# Official Journal C 250/2011

| | ISSN 1725-2423
  doi:10.3000/17252423.C_2011.250.eng |
| --- | --- |
| Official Journal
  of the European Union | C 250 |
| | |
| English edition | Information and Notices | Volume 5426 August 2011 |

ISSN 1725-2423

doi:10.3000/17252423.C_2011.250.eng

Official Journal

of the European Union

C 250

English edition

Information and Notices

Volume 5426 August 2011

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| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2011/C 250/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2011 to 30 June 2011(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |
| 2011/C 250/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2011 to 30 June 2011(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) | 18 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2011/C 250/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2011 to 30 June 2011(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

2011/C 250/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2011 to 30 June 2011(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)

18

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

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 26.8.2011 | EN | Official Journal of the European Union | C 250/1 |
| --- | --- | --- | --- |

26.8.2011

EN

Official Journal of the European Union

C 250/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2011 to 30 June 2011

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

2011/C 250/01

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 6.5.2011 | Methylthioninium chloride Proveblue | methylthioninium chloride | Provepharm S.A.S. |
| Technopole de Chateau Gombert, 45 rue Frederic Joliot Curie, FR-13013 Marseille |

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

6.5.2011

Methylthioninium chloride Proveblue

methylthioninium chloride

Provepharm S.A.S.

Technopole de Chateau Gombert, 45 rue Frederic Joliot Curie, FR-13013 Marseille

EU/1/11/682/001

Solution for injection

V03AB17

12.5.2011

18.5.2011

Eliquis

apixaban

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

Bristol-Myers Squibb/Pfizer EEIG

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

EU/1/11/691/001-005

Film-coated tablet

B01A

20.5.2011

18.5.2011

Yellox

bromfenac

| Croma-Pharma GmbH |
| --- |
| Industriezeile 6, A-2100 Leobendorf, Österreich |

Croma-Pharma GmbH

Industriezeile 6, A-2100 Leobendorf, Österreich

EU/1/11/692/001

Eye drops, solution

S01BC11

23.5.2011

15.6.2011

Cinryze

c1 inhibitor, human

| ViroPharma SPRL-BVBA |
| --- |
| rue Montoyer 47, 1000 Bruxelles, Belgique / Montoyerstraat 47, 1000 Brussel, België |

ViroPharma SPRL-BVBA

rue Montoyer 47, 1000 Bruxelles, Belgique / Montoyerstraat 47, 1000 Brussel, België

EU/1/11/688/001

Powder and solvent for solution for injection

B02AB03

20.6.2011

16.6.2011

Clopidogrel Teva Pharma B.V.

Clopidogrel

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

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/10/649/001-016

Film-coated tablet

B01AC04

21.6.2011

16.6.2011

Leganto

Rotigotine

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

Schwarz Pharma Ltd

Shannon, Industrial Estate, Co.Clare, Ireland

EU/1/11/695/001-055

Transdermal patch

N04BC09

22.6.2011

16.6.2011

Rivastigmine Actavis

Rivastigmine

| Actavis Group PTC ehf. |
| --- |
| ReykjavÍkurvegur 76-78, Hafnarfjörður 220, Iceland |

Actavis Group PTC ehf.

ReykjavÍkurvegur 76-78, Hafnarfjörður 220, Iceland

EU/1/11/693/001-016

Capsule, hard

N06DA03

21.6.2011

17.6.2011

BYDUREON

exenatide

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

Eli Lilly Nederland B.V.

Grootslag 1-5, 3991 RA Houten, Nederland

EU/1/11/696/001-002

powder and solvent for prolonged release suspension for injection

A10BX04

23.6.2011

17.6.2011

NULOJIX

belatacept

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

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/11/694/001-002

powder for concentrate for solution for infusion

L04AA28

23.6.2011

23.6.2011

Sprimeo HCT

aliskiren hemifumarate / hydrochlorothiazide

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

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom

EU/1/11/683/001-080

Film-coated tablet

C09XA52

28.6.2011

—   Issuing 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 |
| --- | --- | --- | --- | --- |
| 17.6.2011 | Movectro | Merck Serono Europe Limited |
| 56, Marsh Wall, London E14 9TP, United Kingdom |

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

17.6.2011

Movectro

Merck Serono Europe Limited

56, Marsh Wall, London E14 9TP, United Kingdom

23.6.2011

—   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 |
| --- | --- | --- | --- | --- |
| 2.5.2011 | Combivir | ViiV Healthcare UK Ltd |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |

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

2.5.2011

Combivir

ViiV Healthcare UK Ltd

980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

EU/1/98/058/001-002

4.5.2011

2.5.2011

Kepivance

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

Swedish Orphan Biovitrum AB (publ)

SE-112 76, Stockholm, Sverige

EU/1/05/314/001

4.5.2011

2.5.2011

Kinzalkomb

| Bayer Schering Pharma AG |
| --- |
| D-13342 Berlin, Deutschland |

Bayer Schering Pharma AG

D-13342 Berlin, Deutschland

EU/1/02/214/001-015

4.5.2011

2.5.2011

Kinzalmono

| Bayer Schering Pharma AG |
| --- |
| D-13342 Berlin, Deutschland |

Bayer Schering Pharma AG

D-13342 Berlin, Deutschland

EU/1/98/091/001-014

4.5.2011

2.5.2011

Micardis

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

Boehringer Ingelheim International GmbH

Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland

EU/1/98/090/001-020

4.5.2011

2.5.2011

MicardisPlus

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

Boehringer Ingelheim International GmbH

Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland

EU/1/02/213/001-023

4.5.2011

2.5.2011

Nexavar

| Bayer Schering Pharma AG |
| --- |
| 13342 Berlin, Deutschland |

Bayer Schering Pharma AG

13342 Berlin, Deutschland

EU/1/06/342/001

4.5.2011

2.5.2011

Osigraft

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

Howmedica International S. de R.L.

Division of Stryker Corporation, Raheen Industrial Estate, Raheen, Limerick, Ireland

EU/1/01/179/001

4.5.2011

2.5.2011

Pritor

| Bayer Schering Pharma AG |
| --- |
| 13342 Berlin, Deutschland |

Bayer Schering Pharma AG

13342 Berlin, Deutschland

EU/1/98/089/001-022

4.5.2011

2.5.2011

PritorPlus

| Bayer Schering Pharma AG |
| --- |
| 13342 Berlin, Deutschland |

Bayer Schering Pharma AG

13342 Berlin, Deutschland

EU/1/02/215/001-021

4.5.2011

2.5.2011

Revatio

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

Pfizer Limited

Sandwich, Kent, CT13 9NJ, United Kingdom

EU/1/05/318/001-002

4.5.2011

2.5.2011

Revolade

| GlaxoSmithKline Trading Services Limited |
| --- |
| 6900 Cork Airport Business Park, Kinsale Road, Cork, Ireland |

GlaxoSmithKline Trading Services Limited

6900 Cork Airport Business Park, Kinsale Road, Cork, Ireland

EU/1/10/612/001-006

4.5.2011

2.5.2011

Votrient

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

Glaxo Group Limited

Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/10/628/001-004

4.5.2011

5.5.2011

M-M-RVAXPRO

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

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk, 69007 Lyon, France

EU/1/06/337/001-013

9.5.2011

6.5.2011

Foclivia

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

Novartis Vaccines and Diagnostics S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

EU/1/09/577/001-004

12.5.2011

6.5.2011

Kivexa

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

ViiV Healthcare UK Ltd

980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

EU/1/04/298/001-003

12.5.2011

6.5.2011

Rasilez HCT

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/08/491/001-080

12.5.2011

6.5.2011

ReFacto AF

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

Wyeth Europa Ltd.

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

EU/1/99/103/001-008

12.5.2011

6.5.2011

Rotarix

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

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, Rixensart, B-1330 Belgique

EU/1/05/330/001-011

12.5.2011

6.5.2011

Tygacil

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

Wyeth Europa Ltd.

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

EU/1/06/336/001

12.5.2011

6.5.2011

Vimpat

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

UCB Pharma SA.

Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België

EU/1/08/470/001-017

12.5.2011

6.5.2011

Votrient

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

Glaxo Group Limited

Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/10/628/001-004

12.5.2011

6.5.2011

Xagrid

| Shire Pharmaceutical Contracts Ltd |
| --- |
| Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom |

Shire Pharmaceutical Contracts Ltd

Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom

EU/1/04/295/001

12.5.2011

12.5.2011

Baraclude

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

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/06/343/001-007

16.5.2011

12.5.2011

Extavia

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/08/454/001-002

EU/1/08/454/005-007

16.5.2011

12.5.2011

Ketek

| Aventis Pharma S.A. |
| --- |
| 20 avenue Raymond Aron, F-92160 Antony, France |

Aventis Pharma S.A.

20 avenue Raymond Aron, F-92160 Antony, France

EU/1/01/191/001-005

16.5.2011

12.5.2011

MabCampath

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

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/01/193/001-002

16.5.2011

12.5.2011

Olanzapine Apotex

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

Apotex Europe B.V.

Darwingweg 20, 2333 CR Leiden, Nederland

EU/1/10/635/001-014

16.5.2011

16.5.2011

Elonva

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

N.V. Organon

Kloosterstraat 6, 5349 AB Oss, Nederland

EU/1/09/609/001-002

18.5.2011

16.5.2011

Pramipexole Teva

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

Teva Pharma B.V.

Computerweg 10, DR Utrecht 3542, Nederland

EU/1/08/490/001-024

18.5.2011

16.5.2011

Yondelis

| Pharma Mar, S.A. |
| --- |
| Avda. de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo (Madrid), Espana |

Pharma Mar, S.A.

Avda. de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo (Madrid), Espana

EU/1/07/417/001-002

18.5.2011

16.5.2011

Zavesca

| Actelion Registration Ltd |
| --- |
| BSI Building 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom |

Actelion Registration Ltd

BSI Building 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom

EU/1/02/238/001

18.5.2011

18.5.2011

Arixtra

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

Glaxo Group Ltd.

Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/02/206/001-035

20.5.2011

18.5.2011

Celvapan

| Baxter AG |
| --- |
| Industriestraße 67, A - 1221 Wien, Österreich |

Baxter AG

Industriestraße 67, A - 1221 Wien, Österreich

EU/1/08/506/001

20.5.2011

18.5.2011

DepoCyte

| Pacira Limited |
| --- |
| 3 Glory Park Avenue, Wooburn Green, High Wycombe, Buckinghamshire, HP10 0DF, United Kingdom |

Pacira Limited

3 Glory Park Avenue, Wooburn Green, High Wycombe, Buckinghamshire, HP10 0DF, United Kingdom

EU/1/01/187/001

20.5.2011

18.5.2011

Hepsera

| Gilead Sciences International Limited |
| --- |
| Cambridge, CB21 6GT, United Kingdom |

Gilead Sciences International Limited

Cambridge, CB21 6GT, United Kingdom

EU/1/03/251/001-002

20.5.2011

18.5.2011

Karvea

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

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/97/049/001-039

23.5.2011

18.5.2011

Karvezide

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

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/98/085/001-034

23.5.2011

18.5.2011

Pelzont

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

Merck Sharp & Dohme Ltd

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/08/460/001-014

23.5.2011

18.5.2011

PREZISTA

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

Janssen-Cilag International NV

Turnhoutseweg, 30 - 2340 Beerse – België

EU/1/06/380/001-005

23.5.2011

18.5.2011

Rotarix

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

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, Rixensart, B-1330 Belgique

EU/1/05/330/001-011

20.5.2011

18.5.2011

RotaTeq

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

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk, Lyon 69007, France

EU/1/06/348/001-002

23.5.2011

18.5.2011

Sprimeo

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/07/407/001-020

23.5.2011

18.5.2011

Tarceva

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

Roche Registration Limited

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

EU/1/05/311/001-003

20.5.2011

18.5.2011

Viread

| Gilead Sciences International Limited |
| --- |
| Cambridge CB21 6GT United Kingdom |

Gilead Sciences International Limited

Cambridge CB21 6GT United Kingdom

EU/1/01/200/001-002

23.5.2011

23.5.2011

Aprovel

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

Sanofi Pharma Bristol-Myers Squibb SNC

174 avenue de France - 75013 Paris, France

EU/1/97/046/001-039

26.5.2011

23.5.2011

CoAprovel

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

Sanofi Pharma Bristol-Myers Squibb SNC

174 avenue de France - 75013 Paris, France

EU/1/98/086/001-034

30.5.2011

23.5.2011

Emtriva

| Gilead Sciences International Limited |
| --- |
| Cambridge CB21 6GT United Kingdom |

Gilead Sciences International Limited

Cambridge CB21 6GT United Kingdom

EU/1/03/261/001-003

26.5.2011

23.5.2011

Exalief

| BIAL - Portela & Ca, SA |
| --- |
| A Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado – Portugal |

BIAL - Portela & Ca, SA

A Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado – Portugal

EU/1/09/520/001-020

26.5.2011

23.5.2011

Exelon

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/98/066/001-026

26.5.2011

23.5.2011

Glivec

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/01/198/001-013

26.5.2011

23.5.2011

GONAL-f

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

Merck Serono Europe Ltd.

