

| PHARMACIA GRUPO PFIZER, S.L. |
| --- |
| Avda. de Europa 20B |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Spain |

PHARMACIA GRUPO PFIZER, S.L.

Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Atorvastatina Pharmacia

80 mg

Film-coated tablet

Oral use

Spain

| Almirall S.A. |
| --- |
| General Mitre, 151 |
| 08022 - Barcelona |
| Spain |

Almirall S.A.

General Mitre, 151

08022 - Barcelona

Spain

Prevencor

10 mg

Film-coated tablet

Oral use

Spain

| Almirall S.A. |
| --- |
| General Mitre, 151 |
| 08022 - Barcelona |
| Spain |

Almirall S.A.

General Mitre, 151

08022 - Barcelona

Spain

Prevencor

20 mg

Film-coated tablet

Oral use

Spain

| Almirall S.A. |
| --- |
| General Mitre, 151 |
| 08022 - Barcelona |
| Spain |

Almirall S.A.

General Mitre, 151

08022 - Barcelona

Spain

Prevencor

40 mg

Film-coated tablet

Oral use

Spain

| Almirall S.A. |
| --- |
| General Mitre, 151 |
| 08022 - Barcelona |
| Spain |

Almirall S.A.

General Mitre, 151

08022 - Barcelona

Spain

Prevencor

80 mg

Film-coated tablet

Oral use

Sweden

| Pfizer AB |
| --- |
| 191 90 Sollentuna |
| Sweden |

Pfizer AB

191 90 Sollentuna

Sweden

Lipitor

10 mg

Film-coated tablet

Oral use

Sweden

| Pfizer AB |
| --- |
| 191 90 Sollentuna |
| Sweden |

Pfizer AB

191 90 Sollentuna

Sweden

Lipitor

20 mg

Film-coated tablet

Oral use

Sweden

| Pfizer AB |
| --- |
| 191 90 Sollentuna |
| Sweden |

Pfizer AB

191 90 Sollentuna

Sweden

Lipitor

40 mg

Film-coated tablet

Oral use

Sweden

| Pfizer AB |
| --- |
| 191 90 Sollentuna |
| Sweden |

Pfizer AB

191 90 Sollentuna

Sweden

Lipitor

80 mg

Film-coated tablet

Oral use

United Kingdom

| Pfizer Ireland Pharmaceuticals, |
| --- |
| Pottery Road, Dun Laoghaire, Co Dublin |
| Ireland |

Pfizer Ireland Pharmaceuticals,

Pottery Road, Dun Laoghaire, Co Dublin

Ireland

Lipitor

10 mg

Film-coated tablet

Oral use

United Kingdom

| Pfizer Ireland Pharmaceuticals, |
| --- |
| Pottery Road, Dun Laoghaire, Co Dublin |
| Ireland |

Pfizer Ireland Pharmaceuticals,

Pottery Road, Dun Laoghaire, Co Dublin

Ireland

Lipitor

20 mg

Film-coated tablet

Oral use

United Kingdom

| Pfizer Ireland Pharmaceuticals, |
| --- |
| Pottery Road, Dun Laoghaire, Co Dublin |
| Ireland |

Pfizer Ireland Pharmaceuticals,

Pottery Road, Dun Laoghaire, Co Dublin

Ireland

Lipitor

40 mg

Film-coated tablet

Oral use

United Kingdom

| Pfizer Ireland Pharmaceuticals, |
| --- |
| Pottery Road, Dun Laoghaire, Co Dublin Ireland |

Pfizer Ireland Pharmaceuticals,

Pottery Road, Dun Laoghaire, Co Dublin Ireland

Lipitor

80 mg

Film-coated tablet

Oral use

---

ANNEX XI

SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET

All veterinary medicinal products for food producing species containing quinolones and/or fluoroquinolones as active substances.

---

ANNEX XII

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES

| Member State | Marketing Authorisation Holder | Invented name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | AstraZeneca Österreich GmbH |
| Schwarzenbergplatz 7 |
| A-1037 Wien |
| Austria |

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Austria

AstraZeneca Österreich GmbH

Schwarzenbergplatz 7

A-1037 Wien

Austria

Seroquel XR 50 mg – Retardtabletten

50 mg

Prolonged-release tablet

Oral use

Austria

| AstraZeneca Österreich GmbH |
| --- |
| Schwarzenbergplatz 7 |
| A-1037 Wien |
| Austria |

AstraZeneca Österreich GmbH

Schwarzenbergplatz 7

A-1037 Wien

Austria

Seroquel XR 150 mg – Retardtabletten

150 mg

Prolonged-release tablet

Oral use

Austria

| AstraZeneca Österreich GmbH |
| --- |
| Schwarzenbergplatz 7 |
| A-1037 Wien |
| Austria |

AstraZeneca Österreich GmbH

Schwarzenbergplatz 7

A-1037 Wien

Austria

Seroquel XR 200 mg – Retardtabletten

200 mg

Prolonged-release tablet

Oral use

Austria

| AstraZeneca Österreich GmbH |
| --- |
| Schwarzenbergplatz 7 |
| A-1037 Wien |
| Austria |

AstraZeneca Österreich GmbH

Schwarzenbergplatz 7

A-1037 Wien

Austria

Seroquel XR 300 mg – Retardtabletten

300 mg

Prolonged-release tablet

Oral use

Austria

| AstraZeneca Österreich GmbH |
| --- |
| Schwarzenbergplatz 7 |
| A-1037 Wien |
| Austria |

AstraZeneca Österreich GmbH

Schwarzenbergplatz 7

A-1037 Wien

Austria

Seroquel XR 400 mg – Retardtabletten

400 mg

Prolonged-release tablet

Oral use

Belgium

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussel |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel

Belgium

Seroquel XR 50 mg prolonged-release tablets

50 mg

Prolonged-release tablet

Oral use

Belgium

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussel |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel

Belgium

Seroquel XR 150 mg prolonged-release tablets

150 mg

Prolonged-release tablet

Oral use

Belgium

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussel |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel

Belgium

Seroquel XR 200 mg prolonged-release tablets

200 mg

Prolonged-release tablet

Oral use

Belgium

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussel |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel

Belgium

Seroquel XR 300 mg prolonged-release tablets

300 mg

Prolonged-release tablet

Oral use

Belgium

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussel |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel

Belgium

Seroquel XR 400 mg prolonged-release tablets

400 mg

Prolonged-release tablet

Oral use

Cyprus

| AstraZeneca UK Limited, |
| --- |
| Silk Road Business Park, |
| Macclesfield, Cheshire, SK10 2NA, |
| United Kingdom |

AstraZeneca UK Limited,

Silk Road Business Park,

Macclesfield, Cheshire, SK10 2NA,

United Kingdom

Seroquel XR 50 mg prolonged-release tablets

50 mg

Prolonged-release tablet

Oral use

Cyprus

| AstraZeneca UK Limited, |
| --- |
| Silk Road Business Park, |
| Macclesfield, Cheshire, SK10 2NA, |
| United Kingdom |

AstraZeneca UK Limited,

Silk Road Business Park,

Macclesfield, Cheshire, SK10 2NA,

United Kingdom

Seroquel XR 200 mg prolonged-release tablets

200 mg

Prolonged-release tablet

Oral use

Cyprus

| AstraZeneca UK Limited, |
| --- |
| Silk Road Business Park, |
| Macclesfield, Cheshire, SK10 2NA, |
| United Kingdom |

AstraZeneca UK Limited,

Silk Road Business Park,

Macclesfield, Cheshire, SK10 2NA,

United Kingdom

Seroquel XR 300 mg prolonged-release tablets

300 mg

Prolonged-release tablet

Oral use

Cyprus

| AstraZeneca UK Limited, |
| --- |
| Silk Road Business Park, |
| Macclesfield, Cheshire, SK10 2NA, |
| United Kingdom |

AstraZeneca UK Limited,

Silk Road Business Park,

Macclesfield, Cheshire, SK10 2NA,

United Kingdom

Seroquel XR 400 mg prolonged-release tablets

400 mg

Prolonged-release tablet

Oral use

Germany

| AstraZeneca GmbH, |
| --- |
| Tinsdaler Weg 183, |
| 22880 Wedel, |
| Germany |

AstraZeneca GmbH,

Tinsdaler Weg 183,

22880 Wedel,

Germany

Seroquel Prolong 50 mg Retardtabletten

50 mg

Prolonged-release tablet

Oral use

Germany

| AstraZeneca GmbH, |
| --- |
| Tinsdaler Weg 183, |
| 22880 Wedel, |
| Germany |

AstraZeneca GmbH,

Tinsdaler Weg 183,

22880 Wedel,

Germany

Seroquel Prolong 150 mg Retardtabletten

150 mg

Prolonged-release tablet

Oral use

Germany

| AstraZeneca GmbH, |
| --- |
| Tinsdaler Weg 183, |
| 22880 Wedel, |
| Germany |

AstraZeneca GmbH,

Tinsdaler Weg 183,

22880 Wedel,

Germany

Seroquel Prolong 200 mg Retardtabletten

200 mg

Prolonged-release tablet

Oral use

Germany

| AstraZeneca GmbH, |
| --- |
| Tinsdaler Weg 183, |
| 22880 Wedel, |
| Germany |

AstraZeneca GmbH,

Tinsdaler Weg 183,

22880 Wedel,

Germany

Seroquel Prolong 300 mg Retardtabletten

300 mg

Prolonged-release tablet

Oral use

Germany

| AstraZeneca GmbH, |
| --- |
| Tinsdaler Weg 183, |
| 22880 Wedel, |
| Germany |

AstraZeneca GmbH,

Tinsdaler Weg 183,

22880 Wedel,

Germany

Seroquel Prolong 400 mg Retardtabletten

400 mg

Prolonged-release tablet

Oral use

Denmark

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| 2620 Albertslund |
| Denmark |

AstraZeneca A/S

Roskildevej 22

2620 Albertslund

Denmark

Seroquel Prolong 50 mg prolonged-release tablets

50 mg

Prolonged-release tablet

Oral use

Denmark

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| 2620 Albertslund |
| Denmark |

AstraZeneca A/S

Roskildevej 22

2620 Albertslund

Denmark

Seroquel Prolong 150 mg prolonged-release tablets

150 mg

Prolonged-release tablet

Oral use

Denmark

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| 2620 Albertslund |
| Denmark |

AstraZeneca A/S

Roskildevej 22

2620 Albertslund

Denmark

Seroquel Prolong 200 mg prolonged-release tablets

200 mg

Prolonged-release tablet

Oral use

Denmark

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| 2620 Albertslund |
| Denmark |

AstraZeneca A/S

Roskildevej 22

2620 Albertslund

Denmark

Seroquel Prolong 300 mg prolonged-release tablets

300 mg

Prolonged-release tablet

Oral use

Denmark

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| 2620 Albertslund |
| Denmark |

AstraZeneca A/S

Roskildevej 22

2620 Albertslund

Denmark

Seroquel Prolong 400 mg prolonged-release tablets

400 mg

Prolonged-release tablet

Oral use

Greece

| AstraZeneca S.A. |
| --- |
| 4 Theotokopoulou & Astronafton 151 25 Maroussi, Athens |
| Greece |

AstraZeneca S.A.

4 Theotokopoulou & Astronafton 151 25 Maroussi, Athens

Greece

Seroquel XR 50 mg

50 mg

Prolonged-release tablet

Oral use

Greece

| AstraZeneca S.A. |
| --- |
| 4 Theotokopoulou & Astronafton 151 25 Maroussi, Athens |
| Greece |

AstraZeneca S.A.

4 Theotokopoulou & Astronafton 151 25 Maroussi, Athens

Greece

Seroquel XR 150 mg

150 mg

Prolonged-release tablet

Oral use

Greece

| AstraZeneca S.A. |
| --- |
| 4 Theotokopoulou & Astronafton 151 25 Maroussi, Athens |
| Greece |

AstraZeneca S.A.

4 Theotokopoulou & Astronafton 151 25 Maroussi, Athens

Greece

Seroquel XR 200 mg

200 mg

Prolonged-release tablet

Oral use

Greece

| AstraZeneca S.A. |
| --- |
| 4 Theotokopoulou & Astronafton 151 25 Maroussi, Athens |
| Greece |

AstraZeneca S.A.

4 Theotokopoulou & Astronafton 151 25 Maroussi, Athens

Greece

Seroquel XR 300 mg

300 mg

Prolonged-release tablet

Oral use

Greece

| AstraZeneca S.A. |
| --- |
| 4 Theotokopoulou & Astronafton 151 25 Maroussi, Athens |
| Greece |

AstraZeneca S.A.

4 Theotokopoulou & Astronafton 151 25 Maroussi, Athens

Greece

Seroquel XR 400 mg

400 mg

Prolonged-release tablet

Oral use

Spain

| AstraZeneca Farmacéutica Spain, S.A. |
| --- |
| C/ Serrano Galvache, 56 – Edificio Roble |
| 28033 Madrid |
| Spain |

AstraZeneca Farmacéutica Spain, S.A.

C/ Serrano Galvache, 56 – Edificio Roble

28033 Madrid

Spain

Seroquel Prolong 50 mg comprimidos de liberación prolongada

50 mg

Prolonged-release tablet

Oral use

Spain

| AstraZeneca Farmacéutica Spain, S.A. |
| --- |
| C/ Serrano Galvache, 56 – Edificio Roble |
| 28033 Madrid |
| Spain |

AstraZeneca Farmacéutica Spain, S.A.

C/ Serrano Galvache, 56 – Edificio Roble

28033 Madrid

Spain

Seroquel Prolong 150 mg comprimidos de liberación prolongada

150 mg

Prolonged-release tablet

Oral use

Spain

| AstraZeneca Farmacéutica Spain, S.A. |
| --- |
| C/ Serrano Galvache, 56 – Edificio Roble |
| 28033 Madrid |
| Spain |

AstraZeneca Farmacéutica Spain, S.A.

C/ Serrano Galvache, 56 – Edificio Roble

28033 Madrid

Spain

Seroquel Prolong 200 mg comprimidos de liberación prolongada

200 mg

Prolonged-release tablet

Oral use

Spain

| AstraZeneca Farmacéutica Spain, S.A. |
| --- |
| C/ Serrano Galvache, 56 – Edificio Roble |
| 28033 Madrid |
| Spain |

AstraZeneca Farmacéutica Spain, S.A.

C/ Serrano Galvache, 56 – Edificio Roble

28033 Madrid

Spain

Seroquel Prolong 300 mg comprimidos de liberación prolongada

300 mg

Prolonged-release tablet

Oral use

Spain

| AstraZeneca Farmacéutica Spain, S.A. |
| --- |
| C/ Serrano Galvache, 56 – Edificio Roble |
| 28033 Madrid |
| Spain |

AstraZeneca Farmacéutica Spain, S.A.