56, Marsh Wall, London E14 9TP, United Kingdom

EU/1/95/001/033-035

26.5.2011

23.5.2011

Luveris

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

Merck Serono Europe Limited

56, Marsh Wall, London E14 9TP, United Kingdom

EU/1/00/155/007

25.5.2011

23.5.2011

Prometax

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/98/092/001-028

25.5.2011

23.5.2011

Rapamune

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

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

26.5.2011

23.5.2011

Rasilez

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/07/405/001-040

25.5.2011

23.5.2011

Riprazo

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/07/409/001-040

26.5.2011

23.5.2011

Sprycel

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

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/06/363/001-015

26.5.2011

23.5.2011

Tasigna

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/07/422/001-006

25.5.2011

23.5.2011

Telzir

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

ViiV Healthcare UK Ltd

980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

EU/1/04/282/001-002

26.5.2011

23.5.2011

Tredaptive

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

Merck Sharp & Dohme Ltd

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/08/459/001-014

25.5.2011

23.5.2011

Trevaclyn

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

Merck Sharp & Dohme Ltd

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/08/458/001-014

25.5.2011

23.5.2011

Tygacil

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

Wyeth Europa Ltd.

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

EU/1/06/336/001

26.5.2011

23.5.2011

Tyverb

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

Glaxo Group Limited

Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/07/440/001-006

27.5.2011

23.5.2011

Vectibix

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

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/07/423/001-003

26.5.2011

27.5.2011

Avonex

| Biogen Idec Ltd |
| --- |
| Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom |

Biogen Idec Ltd

Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom

EU/1/97/033/002-006

1.6.2011

27.5.2011

Carbaglu

| Orphan Europe SARL |
| --- |
| Immeuble Le Wilson - 70 Avenue du Général de Gaulle - F 92 800 Puteaux – France |

Orphan Europe SARL

Immeuble Le Wilson - 70 Avenue du Général de Gaulle - F 92 800 Puteaux – France

EU/1/02/246/001-003

1.6.2011

27.5.2011

CellCept

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

Roche Registration Limited

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

EU/1/96/005/001-006

31.5.2011

27.5.2011

Competact

| 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

EU/1/06/354/001-012

1.6.2011

27.5.2011

Enbrel

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

Wyeth Europa Limited

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

EU/1/99/126/001-021

31.5.2011

27.5.2011

Forsteo

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

Eli Lilly Nederland B.V.

Grootslag 1-5, 3991 RA Houten, Nederland

EU/1/03/247/001-002

1.6.2011

27.5.2011

Levemir

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

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/04/278/001-016

1.6.2011

27.5.2011

Lucentis

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/06/374/001

31.5.2011

27.5.2011

Mycophenolate mofetil Teva

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

Teva Pharma B.V.

Computerweg 10, DR Utrecht 3542, Nederland

EU/1/07/439/001-006

31.5.2011

27.5.2011

Myfenax

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

Teva Pharma B.V.

Computerweg 10, DR Utrecht 3542, Nederland

EU/1/07/438/001-006

31.5.2011

27.5.2011

Neulasta

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

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/02/227/001-002

EU/1/02/227/004

1.6.2011

27.5.2011

Olanzapine Neopharma

| Neopharma Limited |
| --- |
| 57 High Street, Odiham, Hampshire RG29 1LF, United Kingdom |

Neopharma Limited

57 High Street, Odiham, Hampshire RG29 1LF, United Kingdom

EU/1/07/426/001-011

31.5.2011

27.5.2011

Simponi

| Janssen Biologics B.V. |
| --- |
| Einsteinweg 101, CB Leiden 2333, Nederland |

Janssen Biologics B.V.

Einsteinweg 101, CB Leiden 2333, Nederland

EU/1/09/546/001-004

1.6.2011

27.5.2011

Temozolomide Hospira

| Hospira UK Ltd. |
| --- |
| Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom |

Hospira UK Ltd.

Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom

EU/1/10/615/001-024

31.5.2011

27.5.2011

Truvada

| Gilead Sciences International Limited |
| --- |
| Cambridge CB21 6GT United Kingdom |

Gilead Sciences International Limited

Cambridge CB21 6GT United Kingdom

EU/1/04/305/001-002

31.5.2011

27.5.2011

Viracept

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

Roche Registration Limited

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

EU/1/97/054/001

EU/1/97/054/004-005

1.6.2011

7.6.2011

Caelyx

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

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/96/011/001-004

9.6.2011

7.6.2011

Champix

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

Pfizer Ltd

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

EU/1/06/360/001-013

9.6.2011

7.6.2011

Fabrazyme

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

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/01/188/001-006

9.6.2011

7.6.2011

Irbesartan Winthrop

| Sanofi-Aventis |
| --- |
| 174, avenue de France, F-75013 Paris, France |

Sanofi-Aventis

174, avenue de France, F-75013 Paris, France

EU/1/06/376/001-033

9.6.2011

7.6.2011

Multaq

| Sanofi-Aventis |
| --- |
| 174, avenue de France, F-75013 Paris, France |

Sanofi-Aventis

174, avenue de France, F-75013 Paris, France

EU/1/09/591/001-004

9.6.2011

7.6.2011

Norvir

| Abbott Laboratories Ltd |
| --- |
| Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom |

Abbott Laboratories Ltd

Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom

EU/1/96/016/001

EU/1/96/016/003-004

EU/1/96/016/008

9.6.2011

7.6.2011

Tractocile

| Ferring Pharmaceuticals A/S |
| --- |
| Kay Fiskers Plads 11, Copenhagen S 2300, Danmark |

Ferring Pharmaceuticals A/S

Kay Fiskers Plads 11, Copenhagen S 2300, Danmark

EU/1/99/124/001-002

9.6.2011

7.6.2011

Trizivir

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

ViiV Healthcare UK Limited

980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

EU/1/00/156/002-004

9.6.2011

14.6.2011

Afinitor

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/538/001-008

16.6.2011

14.6.2011

Doribax

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

Janssen-Cilag International NV

Turnhoutseweg, 30 - 2340 Beerse – België

EU/1/08/467/001-002

16.6.2011

14.6.2011

Ivemend

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/07/437/001-004

16.6.2011

14.6.2011

Olanzapine Teva

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

Teva Pharma B.V.

Computerweg 10, DR Utrecht 3542, Nederland

EU/1/07/427/001-057

16.6.2011

14.6.2011

Opgenra

| Howmedica International S. de R. L. |
| --- |
| Raheen Business Park, Limerick, Ireland |

Howmedica International S. de R. L.

Raheen Business Park, Limerick, Ireland

EU/1/08/489/001-002

16.6.2011

14.6.2011

PecFent

| Archimedes Development Ltd |
| --- |
| Nottingham, NGT7 2TN, United Kingdom |

Archimedes Development Ltd

Nottingham, NGT7 2TN, United Kingdom

EU/1/10/644/001-006

16.6.2011

14.6.2011

Ribavirin BioPartners

| BioPartners GmbH |
| --- |
| Kaiserpassage 11 - D-72764 Reutlingen, Deutschland |

BioPartners GmbH

Kaiserpassage 11 - D-72764 Reutlingen, Deutschland

EU/1/10/626/001-004

16.6.2011

14.6.2011

Temodal

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

Schering Plough Europe

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

EU/1/98/096/001-025

16.6.2011

14.6.2011

Twynsta

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

Boehringer Ingelheim International GmbH

Binger Strasse 173 - D - 55216 Ingelheim am Rhein, Deutschland

EU/1/10/648/001-028

16.6.2011

14.6.2011

Vidaza

| Celgene Europe Ltd |
| --- |
| Riverside House, Riverside Walk, Windsor, SL4 1NA, United Kingdom |

Celgene Europe Ltd

Riverside House, Riverside Walk, Windsor, SL4 1NA, United Kingdom

EU/1/08/488/001

16.6.2011

15.6.2011

InductOs

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

Wyeth Europa Ltd.

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

EU/1/02/226/001

20.6.2011

15.6.2011

Infanrix hexa

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

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, Rixensart, B-1330 Belgique

EU/1/00/152/009-018

17.6.2011

15.6.2011

PegIntron

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

Schering Plough Europe

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

EU/1/00/131/001-050

17.6.2011

15.6.2011

Ziagen

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

ViiV Healthcare UK Ltd

980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

EU/1/99/112/001-002

17.6.2011

16.6.2011

INCRELEX

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

Ipsen Pharma

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

EU/1/07/402/001

21.6.2011

16.6.2011

IntronA

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

Schering Plough Europe

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

EU/1/99/127/011-039

EU/1/99/127/041-044

22.6.2011

16.6.2011

Irbesartan HCT Winthrop

| Sanofi-Aventis |
| --- |
| 174, avenue de France, F-75013 Paris, France |

Sanofi-Aventis

174, avenue de France, F-75013 Paris, France

EU/1/06/377/001-028

21.6.2011

16.6.2011

Macugen

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

Pfizer Ltd

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

EU/1/05/325/002

21.6.2011

16.6.2011

Olanzapine Mylan

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

Generics [UK] Limited

Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

EU/1/08/475/001-034

21.6.2011

16.6.2011

Omnitrope

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10, Kundl 6250, Österreich |

Sandoz GmbH

Biochemiestrasse 10, Kundl 6250, Österreich

EU/1/06/332/001-012

21.6.2011

16.6.2011

Ozurdex

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

Allergan Pharmaceuticals (Ireland) Ltd,

Castlebar Road, Westport, Co. Mayo, Ireland

EU/1/10/638/001

21.6.2011

16.6.2011

Samsca

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

Otsuka Pharmaceutical Europe Ltd

Hunton House, Highbridge Business Park, Oxford Road, Uxbridge, Middlesex UB8 1HU, United Kingdom

EU/1/09/539/001-004

21.6.2011

16.6.2011

Tysabri

| Elan Pharma International Ltd. |
| --- |
| Monksland, Athlone, County Westmeath, Ireland |

Elan Pharma International Ltd.

Monksland, Athlone, County Westmeath, Ireland

EU/1/06/346/001

21.6.2011

16.6.2011

ViraferonPeg

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

Schering Plough Europe

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

EU/1/00/132/001-050

24.6.2011

16.6.2011

Zebinix

| BIAL - Portela & Ca, SA |
| --- |
| A Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado – Portugal |

BIAL - Portela & Ca, SA

A Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado – Portugal

EU/1/09/514/001-020

21.6.2011

17.6.2011

Aprovel

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

Sanofi Pharma Bristol-Myers Squibb SNC

174 avenue de France - 75013 Paris, France

EU/1/97/046/001-039

23.6.2011

17.6.2011

Champix

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

Pfizer Ltd

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

EU/1/06/360/001-013

23.6.2011

17.6.2011

INCRELEX

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

Ipsen Pharma

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

EU/1/07/402/001

23.6.2011

17.6.2011

Lyrica

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

Pfizer Ltd

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

EU/1/04/279/001-044

23.6.2011

17.6.2011

Mirapexin

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

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

24.6.2011

17.6.2011

Mircera

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

Roche Registration Limited

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

EU/1/07/400/008-013

EU/1/07/400/017-024

23.6.2011

17.6.2011

Pandemrix

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

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, Rixensart, B-1330 Belgique

EU/1/08/452/001

23.6.2011

17.6.2011

Ranexa

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

Menarini International Operations Luxembourg S.A.

1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg

EU/1/08/462/001-012

21.6.2011

17.6.2011

Relistor

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

Wyeth Europa Limited

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

EU/1/08/463/001-011

21.6.2011

17.6.2011

Remicade

| Janssen Biologics B.V. |
| --- |
| Einsteinweg 101, 2333 CB Leiden, Nederland |

Janssen Biologics B.V.

Einsteinweg 101, 2333 CB Leiden, Nederland

EU/1/99/116/001-005

21.6.2011

17.6.2011

Sifrol

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

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

24.6.2011

17.6.2011

Tasigna

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/07/422/001-008

23.6.2011

17.6.2011

Tygacil

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

Wyeth Europa Ltd.

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

EU/1/06/336/001

23.6.2011

17.6.2011

Tysabri

| Elan Pharma International Ltd. |
| --- |
| Monksland, Athlone, County Westmeath, Ireland |

Elan Pharma International Ltd.

Monksland, Athlone, County Westmeath, Ireland

EU/1/06/346/001

23.6.2011

17.6.2011

Xeloda

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

Roche Registration Limited

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

EU/1/00/163/001-002

21.6.2011

17.6.2011

Xolair

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/05/319/001-010

23.6.2011

23.6.2011

BeneFIX

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

Wyeth Europa Ltd.

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

EU/1/97/047/001-007

28.6.2011

23.6.2011

Docefrez

| Sun Pharmaceuticals Industries Europe B.V. |
| --- |
| Polarisavenue 87, 2132 JH Hoofddorp, Nederland |

Sun Pharmaceuticals Industries Europe B.V.

Polarisavenue 87, 2132 JH Hoofddorp, Nederland

EU/1/10/630/001-002

28.6.2011

23.6.2011

Dynastat

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

Pfizer Ltd

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

EU/1/02/209/001-008

28.6.2011

23.6.2011

Erbitux

| Merck KGaA |
| --- |
| Frankfurter Straße 250, 64271 Darmstadt, Deutschland |

Merck KGaA

Frankfurter Straße 250, 64271 Darmstadt, Deutschland

EU/1/04/281/001-005

27.6.2011

23.6.2011

Ganfort

| Allergan Pharmaceuticals Ireland |
| --- |
| Castlebar Road, Westport, Co. Mayo, Ireland |

Allergan Pharmaceuticals Ireland

Castlebar Road, Westport, Co. Mayo, Ireland

EU/1/06/340/001-002

28.7.2011

23.6.2011

Herceptin

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

Roche Registration Limited

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

EU/1/00/145/001

27.6.2011

23.6.2011

Invirase

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

Roche Registration Limited

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

EU/1/96/026/001-002

28.6.2011

23.6.2011

Mabthera

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

Roche Registration Limited

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

EU/1/98/067/001-002

27.6.2011

23.6.2011

NovoSeven

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

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/96/006/001-007

27.6.2011

23.6.2011

Orencia

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

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/07/389/001-003

28.6.2011

23.6.2011

Ovitrelle

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

Merck Serono Europe Limited

56, Marsh Wall, London E14 9TP, United Kingdom

EU/1/00/165/001-008

27.6.2011

23.6.2011

Protopic

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

Astellas Pharma Europe B.V.

Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland

EU/1/02/201/001-006

27.6.2011

23.6.2011

Tamiflu

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

Roche Registration Limited

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

EU/1/02/222/001-004

28.6.2011

23.6.2011

Temozolomide HEXAL

| HEXAL AG |
| --- |
| Industriestrasse 25, D-83607 Holzkirchen, Deutschland |

HEXAL AG

Industriestrasse 25, D-83607 Holzkirchen, Deutschland

EU/1/10/616/001-024

27.6.2011

23.6.2011

Temozolomide Sandoz

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland |

Sandoz Pharmaceuticals GmbH

Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland

EU/1/10/617/001-024

27.6.2011

23.6.2011

Tevagrastim

| Teva GmbH |
| --- |
| Wasastraße 50, 01445 Radebeul, Deutschland |

Teva GmbH

Wasastraße 50, 01445 Radebeul, Deutschland

EU/1/08/445/001-014

27.6.2011

23.6.2011

Torisel

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

Wyeth Europa Ltd

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

EU/1/07/424/001

27.6.2011

23.6.2011

Twinrix Adult

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

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, Rixensart, B-1330 Belgique

EU/1/96/020/001-009

27.6.2011

23.6.2011

Viramune

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

Boehringer Ingelheim International GmbH

Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland

EU/1/97/055/001-004

28.6.2011

29.6.2011

Abraxane

| Celgene Europe Limited |
| --- |
| 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex, UB11 1BD, United Kingdom |

Celgene Europe Limited

1 Longwalk Road, Stockley Park, Uxbridge, Middlesex, UB11 1BD, United Kingdom

EU/1/07/428/001

5.7.2011

29.6.2011

Aclasta

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/05/308/001-002

4.7.2011

29.6.2011

Adrovance

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

Merck Sharp & Dohme Ltd

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/06/364/001-009

1.7.2011

29.6.2011

Advagraf

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

Astellas Pharma Europe B.V.

Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland

EU/1/07/387/001-026

5.7.2011

29.6.2011

Advate

| Baxter AG |
| --- |
| Industriesstrasse 67, 1220 Vienna, Österreich |

Baxter AG

Industriesstrasse 67, 1220 Vienna, Österreich

EU/1/03/271/001-006

4.7.2011

29.6.2011

APTIVUS

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

Boehringer Ingelheim International GmbH

Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland

EU/1/05/315/001-002

4.7.2011

29.6.2011

Avastin

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

Roche Registration Limited

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

EU/1/04/300/001-002

4.7.2011

29.6.2011

Bondenza

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

Roche Registration Limited

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

EU/1/03/266/003-006

1.7.2011

29.6.2011

Bondronat

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

Roche Registration Limited

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

EU/1/96/012/004

EU/1/96/012/009-013

1.7.2011

29.6.2011

Bonviva

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

Roche Registration Limited

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

EU/1/03/265/003-006

1.7.2011

29.6.2011

Byetta

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

Eli Lilly Nederland B.V.

Grootslag 1-5, 3991 RA Houten, Nederland

EU/1/06/362/001-004

5.7.2011

29.6.2011

Ecalta

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

Pfizer Limited

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

EU/1/07/416/001-002

1.7.2011

29.6.2011

Enbrel

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

Wyeth Europa Limited

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

EU/1/99/126/001-022

1.7.2011

29.6.2011

Enbrel

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

Wyeth Europa Limited

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

EU/1/99/126/001-022

5.7.2011

29.6.2011

Fosavance

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

Merck Sharp & Dohme Ltd

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/05/310/001-009

1.7.2011

29.6.2011

Ibandronic Acid Teva

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

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/10/642/001-004

1.7.2011

29.6.2011

Instanyl

| Nycomed Danmark ApS |
| --- |
| Langebjerg 1, DK-4000 Roskilde, Danmark |

Nycomed Danmark ApS

Langebjerg 1, DK-4000 Roskilde, Danmark

EU/1/09/531/001-021

5.7.2011

29.6.2011

IntronA

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

Schering Plough Europe

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

EU/1/99/127/011-039

EU/1/99/127/041-044

4.7.2011

29.6.2011

Karvea

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

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/97/049/001-039

5.7.2011

29.6.2011

Keppra

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

UCB Pharma SA.

Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België

EU/1/00/146/001-032

4.7.2011

29.6.2011

Nexavar

| Bayer Schering Pharma AG |
| --- |
| 13342 Berlin, Deutschland |

Bayer Schering Pharma AG

13342 Berlin, Deutschland

EU/1/06/342/001

5.7.2011

29.6.2011

Pegasys

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

Roche Registration Limited

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

EU/1/02/221/001-016

1.7.2011

29.6.2011

PegIntron

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

Schering Plough Europe

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

EU/1/00/131/001-050

1.7.2011

29.6.2011

Prevenar 13

| Wyeth Lederle Vaccines S.A. |
| --- |
| Pleainlaan 17 Boulevard de la Plaine, 1050 Brussels - Bruxelles, Belgium |

Wyeth Lederle Vaccines S.A.

Pleainlaan 17 Boulevard de la Plaine, 1050 Brussels - Bruxelles, Belgium

EU/1/09/590/001-006

5.7.2011

29.6.2011

Rasilez HCT

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/08/491/001-080

1.7.2011

29.6.2011

Rebetol

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

Schering Plough Europe

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

EU/1/99/107/001-005

1.7.2011

29.6.2011

Siklos

| ADDMEDICA |
| --- |
| 101, rue Saint Lazare, Paris 75009, France |

ADDMEDICA

101, rue Saint Lazare, Paris 75009, France

EU/1/07/397/001-004

4.7.2011

29.6.2011

Synflorix

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

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/09/508/001-011

5.7.2011

29.6.2011

Telmisartan Teva

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

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/09/610/031-060

5.7.2011

29.6.2011

Vantavo

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

Merck Sharp & Dohme Ltd.

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/09/572/001-009

1.7.2011

29.6.2011

Velcade

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

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/04/274/001-002

5.7.2011

29.6.2011

VPRIV

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

Shire Pharmaceuticals Ireland Limited

5 Riverside Walk, Citywest Business Campus, Dublin 24, Ireland

EU/1/10/646/003-006

5.7.2011

29.6.2011

Zometa

| Novartis Europharm Ltd |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/01/176/001-006

1.7.2011

—   Withdrawal of a marketing authorization (Article 13 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 |
| --- | --- | --- | --- | --- |
| 14.6.2011 | Humenza | Sanofi Pasteur SA |
| 2, avenue Pont Pasteur, F-69007 Lyon, France |

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

14.6.2011

Humenza

Sanofi Pasteur SA

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

EU/1/10/629/001

16.6.2011

—   Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
   (2)
  ): Accepted

| Date of the Décision | 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 6.5.2011 | CERTIFECT | (S)-Methoprene, Fipronil, Amitraz | MERIAL |
| 29 avenue Tony Garnier, 69007 LYON, France |

Date of the Décision

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

6.5.2011

CERTIFECT

(S)-Methoprene, Fipronil, Amitraz

MERIAL

29 avenue Tony Garnier, 69007 LYON, France

EU/2/11/125/001-008

Spot-on solution

QP53AX65

12.5.2011

6.5.2011

Zuprevo

Tildipirosin

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

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/11/124/001-008

Solution for injection

QJ01FA96

12.5.2011

14.6.2011

MS-H vaccine

Mycoplasma synoviae

Strain MS-H live attenuated thermosensitive

| Pharmsure Ltd |
| --- |
| Bewell House, Bewell St, Hereford HR4 0BA, United Kingdom |

Pharmsure Ltd

Bewell House, Bewell St, Hereford HR4 0BA, United Kingdom

EU/2/11/126/001

Eye drops, suspension

QI01AE03

16.6.2011

—   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 |
| --- | --- | --- | --- | --- |
| 16.5.2011 | Rheumocam | Chanelle Pharmaceuticals Manufacturing Limited |
| Loughrea, Co. Galway, IRELAND |

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

16.5.2011

Rheumocam

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, IRELAND

EU/2/07/078/001-014

18.5.2011

18.5.2011

Aivlosin

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom |

ECO Animal Health Ltd

78 Coombe Road New Malden Surrey KT3 4QS United Kingdom

EU/2/04/044/001-006

EU/2/04/044/013

23.5.2011

18.5.2011

Previcox

| Merial |
| --- |
| 29 Avenue Tony Garnier, 69007 Lyon, France |

Merial

29 Avenue Tony Garnier, 69007 Lyon, France

EU/2/04/045/001-007

20.5.2011

18.5.2011

ProteqFlu

| Merial |
| --- |
| 29 Avenue Tony Garnier, 69007 Lyon, France |

Merial

29 Avenue Tony Garnier, 69007 Lyon, France

EU/2/03/037/005

20.5.2011

18.5.2011

ProteqFlu-Te

| Merial |
| --- |
| 29 Avenue Tony Garnier, 69007 Lyon, France |

Merial

29 Avenue Tony Garnier, 69007 Lyon, France

EU/2/03/038/005

20.5.2011

23.5.2011

Suvaxyn PCV

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

Fort Dodge Animal Health Ltd

Flanders Road, Hedge End, Southampton SO30 4QH, United Kingdom

EU/2/09/099/001-006

25.5.2011

7.6.2011

Fevaxyn Pentofel

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

Pfizer Limited

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

EU/2/96/002/001-003

9.6.2011

14.6.2011

Advocate

| Bayer Animal Health GmbH |
| --- |
| 51368 Leverkusen, Deutschland |

Bayer Animal Health GmbH

51368 Leverkusen, Deutschland

EU/2/03/039/031-054

16.6.2011

14.6.2011

Naxcel

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

Pfizer Ltd

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

EU/2/05/053/003

16.6.2011

15.6.2011

Convenia

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

Pfizer Ltd

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

EU/2/06/059/001

17.6.2011

23.6.2011

Metacam

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| 55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim am Rhein, Deutschland

EU/2/97/004/026

EU/2/97/004/033-034

EU/2/97/004/039-040

EU/2/97/004/043-048

28.6.2011

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.