C/ Serrano Galvache, 56 – Edificio Roble

28033 Madrid

Spain

Seroquel Prolong 400 mg comprimidos de liberación prolongada

400 mg

Prolonged-release tablet

Oral use

Finland

| AstraZeneca Oy |
| --- |
| Luomanportti 3 |
| FI-02200 Espoo |
| Finland |

AstraZeneca Oy

Luomanportti 3

FI-02200 Espoo

Finland

Seroquel Prolong 50 mg depottabletti

50 mg

Prolonged-release tablet

Oral use

Finland

| AstraZeneca Oy |
| --- |
| Luomanportti 3 |
| FI-02200 Espoo |
| Finland |

AstraZeneca Oy

Luomanportti 3

FI-02200 Espoo

Finland

Seroquel Prolong 150 mg depottabletti

150 mg

Prolonged-release tablet

Oral use

Finland

| AstraZeneca Oy |
| --- |
| Luomanportti 3 |
| FI-02200 Espoo |
| Finland |

AstraZeneca Oy

Luomanportti 3

FI-02200 Espoo

Finland

Seroquel Prolong 200 mg depottabletti

200 mg

Prolonged-release tablet

Oral use

Finland

| AstraZeneca Oy |
| --- |
| Luomanportti 3 |
| FI-02200 Espoo |
| Finland |

AstraZeneca Oy

Luomanportti 3

FI-02200 Espoo

Finland

Seroquel Prolong 300 mg depottabletti

300 mg

Prolonged-release tablet

Oral use

Finland

| AstraZeneca Oy |
| --- |
| Luomanportti 3 |
| FI-02200 Espoo |
| Finland |

AstraZeneca Oy

Luomanportti 3

FI-02200 Espoo

Finland

Seroquel Prolong 400 mg depottabletti

400 mg

Prolonged-release tablet

Oral use

Iceland

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| 2620 Albertslund |
| Denmark |

AstraZeneca A/S

Roskildevej 22

2620 Albertslund

Denmark

Seroquel Prolong

50 mg

Prolonged-release tablet

Oral use

Iceland

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| 2620 Albertslund |
| Denmark |

AstraZeneca A/S

Roskildevej 22

2620 Albertslund

Denmark

Seroquel Prolong

150 mg

Prolonged-release tablet

Oral use

Iceland

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| 2620 Albertslund |
| Denmark |

AstraZeneca A/S

Roskildevej 22

2620 Albertslund

Denmark

Seroquel Prolong

200 mg

Prolonged-release tablet

Oral use

Iceland

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| 2620 Albertslund |
| Denmark |

AstraZeneca A/S

Roskildevej 22

2620 Albertslund

Denmark

Seroquel Prolong

300 mg

Prolonged-release tablet

Oral use

Iceland

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| 2620 Albertslund |
| Denmark |

AstraZeneca A/S

Roskildevej 22

2620 Albertslund

Denmark

Seroquel Prolong

400 mg

Prolonged-release tablet

Oral use

Ireland

| AstraZeneca UK Ltd |
| --- |
| 600 Capability Green |
| Luton LU1 3LU |
| United Kingdom |

AstraZeneca UK Ltd

600 Capability Green

Luton LU1 3LU

United Kingdom

Seroquel XR 50 mg prolonged-release tablets

50 mg

Prolonged-release tablet

Oral use

Ireland

| AstraZeneca UK Ltd |
| --- |
| 600 Capability Green |
| Luton LU1 3LU |
| United Kingdom |

AstraZeneca UK Ltd

600 Capability Green

Luton LU1 3LU

United Kingdom

Seroquel XR 150 mg prolonged-release tablets

150 mg

Prolonged-release tablet

Oral use

Ireland

| AstraZeneca UK Ltd |
| --- |
| 600 Capability Green |
| Luton LU1 3LU |
| United Kingdom |

AstraZeneca UK Ltd

600 Capability Green

Luton LU1 3LU

United Kingdom

Seroquel XR 200 mg prolonged-release tablets

200 mg

Prolonged-release tablet

Oral use

Ireland

| AstraZeneca UK Ltd |
| --- |
| 600 Capability Green |
| Luton LU1 3LU |
| United Kingdom |

AstraZeneca UK Ltd

600 Capability Green

Luton LU1 3LU

United Kingdom

Seroquel XR 300 mg prolonged-release tablets

300 mg

Prolonged-release tablet

Oral use

Ireland

| AstraZeneca UK Ltd |
| --- |
| 600 Capability Green |
| Luton LU1 3LU |
| United Kingdom |

AstraZeneca UK Ltd

600 Capability Green

Luton LU1 3LU

United Kingdom

Seroquel XR 400 mg prolonged-release tablets

400 mg

Prolonged-release tablet

Oral use

Luxembourg

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussel |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel

Belgium

Seroquel XR 50 mg prolonged-release tablets

50 mg

Prolonged-release tablet

Oral use

Luxembourg

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussel |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel

Belgium

Seroquel XR 150 mg prolonged-release tablets

150 mg

Prolonged-release tablet

Oral use

Luxembourg

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussel |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel

Belgium

Seroquel XR 200 mg prolonged-release tablets

200 mg

Prolonged-release tablet

Oral use

Luxembourg

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussel |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel

Belgium

Seroquel XR 300 mg prolonged-release tablets

300 mg

Prolonged-release tablet

Oral use

Luxembourg

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussel |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel

Belgium

Seroquel XR 400 mg prolonged-release tablets

400 mg

Prolonged-release tablet

Oral use

Malta

| AstraZeneca UK Ltd |
| --- |
| Silk Road Business Park |
| Macclesfield |
| Cheshire SK10 2NA |
| United Kingdom |

AstraZeneca UK Ltd

Silk Road Business Park

Macclesfield

Cheshire SK10 2NA

United Kingdom

Seroquel XR 50 mg prolonged-release tablets

50 mg

Prolonged-release tablet

Oral use

Malta

| AstraZeneca UK Ltd |
| --- |
| Silk Road Business Park |
| Macclesfield |
| Cheshire SK10 2NA |
| United Kingdom |

AstraZeneca UK Ltd

Silk Road Business Park

Macclesfield

Cheshire SK10 2NA

United Kingdom

Seroquel XR 150 mg prolonged-release tablets

150 mg

Prolonged-release tablet

Oral use

Malta

| AstraZeneca UK Ltd |
| --- |
| Silk Road Business Park |
| Macclesfield |
| Cheshire SK10 2NA |
| United Kingdom |

AstraZeneca UK Ltd

Silk Road Business Park

Macclesfield

Cheshire SK10 2NA

United Kingdom

Seroquel XR 200 mg prolonged-release tablets

200 mg

Prolonged-release tablet

Oral use

Malta

| AstraZeneca UK Ltd |
| --- |
| Silk Road Business Park |
| Macclesfield |
| Cheshire SK10 2NA |
| United Kingdom |

AstraZeneca UK Ltd

Silk Road Business Park

Macclesfield

Cheshire SK10 2NA

United Kingdom

Seroquel XR 300 mg prolonged-release tablets

300 mg

Prolonged-release tablet

Oral use

Malta

| AstraZeneca UK Ltd |
| --- |
| Silk Road Business Park |
| Macclesfield |
| Cheshire SK10 2NA |
| United Kingdom |

AstraZeneca UK Ltd

Silk Road Business Park

Macclesfield

Cheshire SK10 2NA

United Kingdom

Seroquel XR 400 mg prolonged-release tablets

400 mg

Prolonged-release tablet

Oral use

Netherlands

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE Zoetermeer |
| The Netherlands |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Seroquel XR 50 mg prolonged-release tablets

50 mg

Prolonged-release tablet

Oral use

Netherlands

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE Zoetermeer |
| The Netherlands |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Seroquel XR 150 mg prolonged-release tablets

150 mg

Prolonged-release tablet

Oral use

Netherlands

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE Zoetermeer |
| The Netherlands |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Seroquel XR 200 mg prolonged-release tablets

200 mg

Prolonged-release tablet

Oral use

Netherlands

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE Zoetermeer |
| The Netherlands |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Seroquel XR 300 mg prolonged-release tablets

300 mg

Prolonged-release tablet

Oral use

Netherlands

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE Zoetermeer |
| The Netherlands |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Seroquel XR 400 mg prolonged-release tablets

400 mg

Prolonged-release tablet

Oral use

Norway

| AstraZeneca AS, |
| --- |
| Hoffsveien 70B, |
| (PO Box 200), |
| 0319 Oslo, Norway |

AstraZeneca AS,

Hoffsveien 70B,

(PO Box 200),

0319 Oslo, Norway

Seroquel Depot 50 mg depottabletter

50 mg

Prolonged-release tablet

Oral use

Norway

| AstraZeneca AS, |
| --- |
| Hoffsveien 70B, |
| (PO Box 200), |
| 0319 Oslo, Norway |

AstraZeneca AS,

Hoffsveien 70B,

(PO Box 200),

0319 Oslo, Norway

Seroquel Depot 150 mg depottabletter

150 mg

Prolonged-release tablet

Oral use

Norway

| AstraZeneca AS, |
| --- |
| Hoffsveien 70B, |
| (PO Box 200), |
| 0319 Oslo, Norway |

AstraZeneca AS,

Hoffsveien 70B,

(PO Box 200),

0319 Oslo, Norway

Seroquel Depot 200 mg depottabletter

200 mg

Prolonged-release tablet

Oral use

Norway

| AstraZeneca AS, |
| --- |
| Hoffsveien 70B, |
| (PO Box 200), |
| 0319 Oslo, Norway |

AstraZeneca AS,

Hoffsveien 70B,

(PO Box 200),

0319 Oslo, Norway

Seroquel Depot 300 mg depotabletter

300 mg

Prolonged-release tablet

Oral use

Norway

| AstraZeneca AS, |
| --- |
| Hoffsveien 70B, |
| (PO Box 200), |
| 0319 Oslo, Norway |

AstraZeneca AS,

Hoffsveien 70B,

(PO Box 200),

0319 Oslo, Norway

Seroquel Depot 400 mg depottabletter

400 mg

Prolonged-release tablet

Oral use

Poland

| AstraZeneca UK Limited, |
| --- |
| 15 Stanhope Gate, |
| London |
| W1K 1LN, UK |

AstraZeneca UK Limited,

15 Stanhope Gate,

London

W1K 1LN, UK

Seroquel XR

50 mg

Prolonged-release tablet

Oral use

Poland

| AstraZeneca UK Limited, |
| --- |
| 15 Stanhope Gate, |
| London |
| W1K 1LN, UK |

AstraZeneca UK Limited,

15 Stanhope Gate,

London

W1K 1LN, UK

Seroquel XR

150 mg

Prolonged-release tablet

Oral use

Poland

| AstraZeneca UK Limited, |
| --- |
| 15 Stanhope Gate, |
| London |
| W1K 1LN, UK |

AstraZeneca UK Limited,

15 Stanhope Gate,

London

W1K 1LN, UK

Seroquel XR

200 mg

Prolonged-release tablet

Oral use

Poland

| AstraZeneca UK Limited, |
| --- |
| 15 Stanhope Gate, |
| London |
| W1K 1LN, UK |

AstraZeneca UK Limited,

15 Stanhope Gate,

London

W1K 1LN, UK

Seroquel XR

300 mg

Prolonged-release tablet

Oral use

Poland

| AstraZeneca UK Limited, |
| --- |
| 15 Stanhope Gate, |
| London |
| W1K 1LN, UK |

AstraZeneca UK Limited,

15 Stanhope Gate,

London

W1K 1LN, UK

Seroquel XR

400 mg

Prolonged-release tablet

Oral use

Portugal

| AstraZeneca Produtos Farmacêuticos, Lda. |
| --- |
| Rua Humberto Madeira, 7 |
| Valejas |
| 2745-663 Barcarena |
| Portugal |

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, 7

Valejas

2745-663 Barcarena

Portugal

Seroquel SR

50 mg

Prolonged-release tablet

Oral use

Portugal

| AstraZeneca Produtos Farmacêuticos, Lda. |
| --- |
| Rua Humberto Madeira, 7 |
| Valejas |
| 2745-663 Barcarena |
| Portugal |

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, 7

Valejas

2745-663 Barcarena

Portugal

Seroquel SR

150 mg

Prolonged-release tablet

Oral use

Portugal

| AstraZeneca Produtos Farmacêuticos, Lda. |
| --- |
| Rua Humberto Madeira, 7 |
| Valejas |
| 2745-663 Barcarena |
| Portugal |

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, 7

Valejas

2745-663 Barcarena

Portugal

Seroquel SR

200 mg

Prolonged-release tablet

Oral use

Portugal

| AstraZeneca Produtos Farmacêuticos, Lda. |
| --- |
| Rua Humberto Madeira, 7 |
| Valejas |
| 2745-663 Barcarena |
| Portugal |

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, 7

Valejas

2745-663 Barcarena

Portugal

Seroquel SR

300 mg

Prolonged-release tablet

Oral use

Portugal

| AstraZeneca Produtos Farmacêuticos, Lda. |
| --- |
| Rua Humberto Madeira, 7 |
| Valejas |
| 2745-663 Barcarena |
| Portugal |

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, 7

Valejas

2745-663 Barcarena

Portugal

Seroquel SR

400 mg

Prolonged-release tablet

Oral use

Sweden

| AstraZeneca AB |
| --- |
| AstraZeneca Sverige |
| SE-151 85 Södertälje |
| Sweden |

AstraZeneca AB

AstraZeneca Sverige

SE-151 85 Södertälje

Sweden

Seroquel Depot 50 mg depottabletter

50 mg

Prolonged-release tablet

Oral use

Sweden

| AstraZeneca AB |
| --- |
| AstraZeneca Sverige |
| SE-151 85 Södertälje |
| Sweden |

AstraZeneca AB

AstraZeneca Sverige

SE-151 85 Södertälje

Sweden

Seroquel Depot 150 mg depottabletter

150 mg

Prolonged-release tablet

Oral use

Sweden

| AstraZeneca AB |
| --- |
| AstraZeneca Sverige |
| SE-151 85 Södertälje |
| Sweden |

AstraZeneca AB

AstraZeneca Sverige

SE-151 85 Södertälje

Sweden

Seroquel Depot 200 mg depottabletter

200 mg

Prolonged-release tablet

Oral use

Sweden

| AstraZeneca AB |
| --- |
| AstraZeneca Sverige |
| SE-151 85 Södertälje |
| Sweden |

AstraZeneca AB

AstraZeneca Sverige

SE-151 85 Södertälje

Sweden

Seroquel Depot 300 mg depottabletter

300 mg

Prolonged-release tablet

Oral use

Sweden

| AstraZeneca AB |
| --- |
| AstraZeneca Sverige |
| SE-151 85 Södertälje |
| Sweden |

AstraZeneca AB

AstraZeneca Sverige

SE-151 85 Södertälje

Sweden

Seroquel Depot 400 mg depottabletter

400 mg

Prolonged-release tablet

Oral use

---

ANNEX XIII

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State/EEA | Marketing Authorisation Holder | Invented name | Pharmaceutical form | Strength | Animal species | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Novartis Animal Health GmbH., |
| Biochemiestrasse 10, |
| 6250 Kundl |
| AUSTRIA |

Member State/EEA

Marketing Authorisation Holder

Invented name

Pharmaceutical form

Strength

Animal species

Route of administration

Austria

Novartis Animal Health GmbH.,

Biochemiestrasse 10,

6250 Kundl

AUSTRIA

Denagard Novartis 100 g/kg Arzneimittelvormischung zur Herstellung von Fütterungsarzneimitteln für Schweine

Premix

100 g/kg

Pigs

Oral

Austria

| Novartis Animal Health GmbH., |
| --- |
| Biochemiestrasse 10, |
| 6250 Kundl |
| AUSTRIA |

Novartis Animal Health GmbH.,

Biochemiestrasse 10,

6250 Kundl

AUSTRIA

Denagard Novartis 20 g/kg Arzneimittelvormischung zur Herstellung von Fütterungsarzneimitteln für Schweine

Premix

20 g/kg

Pigs

Oral

Austria

| Novartis Animal Health GmbH., |
| --- |
| Biochemiestrasse 10, |
| 6250 Kundl |
| AUSTRIA |

Novartis Animal Health GmbH.,

Biochemiestrasse 10,

6250 Kundl

AUSTRIA

Tiamutin 20 g/kg Arzneimittelvormischung zur Herstellung von Fütterungsarzneimitteln für Schweine

Premix

20 g/kg

Pigs

Oral

Belgium

| VMD nv |
| --- |
| Leo Aerden |
| Hoge Mauw 900, |
| 2370 Arendonk |
| BELGIUM |

VMD nv

Leo Aerden

Hoge Mauw 900,

2370 Arendonk

BELGIUM

Tiamutin 10 % gemedicineerd voormengsel

Premix

100 mg/g

Pigs

Oral

Cyprus

| Novartis Animal Health Inc., |
| --- |
| Basle, |
| SWITZERLAND |

Novartis Animal Health Inc.,

Basle,

SWITZERLAND

Denagard 10 %

Premix

100 mg/g

Pigs

Oral

Czech Republic

| Novartis Animal Health d.o.o., Verovškova 57, |
| --- |
| 1000 Ljubljana |
| SLOVENIA |

Novartis Animal Health d.o.o., Verovškova 57,

1000 Ljubljana

SLOVENIA

Tiamutin 10 % premix ad us.vet.