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

---

| 26.8.2011 | EN | Official Journal of the European Union | C 250/18 |
| --- | --- | --- | --- |

26.8.2011

EN

Official Journal of the European Union

C 250/18

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2011 to 30 June 2011

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

2011/C 250/02

—   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 |
| --- | --- | --- | --- | --- |
| 18.5.2011 | Arimidex and associated names - Referral Art 30 (amend) | See Annex I | See Annex I | 20.5.2011 |
| 12.5.2011 | Dianeal, Extraneal and Nutrineal and associated names - Art. 31 (amend) | See Annex II | See Annex II | 13.5.2011 |
| 15.6.2011 | Cinryze | ViroPharma SPRL-BVBA, rue Montoyer 47, 1000 Bruxelles, Belgique / Montoyerstraat 47, 1000 Brussel, België | These Decisions are addressed to the Member States. | 20.6.2011 |
| 29.6.2011 | Instanyl | Nycomed Danmark ApS, Langebjerg 1, DK-4000 Roskilde, Danmark | These Decisions are addressed to the Member States. | 4.7.2011 |
| 6.5.2011 | ReFacto AF | Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | These Decisions are addressed to the Member States. | 10.5.2011 |
| 6.5.2011 | Tygacil | Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | These Decisions are addressed to the Member States. | 12.5.2011 |
| 27.5.2011 | Lucentis | Novartis Europharm Ltd, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | These Decisions are addressed to the Member States. | 31.5.2011 |
| 16.6.2011 | Tysabri | Elan Pharma International Ltd., Monksland, Athlone, County Westmeath, Ireland | These Decisions are addressed to the Member States. | 20.6.2011 |
| 2.5.2011 | Revolade | GlaxoSmithKline Trading Services Limited, 6900 Cork Airport Business Park, Kinsale Road, Cork, Ireland | These Decisions are addressed to the Member States. | 3.5.2011 |
| 16.6.2011 | Ozurdex | Allergan Pharmaceuticals (Ireland) Ltd, Castlebar Road, Westport, Co. Mayo, Ireland | These Decisions are addressed to the Member States. | 20.6.2011 |
| 6.5.2011 | Rotarix | GlaxoSmithKline Biologicals S.A., rue de l’Institut 89, Rixensart, B-1330 Belgique | These Decisions are addressed to the Member States. | 11.5.2011 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

18.5.2011

Arimidex and associated names - Referral Art 30 (amend)

See Annex I

See Annex I

20.5.2011

12.5.2011

Dianeal, Extraneal and Nutrineal and associated names - Art. 31 (amend)

See Annex II

See Annex II

13.5.2011

15.6.2011

Cinryze

ViroPharma SPRL-BVBA, rue Montoyer 47, 1000 Bruxelles, Belgique / Montoyerstraat 47, 1000 Brussel, België

These Decisions are addressed to the Member States.

20.6.2011

29.6.2011

Instanyl

Nycomed Danmark ApS, Langebjerg 1, DK-4000 Roskilde, Danmark

These Decisions are addressed to the Member States.

4.7.2011

6.5.2011

ReFacto AF

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

These Decisions are addressed to the Member States.

10.5.2011

6.5.2011

Tygacil

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

These Decisions are addressed to the Member States.

12.5.2011

27.5.2011

Lucentis

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

These Decisions are addressed to the Member States.

31.5.2011

16.6.2011

Tysabri

Elan Pharma International Ltd., Monksland, Athlone, County Westmeath, Ireland

These Decisions are addressed to the Member States.

20.6.2011

2.5.2011

Revolade

GlaxoSmithKline Trading Services Limited, 6900 Cork Airport Business Park, Kinsale Road, Cork, Ireland

These Decisions are addressed to the Member States.

3.5.2011

16.6.2011

Ozurdex

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

These Decisions are addressed to the Member States.

20.6.2011

6.5.2011

Rotarix

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

These Decisions are addressed to the Member States.

11.5.2011

—   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 |
| --- | --- | --- | --- | --- |
| 18.5.2011 | Isotretinoin | See Annex III | See Annex III | 19.5.2011 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

18.5.2011

Isotretinoin

See Annex III

See Annex III

19.5.2011

—   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 |
| --- | --- | --- | --- | --- |
| 18.5.2011 | Isotretinoin | See Annex III | See Annex III | 19.5.2011 |
| 23.5.2011 | Octagam Article 107 Final measures | See Annex IV | See Annex IV | 25.5.2011 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

18.5.2011

Isotretinoin

See Annex III

See Annex III

19.5.2011

23.5.2011

Octagam Article 107 Final measures

See Annex IV

See Annex IV

25.5.2011

—   Lift of 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 |
| --- | --- | --- | --- | --- |
| 30.5.2011 | Octagam Art 31 Lift of suspension | See Annex V | See Annex V | 31.5.2011 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

30.5.2011

Octagam Art 31 Lift of suspension

See Annex V

See Annex V

31.5.2011

---

(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 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 | 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

Arimidex

1 mg

Film-coated Tablets

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

Arimidex

1 mg

Film-coated Tablets

Oral use

Bulgaria

| AstraZeneca Pharmaceuticals AB, |
| --- |
| S-15185 Södertälje, |
| Sweden |

AstraZeneca Pharmaceuticals AB,

S-15185 Södertälje,

Sweden

Arimidex

1 mg

Film-coated Tablets

Oral use

Cyprus

| 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

Arimidex

1 mg

Film-coated Tablets

Oral use

Czech Republic

| 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

Arimidex

1 mg

Film-coated Tablets

Oral use

Denmark

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| 2620 Albertslund, |
| Denmark |

AstraZeneca A/S

Roskildevej 22

2620 Albertslund,

Denmark

Arimidex

1 mg

Film-coated Tablets

Oral use

Estonia

| AstraZeneca UK Ltd. |
| --- |
| 2 Kingdom Street, |
| London |
| W2 6BD, |
| United Kingdom |

AstraZeneca UK Ltd.

2 Kingdom Street,

London

W2 6BD,

United Kingdom

Arimidex

1 mg

Film-coated Tablets

Oral use

Finland

| AstraZeneca Oy |
| --- |
| Luomanportti 3 |
| 02200 Espoo |
| Finland |

AstraZeneca Oy

Luomanportti 3

02200 Espoo

Finland

Arimidex

1 mg

Film-coated Tablets

Oral use

France

| AstraZeneca |
| --- |
| 1, Place Renault |
| 92844 RUEIL-MALMAISON CEDEX |
| France |

AstraZeneca

1, Place Renault

92844 RUEIL-MALMAISON CEDEX

France

Arimidex

1 mg

Film-coated Tablets

Oral use

Germany

| AstraZeneca GmbH |
| --- |
| Tinsdaler Weg 183 |
| 22880 Wedel |
| Postanschrift 22876 Wedel |
| Germany |

AstraZeneca GmbH

Tinsdaler Weg 183

22880 Wedel

Postanschrift 22876 Wedel

Germany

Arimidex

1 mg

Film-coated Tablets

Oral use

Greece

| AstraZeneca S.A. |
| --- |
| 4 Theotokopoulou & Astronafton str |
| 151 25 Maroussi |
| Athens, |
| Greece |

AstraZeneca S.A.

4 Theotokopoulou & Astronafton str

151 25 Maroussi

Athens,

Greece

Arimidex

1 mg

Film-coated Tablets

Oral use

Hungary

| AstraZeneca Kft. |
| --- |
| 1113 Budapest, Bocskai ut 134-146 |
| Hungary |

AstraZeneca Kft.

1113 Budapest, Bocskai ut 134-146

Hungary

Arimidex

1 mg

Film-coated Tablets

Oral use

Iceland

| AstraZeneca AB |
| --- |
| 151 85 Södertälje |
| Sweden |

AstraZeneca AB

151 85 Södertälje

Sweden

Arimidex

1 mg

Film-coated Tablets

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

Arimidex

1 mg

Film-coated Tablets

Oral use

Italy

| AstraZeneca UK Limited |
| --- |
| 600 Capability Green |
| Luton LU1 3LU |
| United Kingdom |

AstraZeneca UK Limited

600 Capability Green

Luton LU1 3LU

United Kingdom

Arimidex

1 mg

Film-coated Tablets

Oral use

Latvia

| AstraZeneca UK Limited |
| --- |
| Silk Road Business Park Macclesfield, |
| Cheshire |
| SK 10 2NA |
| United Kingdom |

AstraZeneca UK Limited

Silk Road Business Park Macclesfield,

Cheshire

SK 10 2NA

United Kingdom

Arimidex

1 mg

Film-coated Tablets

Oral use

Lithuania

| 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

Arimidex

1 mg

Film-coated Tablets

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

Arimidex

1 mg

Film-coated Tablets

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

Arimidex

1 mg

Film-coated Tablets

Oral use

Netherlands

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE Zoetermeer |
| The Netherlands |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Arimidex

1 mg

Film-coated Tablets

Oral use

Norway

| AstraZeneca AS |
| --- |
| Innspurten 15, 0663 OSLO, Postboks 6050 |
| Etterstad 0601, |
| OSLO |
| Norway |

AstraZeneca AS

Innspurten 15, 0663 OSLO, Postboks 6050

Etterstad 0601,

OSLO

Norway

Arimidex

1 mg

Film-coated Tablets

Oral use

Poland

| 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

Arimidex

1 mg

Film-coated Tablets

Oral use

Portugal

| AstraZeneca Produtos Farmacêuticos, Lda. |
| --- |
| Rua Humberto Madeira, n.o 7, Queluz de Baixo, |
| 2730-097 Barcarena, |
| Portugal |

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, n.o 7, Queluz de Baixo,

2730-097 Barcarena,

Portugal

Arimidex

1 mg

Film-coated Tablets

Oral use

Romania

| AstraZeneca UK Limited |
| --- |
| 600 Capability Green |
| Luton, |
| LU1 3LU |
| United Kingdom |

AstraZeneca UK Limited

600 Capability Green

Luton,

LU1 3LU

United Kingdom

Arimidex

1 mg

Film-coated Tablets

Oral use

Slovak Republic

| 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

Arimidex

1 mg

Film-coated Tablets

Oral use

Slovenia

| AstraZeneca UK Limited |
| --- |
| 2 Kingdom Street, |
| London |
| W2 6BD, |
| United Kingdom |

AstraZeneca UK Limited

2 Kingdom Street,

London

W2 6BD,

United Kingdom

Arimidex 1 mg filmsko obložene tablete

1 mg

Film-coated Tablets

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

Arimidex

1 mg

Film-coated Tablets

Oral use

Sweden

| AstraZeneca AB |
| --- |
| 151 85 Södertälje |
| Sweden |

AstraZeneca AB

151 85 Södertälje

Sweden

Arimidex

1 mg

Film-coated Tablets

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

Arimidex

1 mg

Film-coated Tablets

Oral use

---

ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORM, 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 | Baxter Healthcare GmbH, Stella-Klein-Löw-Weg 15, A-1020 Wien, Austria | Dianeal PD4 Glucose 1,36 % w/v/13,6 mg/ml - Peritonealdialyselösung | Anhydrous glucose 13,6 g/L, sodium chloride 5,38 g/L, sodium-L(+) lactate 4,48 g/L, calcium chloride dihydrate 0,184 g/L, magnesium chloride hexahydrate 0,051 g/L | Solution for peritoneal dialysis | Intraperitoneal use |
| Austria | Baxter Healthcare GmbH, Stella-Klein-Löw-Weg 15, A-1020 Wien, Austria | Dianeal PD4 Glucose 2,27 % w/v/22,7 mg/ml - Peritonealdialyselösung | Anhydrous glucose 22,7 g/L, sodium chloride 5,38 g/L, sodium-L(+) lactate 4,48 g/L, calcium chloride dihydrate 0,184 g/L, magnesium chloride hexahydrate 0,051 g/L | Solution for peritoneal dialysis | Intraperitoneal use |
| Austria | Baxter Healthcare GmbH, Stella-Klein-Löw-Weg 15, A-1020 Wien, Austria | Dianeal PD4 Glucose 3,86 % w/v/38,6 mg/ml - Peritonealdialyselösung | Anhydrous glucose 38,6 g/L, sodium chloride 5,38 g/L, sodium-L(+) lactate 4,48 g/L, calcium chloride dihydrate 0,184 g/L, magnesium chloride hexahydrate 0,051 g/L | Solution for peritoneal dialysis | Intraperitoneal use |
| Austria | Baxter Healthcare GmbH, Stella-Klein-Löw-Weg 15, A-1020 Wien, Austria | EXTRANEAL - Peritonealdialyselösung | 75 g/L | Solution for peritoneal dialysis | Intraperitoneal use |
| Belgium | Baxter SA |
| Bld R Branquart 80 |
| 7860 Lessines |
| Belgium |

Member State

Marketing authorisation holder

Product name

Strength

Pharmaceutical form

Route of administration

Austria

Baxter Healthcare GmbH, Stella-Klein-Löw-Weg 15, A-1020 Wien, Austria

Dianeal PD4 Glucose 1,36 % w/v/13,6 mg/ml - Peritonealdialyselösung

Anhydrous glucose 13,6 g/L, sodium chloride 5,38 g/L, sodium-L(+) lactate 4,48 g/L, calcium chloride dihydrate 0,184 g/L, magnesium chloride hexahydrate 0,051 g/L

Solution for peritoneal dialysis

Intraperitoneal use

Austria

Baxter Healthcare GmbH, Stella-Klein-Löw-Weg 15, A-1020 Wien, Austria

Dianeal PD4 Glucose 2,27 % w/v/22,7 mg/ml - Peritonealdialyselösung

Anhydrous glucose 22,7 g/L, sodium chloride 5,38 g/L, sodium-L(+) lactate 4,48 g/L, calcium chloride dihydrate 0,184 g/L, magnesium chloride hexahydrate 0,051 g/L

Solution for peritoneal dialysis

Intraperitoneal use

Austria

Baxter Healthcare GmbH, Stella-Klein-Löw-Weg 15, A-1020 Wien, Austria

Dianeal PD4 Glucose 3,86 % w/v/38,6 mg/ml - Peritonealdialyselösung

Anhydrous glucose 38,6 g/L, sodium chloride 5,38 g/L, sodium-L(+) lactate 4,48 g/L, calcium chloride dihydrate 0,184 g/L, magnesium chloride hexahydrate 0,051 g/L

Solution for peritoneal dialysis

Intraperitoneal use

Austria

Baxter Healthcare GmbH, Stella-Klein-Löw-Weg 15, A-1020 Wien, Austria

EXTRANEAL - Peritonealdialyselösung

75 g/L

Solution for peritoneal dialysis

Intraperitoneal use

Belgium

Baxter SA

Bld R Branquart 80

7860 Lessines

Belgium

Dianeal PD4 Glucose 1,36 % (13,6 mg/ml), solution pour dialyse péritonéale.

13,6 g/l glucose anhydrate

Solution for peritoneal dialysis

Intraperitoneal use

Belgium

| Baxter SA |
| --- |
| Bld R Branquart 80 |
| 7860 Lessines |
| Belgium |

Baxter SA

Bld R Branquart 80

7860 Lessines

Belgium

Dianeal PD4 Glucose 2,27 % (22,7 mg/ml), solution pour dialyse péritonéale.

22,7 g/l glucose anhydrate

Solution for peritoneal dialysis

Intraperitoneal use

Belgium

| Baxter SA |
| --- |
| Bld R Branquart 80 |
| 7860 Lessines |
| Belgium |

Baxter SA

Bld R Branquart 80

7860 Lessines

Belgium

Dianeal PD4 Glucose 3,86 % (38,6 mg/ml), solution pour dialyse péritonéale.

38,6 g/l glucose anhydrate

Solution for peritoneal dialysis

Intraperitoneal use

Belgium

| Baxter SA |
| --- |
| Bld R Branquart 80 |
| 7860 Lessines |
| Belgium |

Baxter SA

Bld R Branquart 80

7860 Lessines

Belgium

EXTRANEAL 7,5 %, solution pour dialyse péritonéale

75,00 g/l Icodextrine

Solution for peritoneal dialysis

Intraperitoneal use

Bulgaria

BAXTER d.o.o., Zelezna cesta 18, 1000 Ljubljana, Slovenia

Dianeal PD4 Glucose

2,27 % w/v/ 22,7 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Bulgaria

BAXTER d.o.o., Zelezna cesta 18, 1000 Ljubljana, Slovenia

Dianeal PD4 Glucose

3,86 % w/v/ 38,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Bulgaria

BAXTER d.o.o., Zelezna cesta 18, 1000 Ljubljana, Slovenia

Dianeal PD4 Glucose 1,36 % w/v/ 13,6 mg/ml

1,36 % w/v/ 13,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Bulgaria

BAXTER d.o.o., Zelezna cesta 18, 1000 Ljubljana, Slovenia

Extraneal

7,50 %

Solution for peritoneal dialysis

Intraperitoneal use

Czech Republic

Baxter Healthcare S.A. Moneen Road Castlebar, Co. Mayo Ireland

Dianeal PD4 Glucose 1,36 % w/v/13,6 mg/ml

1,36 % w/v/13,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Czech Republic

Baxter Healthcare S.A. Moneen Road Castlebar, Co. Mayo Ireland

Dianeal PD4 Glucose 2,27 % w/v/22,7 mg/ml

2,27 % w/v/22,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Czech Republic

Baxter Healthcare S.A. Moneen Road Castlebar, Co. Mayo Ireland

Dianeal PD4 Glucose 3,86 % w/v/38,6 mg/ml

3,86 % w/v/38,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Czech Republic

Baxter Healthcare S.A. Moneen Road Castlebar, Co. Mayo Ireland

EXTRANEAL

7,5 % 75 g/1 000 ml

Solution for peritoneal dialysis

Intraperitoneal use

Denmark

Baxter A/S, Gydevang 43, DK-3450 Allerød, Denmark

Dianeal PD4 med Glucos

13,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Denmark

Baxter A/S, Gydevang 43, DK-3450 Allerød, Denmark

Dianeal PD4 med Glucos

22,7 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Denmark

Baxter A/S, Gydevang 43, DK-3450 Allerød, Denmark

Dianeal PD4 med Glucos

38,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Denmark

Baxter A/S, Gydevang 43, DK-3450 Allerød, Denmark

Extraneal

75 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Estonia

Baxter OY P.O box 270, Valimotie 15A, Helsinki 00381 Finland

EXTRANEAL

7,50 %

Solution for peritoneal dialysis

Intraperitoneal use

Finland

Baxter Healthcare S.A. Moneen Road, Castlebar County Mayo Ireland

Dianeal PD4 Glucose

13,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Finland

Baxter Healthcare S.A. Moneen Road, Castlebar County Mayo Ireland

Dianeal PD4 Glucose

22,7 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Finland

Baxter Healthcare S.A. Moneen Road, Castlebar County Mayo Ireland

Dianeal PD4 Glucose

38,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Finland

Baxter Oy Valimotie 15 A 00380 Helsinki Finland

Extraneal

7,5 %

Solution for peritoneal dialysis

Intraperitoneal use

France

| Baxter SAS |
| --- |
| Avenue louis Pasteur |
| ZA de Coignères Maurepas |
| 78310 Maurepas |
| France |

Baxter SAS

Avenue louis Pasteur

ZA de Coignères Maurepas

78310 Maurepas

France

DIANEAL PD4 GLUCOSE 1,36 %, solution pour dialyse péritonéale en poche

1,36 %

Solution for peritoneal dialysis

Intraperitoneal use

France

| Baxter SAS |
| --- |
| Avenue louis Pasteur |
| ZA de Coignères Maurepas |
| 78310 Maurepas |
| France |

Baxter SAS

Avenue louis Pasteur

ZA de Coignères Maurepas

78310 Maurepas

France

DIANEAL PD4 GLUCOSE 2,27 %, solution pour dialyse péritonéale en poche

2,27 %

Solution for peritoneal dialysis

Intraperitoneal use

France

| Baxter SAS |
| --- |
| Avenue louis Pasteur |
| ZA de Coignères Maurepas |
| 78310 Maurepas |
| France |

Baxter SAS

Avenue louis Pasteur

ZA de Coignères Maurepas

78310 Maurepas

France

DIANEAL PD4 GLUCOSE 3,86 %, solution pour dialyse péritonéale en poche

3,86 %

Solution for peritoneal dialysis

Intraperitoneal use

France

| Baxter SAS |
| --- |
| Avenue louis Pasteur |
| ZA de Coignères Maurepas |
| 78310 Maurepas |
| France |

Baxter SAS

Avenue louis Pasteur

ZA de Coignères Maurepas

78310 Maurepas

France

EXTRANEAL, solution pour dialyse péritonéale

7,50 %

Solution for peritoneal dialysis

Intraperitoneal use

Germany

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Dianeal PD4 Glucose 1,36 % w/v

13,6 g/l

5,4 g/l

4,5 g/l

0,184 g/l

0,051 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Germany

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Dianeal PD4 Glucose 2,27 % w/v

22,7 g/l

5,4 g/l

4,5 g/l

0,184 g/l

0,051 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Germany

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Dianeal PD4 Glucose 3,86 % w/v

38,6 g/l

5,4 g/l

4,5 g/l

0,184 g/l

0,051 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Germany

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Dianeal PDG4 1,36 %

13,6 g/l

5,38 g/l

4,48 g/ l

0,184 g/l

0,051 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Germany

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Dianeal PDG4 2,27 %

22,7 g/l

5,38 g/l

4,48 g/ l

0,184 g/l

0,051 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Germany

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Extraneal

75 g/l

5,4. g/l

4,5 g/l

0,257 g/l

0,051 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Greece

| DIOPHAR S.A. |
| --- |
| Kifissias Avenue 368, |
| Halandri, 152 33 |
| Greece |

DIOPHAR S.A.

Kifissias Avenue 368,

Halandri, 152 33

Greece

DIANEAL PD4

1,36 %

Solution for peritoneal dialysis

Intraperitoneal use

Greece

| DIOPHAR S.A. |
| --- |
| Kifissias Avenue 368, |
| Halandri, 152 33 |
| Greece |

DIOPHAR S.A.

Kifissias Avenue 368,

Halandri, 152 33

Greece

EXTRANEAL

(7,5 + 0,54 + 0,45 + 0,0257 + 0,0051) % w/v

Solution for peritoneal dialysis

Intraperitoneal use

Hungary

| Baxter Hungary Kft. |
| --- |
| Népfürdő u. 22. |
| 1138, Budapest |
| Hungary |

Baxter Hungary Kft.

Népfürdő u. 22.

1138, Budapest

Hungary

DIANEAL PD 4 Glucose 1,36 % peritoneális dializáló oldat

1,36 %

Solution for peritoneal dialysis

Intraperitoneal use

Hungary

| Baxter Hungary Kft. |
| --- |
| Népfürdő u. 22. |
| 1138, Budapest |
| Hungary |

Baxter Hungary Kft.

Népfürdő u. 22.

1138, Budapest

Hungary

DIANEAL PD 4 Glucose 2,27 % peritoneális dializáló oldat

2,27 %

Solution for peritoneal dialysis

Intraperitoneal use

Hungary

| Baxter Hungary Kft. |
| --- |
| Népfürdő u. 22. |
| 1138, Budapest |
| Hungary |

Baxter Hungary Kft.

Népfürdő u. 22.

1138, Budapest

Hungary

DIANEAL PD 4 Glucose 3,86 % peritoneális dializáló oldat

3,86 %

Solution for peritoneal dialysis

Intraperitoneal use

Hungary

| Baxter Hungary Kft. |
| --- |
| Népfürdő u. 22. |
| 1138, Budapest |
| Hungary |

Baxter Hungary Kft.

Népfürdő u. 22.

1138, Budapest

Hungary

EXTRANEAL peritoneális dializáló oldat

7,5 % (icodextrin)

Solution for peritoneal dialysis

Intraperitoneal use

Iceland

Baxter Healthare SA Moneen Road Castlebar County Mayo Irland

Dianeal PD4 Glucose

13,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Iceland

Baxter Healthare SA Moneen Road Castlebar County Mayo Irland

Dianeal PD4 Glucose

22,7 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Iceland

Baxter Healthare SA Moneen Road Castlebar County Mayo Irland

Dianeal PD4 Glucose

38,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Ireland

Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom

Dianeal PD4 Glucose 1,36 % w/v (13,6 mg/ml) Solution for peritoneal dialysis

1,36 % w/v (13,6 mg/ml)

Solution for peritoneal dialysis

Intraperitoneal use

Ireland

Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom

Dianeal PD4 Glucose 2,27 % w/v (22,7 mg/ml) Solution for peritoneal dialysis

2,27 % w/v (22,7 mg/ml)

Solution for peritoneal dialysis

Intraperitoneal use

Ireland

Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom

Dianeal PD4 Glucose 3,86 % w/v (38,6 mg/ml) Solution for peritoneal dialysis

3,86 % w/v (38,6 mg/ml)

Solution for peritoneal dialysis

Intraperitoneal use

Ireland

Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom

EXTRANEAL Solution for peritoneal dialysis

Solution for peritoneal dialysis

Intraperitoneal use

Italy

| Baxter SPA piazzale dell’ industria 20 - 00144-Roma |
| --- |
| Italy |

Baxter SPA piazzale dell’ industria 20 - 00144-Roma

Italy

EXTRANEAL

7,5 %

Solution for dialysis peritoneal

Intraperitoneal use

Italy

| Baxter SPA piazzale dell’ industria 20 - 00144-Roma |
| --- |
| Italy |

Baxter SPA piazzale dell’ industria 20 - 00144-Roma

Italy

SOLUZIONI PER DIALISI PERITONEALE BAXTER

4,95 g/l - 49,54 g/l;