Premix

100 mg/g

Pigs

Chickens

Turkeys

Oral

Czech Republic

| Novartis Animal Health d.o.o., Verovškova 57, |
| --- |
| 1000 Ljubljana |
| SLOVENIA |

Novartis Animal Health d.o.o., Verovškova 57,

1000 Ljubljana

SLOVENIA

Tiamutin 2 % premix ad us.vet.

Premix

20 mg/g

Pigs

Chickens

Turkeys

Oral

France

| Novartis Sante Animale |
| --- |
| 14 Boulevard Richelieu |
| 92500 Rueil Malmaison |
| FRANCE |

Novartis Sante Animale

14 Boulevard Richelieu

92500 Rueil Malmaison

FRANCE

Denagard prémélange tiamuline 16,2 pneumonie volaille - porc

Premix

16,2 mg/g

Pigs

Turkeys

Chickens

Oral

France

| Novartis Sante Animale |
| --- |
| 14 Boulevard Richelieu |
| 92500 Rueil Malmaison |
| FRANCE |

Novartis Sante Animale

14 Boulevard Richelieu

92500 Rueil Malmaison

FRANCE

Denagard prémélange tiamuline 6,5 enterite porc enterocolite lapin

Premix

6,5 mg/g

Rabbits

Pigs

Oral

Germany

| Novartis Tiergesundheit GmbH |
| --- |
| Zielstattstr. 40, |
| 81379 München |
| GERMANY |

Novartis Tiergesundheit GmbH

Zielstattstr. 40,

81379 München

GERMANY

Denagard 10 % AMV

Premix

100 g/kg

Pigs

Oral

Greece

| Premier Shukuroglou Hellas S.A |
| --- |
| Mesogion Av 198, |
| 15561 Holargos |
| GREECE |

Premier Shukuroglou Hellas S.A

Mesogion Av 198,

15561 Holargos

GREECE

Denagard 2 %

Premix

20 mg/g

Pigs

Oral

Greece

| Premier Shukuroglou Hellas S.A |
| --- |
| Mesogion Av 198, |
| 15561 Holargos |
| GREECE |

Premier Shukuroglou Hellas S.A

Mesogion Av 198,

15561 Holargos

GREECE

Denagard 10 %

Premix

100 mg/g

Pigs

Oral

Hungary

| Novartis Animal Health d.o.o. |
| --- |
| Verovskova 57, |
| 1000 Ljubljana |
| SLOVENIA |

Novartis Animal Health d.o.o.

Verovskova 57,

1000 Ljubljana

SLOVENIA

Denagard 10 % gyógypremix A.U.V.

Premix

100 mg/g

Pigs

Oral

Ireland

| Novartis Animal Health Ireland Ltd., |
| --- |
| Industrial Park, |
| Cork Road, |
| Waterford |
| IRELAND |

Novartis Animal Health Ireland Ltd.,

Industrial Park,

Cork Road,

Waterford

IRELAND

Tiamutin 2 %

Premix

20 mg/g

Pigs

Oral

Ireland

| Novartis Animal Health Ireland Ltd., |
| --- |
| Industrial Park, |
| Cork Road, |
| Waterford |
| IRELAND |

Novartis Animal Health Ireland Ltd.,

Industrial Park,

Cork Road,

Waterford

IRELAND

Tiamutin 80 %

Premix

800 mg/g

Pigs

Oral

Italy

| Novartis Animal Health S.P.A |
| --- |
| Largo Umberto Boccioni, 1 |
| 21040 Origlio (Varese) |
| ITALY |

Novartis Animal Health S.P.A

Largo Umberto Boccioni, 1

21040 Origlio (Varese)

ITALY

Denagard 10 % Premix

Premix

100 mg/g

Pigs

Chickens

Turkeys

Oral

Italy

| Novartis Animal Health S.P.A |
| --- |
| Largo Umberto Boccioni, 1 |
| 21040 Origlio (Varese) |
| ITALY |

Novartis Animal Health S.P.A

Largo Umberto Boccioni, 1

21040 Origlio (Varese)

ITALY

Denagard 10 % Premix Plus

Premix

100 mg/g

Pigs

Oral

Latvia

| Novartis Animal Health d.o.o. |
| --- |
| Verovškova 57, |
| 1000 Ljubljana |
| SLOVENIA |

Novartis Animal Health d.o.o.

Verovškova 57,

1000 Ljubljana

SLOVENIA

Tiamutin 10 % premix

Premix

100 mg/g

Pigs

Oral

Lithuania

| Novartis Animal Health d.o.o. |
| --- |
| Verovškova 57, |
| 1000 Ljubljana |
| SLOVENIA |

Novartis Animal Health d.o.o.

Verovškova 57,

1000 Ljubljana

SLOVENIA

Tiamutin 10 % vaistinis premiksas kiaulėms

Premix

100 mg/g

Pigs

Oral

Portugal

| Novartis Farma Produtos Farmacêuticos S.A |
| --- |
| Rua do Centro Empresarial |
| Edifício 8 |
| Quinta da Beloura |
| 2710-444 Sintra |
| PORTUGAL |

Novartis Farma Produtos Farmacêuticos S.A

Rua do Centro Empresarial

Edifício 8

Quinta da Beloura

2710-444 Sintra

PORTUGAL

Denagard 20 g/Kg

Premix

20 g/kg

Pigs

Chickens

Turkeys

Oral

Portugal

| Novartis Farma Produtos Farmacêuticos S.A |
| --- |
| Rua do Centro Empresarial |
| Edifício 8 |
| Quinta da Beloura |
| 2710-444 Sintra |
| PORTUGAL |

Novartis Farma Produtos Farmacêuticos S.A

Rua do Centro Empresarial

Edifício 8

Quinta da Beloura

2710-444 Sintra

PORTUGAL

Denagard 100 g/Kg

Premix

100 g/kg

Pigs

Chickens

Turkeys

Rabbits

Oral

Portugal

| Novartis Farma Produtos Farmacêuticos S.A |
| --- |
| Rua do Centro Empresarial |
| Edifício 8 |
| Quinta da Beloura |
| 2710-444 Sintra |
| PORTUGAL |

Novartis Farma Produtos Farmacêuticos S.A

Rua do Centro Empresarial

Edifício 8

Quinta da Beloura

2710-444 Sintra

PORTUGAL

Dynamutilin 100 g/Kg

Premix

100 g/kg

Pigs

Chickens

Turkeys

Oral

Poland

| Novartis Animal Health d.o.o. |
| --- |
| Verovškova 57, |
| 1000 Ljubljana |
| SLOVENIA |

Novartis Animal Health d.o.o.

Verovškova 57,

1000 Ljubljana

SLOVENIA

Tiamutin 10 % premiks leczniczy dla świń

Premix

100 mg/g

Pigs

Oral

Poland

| Novartis Animal Health d.o.o. |
| --- |
| Verovškova 57, |
| 1000 Ljubljana |
| SLOVENIA |

Novartis Animal Health d.o.o.

Verovškova 57,

1000 Ljubljana

SLOVENIA

Tiamutin 2 % 20 mg/g premiks do sporządzania paszy leczniczej dla świń

Premix

20 mg/g

Pigs

Oral

Romania

| Novartis Animal Health d.o.o. |
| --- |
| Verovškova 57, |
| 1000 Ljubljana |
| SLOVENIA |

Novartis Animal Health d.o.o.

Verovškova 57,

1000 Ljubljana

SLOVENIA

Tiamutin 10 % Premix pentru furaje medicamentate pentru porci

Premix

100 mg/g

Pigs

Chickens

Turkeys

Oral

Romania

| Novartis Animal Health d.o.o. |
| --- |
| Verovškova 57, |
| SI-1000 Ljubljana |
| SLOVENIA |

Novartis Animal Health d.o.o.

Verovškova 57,

SI-1000 Ljubljana

SLOVENIA

Tiamutin 80 % coated

Premix

800 g/100 kg

Pigs

Chickens

Turkeys

Oral

Slovakia

| Novartis Animal Health d.o.o. |
| --- |
| Verovškova 57, |
| 1000 Ljubljana |
| SLOVENIA |

Novartis Animal Health d.o.o.

Verovškova 57,

1000 Ljubljana

SLOVENIA

Tiamutin 10 % prm. ad us. vet.

Premix

100 mg/g

Pigs

Chickens

Turkeys

Oral

Slovakia

| Novartis Animal Health d.o.o. |
| --- |
| Verovškova 57, |
| 1000 Ljubljana |
| SLOVENIA |

Novartis Animal Health d.o.o.

Verovškova 57,

1000 Ljubljana

SLOVENIA

Tiamutin 2 % prm. ad us. vet.

Premix

20 mg/g

Pigs

Chickens

Turkeys

Oral

Spain

| Novartis Sanidad Animal, S.L. |
| --- |
| c/De la Marina, 206 |
| 08013 Barcelona |
| SPAIN |

Novartis Sanidad Animal, S.L.

c/De la Marina, 206

08013 Barcelona

SPAIN

Denagard 100 g/kg Premezcla medicamentosa

Premix

100 g/kg

Pigs

Chickens

Turkeys

Rabbits

Oral

Spain

| Novartis Sanidad Animal, S.L. |
| --- |
| c/De la Marina, 206 |
| 08013 Barcelona |
| SPAIN |

Novartis Sanidad Animal, S.L.

c/De la Marina, 206

08013 Barcelona

SPAIN

Denagard 20 g/kg Premezcla medicamentosa

Premix

20 g/kg

Pigs

Rabbits

Oral

Spain

| Novartis Sanidad Animal, S.L. |
| --- |
| c/De la Marina, 206 |
| 08013 Barcelona |
| SPAIN |

Novartis Sanidad Animal, S.L.

c/De la Marina, 206

08013 Barcelona

SPAIN

Dynamutilin 10 %

Premix

100 g/kg

Pigs

Chickens

Turkeys

Oral

Sweden

| Novartis Healthcare A/S |
| --- |
| Animal Health |
| Lyngbyvej 172 |
| DK-2100 Köpenhamn Ö |
| DENMARK |

Novartis Healthcare A/S

Animal Health

Lyngbyvej 172

DK-2100 Köpenhamn Ö

DENMARK

Denagard vet.

Premix

20 mg/g

Pigs

Oral

The Netherlands

| Novartis Consumer health |
| --- |
| Claudius Prinsenlaan 142 |
| 4818 CP Breda |
| The NETHERLANDS |

Novartis Consumer health

Claudius Prinsenlaan 142

4818 CP Breda

The NETHERLANDS

Tiamutin 10 %

Premix

100 g/kg

Pigs

Oral

The Netherlands

| Novartis Consumer health |
| --- |
| Claudius Prinsenlaan 142 |
| 4818 CP Breda |
| The NETHERLANDS |

Novartis Consumer health

Claudius Prinsenlaan 142

4818 CP Breda

The NETHERLANDS

Denagard 2 %

Premix

20 g/kg

Pigs

Oral

United Kingdom

| Novartis Animal Health UK Ltd |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey |
| GU16 7SR |
| United Kingdom |

Novartis Animal Health UK Ltd

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

United Kingdom

Denagard 2 % w/w

Premix

2 mg/g

Pigs

Oral

United Kingdom

| Novartis Animal Health UK Ltd |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey |
| GU16 7SR |
| United Kingdom |

Novartis Animal Health UK Ltd

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

United Kingdom

Denagard 80 % w/w

Premix

80 mg/g

Pigs

Oral

United Kingdom

| Novartis Animal Health UK Ltd |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey |
| GU16 7SR |
| United Kingdom |

Novartis Animal Health UK Ltd

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

United Kingdom

Denagard 10 % w/w

Premix

100 mg/g

Pigs

Oral

---

ANNEX XIV

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT/MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES

| Member State EU/EEA | Marketing Authorisation Holder | Applicant | (Invented) Name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Belgium | | IDL, 36 avenue Hoche, |
| 75008 Paris. FRANCE |

Member State EU/EEA

Marketing Authorisation Holder

Applicant

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

Belgium

IDL, 36 avenue Hoche,

75008 Paris. FRANCE

Ciclosporin IDL 25 mg

25 mg

capsule

oral use

Belgium

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANCE |

IDL, 36 avenue Hoche,

75008 Paris. FRANCE

Ciclosporin IDL 50 mg

50 mg

capsule

oral use

Belgium

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANCE |

IDL, 36 avenue Hoche,

75008 Paris. FRANCE

Ciclosporin IDL 100 mg

100 mg

capsule

oral use

Germany

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANCE |

IDL, 36 avenue Hoche,

75008 Paris. FRANCE

Ciclosporin IDL 25 mg

25 mg

capsule

oral use

Germany

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANCE |

IDL, 36 avenue Hoche,

75008 Paris. FRANCE

Ciclosporin IDL 50 mg

50 mg

capsule

oral use

Germany

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANCE |

IDL, 36 avenue Hoche,

75008 Paris. FRANCE

Ciclosporin IDL 100 mg

100 mg

capsule

oral use

Italy

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANCE |

IDL, 36 avenue Hoche,

75008 Paris. FRANCE

Ciclosporina IDL 25 mg

25 mg

capsule

oral use

Italy

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANCE |

IDL, 36 avenue Hoche,

75008 Paris. FRANCE

Ciclosporina IDL 50 mg

50 mg

capsule

oral use

Italy

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANCE |

IDL, 36 avenue Hoche,

75008 Paris. FRANCE

Ciclosporina IDL 100 mg

100 mg

capsule

oral use

Netherlands

| IDL, 36 avenue Hoche |
| --- |
| 75008 Paris. FRANCE |

IDL, 36 avenue Hoche

75008 Paris. FRANCE

Ciclosporin IDL 25 mg

25 mg

capsule, soft

oral use

Netherlands

| IDL, 36 avenue Hoche |
| --- |
| 75008 Paris. FRANCE |

IDL, 36 avenue Hoche

75008 Paris. FRANCE

Ciclosporin IDL 50 mg

50 mg

capsule, soft

oral use

Netherlands

| IDL, 36 avenue Hoche |
| --- |
| 75008 Paris. FRANCE |

IDL, 36 avenue Hoche

75008 Paris. FRANCE

Ciclosporin IDL 100 mg

100 mg

capsule, soft

oral use

Spain

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANCE |

IDL, 36 avenue Hoche,

75008 Paris. FRANCE

Ciclosporina IDL 25 mg

25 mg

capsule

oral use

Spain

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANCE |

IDL, 36 avenue Hoche,

75008 Paris. FRANCE

Ciclosporina IDL 50 mg

50 mg

capsule

oral use

Spain

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANCE |

IDL, 36 avenue Hoche,

75008 Paris. FRANCE

Ciclosporina IDL 100 mg

100 mg

capsule

oral use

Sweden

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANCE |

IDL, 36 avenue Hoche,

75008 Paris. FRANCE

Ciklosporin IDL 25 mg

25 mg

capsule

oral use

Sweden

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANCE |

IDL, 36 avenue Hoche,

75008 Paris. FRANCE

Ciklosporin IDL 50 mg

50 mg

capsule

oral use

Sweden

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANCE |

IDL, 36 avenue Hoche,

75008 Paris. FRANCE

Ciklosporin IDL 100 mg

100 mg

capsule

oral use

United Kingdom

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANCE |

IDL, 36 avenue Hoche,

75008 Paris. FRANCE

Ciclosporin IDL 25 mg

25 mg

capsule

oral use

United Kingdom

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANCE |

IDL, 36 avenue Hoche,

75008 Paris. FRANCE

Ciclosporin IDL 50 mg

50 mg

capsule

oral use

United Kingdom

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANCE |

IDL, 36 avenue Hoche,

75008 Paris. FRANCE

Ciclosporin IDL 100 mg

100 mg

capsule

oral use

---

ANNEX XV

LIST OF THE INVENTED NAME, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES (EU/EEA)

| Member State EU/EEA | Marketing Authorisation Holder | Invented Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Abbott GmbH |
| Perfektastraße 84A |
| A-1230 Wien |
| Austria |

Member State EU/EEA

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical form

Route of administration

Austria

Abbott GmbH

Perfektastraße 84A

A-1230 Wien

Austria

Reductil 10 mg - Hartkapseln

10 mg

Capsule, hard

oral use

Austria

| Abott GmbH |
| --- |
| Perfektastraße 84A |
| A-1230 Wien |
| Austria |

Abott GmbH

Perfektastraße 84A

A-1230 Wien

Austria

Reductil 15 mg - Hartkapseln

15 mg

Capsule, hard

oral use

Austria

| Teva Pharma B.V. |
| --- |
| Computerweg 10 |
| 3542 DR Utrecht |
| The Netherlands |

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

The Netherlands

Sibutramin Teva 10 mg Kapseln

10 mg

Capsule, hard

oral use

Austria

| Teva Pharma B.V. |
| --- |
| Computerweg 10 |
| 3542 DR Utrecht |
| The Netherlands |

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

The Netherlands

Sibutramin Teva 15 mg Kapseln

15 mg

Capsule, hard

oral use

Belgium

| Abbott SA |
| --- |
| rue du Bosquet 2 |
| 1348 Ottignies/LLN |
| Belgium |

Abbott SA

rue du Bosquet 2

1348 Ottignies/LLN

Belgium

Reductil 10 mg

10 mg

Capsule, hard

oral use

Belgium

| Abbott SA |
| --- |
| rue du Bosquet 2 |
| 1348 Ottignies/LLN |
| Belgium |

Abbott SA

rue du Bosquet 2

1348 Ottignies/LLN

Belgium

Reductil 15 mg

15 mg

Capsule, hard

oral use

Belgium

| Sandoz NV |
| --- |
| Telecom Gardens |
| Medialaan 40 |
| 1800 Vilvoorde |
| Belgium |

Sandoz NV

Telecom Gardens

Medialaan 40

1800 Vilvoorde

Belgium

Sibutramin Sandoz 10 mg

10 mg

Capsule, hard

oral use

Belgium

| Sandoz NV |
| --- |
| Telecom Gardens |
| Medialaan 40 |
| 1800 Vilvoorde |
| Belgium |

Sandoz NV

Telecom Gardens

Medialaan 40

1800 Vilvoorde

Belgium

Sibutramin Sandoz 15 mg

15 mg

Capsule, hard

oral use

Belgium

| Teva pharma belgium |
| --- |
| Laarstraat 16 |
| 2610 Wilrijk |
| Belgium |

Teva pharma belgium

Laarstraat 16

2610 Wilrijk

Belgium

Sibutramin Teva 10 mg

10 mg

Capsule, hard

oral use

Belgium

| Teva pharma belgium |
| --- |
| Laarstraat 16 |
| 2610 Wilrijk |
| Belgium |

Teva pharma belgium

Laarstraat 16

2610 Wilrijk

Belgium

Sibutramin Teva 15 mg

15 mg

Capsule, hard

oral use

Bulgaria

| Abbott GmbH & Co KG |
| --- |
| Max-Planck-Ring 2 |
| 65205 Wiesbaden |
| Germany |

Abbott GmbH & Co KG

Max-Planck-Ring 2

65205 Wiesbaden

Germany

Reductil

10 mg

Capsule, hard

oral use

Bulgaria

| Abbott GmbH & Co KG |
| --- |
| Max-Planck-Ring 2 |
| 65205 Wiesbaden |
| Germany |

Abbott GmbH & Co KG

Max-Planck-Ring 2

65205 Wiesbaden

Germany

Reductil

15 mg

Capsule, hard

oral use

Bulgaria

| Sandoz d.d., |
| --- |
| Verovskova 57 |
| SI - 1000 Ljubljana |
| Slovenia |

Sandoz d.d.,

Verovskova 57

SI - 1000 Ljubljana

Slovenia

Sibutramin Sandoz

10 mg

Capsule, hard

oral use

Bulgaria

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| SI - 1000 Ljubljana |
| Slovenia |

Sandoz d.d.

Verovskova 57

SI - 1000 Ljubljana

Slovenia

Sibutramin Sandoz

15 mg

Capsule, hard

oral use

Bulgaria

| Zentiva k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Lindaxa

10 mg

Capsule, hard

oral use

Bulgaria

| Zentiva k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Lindaxa

15 mg

Capsule, hard

oral use

Bulgaria

| Teva Pharmaceuticals Bulgaria EOOD |
| --- |
| 15 N.V. Gogol str. |
| Sredetz district |
| 1124 Sofia |
| Bulgaria |

Teva Pharmaceuticals Bulgaria EOOD

15 N.V. Gogol str.

Sredetz district

1124 Sofia

Bulgaria

Meissa

10 mg

Capsule, hard

oral use

Bulgaria

| Teva Pharmaceuticals Bulgaria EOOD |
| --- |
| 15 N.V. Gogol str. |
| Sredetz district |
| 1124 Sofia |
| Bulgaria |

Teva Pharmaceuticals Bulgaria EOOD

15 N.V. Gogol str.

Sredetz district

1124 Sofia

Bulgaria

Meissa

15 mg

Capsule, hard

oral use

Czech Republic

| Abbott GmbH &Co.KG |
| --- |
| Max-Planck-Ring-2 |
| 65202 Wiesbaden |
| Germany |

Abbott GmbH &Co.KG

Max-Planck-Ring-2

65202 Wiesbaden

Germany

MERIDIA 10 MG

10 mg

Capsule, hard

oral use

Czech Republic

| Abbott GmbH &Co.KG |
| --- |
| Max-Planck-Ring-2 |
| 65202 Wiesbaden |
| Germany |

Abbott GmbH &Co.KG

Max-Planck-Ring-2

65202 Wiesbaden

Germany

MERIDIA 15 MG

15 mg

Capsule, hard

oral use

Czech Republic

| Zentiva, k.s. |
| --- |
| U kabelovny 130, 102 37 |
| Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130, 102 37

Prague 10

Czech Republic

LINDAXA 10

10 mg

Capsule, hard

oral use

Czech Republic

| Zentiva, k.s. |
| --- |
| U kabelovny 130, 102 37 |
| Prague 10 |
| Czech Republic |

Zentiva, k.s.

U kabelovny 130, 102 37

Prague 10

Czech Republic

LINDAXA 15

15 mg

Capsule, hard

oral use

Czech Republic

| TEVA Pharmaceuticals ČR, s.r.o. |
| --- |
| Radlická 3185/Ic |
| 150 00 Prague 5 |
| Czech Republic |

TEVA Pharmaceuticals ČR, s.r.o.

Radlická 3185/Ic

150 00 Prague 5

Czech Republic

SIBUTRAMIN-TEVA 10 MG TOBOLKY

10 mg

Capsule, hard

oral use

Czech Republic

| TEVA Pharmaceuticals ČR, s.r.o. |
| --- |
| Radlická 3185/Ic |
| 150 00 Prague 5 |
| Czech Republic |

TEVA Pharmaceuticals ČR, s.r.o.

Radlická 3185/Ic

150 00 Prague 5

Czech Republic

SIBUTRAMIN-TEVA 15 MG TOBOLKY

15 mg

Capsule, hard

oral use

Denmark

| Abbott Scandinavia AB |
| --- |
| Postboks 509 |
| SE-169 29, Solna |
| Sweden |

Abbott Scandinavia AB

Postboks 509

SE-169 29, Solna

Sweden

Reductil

10 mg

Capsule, hard

oral use

Denmark

| Abbott Scandinavia AB |
| --- |
| Postboks 509 |
| SE-169 29, Solna |
| Sweden |

Abbott Scandinavia AB

Postboks 509

SE-169 29, Solna

Sweden

Reductil

15 mg

Capsule, hard

oral use

Denmark

| 1A Farma A/S |
| --- |
| Herstedøstervej 27-29 |
| DK-2620 Albertslund |
| Denmark |

1A Farma A/S

Herstedøstervej 27-29

DK-2620 Albertslund

Denmark

Sibutramin ‘1A Farma’

10 mg

Capsule, hard

oral use

Denmark

| 1A Farma A/S |
| --- |
| Herstedøstervej 27-29 |
| DK-2620 Albertslund |
| Denmark |

1A Farma A/S

Herstedøstervej 27-29

DK-2620 Albertslund

Denmark

Sibutramin ‘1A Farma’

15 mg

Capsule, hard

oral use

Denmark

| Sandoz A/S |
| --- |
| C. F. Tietgens Boulevard 40 |
| DK-5220 Odense SØ |
| Denmark |

Sandoz A/S

C. F. Tietgens Boulevard 40

DK-5220 Odense SØ

Denmark

Sibutramin ‘Sandoz’

10 mg

Capsule, hard

oral use

Denmark

| Sandoz A/S |
| --- |
| C. F. Tietgens Boulevard 40 |
| DK-5220 Odense SØ |
| Denmark |

Sandoz A/S

C. F. Tietgens Boulevard 40

DK-5220 Odense SØ

Denmark

Sibutramin ‘Sandoz’

15 mg

Capsule, hard

oral use

Denmark

| Teva Danmark A/S |
| --- |
| Østergade 38 |
| DK-1100 København K |
| Denmark |

Teva Danmark A/S

Østergade 38

DK-1100 København K

Denmark

Sibutramin ‘Teva’

10 mg

Capsule, hard

oral use

Denmark

| Teva Danmark A/S |
| --- |
| Østergade 38 |
| DK-1100 København K |
| Denmark |

Teva Danmark A/S

Østergade 38

DK-1100 København K

Denmark

Sibutramin ‘Teva’

15 mg

Capsule, hard

oral use

Estonia

| Abbott GmbH & Co. KG |
| --- |
| Max-Planck-Ring 2 |
| 65205 Wiesbaden |
| Germany |

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Germany

REDUCTIL

10 mg

Capsule, hard

oral use

Estonia

| Abbott GmbH & Co. KG |
| --- |
| Max-Planck-Ring 2 |
| 65205 Wiesbaden |
| Germany |

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Germany

REDUCTIL

15 mg

Capsule, hard

oral use

Estonia

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| 1000 Ljubljana |
| Slovenia |

Sandoz d.d.

Verovskova 57

1000 Ljubljana

Slovenia

SIBUTRIL

10 mg

Capsule, hard

oral use

Estonia

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| 1000 Ljubljana |
| Slovenia |

Sandoz d.d.

Verovskova 57

1000 Ljubljana

Slovenia

SIBUTRIL

15 mg

Capsule, hard

oral use

Estonia

| Zentiva, k.s. |
| --- |
| U Kabelovny 130 |
| Dolni Mecholupy |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U Kabelovny 130

Dolni Mecholupy

102 37 Prague 10

Czech Republic

LINDAXA 10

10 mg

Capsule, hard

oral use

Estonia

| Zentiva, k.s. |
| --- |
| U Kabelovny 130 |
| Dolni Mecholupy |
| 102 37 Prague 10 |
| Czech Republic |

Zentiva, k.s.

U Kabelovny 130

Dolni Mecholupy

102 37 Prague 10

Czech Republic

LINDAXA 15

15 mg

Capsule, hard

oral use

Estonia

| Teva Pharma B.V. |
| --- |
| Computerweg 10 |
| 3542 DR Utrecht |
| The Netherlands |

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

The Netherlands

SIBUTRAMINE TEVA

10 mg

Capsule, hard

oral use

Estonia

| Teva Pharma B.V. |
| --- |
| Computerweg 10 |
| 3542 DR Utrecht |
| The Netherlands |

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

The Netherlands

SIBUTRAMINE TEVA

15 mg

Capsule, hard

oral use

Finland

| Abbott Scandinavia AB |
| --- |
| P.O. Box 509 |
| 16929 Solna |
| Sweden |

Abbott Scandinavia AB

P.O. Box 509

16929 Solna

Sweden

Reductil

10 mg, 15 mg

Capsule, hard

oral use

Finland

| Sandoz A/S C.F. |
| --- |
| Tietgens Boulevard 40 |
| 5220 Odense SØ |
| Denmark |

Sandoz A/S C.F.