Solution for dialysis peritoneal

Intraperitoneal use

Latvia

| Baxter Healthcare S.A. Moneen Road |
| --- |
| Castlebar |
| County Mayo |
| IRELAND |

Baxter Healthcare S.A. Moneen Road

Castlebar

County Mayo

IRELAND

Dianeal PD4 Glucose 1,36 % w/v/13,6 mg/ml solution for peritoneal dialysis

1,36 % w/v 0,538 % w/v 0,448 % w/v 0,0184 % w/v 0,0051 % w/v

Solution for peritoneal dialysis

Intraperitoneal use

Latvia

| Baxter Healthcare S.A. Moneen Road |
| --- |
| Castlebar |
| County Mayo |
| IRELAND |

Baxter Healthcare S.A. Moneen Road

Castlebar

County Mayo

IRELAND

Dianeal PD4 Glucose 2,27 % w/v/22,7 mg/ml solution for peritoneal dialysis

2,27 % w/v

0,538 % w/v 0,448 % w/v

0,0184 % w/v 0,0051 % w/v

Solution for peritoneal dialysis

Intraperitoneal use

Latvia

| Baxter Healthcare S.A. Moneen Road |
| --- |
| Castlebar |
| County Mayo |
| IRELAND |

Baxter Healthcare S.A. Moneen Road

Castlebar

County Mayo

IRELAND

Dianeal PD4 Glucose 3,86 % w/v/38,6 mg/ml solution for peritoneal dialysis

3,86 % w/v 0,538 % w/v 0,448 % w/v 0,0184 % w/v 0,0051 % w/v

Solution for peritoneal dialysis

Intraperitoneal use

Latvia

| Baxter Oy Valimotie 15 A 00380 Helsinki Finland |
| --- |
| FINLAND |

Baxter Oy Valimotie 15 A 00380 Helsinki Finland

FINLAND

Extraneal solution for peritoneal dialysis

75 g/L 5,4 g/L 4,5 g/L 0,257 g/L 0,051 g/L

Solution for peritoneal dialysis

Intraperitoneal use

Lithuania

Baxter Healthcare S.A., Moneen Road, Castlebar County Mayo, Ireland

Dianeal PD4 Glucose

13,6 g + 5,38g + 4,48 g + 0,184 g + 0,051 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Lithuania

Baxter Healthcare S.A., Moneen Road, Castlebar County Mayo, Ireland

Dianeal PD4 Glucose

22,7 g + 5,38 g + 4,48 g + 0,184 g + 0,051 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Lithuania

Baxter Healthcare S.A., Moneen Road, Castlebar County Mayo, Ireland

Dianeal PD4 Glucose

38,6 g + 5,38 g + 4,48 g + 0,184 g + 0,051 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Lithuania

Baxter Oy, P.O. Box 270 Valimotie 15A 00381 Helsinki, Finland

EXTRANEAL

75 g + 5,4 g + 4,5 g + 0,257 g + 0,051 g/1 000 ml

Solution for peritoneal dialysis

Intraperitoneal use

Luxembourg

| Baxter SA, |
| --- |
| Bd René Branquart 80, |
| B-7860 Lessines |
| Belgium |

Baxter SA,

Bd René Branquart 80,

B-7860 Lessines

Belgium

Dianeal PD4 Glucose

1,36 %/2,27 %/3,86 % dextrose anydre

Solution for peritoneal dialysis

Intraperitoneal use

Luxembourg

| Baxter SA, |
| --- |
| Bd René Branquart 80, |
| B-7860 Lessines |
| Belgium |

Baxter SA,

Bd René Branquart 80,

B-7860 Lessines

Belgium

Extraneal

75,00 g/l Icodextrine

Solution for peritoneal dialysis

Intraperitoneal use

Malta

| Baxter Healthcare Ltd., |
| --- |
| Caxton Way, |
| Thetford, |
| Norfolk, |
| IP24 3SE |
| United Kingdom |

Baxter Healthcare Ltd.,

Caxton Way,

Thetford,

Norfolk,

IP24 3SE

United Kingdom

Dianeal PD4 Glucose 1,36 % w/v 13,6 mg/ml

Anhydrous Glucose Ph.Eur. 1,36 % w/v

or Glucose Monohydrate Ph.Eur. 1,50 % w/v

Sodium Chloride Ph.Eur. 0,538 % w/v

Sodium Lactate Ph.Eur. 0,448 % w/v

Calcium Chloride Ph.Eur. 0,0184 % w/v

Magnesium Chloride Ph.Eur. 0,0051 % w/v

Solution for peritoneal dialysis

Intraperitoneal use

Malta

| Baxter Healthcare Ltd., |
| --- |
| Caxton Way, |
| Thetford, |
| Norfolk, |
| IP24 3SE |
| United Kingdom |

Baxter Healthcare Ltd.,

Caxton Way,

Thetford,

Norfolk,

IP24 3SE

United Kingdom

Dianeal PD4 Glucose 2,27 % w/v 22,7 mg/ml

Anhydrous Glucose Ph.Eur. 2,27 % w/v

or Glucose Monohydrate Ph.Eur. 2,50 % w/v

Sodium Chloride Ph.Eur. 0,538 % w/v

Sodium Lactate Ph.Eur. 0,448 % w/v

Calcium Chloride Ph.Eur. 0,0184 % w/v

Magnesium Chloride Ph.Eur. 0,0051 % w/v

Solution for peritoneal dialysis

Intraperitoneal use

Malta

| Baxter Healthcare Ltd., |
| --- |
| Caxton Way, |
| Thetford, |
| Norfolk, |
| IP24 3SE |
| United Kingdom |

Baxter Healthcare Ltd.,

Caxton Way,

Thetford,

Norfolk,

IP24 3SE

United Kingdom

Dianeal PD4 Glucose 3,86 % w/v 38,6 mg/ml

Anhydrous Glucose Ph.Eur. 3,86 % w/v

or Glucose Monohydrate Ph.Eur. 4,25 % w/v

Sodium Chloride Ph.Eur. 0,538 % w/v

Sodium Lactate Ph.Eur. 0,448 % w/v

Calcium Chloride Ph.Eur. 0,0184 % w/v

Magnesium Chloride Ph.Eur. 0,0051 % w/v

Solution for peritoneal dialysis

Intraperitoneal use

Malta

| Baxter Healthcare Ltd., |
| --- |
| Caxton Way, |
| Thetford, |
| Norfolk, |
| IP24 3SE |
| United Kingdom |

Baxter Healthcare Ltd.,

Caxton Way,

Thetford,

Norfolk,

IP24 3SE

United Kingdom

Extraneal (Icodextrin 7,5 %)

Icodextrin (75 g/l), Sodium chloride (5,4 g/l),

Calcium chloride (0,257 g/l), Magnesium chloride

(0,051 g/l), Sodium lactate solution (4,5 g/l)

Solution for peritoneal dialysis

Intraperitoneal use

Norway

| Baxter AS |
| --- |
| Gjerdrumsvei 11 |
| 0484 Oslo, Norway |

Baxter AS

Gjerdrumsvei 11

0484 Oslo, Norway

Extraneal

75 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Poland

| Baxter Polska SP. z o.o. |
| --- |
| Kruczkowskiego 8 st., |
| 00-380 Warsawa, Poland |

Baxter Polska SP. z o.o.

Kruczkowskiego 8 st.,

00-380 Warsawa, Poland

Dianeal PD4 (glukoza 1,36 %). Zestaw do dializy otrzewnowej

Solution for peritoneal dialysis

Intraperitoneal use

Poland

| Baxter Polska SP. z o.o. |
| --- |
| Kruczkowskiego 8 st., |
| 00-380 Warsawa, Poland |

Baxter Polska SP. z o.o.

Kruczkowskiego 8 st.,

00-380 Warsawa, Poland

Dianeal PD4 (glukoza 2,27 %). Zestaw do dializy otrzewnowej

Solution for peritoneal dialysis

Intraperitoneal use

Poland

| Baxter Polska SP. z o.o. |
| --- |
| Kruczkowskiego 8 st., |
| 00-380 Warsawa, Poland |

Baxter Polska SP. z o.o.

Kruczkowskiego 8 st.,

00-380 Warsawa, Poland

Dianeal PD4 (glukoza 3,86 %). Zestaw do dializy otrzewnowej

Solution for peritoneal dialysis

Intraperitoneal use

Poland

| Baxter Polska SP. z o.o. |
| --- |
| Kruczkowskiego 8 st., |
| 00-380 Warsawa, Poland |

Baxter Polska SP. z o.o.

Kruczkowskiego 8 st.,

00-380 Warsawa, Poland

Extraneal Zestaw do dializy otrzewnowej

Solution for peritoneal dialysis

Intraperitoneal use

Poland

| Baxter Polska SP. z o.o. |
| --- |
| Kruczkowskiego 8 st., |
| 00-380 Warsawa, Poland |

Baxter Polska SP. z o.o.

Kruczkowskiego 8 st.,

00-380 Warsawa, Poland

Extraneal Zestaw do dializy otrzewnowej

Solution for peritoneal dialysis

Intraperitoneal use

Portugal

Baxter Médico-Farmacêutica, Lda. Zona Industrial da Abrunheira - Edifício 10 - Sintra Business Park, 2710-089 Sintra Portugal

Dianeal Pd4

42,5 mg/ml Glucose Monohydrate; 5,38 mg/ml Sodium Chloride; 0,184 mg/ml Calcium Chloride Dihydrate; 0,051 mg/ml Magnesium Chloride Hexahydrate; 4,48 mg/ml Sodium Lactate.

Solution for peritoneal dialysis

Intraperitoneal use

Portugal

Baxter Médico-Farmacêutica, Lda. Zona Industrial da Abrunheira - Edifício 10 - Sintra Business Park, 2710-089 Sintra Portugal

Dianeal Pd4

25 mg/ml Glucose Monohydrate; 5,38 mg/ml Sodium Chloride; 0,184 mg/ml Calcium Chloride Dihydrate; 0,051 mg/ml Magnesium Chloride Hexahydrate; 4,48 mg/ml Sodium Lactate.

Solution for peritoneal dialysis

Intraperitoneal use

Portugal

Baxter Médico-Farmacêutica, Lda. Zona Industrial da Abrunheira - Edifício 10 - Sintra Business Park, 2710-089 Sintra Portugal

Dianeal Pd4

15 mg/ml Glucose Monohydrate; 5,38 mg/ml Sodium Chloride; 0,184 mg/ml Calcium Chloride Dihydrate; 0,051 mg/ml Magnesium Chloride Hexahydrate; 4,48 mg/ml Sodium Lactate.

Solution for peritoneal dialysis

Intraperitoneal use

Portugal

Baxter Médico-Farmacêutica, Lda. Zona Industrial da Abrunheira - Edifício 10 - Sintra Business Park, 2710-089 Sintra Portugal

Extraneal

75 mg/ml Icodextrin; 5,4 mg/ml Sodium Chloride; 4,5 mg/ml Sodium (S) - lactate solution; 0,051 mg/ml Magnesium Chloride; 0,257 mg/ml Calcium Chloride.

Solution for peritoneal dialysis

Intraperitoneal use

Romania

| BAXTER HEALTHCARE S.A. |
| --- |
| Moneen Road, Castelbar, County Mayo, Ireland |

BAXTER HEALTHCARE S.A.

Moneen Road, Castelbar, County Mayo, Ireland

DIANEAL PD4 GLUCOSE 1,36 % m/v (13,6 mg/ml),

13,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Romania

| BAXTER HEALTHCARE S.A. |
| --- |
| Moneen Road, Castelbar, County Mayo, Ireland |

BAXTER HEALTHCARE S.A.

Moneen Road, Castelbar, County Mayo, Ireland

DIANEAL PD4 GLUCOSE 2,27 % m/v (22,7 mg/ml)

22,7 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Romania

| BAXTER HEALTHCARE S.A. |
| --- |
| Moneen Road, Castelbar, County Mayo, Ireland |

BAXTER HEALTHCARE S.A.