Tietgens Boulevard 40

5220 Odense SØ

Denmark

Sibutramin Sandoz

10 mg, 15 mg

Capsule, hard

oral use

Finland

| Teva Sweden AB |
| --- |
| Järnvägsgatan 11 |
| Box 1070 |
| 25110 Helsingborg |
| Sweden |

Teva Sweden AB

Järnvägsgatan 11

Box 1070

25110 Helsingborg

Sweden

Sibutramine Teva

10 mg, 15 mg

Capsule, hard

oral use

France

| ABBOT France |
| --- |
| 10, RUE D'ARCUEIL |
| SILIC 233 |
| 94528 RUNGIS CEDEX |
| FRANCE |

ABBOT France

10, RUE D'ARCUEIL

SILIC 233

94528 RUNGIS CEDEX

FRANCE

SIBUTRAL 10 mg, gélule

10 mg

capsule

oral use

France

| ABBOT France |
| --- |
| 10, RUE D'ARCUEIL |
| SILIC 233 |
| 94528 RUNGIS CEDEX |
| FRANCE |

ABBOT France

10, RUE D'ARCUEIL

SILIC 233

94528 RUNGIS CEDEX

FRANCE

SIBUTRAL 15 mg, gélule

15 mg

capsule

oral use

Germany

| Abbott GmbH & Co. KG |
| --- |
| Max-Planck-Ring 2 |
| 65205 Wiesbaden |
| Germany |

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Germany

Reductil 10 mg Hartkapseln

10 mg

Capsule, hard

oral use

Germany

| Abbott GmbH & Co. KG |
| --- |
| Max-Planck-Ring 2 |
| 65205 Wiesbaden |
| Germany |

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Germany

Reductil 15 mg Hartkapseln

15 mg

Capsule, hard

oral use

Germany

| Abbott GmbH & Co. KG |
| --- |
| Max-Planck-Ring 2 |
| 65205 Wiesbaden |
| Germany |

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Germany

Zelium 10 mg Hartkapseln

10 mg

Capsule, hard

oral use

Germany

| Abbott GmbH & Co. KG |
| --- |
| Max-Planck-Ring 2 |
| 65205 Wiesbaden |
| Germany |

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Germany

Zelium 15 mg Hartkapseln

15 mg

Capsule, hard

oral use

Germany

| Abbott GmbH & Co. KG |
| --- |
| Max-Planck-Ring 2 |
| 65205 Wiesbaden |
| Germany |

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Germany

Reduxade 10 mg Hartkapseln

10 mg

Capsule, hard

oral use

Germany

| Abbott GmbH & Co. KG |
| --- |
| Max-Planck-Ring 2 |
| 65205 Wiesbaden |
| Germany |

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Germany

Reduxade 15 mg Hartkapseln

15 mg

Capsule, hard

oral use

Germany

| 1 A Pharma GmbH |
| --- |
| Keltenring 1 + 3 |
| 82041 Oberhaching |
| Germany |

1 A Pharma GmbH

Keltenring 1 + 3

82041 Oberhaching

Germany

Sibutramin - 1A Pharma 10 mg Hartkapseln

10 mg

Capsule, hard

oral use

Germany

| 1 A Pharma GmbH |
| --- |
| Keltenring 1 + 3 |
| 82041 Oberhaching |
| Germany |

1 A Pharma GmbH

Keltenring 1 + 3

82041 Oberhaching

Germany

Sibutramin - 1A Pharma 15 mg Hartkapseln

15 mg

Capsule, hard

oral use

Germany

| HEXAL AG |
| --- |
| Postfach 1263 |
| 83602 Holzkirchen |
| Germany |

HEXAL AG

Postfach 1263

83602 Holzkirchen

Germany

Sibutramin-HEXAL 10 mg Hartkapseln

10 mg

Capsule, hard

oral use

Germany

| HEXAL AG |
| --- |
| Postfach 1263 |
| 83602 Holzkirchen |
| Germany |

HEXAL AG

Postfach 1263

83602 Holzkirchen

Germany

Sibutramin-HEXAL 15 mg Hartkapseln

15 mg

Capsule, hard

oral use

Greece

| Abbott Laboratories (Hellas) S.A. |
| --- |
| 512, Vouliagmenis Avenue |
| GR 17456, Alimos |
| Athens |
| Greece |

Abbott Laboratories (Hellas) S.A.

512, Vouliagmenis Avenue

GR 17456, Alimos

Athens

Greece

Reductil

10 mg

Capsule, hard

oral use

Greece

| Abbott Laboratories (Hellas) S.A. |
| --- |
| 512, Vouliagmenis Avenue |
| GR 17456, Alimos |
| Athens |
| Greece |

Abbott Laboratories (Hellas) S.A.

512, Vouliagmenis Avenue

GR 17456, Alimos

Athens

Greece

Reductil

15 mg

Capsule, hard

oral use

Greece

| Teva Pharmaceuticals Europe B.V. |
| --- |
| European Headquarters |
| Computerweg 10 |
| 3542 DR Utrecht |
| The Netherlands |

Teva Pharmaceuticals Europe B.V.

European Headquarters

Computerweg 10

3542 DR Utrecht

The Netherlands

Sibutramine/Teva

10 mg

Capsule, hard

oral use

Greece

| Teva Pharmaceuticals Europe B.V. |
| --- |
| European Headquarters |
| Computerweg 10 |
| 3542 DR Utrecht |
| The Netherlands |

Teva Pharmaceuticals Europe B.V.

European Headquarters

Computerweg 10

3542 DR Utrecht

The Netherlands

Sibutramine/Teva

15 mg

Capsule, hard

oral use

Hungary

| Zentiva k. s. |
| --- |
| U Kabelovny 130 |
| 102 37 Praha 10 |
| Czech Republic |

Zentiva k. s.

U Kabelovny 130

102 37 Praha 10

Czech Republic

LINDAXA

10 mg

Capsule, hard

oral use

Hungary

| Zentiva k. s. |
| --- |
| U Kabelovny 130 |
| 102 37 Praha 10 |
| Czech Republic |

Zentiva k. s.

U Kabelovny 130

102 37 Praha 10

Czech Republic

LINDAXA

15 mg

Capsule, hard

oral use

Hungary

| Teva Magyarország zrt. |
| --- |
| Rákóczi út 70-72. |
| 1074 Budapest |
| Hungary |

Teva Magyarország zrt.

Rákóczi út 70-72.

1074 Budapest

Hungary

MINIMECTIL

10 mg

Capsule, hard

oral use

Hungary

| Teva Magyarország zrt. |
| --- |
| Rákóczi út 70-72. |
| 1074 Budapest |
| Hungary |

Teva Magyarország zrt.

Rákóczi út 70-72.

1074 Budapest

Hungary

MINIMECTIL

15 mg

Capsule, hard

oral use

Hungary

| Abbott Laboratories Kft. |
| --- |
| Teve u. 1/a-c |
| 1139 Budapest |
| Hungary |

Abbott Laboratories Kft.

Teve u. 1/a-c

1139 Budapest

Hungary

REDUCTIL

10 mg

Capsule, hard

oral use

Hungary

| Abbott Laboratories Kft. |
| --- |
| Teve u. 1/a-c |
| 1139 Budapest |
| Hungary |

Abbott Laboratories Kft.

Teve u. 1/a-c

1139 Budapest

Hungary

REDUCTIL

15 mg

Capsule, hard

oral use

Iceland

| Abbott Scandinavia |
| --- |
| Gårdsvägen 8 |
| Box 5091 |
| SE-169 29 Solna |
| Sweden |

Abbott Scandinavia

Gårdsvägen 8

Box 5091

SE-169 29 Solna

Sweden

Reductil

10 mg

Capsule, hard

oral use

Iceland

| Abbott Scandinavia |
| --- |
| Gårdsvägen 8 |
| Box 5091 |
| SE-169 29 Solna |
| Sweden |

Abbott Scandinavia

Gårdsvägen 8

Box 5091

SE-169 29 Solna

Sweden

Reductil

15 mg

Capsule, hard

oral use

Ireland

| Teva Pharma B.V. |
| --- |
| Computerweg 10 |
| 3542 Dr Utrecht |
| Netherlands |

Teva Pharma B.V.

Computerweg 10

3542 Dr Utrecht

Netherlands

Sibutramine Teva 10 mg Capsules

10 mg

Capsule, hard

oral use

Ireland

| Teva Pharma B.V. |
| --- |
| Computerweg 10 |
| 3542 Dr Utrecht |
| Netherlands |

Teva Pharma B.V.

Computerweg 10

3542 Dr Utrecht

Netherlands

Sibutramine Teva 15 mg Capsules

15 mg

Capsule, hard

oral use

Ireland

| Abbot Laboratories Ireland Ltd |
| --- |
| 4051 Kingswood Drive |
| Citywest Business Campus |
| Dublin 24 |
| Ireland |

Abbot Laboratories Ireland Ltd

4051 Kingswood Drive

Citywest Business Campus

Dublin 24

Ireland

Reductil 10 mg capsules, hard

10 mg

Capsule, hard

oral use

Ireland

| Abbot Laboratories Ireland Ltd |
| --- |
| 4051 Kingswood Drive |
| Citywest Business Campus |
| Dublin 24 |
| Ireland |

Abbot Laboratories Ireland Ltd

4051 Kingswood Drive

Citywest Business Campus

Dublin 24

Ireland

Reductil 15 mg capsules, hard

15 mg

Capsule, hard

oral use

Ireland

| Rowex Ltd |
| --- |
| Bantry |
| Co.Cork |
| Ireland |

Rowex Ltd

Bantry

Co.Cork

Ireland

Sitrane 10 mg hard capsules

10 mg

Capsule, hard

oral use

Ireland

| Rowex Ltd |
| --- |
| Bantry |
| Co.Cork |
| Ireland |

Rowex Ltd

Bantry

Co.Cork

Ireland

Sitrane 15 mg hard capsules

15 mg

Capsule, hard

oral use

Italy

| ABBOTT srl |
| --- |
| Via Pontina Km 52 |
| 04010 Campoverde di Aprilia |
| Italy |

ABBOTT srl

Via Pontina Km 52

04010 Campoverde di Aprilia

Italy

REDUXATE

10 mg

capsule

oral use

Italy

| ABBOTT srl |
| --- |
| Via Pontina Km 52 |
| 04010 Campoverde di Aprilia |
| Italy |

ABBOTT srl

Via Pontina Km 52

04010 Campoverde di Aprilia

Italy

REDUXATE

15 mg

capsule

oral use

Italy

| ABBOTT srl |
| --- |
| Via Pontina Km 52 |
| 04010 Campoverde di Aprilia |
| Italy |

ABBOTT srl

Via Pontina Km 52

04010 Campoverde di Aprilia

Italy

ECTIVA

10 mg

capsule

oral use

Italy

| ABBOTT srl |
| --- |
| Via Pontina Km 52 |
| 04010 Campoverde di Aprilia |
| Italy |

ABBOTT srl

Via Pontina Km 52

04010 Campoverde di Aprilia

Italy

ECTIVA

15 mg

capsule

oral use

Italy

| ABBOTT srl |
| --- |
| Via Pontina Km 52 |
| 04010 Campoverde di Aprilia |
| Italy |

ABBOTT srl

Via Pontina Km 52

04010 Campoverde di Aprilia

Italy

REDUCTIL

10 mg

capsule

oral use

Italy

| ABBOTT srl |
| --- |
| Via Pontina Km 52 |
| 04010 Campoverde di Aprilia |
| Italy |

ABBOTT srl

Via Pontina Km 52

04010 Campoverde di Aprilia

Italy

REDUCTIL

15 mg

capsule

oral use

Latvia

| Abbott GmbH & Co. KG |
| --- |
| Max-Planck-Ring 2 |
| 65205 Wiesbaden |
| Germany |

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Germany

Reductil 15 mg hard capsules

15 mg

Capsule, hard

oral use

Latvia

| Abbott GmbH & Co. KG |
| --- |
| Max-Planck-Ring 2 |
| 65205 Wiesbaden |
| Germany |

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Germany

Reductil 10 mg hard capsules

10 mg

Capsule, hard

oral use

Latvia

| Sandoz d.d. |
| --- |
| Verovškova 57 |
| 1000 Ljubljana |
| Slovenia |

Sandoz d.d.

Verovškova 57

1000 Ljubljana

Slovenia

Sibutril 15 mg capsules, hard

15 mg

Capsule, hard

oral

Latvia

| Sandoz d.d. |
| --- |
| Verovškova 57 |
| 1000 Ljubljana |
| Slovenia |

Sandoz d.d.

Verovškova 57

1000 Ljubljana

Slovenia

Sibutril 10 mg capsules, hard

10 mg

Capsule, hard

oral

Lithuania

| Abbott GmbH & Co. KG |
| --- |
| Max-Planck-Ring 2 |
| 65205 Wiesbaden |
| Germany |

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Germany

Reductil

10 mg

Capsule, hard

oral use

Lithuania

| Abbott GmbH & Co. KG |
| --- |
| Max-Planck-Ring 2 |
| 65205 Wiesbaden |
| Germany |

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Germany

Reductil

15 mg

Capsule, hard

oral use

Lithuania

| Zentiva k. s. |
| --- |
| U kabelovny 130 |
| 10237 Prague 10 Dolni Mecholupy Czech Republic |

Zentiva k. s.

U kabelovny 130

10237 Prague 10 Dolni Mecholupy Czech Republic

Lindaxa

10 mg

Capsule, hard

oral use

Lithuania

| Zentiva k. s. |
| --- |
| U kabelovny 130 |
| 10237 Prague 10 Dolni Mecholupy Czech Republic |

Zentiva k. s.

U kabelovny 130

10237 Prague 10 Dolni Mecholupy Czech Republic

Lindaxa

15 mg

Capsule, hard

oral use

Lithuania

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| 1000 Ljubljana |
| Slovenia |

Sandoz d.d.

Verovskova 57

1000 Ljubljana

Slovenia

Sibutril

10 mg

Capsule, hard

oral use

Lithuania

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| 1000 Ljubljana |
| Slovenia |

Sandoz d.d.

Verovskova 57

1000 Ljubljana

Slovenia

Sibutril

15 mg

Capsule, hard

oral use

Lithuania

| Teva Pharma B.V. |
| --- |
| Computerweg 10 |
| 3542 DR Utrecht |
| The Netherlands |

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

The Netherlands

Sibutramine Teva

10 mg

Capsule, hard

oral use

Lithuania

| Teva Pharma B.V. |
| --- |
| Computerweg 10 |
| 3542 DR Utrecht |
| The Netherlands |

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

The Netherlands

Sibutramine Teva

15 mg

Capsule, hard

oral use

Luxembourg

| Abbott Laboratoires |
| --- |
| 2, rue du Bosquet |
| B- 1348 Ottignies L.L.N. |
| Belgium |

Abbott Laboratoires

2, rue du Bosquet

B- 1348 Ottignies L.L.N.

Belgium

Reductil

10 mg

capsule

oral use

Luxembourg

| Abbott Laboratoires |
| --- |
| 2, rue du Bosquet |
| B- 1348 Ottignies L.L.N. |
| Belgium |

Abbott Laboratoires

2, rue du Bosquet

B- 1348 Ottignies L.L.N.

Belgium

Reductil

15 mg

capsules

oral use

Malta

| Abbott Laboratories Limited Queenborough |
| --- |
| Kent |
| ME11 5EL |
| United Kingdom |

Abbott Laboratories Limited Queenborough

Kent

ME11 5EL

United Kingdom

Reductil

10 mg

Capsule, hard

oral use

Malta

| Abbott Laboratories Limited Queenborough |
| --- |
| Kent |
| ME11 5EL |
| United Kingdom |

Abbott Laboratories Limited Queenborough

Kent

ME11 5EL

United Kingdom

Reductil

15 mg

Capsule, hard

oral use

Netherlands

| Abbott B.V. |
| --- |
| Siriusdreef 51 |
| 2132 WT, Hoofddorp |
| Netherlands |

Abbott B.V.

Siriusdreef 51

2132 WT, Hoofddorp

Netherlands

Reductil 10 mg, capsules, hard

10 mg

Capsule, hard

oral use

Netherlands

| Abbott B.V. |
| --- |
| Siriusdreef 51 |
| 2132 WT, Hoofddorp |
| Netherlands |

Abbott B.V.

Siriusdreef 51

2132 WT, Hoofddorp

Netherlands

Reductil 15 mg, capsules, hard

15 mg

Capsule, hard

oral use

Netherlands

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH, Almere |
| Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH, Almere

Netherlands

Sibutramine HCL monohydraat Sandoz 10 mg, harde capsules

10 mg

Capsule, hard

oral use

Netherlands

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH, Almere |
| Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH, Almere

Netherlands

Sibutramine HCL monohydraat Sandoz 15 mg, harde capsules

15 mg

Capsule, hard

oral use

Netherlands

| Medcor Pharmaceuticals B.V. Ketelmeerstraat 142-144 |
| --- |
| 8226 JX, Lelystad |
| Netherlands |

Medcor Pharmaceuticals B.V. Ketelmeerstraat 142-144

8226 JX, Lelystad

Netherlands

Reductil 15 mg, capsules

15 mg

Capsule, hard

oral use

Netherlands

| Medcor Pharmaceuticals B.V. Ketelmeerstraat 142-144 |
| --- |
| 8226 JX, Lelystad |
| Netherlands |

Medcor Pharmaceuticals B.V. Ketelmeerstraat 142-144

8226 JX, Lelystad

Netherlands

Reductil 10 mg, capsules

10 mg

Capsule, hard

oral use

Netherlands

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| 2031 GA, Haarlem |
| Netherlands |

Pharmachemie B.V.

Swensweg 5

2031 GA, Haarlem

Netherlands

Sibutramine HCL- monohydraat 10 mg PCH, capsules

10 mg

Capsule, hard

oral use

Netherlands

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| 2031 GA, Haarlem |
| Netherlands |

Pharmachemie B.V.

Swensweg 5

2031 GA, Haarlem

Netherlands

Sibutramine HCL- monohydraat 15 mg PCH, capsules

15 mg

Capsule, hard

oral use

Norway

| Abbot Scandinavia |
| --- |
| AB Box 509 |
| 169 29 Solna |
| Sweden |

Abbot Scandinavia

AB Box 509

169 29 Solna

Sweden

REDUCTIL

10 mg

Capsule, hard

oral use

Norway

| Abbot Scandinavia |
| --- |
| AB Box 509 |
| 169 29 Solna |
| Sweden |

Abbot Scandinavia

AB Box 509

169 29 Solna

Sweden

REDUCTIL

15 mg

Capsule, hard

oral use

Norway

| Euromedica Norge AS |
| --- |
| Jerikoveien 28 C |
| 1067 Oslo |
| Norway |

Euromedica Norge AS

Jerikoveien 28 C

1067 Oslo

Norway

REDUCTIL

10 mg

Capsule, hard

oral use

Norway

| Euromedica Norge AS |
| --- |
| Jerikoveien 28 C |
| 1067 Oslo |
| Norway |

Euromedica Norge AS

Jerikoveien 28 C

1067 Oslo

Norway

REDUCTIL

15 mg

Capsule, hard

oral use

Norway

| Sandoz A/ |
| --- |
| Edvard Thomsens Vej 14 |
| 2300 København S |
| Danmark |

Sandoz A/

Edvard Thomsens Vej 14

2300 København S

Danmark

SIBUTRAMIN SANDOZ

10 mg

Capsule, hard

oral use

Norway

| Sandoz A/ |
| --- |
| Edvard Thomsens Vej 14 |
| 2300 København S |
| Danmark |

Sandoz A/

Edvard Thomsens Vej 14

2300 København S

Danmark

SIBUTRAMIN SANDOZ

15 mg

Capsule, hard

oral use

Poland

| Teva Pharmaceuticals Polska Sp. z o.o. |
| --- |
| 53 Emilii Plater St. |
| 00-113 Warsaw |
| Poland |

Teva Pharmaceuticals Polska Sp. z o.o.

53 Emilii Plater St.

00-113 Warsaw

Poland

Afibron

10 mg

Capsule, hard

oral use

Poland

| Teva Pharmaceuticals Polska Sp. z o.o. |
| --- |
| 53 Emilii Plater St. |
| 00-113 Warsaw |
| Poland |

Teva Pharmaceuticals Polska Sp. z o.o.

53 Emilii Plater St.

00-113 Warsaw

Poland

Afibron

15 mg

Capsule, hard

oral use

Poland

| Zentiva a.s. |
| --- |
| U Kabelovny 130 |
| Dolni Mecholupy |
| 102 37 Praha 10 |
| Czech Republic |

Zentiva a.s.

U Kabelovny 130

Dolni Mecholupy

102 37 Praha 10

Czech Republic

Lindaxa 10

10 mg

Capsule, hard

oral use

Poland

| Zentiva a.s. |
| --- |
| U Kabelovny 130 |
| Dolni Mecholupy |
| 102 37 Praha 10 |
| Czech Republic |

Zentiva a.s.

U Kabelovny 130

Dolni Mecholupy

102 37 Praha 10

Czech Republic

Lindaxa 15

15 mg

Capsule, hard

oral use

Poland

| Abbott Laboratories Poland Sp. z o. o. |
| --- |
| ul. Postępu 18A |
| 02-676 Warsaw |
| Poland |

Abbott Laboratories Poland Sp. z o. o.

ul. Postępu 18A

02-676 Warsaw

Poland

Meridia 10

10 mg

Capsule, hard

oral use

Poland

| Abbott Laboratories Poland Sp. z o. o. |
| --- |
| ul. Postępu 18A |
| 02-676 Warsaw |
| Poland |

Abbott Laboratories Poland Sp. z o. o.

ul. Postępu 18A

02-676 Warsaw

Poland

Meridia 15

15 mg

Capsule, hard

oral use

Poland

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10 |
| A-6250 Kundl |
| Austria |

Sandoz GmbH

Biochemiestrasse 10

A-6250 Kundl

Austria

Obesan

10 mg

Capsule, hard

oral use

Poland

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10 |
| A-6250 Kundl |
| Austria |

Sandoz GmbH

Biochemiestrasse 10

A-6250 Kundl

Austria

Obesan

15 mg

Capsule, hard

oral use

Poland

| 1A Pharma GmbH |
| --- |
| Keltenring 1 + 3 |
| 82041 Oberhaching |

1A Pharma GmbH

Keltenring 1 + 3

82041 Oberhaching

Sibutramine-1A Pharma

10 mg

Capsule, hard

oral use

Poland

| 1A Pharma GmbH |
| --- |
| Keltenring 1 + 3 |
| 82041 Oberhaching |
| Germany |

1A Pharma GmbH

Keltenring 1 + 3

82041 Oberhaching

Germany

Sibutramine-1A Pharma

15 mg

Capsule, hard

oral use

Poland

| Biofarm Sp. z o.o. |
| --- |
| Wałbrzyska 13, 60-198 |
| Poznan |
| Poland |

Biofarm Sp. z o.o.

Wałbrzyska 13, 60-198

Poznan

Poland

Zelixa

10 mg

Film-coated tablet

oral use

Poland

| Biofarm Sp. z o.o. |
| --- |
| Wałbrzyska 13, 60-198 |
| Poznan |
| Poland |

Biofarm Sp. z o.o.

Wałbrzyska 13, 60-198

Poznan

Poland

Zelixa

15 mg

Film-coated tablet

oral use

Portugal

| ABBOTT LABORATORIOS, LDA |
| --- |
| Estrada Alfragide 67-AlfraparK-Edifício D, |
| 2610-008 AMADORA |
| Portugal |

ABBOTT LABORATORIOS, LDA

Estrada Alfragide 67-AlfraparK-Edifício D,

2610-008 AMADORA

Portugal

Zelium

10 mg

Capsule, hard

oral use

Portugal

| ABBOTT LABORATORIOS, LDA |
| --- |
| Estrada Alfragide 67-AlfraparK-Edifício D, |
| 2610-008 AMADORA |
| Portugal |

ABBOTT LABORATORIOS, LDA

Estrada Alfragide 67-AlfraparK-Edifício D,

2610-008 AMADORA

Portugal

Zelium

15 mg

Capsule, hard

oral use

Portugal

| ABBOTT LABORATORIOS, LDA |
| --- |
| Estrada Alfragide 67-AlfraparK-Edifício D, |
| 2610-008 AMADORA |
| Portugal |

ABBOTT LABORATORIOS, LDA

Estrada Alfragide 67-AlfraparK-Edifício D,

2610-008 AMADORA

Portugal

Reductil

10 mg

Capsule, hard

oral use

Portugal

| ABBOTT LABORATORIOS, LDA |
| --- |
| Estrada Alfragide 67-AlfraparK-Edifício D, |
| 2610-008 AMADORA |
| Portugal |

ABBOTT LABORATORIOS, LDA

Estrada Alfragide 67-AlfraparK-Edifício D,

2610-008 AMADORA

Portugal

Reductil

15 mg

Capsule, hard

oral use

Portugal

| Teva Pharma – |
| --- |
| Produtos Farmacêuticos, Lda. |
| Empreendimento Lagoas Park |
| Edifício 1 - 3 |
| 2740-264 Porto Salvo |
| Portugal |

Teva Pharma –

Produtos Farmacêuticos, Lda.

Empreendimento Lagoas Park

Edifício 1 - 3

2740-264 Porto Salvo

Portugal

Sibutramina Teva

10 mg

Capsule, hard

oral use

Portugal

| Teva Pharma – |
| --- |
| Produtos Farmacêuticos, Lda. |
| Empreendimento Lagoas Park |
| Edifício 1 - 3 |
| 2740-264 Porto Salvo |
| Portugal |

Teva Pharma –

Produtos Farmacêuticos, Lda.

Empreendimento Lagoas Park

Edifício 1 - 3

2740-264 Porto Salvo

Portugal

Sibutramina Teva

15 mg

Capsule, hard

oral use

Portugal

| Solufarma - Produtos Farmacêuticos Unipessoal, Lda. |
| --- |
| Rua do Tejo, 56 - 9o A Esq |
| 2775-325 Parede |
| Portugal |

Solufarma - Produtos Farmacêuticos Unipessoal, Lda.

Rua do Tejo, 56 - 9o A Esq

2775-325 Parede

Portugal

Sibutramina Sibulaite

10 mg

Capsule, hard

oral use

Portugal

| Solufarma - Produtos Farmacêuticos Unipessoal, Lda |
| --- |
| Rua do Tejo, 56 - 9o A Esq |
| 2775-325 Parede |
| Portugal |

Solufarma - Produtos Farmacêuticos Unipessoal, Lda

Rua do Tejo, 56 - 9o A Esq

2775-325 Parede

Portugal

Sibutramina Sibulaite

15 mg

Capsule, hard

oral use

Portugal

| Solufarma - Produtos Farmacêuticos Unipessoal, Lda |
| --- |
| Rua do Tejo, 56 - 9o A Esq |
| 2775-325 Parede |
| Portugal |

Solufarma - Produtos Farmacêuticos Unipessoal, Lda

Rua do Tejo, 56 - 9o A Esq

2775-325 Parede

Portugal

Sibutramina Solufarma

10 mg

Capsule, hard

oral use

Portugal

| Solufarma - Produtos Farmacêuticos Unipessoal, Lda |
| --- |
| Rua do Tejo, 56 - 9o A Esq |
| 2775-325 Parede |
| Portugal |

Solufarma - Produtos Farmacêuticos Unipessoal, Lda

Rua do Tejo, 56 - 9o A Esq

2775-325 Parede

Portugal

Sibutramina Solufarma

15 mg

Capsule, hard

oral use

Portugal

| Farmoz - Sociedade Técnico Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, 2 |
| Abrunheira |
| 2710-089 Sintra |
| Portugal |

Farmoz - Sociedade Técnico Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Farmoz

10 mg

Capsule, hard

oral use

Portugal

| Farmoz - Sociedade Técnico Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, 2 |
| Abrunheira |
| 2710-089 Sintra |
| Portugal |

Farmoz - Sociedade Técnico Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Farmoz

15 mg

Capsule, hard

oral use

Portugal

| Pentafarma - Sociedade Técnico-Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, no 2 -Abrunheira |
| 2710-089 Sintra |
| Portugal |

Pentafarma - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, no 2 -Abrunheira

2710-089 Sintra

Portugal

Sibutramina Egostar

10 mg

Capsule, hard

oral use

Portugal

| Pentafarma - Sociedade Técnico-Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, no 2 Abrunheira |
| 2710-089 Sintra |
| Portugal |

Pentafarma - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, no 2 Abrunheira

2710-089 Sintra

Portugal

Sibutramina Egostar

15 mg

Capsule, hard

oral use

Portugal

| Pentafarma - Sociedade Técnico-Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, no 2 Abrunheira |
| 2710-089 Sintra |
| Portugal |

Pentafarma - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, no 2 Abrunheira

2710-089 Sintra

Portugal

Sibutramina Blixie

10 mg

Capsule, hard

oral use

Portugal

| Tecnimede - Sociedade Técnico-Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, 2 |
| Abrunheira |
| 2710-089 Sintra |
| Portugal |

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Blixie

15 mg

Capsule, hard

oral use

Portugal

| Tecnimede - Sociedade Técnico-Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, 2 |
| Abrunheira |
| 2710-089 Sintra |
| Portugal |

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Atrolex

10 mg

Capsule, hard

oral use

Portugal

| Tecnimede - Sociedade Técnico-Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, 2 |
| Abrunheira |
| 2710-089 Sintra |
| Portugal |

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Atrolex

15 mg

Capsule, hard

oral use

Portugal

| Tecnimede - Sociedade Técnico-Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, 2 |
| Abrunheira |
| 2710-089 Sintra |
| Portugal |

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Argam

10 mg

Capsule, hard

oral use

Portugal

| Tecnimede - Sociedade Técnico-Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, 2 |
| Abrunheira |
| 2710-089 Sintra |
| Portugal |

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Argam

15 mg

Capsule, hard

oral use

Portugal

| Tecnimede - Sociedade Técnico-Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, 2 |
| Abrunheira |
| 2710-089 Sintra |
| Portugal. |

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal.