Moneen Road, Castelbar, County Mayo, Ireland

DIANEAL PD4 GLUCOSE 3,86 % m/v (38,6 mg/ml)

38,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Romania

| BAXTER HEALTHCARE Ltd., |
| --- |
| Caxton Way, Thetford, Norfolk, 1P24 3SE, Thetford, |
| United Kingdom |

BAXTER HEALTHCARE Ltd.,

Caxton Way, Thetford, Norfolk, 1P24 3SE, Thetford,

United Kingdom

EXTRANEAL

75 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Slovak Republic

| Baxter Healthcare SA Moneen Rd |
| --- |
| Castlebar, Co. Mayo Ireland |

Baxter Healthcare SA Moneen Rd

Castlebar, Co. Mayo Ireland

DIANEAL PD4 glucose 1,36 % w/v/13,6 mg/ ml

13,6 mg/1 ml

Solution for peritoneal dialysis

Intraperitoneal use

Slovak Republic

| Baxter Healthcare SA Moneen Rd |
| --- |
| Castlebar, Co. Mayo Ireland |

Baxter Healthcare SA Moneen Rd

Castlebar, Co. Mayo Ireland

DIANEAL PD4 glucose 2,27 % w/v/22,7 mg/ ml

22,7 mg/1 ml

Solution for peritoneal dialysis

Intraperitoneal use

Slovak Republic

| Baxter Healthcare SA Moneen Rd |
| --- |
| Castlebar, Co. Mayo Ireland |

Baxter Healthcare SA Moneen Rd

Castlebar, Co. Mayo Ireland

DIANEAL PD4 glucose 3,86 % w/v/38,6 mg/ ml

38,6 mg/1 ml

Solution for peritoneal dialysis

Intraperitoneal use

Slovak Republic

Baxter Healthcare Ltd. Caxton Way Thetford Norfolk IP24 3SE United Kingdom

EXTRANEAL

7,5 %

Solution for peritoneal dialysis

Intraperitoneal use

Slovenia

Baxter d.o.o., Zelezna cesta 18, Ljubljana, SI-1000, Slovenia

Dianeal PD4 13,6 mg/ml glukoze raztopina za peritonelano dializo

13,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Slovenia

Baxter d.o.o., Zelezna cesta 18, Ljubljana, SI-1000, Slovenia

Dianeal PD4 22,7 mg/ml glukoze raztopina za peritonelano dializo

22,7 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Slovenia

Baxter d.o.o., Zelezna cesta 18, Ljubljana, SI-1000, Slovenia

Dianeal PD4 38,6 mg/ml glukoze raztopina za peritonelano dializo

38,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Slovenia

Baxter d.o.o., Zelezna cesta 18, Ljubljana, SI-1000, Slovenia

Extraneal 75 mg/ml ikodekstrina raztopina za peritonealno dializo

75 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Spain

| BAXTER S.L. |
| --- |
| Pouet de Camilo 2 |
| Ribarroja del Turia (Valencia) |
| 46394 |
| Spain |

BAXTER S.L.

Pouet de Camilo 2

Ribarroja del Turia (Valencia)

46394

Spain

Dianeal PD4 Glucosa 1,36 %

15,0 g/l; 5,38 g/l; 4,48 g/l; 0,184 g/l; 0,051 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Spain

| BAXTER S.L. |
| --- |
| Pouet de Camilo 2 |
| Ribarroja del Turia (Valencia) |
| 46394 |
| Spain |

BAXTER S.L.

Pouet de Camilo 2

Ribarroja del Turia (Valencia)

46394

Spain

Dianeal PD4 Glucosa 1,36 % con sistema de desconexión integrado

15,0 g/l; 5,38 g/l; 4,48 g/l; 0,184 g/l; 0,051 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Spain

| BAXTER S.L. |
| --- |
| Pouet de Camilo 2 |
| Ribarroja del Turia (Valencia) |
| 46394 |
| Spain |

BAXTER S.L.

Pouet de Camilo 2

Ribarroja del Turia (Valencia)

46394

Spain

Dianeal PD4 Glucosa 2,27 %

25,0 g/l; 5,38 g/l; 4,48 g/l; 0,184 g/l; 0,051 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Spain

| BAXTER S.L. |
| --- |
| Pouet de Camilo 2 |
| Ribarroja del Turia (Valencia) |
| 46394 |
| Spain |

BAXTER S.L.

Pouet de Camilo 2

Ribarroja del Turia (Valencia)

46394

Spain

Dianeal PD4 Glucosa 2,27 % con sistema de desconexión integrado

25,0 g/l; 5,38 g/l; 4,48 g/l; 0,184 g/l; 0,051 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Spain

| BAXTER S.L. |
| --- |
| Pouet de Camilo 2 |
| Ribarroja del Turia (Valencia) |
| 46394 |
| Spain |

BAXTER S.L.

Pouet de Camilo 2

Ribarroja del Turia (Valencia)

46394

Spain

Dianeal PD4 Glucosa 3,86 %

42,50 g/l; 5,38 g/l; 4,48 g/l; 0,184 g/l; 0,051 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Spain

| BAXTER S.L. |
| --- |
| Pouet de Camilo 2 |
| Ribarroja del Turia (Valencia) |
| 46394 |
| Spain |

BAXTER S.L.

Pouet de Camilo 2

Ribarroja del Turia (Valencia)

46394

Spain

Dianeal PD4 Glucosa 3,86 % con sistema de desconexión integrado

42,50 g/l; 5,38 g/l; 4,48 g/l; 0,184 g/l; 0,051 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Spain

| BAXTER S.L. |
| --- |
| Pouet de Camilo 2 |
| 46394 Ribarroja del Turia (Valencia) |
| Spain |

BAXTER S.L.

Pouet de Camilo 2

46394 Ribarroja del Turia (Valencia)

Spain

EXTRANEAL

Solución para diálisis peritoneal

75 g/l; 5,4 g/l; 4,5 g/l; 0,257 g/l; 0,051 g/l

Solution for peritoneal dialysis

Intraperitoneal use

Sweden

Baxter Healthare SA Moneen Road Castlebar County Mayo Irland

Dianeal PD4 med glucos 13,6 mg/ml

13,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Sweden

Baxter Healthare SA Moneen Road Castlebar County Mayo Irland

Dianeal PD4 med glucos 22,7 mg/ml

22,7 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Sweden

Baxter Healthare SA Moneen Road Castlebar County Mayo Irland

Dianeal PD4 med glucos 38,6 mg/ml

38,6 mg/ml

Solution for peritoneal dialysis

Intraperitoneal use

Sweden

Baxter Medical AB Box 63 164 94 Kista Sverige Sweden

Extraneal

7,5 %

Solution for peritoneal dialysis

Intraperitoneal use

The Netherlands

Baxter B.V., Kobaltweg 49, 3542 CE Utrecht, the Netherlands

Dianeal PD4 Glucose 1,36 %/13,6 mg/ml, peritoneaaldialysevloeistof

13,6 g/l glucose anhydrate

Solution for peritoneal dialysis

Intraperitoneal use

The Netherlands

Baxter B.V., Kobaltweg 49, 3542 CE Utrecht, the Netherlands

Dianeal PD4 Glucose 2,27 %/22,7 mg/ml, peritoneaaldialysevloeistof

22,7 g/l glucose anhydrate

Solution for peritoneal dialysis

Intraperitoneal use

The Netherlands

Baxter B.V., Kobaltweg 49, 3542 CE Utrecht, the Netherlands

Dianeal PD4 Glucose 3,86 %/38,6 mg/ml, peritoneaaldialysevloeistof

38,6 g/l glucose anhydrate

Solution for peritoneal dialysis

Intraperitoneal use

The Netherlands

Baxter B.V., Kobaltweg 49, 3542 CE Utrecht, the Netherlands

EXTRANEAL 7,5 %, oplossing voor peritoneale dialyse

75 g/l icodextrine

Solution for peritoneal dialysis

Intraperitoneal use

United Kingdom

Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24 3SE, United Kingdom

Dianeal PD4 Glucose 1,36 % w/v /13,6 mg/ml

magnseium chloride 0,005 % w/v; glucose 1,36 % w/v; sodium lactate 0,45 % w/v; calcium chloride 0,018 % w/v; sodium chloride 0,54 % w/v

Solution for peritoneal dialysis

Intraperitoneal use

United Kingdom

Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24 3SE, United Kingdom

Dianeal PD4 Glucose 2,27 % w/v /22,7 mg/ml

magnseium chloride 0,005 % w/v; glucose 2,27 % w/v; sodium lactate 0,45 % w/v; calcium chloride 0,018 % w/v; sodium chloride 0,54 % w/v

Solution for peritoneal dialysis

Intraperitoneal use

United Kingdom

Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24 3SE, United Kingdom

Dianeal PD4 Glucose 3,86 % w/v /38,6 mg/ml

magnseium chloride 0,005 % w/v; glucose 3,86 % w/v; sodium lactate 0,45 % w/v; calcium chloride 0,018 % w/v; sodium chloride 0,54 % w/v

Solution for peritoneal dialysis

Intraperitoneal use

United Kingdom

Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24 3SE, United Kingdom

Extraneal (Icodextrin 7,5 %) Solution for peritoneal dialysis

icodextrin 75 g/l; sodium chloride 5,4 g/l; calcium chloride 0,257 g/l; magnesium chloride 0,051 g/l; sodium s-lactate 4,5 g/l

Solution for peritoneal dialysis

Intraperitoneal use

---

ANNEX III

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANTS/MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES

| Member State EU/EEA | Marketing authorisation holder | Applicant | (Invented) Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| France | | Ranbaxy (UK) Ltd. |
| Building 4, Chiswick Park, |
| 566 Chiswick High Road, |
| London W4 5YE, |
| United Kingdom |

Member State EU/EEA

Marketing authorisation holder

Applicant

(Invented) Name

Strength

Pharmaceutical form

Route of administration

France

Ranbaxy (UK) Ltd.

Building 4, Chiswick Park,

566 Chiswick High Road,

London W4 5YE,

United Kingdom

ISOTRETINOINE RANBAXY 10 mg, capsule molle

10 mg

Capsules, soft

Oral

France

| Ranbaxy (UK) Ltd. |
| --- |
| Building 4, Chiswick Park, |
| 566 Chiswick High Road, |
| London W4 5YE, |
| United Kingdom |

Ranbaxy (UK) Ltd.

Building 4, Chiswick Park,

566 Chiswick High Road,

London W4 5YE,

United Kingdom

ISOTRETINOINE RANBAXY 20 mg, capsule molle

20 mg

Capsules, soft

Oral

Spain

| Ranbaxy (UK) Ltd. |
| --- |
| Building 4, Chiswick Park, |
| 566 Chiswick High Road, |
| London W4 5YE, |
| United Kingdom |

Ranbaxy (UK) Ltd.

Building 4, Chiswick Park,

566 Chiswick High Road,

London W4 5YE,

United Kingdom

ISOTRETINOINA RANBAXY 10 mg CAPSULAS BLANDAS EFG

10 mg

Capsules, soft

Oral

Spain

| Ranbaxy (UK) Ltd. |
| --- |
| Building 4, Chiswick Park, |
| 566 Chiswick High Road, |
| London W4 5YE, |
| United Kingdom |

Ranbaxy (UK) Ltd.

Building 4, Chiswick Park,

566 Chiswick High Road,

London W4 5YE,

United Kingdom

ISOTRETINOINA RANBAXY 20 mg CAPSULAS BLANDAS EFG

20 mg

Capsules, soft

Oral

United Kingdom

| Ranbaxy (UK) Ltd. |
| --- |
| Building 4, Chiswick Park, |
| 566 Chiswick High Road, |
| London W4 5YE, |
| United Kingdom |

Ranbaxy (UK) Ltd.

Building 4, Chiswick Park,

566 Chiswick High Road,

London W4 5YE,

United Kingdom

Isotretinoin 10 mg Capsules

10 mg

Capsules, soft

Oral

United Kingdom

| Ranbaxy (UK) Ltd. |
| --- |
| Building 4, Chiswick Park, |
| 566 Chiswick High Road, |
| London W4 5YE, |
| United Kingdom |

Ranbaxy (UK) Ltd.

Building 4, Chiswick Park,

566 Chiswick High Road,

London W4 5YE,

United Kingdom

Isotretinoin 20 mg Capsules

20 mg

Capsules, soft

Oral

---

ANNEX IV

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 |
| --- | --- | --- | --- | --- | --- |
| AT - Austria | Octapharma Pharmazeutika |
| Produktionsgesellschaft m.b.H. |
| Oberlaaerstraße 235 |
| A-1100 Wien |
| Austria |

Member State EU/EEA

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

AT - Austria

Octapharma Pharmazeutika

Produktionsgesellschaft m.b.H.

Oberlaaerstraße 235

A-1100 Wien

Austria

Octagam 100 mg/ml Infusionslösung

100 mg/ml

Solution for infusion

Intravenous Use

AT - Austria

| Octapharma Pharmazeutika |
| --- |
| Produktionsgesellschaft m.b.H. |
| Oberlaaerstraße 235 |
| A-1100 Wien |
| Austria |

Octapharma Pharmazeutika

Produktionsgesellschaft m.b.H.