Sibutramina Orexinib

10 mg

Capsule, hard

oral use

Portugal

| Tecnimede - Sociedade Técnico-Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, 2 |
| Abrunheira |
| 2710-089 Sintra |
| Portugal |

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Orexinib

15 mg

Capsule, hard

oral use

Portugal

| Tecnimede - Sociedade Técnico-Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, 2 |
| Abrunheira |
| 2710-089 Sintra |
| Portugal |

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Snomas

10 mg

Capsule, hard

oral use

Portugal

| Tecnimede - Sociedade Técnico-Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, 2 |
| Abrunheira |
| 2710-089 Sintra |
| Portugal |

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Snomas

15 mg

Capsule, hard

oral use

Portugal

| Tecnimede - Sociedade Técnico-Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, 2 |
| Abrunheira |
| 2710-089 Sintra |
| Portugal |

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Arpedex

10 mg

Capsule, hard

oral use

Portugal

| Tecnimede - Sociedade Técnico-Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, 2 |
| Abrunheira |
| 2710-089 Sintra |
| Portugal |

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Arpedex

15 mg

Capsule, hard

oral use

Portugal

| Tecnimede - Sociedade Técnico-Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, 2 |
| Abrunheira |
| 2710-089 Sintra |
| Portugal |

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Marcoliz

10 mg

Capsule, hard

oral use

Portugal

| Tecnimede - Sociedade Técnico-Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, 2 |
| Abrunheira |
| 2710-089 Sintra |
| Portugal |

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Marcoliz

15 mg

Capsule, hard

oral use

Portugal

| Tecnimede - Sociedade Técnico-Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, 2 |
| Abrunheira |
| 2710-089 Sintra |
| Portugal |

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Ocram

10 mg

Capsule, hard

oral use

Portugal

| Tecnimede - Sociedade Técnico-Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, 2 |
| Abrunheira |
| 2710-089 Sintra |
| Portugal |

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Ocram

15 mg

Capsule, hard

oral use

Portugal

| Verum Pharma - Produtos Farmacêuticos - Unipessoal, Lda |
| --- |
| Av. Sidónio Pais, n.o 24, |
| rés-do-chão esq |
| São Sebastião da Pedreira |
| 1000 Lisboa |
| Portugal |

Verum Pharma - Produtos Farmacêuticos - Unipessoal, Lda

Av. Sidónio Pais, n.o 24,

rés-do-chão esq

São Sebastião da Pedreira

1000 Lisboa

Portugal

Sibutramina Strami

10 mg

Capsule, hard

oral use

Portugal

| Verum Pharma - Produtos Farmacêuticos - Unipessoal, Lda |
| --- |
| Av. Sidónio Pais, n.o 24, |
| rés-do-chão esq, |
| São Sebastião da Pedreira |
| 1000 Lisboa |
| Portugal |

Verum Pharma - Produtos Farmacêuticos - Unipessoal, Lda

Av. Sidónio Pais, n.o 24,

rés-do-chão esq,

São Sebastião da Pedreira

1000 Lisboa

Portugal

Sibutramina Strami

15 mg

Capsule, hard

oral use

Portugal

| Tecnimede - Sociedade Técnico-Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, 2 |
| Abrunheira |
| 2710-089 Sintra |
| Portugal |

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Fililex

10 mg

Capsule, hard

oral use

Portugal

| Tecnimede - Sociedade Técnico-Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, 2 |
| Abrunheira |
| 2710-089 Sintra |
| Portugal |

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Fililex

15 mg

Capsule, hard

oral use

Portugal

| Tecnimede - Sociedade Técnico-Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, 2 |
| Abrunheira |
| 2710-089 Sintra |
| Portugal |

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina West Pharma

10 mg

Capsule, hard

oral use

Portugal

| Tecnimede - Sociedade Técnico-Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, 2 |
| Abrunheira |
| 2710-089 Sintra |
| Portugal |

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina West Pharma

15 mg

Capsule, hard

oral use

Portugal

| Generis Farmacêutica, S.A. |
| --- |
| Office Park da Beloura, |
| Edifício 4, |
| Quinta da Beloura |
| 2710-444 Sintra |
| Portugal |

Generis Farmacêutica, S.A.

Office Park da Beloura,

Edifício 4,

Quinta da Beloura

2710-444 Sintra

Portugal

Sibutramina Generis

8,37 mg

Capsule, hard

oral use

Portugal

| Generis Farmacêutica, S.A. |
| --- |
| Office Park da Beloura, |
| Edifício 4, |
| Quinta da Beloura |
| 2710-444 Sintra |
| Portugal |

Generis Farmacêutica, S.A.

Office Park da Beloura,

Edifício 4,

Quinta da Beloura

2710-444 Sintra

Portugal

Sibutramina Generis

12,556 mg

Capsule, hard

oral use

Portugal

| Sandoz Farmacêutica, Lda. |
| --- |
| Alameda da Beloura, |
| Edifício 1, 2o - Escritório 15 |
| 2710-693 Sintra |
| Portugal |

Sandoz Farmacêutica, Lda.

Alameda da Beloura,

Edifício 1, 2o - Escritório 15

2710-693 Sintra

Portugal

Sibutramina Sandoz

10 mg

Capsule, hard

oral use

Portugal

| Sandoz Farmacêutica, Lda. |
| --- |
| Alameda da Beloura, Edifício 1, 2o - Escritório 15 |
| 2710-693 Sintra |
| Portugal |

Sandoz Farmacêutica, Lda.

Alameda da Beloura, Edifício 1, 2o - Escritório 15

2710-693 Sintra

Portugal

Sibutramina Sandoz

15 mg

Capsule, hard

oral use

Romania

| Abbott GmbH & Co.KG |
| --- |
| Max-Planck-Ring 2 |
| 65205 Wiesbaden |
| Germany |

Abbott GmbH & Co.KG

Max-Planck-Ring 2

65205 Wiesbaden

Germany

REDUCTIL 10 mg, capsule

10 mg

Capsule, hard

oral use

Romania

| Abbott GmbH & Co.KG |
| --- |
| Max-Planck-Ring 2 |
| 65205 Wiesbaden |
| Germany |

Abbott GmbH & Co.KG

Max-Planck-Ring 2

65205 Wiesbaden

Germany

REDUCTIL 15 mg, capsule

15 mg

Capsule, hard

oral use

Romania

| SANDOZ S.R.L. ROMÂNIA |
| --- |
| Str. Livezeni nr. 7A, |
| Târgu Mureș, |
| Romania |

SANDOZ S.R.L. ROMÂNIA

Str. Livezeni nr. 7A,

Târgu Mureș,

Romania

MINIMACIN 10 mg, capsule

10 mg

Capsule, hard

oral use

Romania

| SANDOZ S.R.L. ROMÂNIA |
| --- |
| Str. Livezeni nr. 7A, |
| Târgu Mureș, |
| Romania |

SANDOZ S.R.L. ROMÂNIA

Str. Livezeni nr. 7A,

Târgu Mureș,

Romania

MINIMACIN 15 mg, capsule

15 mg

Capsule, hard

oral use

Romania

| S.C. TERAPIA S.A. |
| --- |
| Str. Fabricii, nr. 124, |
| Cluj-Napoca, |
| Romania |

S.C. TERAPIA S.A.

Str. Fabricii, nr. 124,

Cluj-Napoca,

Romania

SILUTON 10 mg, capsule

10 mg

Capsule, hard

oral use

Romania

| S.C. TERAPIA S.A. |
| --- |
| Str. Fabricii, nr. 124, |
| Cluj-Napoca, |
| Romania |

S.C. TERAPIA S.A.

Str. Fabricii, nr. 124,

Cluj-Napoca,

Romania

SILUTON 15 mg, capsule

15 mg

Capsule, hard

oral use

Romania

| TEVA PHARMACEUTICALS S.R.L. |
| --- |
| Str. Domnița Ruxandra nr 12, parter, |
| Sector 2, București |
| Romania |

TEVA PHARMACEUTICALS S.R.L.

Str. Domnița Ruxandra nr 12, parter,

Sector 2, București

Romania

SIBUTRAMINĂ TEVA 10 mg, capsule

10 mg

Capsule, hard

oral use

Romania

| TEVA PHARMACEUTICALS S.R.L. |
| --- |
| Str. Domnița Ruxandra nr 12, parter, |
| Sector 2, București |
| Romania |

TEVA PHARMACEUTICALS S.R.L.

Str. Domnița Ruxandra nr 12, parter,

Sector 2, București

Romania

SIBUTRAMINĂ TEVA 15 mg, capsule

15 mg

Capsule, hard

oral use

Romania

| ZENTIVA a.s., |
| --- |
| U kabelovny 130, |
| 102 37 Praga-10 Dolní Měcholupy, Czech Republic |

ZENTIVA a.s.,

U kabelovny 130,

102 37 Praga-10 Dolní Měcholupy, Czech Republic

LINDAXA 10 mg, capsule

10 mg

Capsule, hard

oral use

Romania

| ZENTIVA a.s., |
| --- |
| U kabelovny 130, |
| 102 37 Praga-10 Dolní Měcholupy |
| Czech Republic |

ZENTIVA a.s.,

U kabelovny 130,

102 37 Praga-10 Dolní Měcholupy

Czech Republic

LINDAXA 15 mg, capsule

15 mg

Capsule, hard

oral use

Slovakia

| Zentiva, k.s. |
| --- |
| Evropská 846/176a |
| 160 00 Praha 6 |
| Czech Republic |

Zentiva, k.s.

Evropská 846/176a

160 00 Praha 6

Czech Republic

LINDAXA 10

10 mg

Capsule, hard

oral use

Slovakia

| Zentiva, k.s. |
| --- |
| Evropská 846/176a |
| 160 00 Praha 6 |
| Czech Republic |

Zentiva, k.s.

Evropská 846/176a

160 00 Praha 6

Czech Republic

LINDAXA 15

15 mg

Capsule, hard

oral use

Slovakia

| TEVA Pharmaceuticals Slovakia s.r.o. |
| --- |
| Teslova 26, 821 02, Bratislava |
| Slovak Republic |

TEVA Pharmaceuticals Slovakia s.r.o.

Teslova 26, 821 02, Bratislava

Slovak Republic

Sibutramin - Teva 10 mg kapsuly

10 mg

Capsule, hard

oral use

Slovakia

| TEVA Pharmaceuticals Slovakia s.r.o. |
| --- |
| Teslova 26, 821 02 Bratislava |
| Slovak Republic |

TEVA Pharmaceuticals Slovakia s.r.o.

Teslova 26, 821 02 Bratislava

Slovak Republic

Sibutramin - Teva 15 mg kapsuly

15 mg

Capsule, hard

oral use

Slovakia

| Abbott Laboratories Slovakia s.r.o. |
| --- |
| Karadžicova 10 |
| 821 08 Bratislava |
| Slovak Republic |

Abbott Laboratories Slovakia s.r.o.

Karadžicova 10

821 08 Bratislava

Slovak Republic

Reductil 10 mg

10 mg

capsule

oral use

Slovakia

| Abbott Laboratories Slovakia s.r.o. |
| --- |
| Karadžicova 10 |
| 821 08 Bratislava |
| Slovak Republic |

Abbott Laboratories Slovakia s.r.o.

Karadžicova 10

821 08 Bratislava

Slovak Republic

Reductil 15 mg

15 mg

capsule

oral use

Slovenia

| Abbott Laboratories d.o.o. |
| --- |
| Dolenjska c. 242c |
| SI-1000 Ljubljana |
| Slovenia |

Abbott Laboratories d.o.o.

Dolenjska c. 242c

SI-1000 Ljubljana

Slovenia

Reductil 10 mg trde kapsule

10 mg

Capsule, hard

oral use

Slovenia

| Abbott Laboratories d.o.o. |
| --- |
| Dolenjska c. 242c |
| SI-1000 Ljubljana |
| Slovenia |

Abbott Laboratories d.o.o.

Dolenjska c. 242c

SI-1000 Ljubljana

Slovenia

Reductil 15 mg trde kapsule

15 mg

Capsule, hard

oral use

Slovenia

| Lek farmacevtska družba d.d., Verovškova c. 57 |
| --- |
| SI-1000 Ljubljana |
| Slovenia |

Lek farmacevtska družba d.d., Verovškova c. 57

SI-1000 Ljubljana

Slovenia

Sibutramin Lek 10 mg trde kapsule

10 mg

Capsule, hard

oral use

Slovenia

| Lek farmacevtska družba d.d., Verovškova c. 57 |
| --- |
| SI-1000 Ljubljana |
| Slovenia |

Lek farmacevtska družba d.d., Verovškova c. 57

SI-1000 Ljubljana

Slovenia

Sibutramin Lek 15 mg trde kapsule

15 mg

Capsule, hard

oral use

Spain

| ABBOTT LABORATORIES, S.A. |
| --- |
| Avda. de Burgos |
| 28050 Madrid |
| Spain |

ABBOTT LABORATORIES, S.A.

Avda. de Burgos

28050 Madrid

Spain

REDUCTIL

10 mg

Capsule, hard

oral use

Spain

| ABBOTT LABORATORIES, S.A. |
| --- |
| Avda. de Burgos |
| 28050 Madrid |
| Spain |

ABBOTT LABORATORIES, S.A.

Avda. de Burgos

28050 Madrid

Spain

REDUCTIL

15 mg

Capsule, hard

oral use

Spain

| TEVA GENERICOS ESPAÑOLA, S.L. |
| --- |
| Guzmán el Bueno 133 |
| Edificio Britania 4oIzq. |
| 28003 MADRID |
| Spain |

TEVA GENERICOS ESPAÑOLA, S.L.

Guzmán el Bueno 133

Edificio Britania 4oIzq.

28003 MADRID

Spain

SIBUTRAMINA TEVA

10 mg

Capsule, hard

oral use

Spain

| TEVA GENERICOS ESPAÑOLA, S.L. |
| --- |
| Guzmán el Bueno 133 |
| Edificio Britania 4oIzq. |
| 28003 MADRID |
| Spain |

TEVA GENERICOS ESPAÑOLA, S.L.

Guzmán el Bueno 133

Edificio Britania 4oIzq.

28003 MADRID

Spain

SIBUTRAMINA TEVA

15 mg

Capsule, hard

oral use

Spain

| IDIFARMA, DESARROLLO FARMACEUTICO |
| --- |
| Polígono Mocholí. Plaza CEIN 5, Nave B-14Noain (Navarra) |
| Spain |

IDIFARMA, DESARROLLO FARMACEUTICO

Polígono Mocholí. Plaza CEIN 5, Nave B-14Noain (Navarra)

Spain

SIBUTRAMINA IDIFARMA

10 mg

Capsule, hard

oral use

Spain

| IDIFARMA, DESARROLLO FARMACEUTICO. |
| --- |
| Polígono Mocholí. Plaza CEIN 5, Nave B-14Noain (Navarra) |
| Spain |

IDIFARMA, DESARROLLO FARMACEUTICO.

Polígono Mocholí. Plaza CEIN 5, Nave B-14Noain (Navarra)

Spain

SIBUTRAMINA IDIFARMA

15 mg

Capsule, hard

oral use

Sweden

| Abbott Scandinavia AB |
| --- |
| Box 509 169 29 Solna |
| Sweden |

Abbott Scandinavia AB

Box 509 169 29 Solna

Sweden

Reductil

10 mg

Capsule, hard

oral use

Sweden

| Abbott Scandinavia AB |
| --- |
| Box 509 169 29 Solna |
| Sweden |

Abbott Scandinavia AB

Box 509 169 29 Solna

Sweden

Reductil

15 mg

Capsule, hard

oral use

Sweden

| Sandoz A/S, C.F. |
| --- |
| Tietgens Boulevard 40 |
| DK-5220 Odense SØ |
| Danmark |

Sandoz A/S, C.F.

Tietgens Boulevard 40

DK-5220 Odense SØ

Danmark

Sibutramin Sandoz

10 mg

Capsule, hard

oral use

Sweden

| Sandoz A/S, C.F. |
| --- |
| Tietgens Boulevard 40 |
| DK-5220 Odense SØ |
| Danmark |

Sandoz A/S, C.F.

Tietgens Boulevard 40

DK-5220 Odense SØ

Danmark

Sibutramin Sandoz

15 mg

Capsule, hard

oral use

Sweden

| Teva Sweden AB |
| --- |
| Box 1070 |
| 251 10 Helsingborg |
| Sweden |

Teva Sweden AB

Box 1070

251 10 Helsingborg

Sweden

Sibutramine Teva

10 mg

Capsule, hard

Oral use

Sweden

| Teva Sweden AB |
| --- |
| Box 1070 |
| 251 10 Helsingborg |
| Sweden |

Teva Sweden AB

Box 1070

251 10 Helsingborg

Sweden

Sibutramine Teva

15 mg

Capsule, hard

Oral use

United Kingdom

| Abbott Laboratories Limited |
| --- |
| Queenborough |
| Kent ME11 5EL |
| United Kingdom |

Abbott Laboratories Limited

Queenborough

Kent ME11 5EL

United Kingdom

Reductil 10 mg

10 mg

Capsule, hard

oral use

United Kingdom

| Abbott Laboratories Limited |
| --- |
| Queenborough |
| Kent ME11 5EL |
| United Kingdom |

Abbott Laboratories Limited

Queenborough

Kent ME11 5EL

United Kingdom

Reductil 15 mg

15 mg

Capsule, hard

oral use

United Kingdom

| Teva UK Limited |
| --- |
| Brampton Road |
| Hampden Park |
| Eastbourne, East Sussex BN22 9AG |
| United Kingdom |

Teva UK Limited

Brampton Road

Hampden Park

Eastbourne, East Sussex BN22 9AG

United Kingdom

Sibutramine Hydrochloride 15 mg Capsules

10 mg

Capsule, hard

oral use

United Kingdom

| Teva UK Limited |
| --- |
| Brampton Road |
| Hampden Park |
| Eastbourne, East Sussex BN22 9AG |
| United Kingdom |

Teva UK Limited

Brampton Road

Hampden Park

Eastbourne, East Sussex BN22 9AG

United Kingdom

Sibutramine Hydrochloride 10 mg Capsules

15 mg

Capsule, hard

oral use

---

ANNEX XVI

LIST OF THE NAME, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE(S) OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES

| Member State | Applicant or Marketing Authorisation Holder | Product invented name | Pharmaceutical form | Strength | Animal species | Frequency and route of administration | Recommended dose | Withdrawal period |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| United Kingdom | CEVA Animal Health Limited | Tildren 500 mg lyophilisate for solution for infusion | Lyophilisate for solution for infusion | 500 mg | Horses | Once (the treatment may be repeated on the advice of the veterinary surgeon)
  Intravenous use | 1 mg/kg body weight (5 ml reconstituted solution per 100 kg) | Zero days
  Not permitted for use in lactating animals producing milk for human consumption |
| Germany | CEVA Animal Health Limited | Tildren 500 mg lyophilisate for solution for infusion | Lyophilisate for solution for infusion | 500 mg | Horses | Once (the treatment may be repeated on the advice of the veterinary surgeon)
  Intravenous use | 1 mg/kg body weight (5 ml reconstituted solution per 100 kg) | Zero days
  Not permitted for use in lactating animals producing milk for human consumption |

Member State

Applicant or Marketing Authorisation Holder

Product invented name

Pharmaceutical form

Strength

Animal species

Frequency and route of administration

Recommended dose

Withdrawal period

United Kingdom

CEVA Animal Health Limited

Tildren 500 mg lyophilisate for solution for infusion

Lyophilisate for solution for infusion

500 mg

Horses

Once (the treatment may be repeated on the advice of the veterinary surgeon)

Intravenous use

1 mg/kg body weight (5 ml reconstituted solution per 100 kg)

Zero days

Not permitted for use in lactating animals producing milk for human consumption

Germany

CEVA Animal Health Limited

Tildren 500 mg lyophilisate for solution for infusion

Lyophilisate for solution for infusion

500 mg

Horses

Once (the treatment may be repeated on the advice of the veterinary surgeon)

Intravenous use

1 mg/kg body weight (5 ml reconstituted solution per 100 kg)

Zero days

Not permitted for use in lactating animals producing milk for human consumption

---

ANNEX XVII

LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES (EEA)

| Member State EU/EEA | Marketing Authorisation Holder | (Invented) Name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Dermapharm GmbH |
| Türkenstraße 25/12 |
| A-1090 Wien |
| Austria |

Member State EU/EEA

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

Austria

Dermapharm GmbH

Türkenstraße 25/12

A-1090 Wien

Austria

Parfenac - Creme

50 mg/g

Cream

Cutaneous use

Austria

| Dermapharm GmbH |
| --- |
| Türkenstraße 25/12 |
| A-1090 Wien |
| Austria |

Dermapharm GmbH

Türkenstraße 25/12

A-1090 Wien

Austria

Parfenac - dermatologische Emulsion

50 mg/g

Cutaneous emulsion

Cutaneous use

Austria

| Dermapharm GmbH |
| --- |
| Türkenstraße 25/12 |
| A-1090 Wien |
| Austria |

Dermapharm GmbH

Türkenstraße 25/12

A-1090 Wien

Austria

Parfenac - Fettsalbe

50 mg/g

Ointment

Cutaneous use

Austria

| Dermapharm GmbH |
| --- |
| Türkenstraße 25/12 |
| A-1090 Wien |
| Austria |

Dermapharm GmbH

Türkenstraße 25/12

A-1090 Wien

Austria

Parfenac - Salbe

50 mg/g

Ointment

Cutaneous use

Bulgaria

| Stada Arzneimittel AG, |
| --- |
| Stadastrasse 2-18 |
| 61118 Bad Vilbel |
| Germany |

Stada Arzneimittel AG,

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Mastu S Forte

Bufexamac 250 mg, Bismuth subgallate 100 mg, Titanium dioxide 100 mg, Lidocaine hydrochloride 10 mg

Suppositories

Rectal use

Bulgaria

| Stada Arzneimittel AG |
| --- |
| Stadastrasse 2-18 |
| 61118 Bad Vilbel |
| Germany |

Stada Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Mastu S

Bufexamac 50 mg/g, Bismuth subgallate 50 mg/g, Titanium dioxide 50 mg/g, Lidocaine hydrochloride 5 mg/g

Rectal ointment

Rectal use

Czech Republic

| STADA Arzneimittel AG |
| --- |
| Stadastrasse 2-18 |
| 61118 Bad Vilbel |
| Germany |

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

MASTU S FORTE

Bufexamac 250 mg, Bismuth subgallate 100 mg, Titanium dioxide 100 mg, Lidocaine hydrochloride 10 mg

suppository

Rectal use

Czech Republic

| STADA Arzneimittel AG |
| --- |
| Stadastrasse 2-18 |
| 61118 Bad Vilbel |
| Germany |

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

MASTU S

Bufexamac 50 mg/g, Bismuth subgallate 50 mg/g, Titanium dioxide 50 mg/g, Lidocaine hydrochloride 5 mg/g

rectal ointment

Rectal use

France

| Pierre Fabre Medicament |
| --- |
| 45 place Abel Gance |
| 92654 Boulogne cedex |
| France |

Pierre Fabre Medicament

45 place Abel Gance

92654 Boulogne cedex

France

BUFAL 5 POUR CENT, crème en tube

5 g/100 g

cream

Cutaneous use

France

| Coopération Pharmaceutique Française |
| --- |
| Place Lucien Auvert |
| 77020 Melun cedex |
| France |

Coopération Pharmaceutique Française

Place Lucien Auvert

77020 Melun cedex

France

BUFEXAMAC COOPER 5 pour cent, crème

5 g/100 g

cream

Cutaneous use

France

| Wyeth Pharmaceuticals France |
| --- |
| Cœur Défense Tour A |
| la Défanse 4 |
| 92931 Paris La Défense Cedex |
| France |

Wyeth Pharmaceuticals France

Cœur Défense Tour A

la Défanse 4

92931 Paris La Défense Cedex

France

BUFEXAMAC NOVALIS 5 pour cent, crème

5 g/100 g

cream

Cutaneous use

France

| Wyeth Pharmaceuticals France |
| --- |
| Cœur Défense Tour A |
| la Défanse 4 |
| 92931 Paris La Défense Cedex |
| France |

Wyeth Pharmaceuticals France

Cœur Défense Tour A

la Défanse 4

92931 Paris La Défense Cedex

France

CALMADERM, crème pour application cutannée

5 g/100 g

cream

Cutaneous use

France

| Wyeth Pharmaceuticals France |
| --- |
| Cœur Défense Tour A |
| la Défanse 4 |
| 92931 Paris La Défense Cedex |
| France |

Wyeth Pharmaceuticals France

Cœur Défense Tour A

la Défanse 4

92931 Paris La Défense Cedex

France

PARFENAC 5 POUR CENT, crème

5 g/100 g

cream

Cutaneous use

France

| Wyeth Pharmaceuticals France |
| --- |
| Cœur Défense Tour A |
| la Défanse 4 |
| 92931 Paris La Défense Cedex |
| France |

Wyeth Pharmaceuticals France

Cœur Défense Tour A

la Défanse 4

92931 Paris La Défense Cedex

France

PARFENOIDE, crème pour application locale

5 g/100 g

cream

Cutaneous use

Hungary

| Stada Arzneimittel AG |
| --- |
| Stadastrasse 2-18 |
| 61118 Bad Vilbel |
| Germany |

Stada Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Mastu S

50 mg Bufexamac (+5 mg Lidocaine)/ 1 g

ointment

Cutaneous use

Hungary

| Stada Arzneimittel AG |
| --- |
| Stadastrasse 2-18 |
| 61118 Bad Vilbel |
| Germany |

Stada Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Mastu S Forte

250 mg Bufexamac, +10 mg Lijdocaine

suppository

Rectal use

Italy

| Farmigea spa |
| --- |
| Via Giovan Battista Oliva 6/8 |
| 56121 PISA |
| Italy |

Farmigea spa

Via Giovan Battista Oliva 6/8

56121 PISA

Italy

FANSAMAC

5 g/100 g

cream

Cutaneous use

Latvia

| Stada Arzneimittel AG, |
| --- |
| Stadastraße 2-18 |
| 61118 Bad Vilbel |
| Germany |

Stada Arzneimittel AG,

Stadastraße 2-18

61118 Bad Vilbel

Germany

Mastu S ointment

Bismuthi subgallas 50 mg, Bufexamacum 50 mg, Titanii dioxidum 50 mg Lidocaini hydrochloridum 5 mg/g

Ointment

Rectal use and Cutaneous use

Latvia

| Stada Arzneimittel AG |
| --- |
| Stadastraße 2-18 |
| 61118 Bad Vilbel, |
| Germany |

Stada Arzneimittel AG

Stadastraße 2-18

61118 Bad Vilbel,

Germany

Mastu S forte suppositories

Titanii dioxidum 250 mg, Lidocaini hydrochloridum 100 mg, Bismuthi subgallas 100 mg, Bufexamacum 10 mg

Suppositories

Rectal use

Lithuania

| Stada Arzneimittel AG |
| --- |
| Stadastrasse 2-18 |
| 61118 Bad Vilbel |
| Germany |

Stada Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Mastu S

Bufexamac 50 mg/g, Bismuth subgallate 50 mg/g, Titanium dioxide 50 mg/g, Lidocaine hydrochloride monohydrate 5 mg/g

Ointment

Cutaneous use

Lithuania

| Stada Arzneimittel AG |
| --- |
| Stadastrasse 2-18 |
| 61118 Bad Vilbel |
| Germany |

Stada Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Mastu S forte

Bufexamac 250 mg, Bismuth subgallate 100 mg, Titanium dioxide 100 mg, Lidocaine hydrochloride monohydrate 10 mg

Suppository

Rectal use

Luxembourg

| PF MEDICAMENT |
| --- |
| 45, Place Abel Gance |
| 92654 Boulogne Cedex |
| France |

PF MEDICAMENT

45, Place Abel Gance

92654 Boulogne Cedex

France

BUFAL

5 g/100 g

cream

Cutaneous use

Portugal

| Home Products de Portugal, Lda. Rua Dr. António Loureiro Borges |
| --- |
| 2 - Arquiparque - Miraflores |
| 1495-131 Algés |
| Portugal |

Home Products de Portugal, Lda. Rua Dr. António Loureiro Borges

2 - Arquiparque - Miraflores

1495-131 Algés

Portugal

Parfenac

50 mg/g

Ointment

Cutaneous use

Romania

| STADA ARZNEIMITTEL AG |
| --- |
| Stadastrasse 2-18 |
| 61118 Bad Vilbel |
| Germany |

STADA ARZNEIMITTEL AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

PROCTOSAN FORTE, suppository

250 mg

suppository

Rectal use

Romania

| STADA ARZNEIMITTEL AG |
| --- |
| Stadastrasse 2-18 |
| 61118 Bad Vilbel |
| Germany |

STADA ARZNEIMITTEL AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

PROCTOSAN, rectal cream

50 mg

rectal cream

Rectal use

Slovakia

| STADA Arzneimittel AG |
| --- |
| Stadastrasse 2 - 18 |
| 61118 Bad Vilbel |
| Germany |

STADA Arzneimittel AG

Stadastrasse 2 - 18

61118 Bad Vilbel

Germany

MASTU S

50 mg/1 g

Rectal ointment

Rectal use

Slovakia

| STADA Arzneimittel AG |
| --- |
| Stadastrasse 2 - 18 |
| 61118 Bad Vilbel |
| Germany |

STADA Arzneimittel AG

Stadastrasse 2 - 18

61118 Bad Vilbel

Germany

MASTU S forte

250 mg

Suppository

Rectal use

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