Oberlaaerstraße 235

A-1100 Wien

Austria

Octagam 50 mg/ml Infusionslösung

50 mg/ml

Solution for infusion

Intravenous Use

BE - Belgium

| OCTAPHARMA BENELUX SA |
| --- |
| Rue de Stalle 63 |
| 1180 Bruxelles (Brussels) |
| Belgium |

OCTAPHARMA BENELUX SA

Rue de Stalle 63

1180 Bruxelles (Brussels)

Belgium

Octagam 10 %, solution pour perfusion

10 % (100 mg/ml)

Solution for infusion

Intravenous Use

BE - Belgium

| OCTAPHARMA BENELUX SA |
| --- |
| Rue de Stalle 63 |
| 1180 Bruxelles (Brussels) |
| Belgium |

OCTAPHARMA BENELUX SA

Rue de Stalle 63

1180 Bruxelles (Brussels)

Belgium

Octagam 50 mg/ml solution pour perfusion

50 mg/ml

Solution for infusion

Intravenous Use

BG - Bulgaria

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 10 %

100 mg/ml

Solution for infusion

Intravenous Use

CY - Cyprus

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

OCTAGAM INFUSION 10 %

10 %

Solution for infusion

Intravenous use

CY - Cyprus

| Hospitec Co Ltd |
| --- |
| 5 Thessalonikis, Block B |
| 2085 Lefkosia |
| Cyprus |

Hospitec Co Ltd

5 Thessalonikis, Block B

2085 Lefkosia

Cyprus

OCTAGAM INFUSION 5 %

5 %

Solution for infusion

Intravenous use

CZ - Czech Republic

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

OCTAGAM

50 mg/ml

Solution for infusion

Intravenous Use

CZ - Czech Republic

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

OCTAGAM 10 %

100 mg/ml

Solution for infusion

Intravenous Use

DE - Germany

| OCTAPHARMA GmbH |
| --- |
| Elisabeth-Selbert-Str. 11 |
| 40764 Langenfeld |
| Germany |

OCTAPHARMA GmbH

Elisabeth-Selbert-Str. 11

40764 Langenfeld

Germany

Octagam 50 mg/ml

50 mg/ml

Solution for infusion

Intravenous Use

DE - Germany

| OCTAPHARMA GmbH |
| --- |
| Elisabeth-Selbert-Str. 11 |
| 40764 Langenfeld |
| Germany |

OCTAPHARMA GmbH

Elisabeth-Selbert-Str. 11

40764 Langenfeld

Germany

Octagam 5 %

50 mg/ml

Solution for infusion

Intravenous Use

DE - Germany

| OCTAPHARMA GmbH |
| --- |
| Elisabeth-Selbert-Str. 11 |
| 40764 Langenfeld |
| Germany |

OCTAPHARMA GmbH

Elisabeth-Selbert-Str. 11

40764 Langenfeld

Germany

Octagam 10 %

100 mg/ml

Solution for infusion

Intravenous Use

DK - Denmark

| Octapharma AB |
| --- |
| Elersvägen 40 |
| SE-11275 Stockholm |
| Sweden |

Octapharma AB

Elersvägen 40

SE-11275 Stockholm

Sweden

Octagam

50 mg/ml

Solution for infusion

Intravenous Use

DK - Denmark

| Octapharma AB |
| --- |
| Elersvägen 40 |
| SE-11275 Stockholm |
| Sweden |

Octapharma AB

Elersvägen 40

SE-11275 Stockholm

Sweden

Octagam

100 mg/ml

Solution for infusion

Intravenous Use

EL - Greece

| Octapharma Hellas SA |
| --- |
| George Kalbitzer |
| 60, posidonos Ave. |
| 166 75 Glyfada Attiki |
| Greece |

Octapharma Hellas SA

George Kalbitzer

60, posidonos Ave.

166 75 Glyfada Attiki

Greece

OCTAGAM

5 % (W/V)

Solution for infusion

Intravenous Use

EL - Greece

| Octapharma Hellas SA |
| --- |
| George Kalbitzer |
| 60, posidonos Ave. |
| 166 75 Glyfada Attiki |
| Greece |

Octapharma Hellas SA

George Kalbitzer

60, posidonos Ave.

166 75 Glyfada Attiki

Greece

OCTAGAM

10 % (100 MG/ML)

Solution for infusion

Intravenous Use

ES - Spain

| OCTAPHARMA, S.A. |
| --- |
| C/ Velázquez, 150 |
| 28002 Madrid |
| ESPAÑA |

OCTAPHARMA, S.A.

C/ Velázquez, 150

28002 Madrid

ESPAÑA

Octagamocta 100 mg/ml solución para perfusión

100 mg/ml

Solution for infusion

Intravenous use

ES - Spain

| OCTAPHARMA, S.A. |
| --- |
| C/ Velázquez, 150 |
| 28002 Madrid |
| ESPAÑA |

OCTAPHARMA, S.A.

C/ Velázquez, 150

28002 Madrid

ESPAÑA

Octagamocta 50 mg/ml solución para perfusión

50 mg/ml

Solution for infusion

Intravenous use

ET - Estonia

| Octapharma AB |
| --- |
| Elersvägen 40 |
| SE-11275 Stockholm |
| Sweden |

Octapharma AB

Elersvägen 40

SE-11275 Stockholm

Sweden

OCTAGAM

50 mg/ml

Solution for infusion

Intravenous Use

ET - Estonia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

OCTAGAM 10 %

100 mg/1 ml

Solution for infusion

Intravenous Use

FI - Finland

| OCTAPHARMA |
| --- |
| Rajatorpantie 41 C |
| 01640 Vantaa |
| FINLAND |

OCTAPHARMA

Rajatorpantie 41 C

01640 Vantaa

FINLAND

OCTAGAM

50 mg/ml

100 mg/ml

Solution for infusion

Intravenous Use

FR - France

| Octapharma France SAS |
| --- |
| Laurent de Narbonne |
| 62Bis Avenue André Morizet |
| F- 92100 Boulogne |
| Billancourt |
| France |

Octapharma France SAS

Laurent de Narbonne

62Bis Avenue André Morizet

F- 92100 Boulogne

Billancourt

France

OCTAGAM 100 mg/ml, solution pour perfusion

100 mg/ml

Solution for infusion

Intravenous Use

FR - France

| Octapharma France SAS |
| --- |
| Laurent de Narbonne |
| 62Bis Avenue André Morizet |
| F- 92100 Boulogne |
| Billancourt |
| France |

Octapharma France SAS

Laurent de Narbonne

62Bis Avenue André Morizet

F- 92100 Boulogne

Billancourt

France

OCTAGAM 50 mg/ml, solution pour perfusion

50 mg/ml

Solution for infusion

Intravenous Use

HU - Hungary

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

OCTAGAM 50 mg/ml oldatos infúzió

50 mg/ml

Solution for infusion

Intravenous Use

HU - Hungary

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

OCTAGAM 100 mg/ml oldatos infúzió

100 mg/ml

Solution for infusion

Intravenous Use

IS - Iceland

| Octapharma AB |
| --- |
| Nordenflychtsvägen 55 |
| SE-112 75 Stockholm |
| Sweden |

Octapharma AB

Nordenflychtsvägen 55

SE-112 75 Stockholm

Sweden

Octagam 5 %

50 mg/ml

Solution for infusion

Intravenous Use

IS - Iceland

| Octapharma AB |
| --- |
| Nordenflychtsvägen 55 |
| SE-112 75 Stockholm |
| Sweden |

Octapharma AB

Nordenflychtsvägen 55

SE-112 75 Stockholm

Sweden

Octagam 10 %

100 mg/ml

Solution for infusion

Intravenous Use

IT - Italy

| Octapharma Ltd |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma Ltd

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

OCTAGAM

5 %

Solution for infusion

Intravenous Use

LT - Lithuania

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

octagam

100 mg/ml

Solution for infusion

Intravenous Use

LU - Luxembourg

| OCTAPHARMA BENELUX SA |
| --- |
| Rue de Stalle 63 |
| 1180 Bruxelles (Brussels) |
| Belgium |

OCTAPHARMA BENELUX SA

Rue de Stalle 63

1180 Bruxelles (Brussels)

Belgium

Octagam

5 %

Solution for infusion

Intravenous use

LU - Luxembourg

| OCTAPHARMA BENELUX SA |
| --- |
| Rue de Stalle 63 |
| 1180 Bruxelles (Brussels) |
| Belgium |

OCTAPHARMA BENELUX SA

Rue de Stalle 63

1180 Bruxelles (Brussels)

Belgium

Octagam-10

10 %

Solution for infusion

Intravenous use

LV - Latvia

| Octapharma AB |
| --- |
| Elesvagen 40 |
| Stockholm, S-112 75 |
| Sweden |

Octapharma AB

Elesvagen 40

Stockholm, S-112 75

Sweden

Octagam 50 mg/ml solution for infusion

1 g/20 ml

Solution for infusion

Intravenous Use

LV - Latvia

| Octapharma AB |
| --- |
| Elesvagen 40 |
| Stockholm, S-112 75 |
| Sweden |

Octapharma AB

Elesvagen 40

Stockholm, S-112 75

Sweden

Octagam 50 mg/ml solution for infusion

2,5 g/50 ml

Solution for infusion

Intravenous Use

LV - Latvia

| Octapharma AB |
| --- |
| Elesvagen 40 |
| Stockholm, S-112 75 |
| Sweden |

Octapharma AB

Elesvagen 40

Stockholm, S-112 75

Sweden

Octagam 50 mg/ml solution for infusion

5 g/100 ml

Solution for infusion

Intravenous Use

LV - Latvia

| Octapharma AB |
| --- |
| Elesvagen 40 |
| Stockholm, S-112 75 |
| Sweden |

Octapharma AB

Elesvagen 40

Stockholm, S-112 75

Sweden

Octagam 50 mg/ml solution for infusion

10 g/200 ml

Solution for infusion

Intravenous Use

LV - Latvia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 100 mg/ml šķīdums infūzijām, 2 g/20 ml

2 g/20 ml

Solution for infusion

Intravenous Use

LV - Latvia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 100 mg/ml šķīdums infūzijām, 5 g/50 ml

5 g/50 ml

Solution for infusion

Intravenous Use

LV - Latvia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 100 mg/ml šķīdums infūzijām, 10 g/100 ml

10 g/100 ml

Solution for infusion

Intravenous Use

LV - Latvia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 100 mg/ml šķīdums infūzijām, 20 g/200 ml

20 g/200 ml

Solution for infusion

Intravenous Use

MT - Malta

| Octapharma (IP) Limited, |
| --- |
| The Zenith Building, |
| 26 Spring Gardens, Manchester M2 1AB, |
| United Kingdom |

Octapharma (IP) Limited,

The Zenith Building,

26 Spring Gardens, Manchester M2 1AB,

United Kingdom

OCTAGAM 10 %

1 ml contains: protein 100 mg (of which ≥ 95 % is human Immunoglobulin G), IgA ≤ 0,4 mg, IgM ≤ 0,3 mg

Solution for infusion

Intravenous use

NL - Netherlands

| Octapharma GmbH |
| --- |
| Reinhard Rettinghaus |
| Elisabeth-Selbert-Str. 11 |
| 40764 Langenfeld |
| Germany |

Octapharma GmbH

Reinhard Rettinghaus

Elisabeth-Selbert-Str. 11

40764 Langenfeld

Germany

Octagam 10 %

100 mg/ml

Solution for infusion

Intravenous Use

NL - Netherlands

| Octapharma GmbH |
| --- |
| Reinhard Rettinghaus |
| Elisabeth-Selbert-Str. 11 |
| 40764 Langenfeld |
| Germany |

Octapharma GmbH

Reinhard Rettinghaus

Elisabeth-Selbert-Str. 11

40764 Langenfeld

Germany

Octagam 5 %

50 mg/ml

Solution for infusion

Intravenous Use

NO - Norway

| Octapharma AG |
| --- |
| Kim Björnstrup |
| Seidenstraße 2 |
| CH-8853 Lachen |
| Switzerland |

Octapharma AG

Kim Björnstrup

Seidenstraße 2

CH-8853 Lachen

Switzerland

Octagam

50 mg/ml

Solution for infusion

Intravenous Use

NO - Norway

| Octapharma AG |
| --- |
| Kim Björnstrup |
| Seidenstraße 2 |
| CH-8853 Lachen |
| Switzerland |

Octapharma AG

Kim Björnstrup

Seidenstraße 2

CH-8853 Lachen

Switzerland

Octagam

100 mg/ml

Solution for infusion

Intravenous Use

PL - Poland

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam

2,5 g/50 ml

Solution for infusion

Intravenous Use

PL - Poland

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam

5 g/100 ml

Solution for infusion

Intravenous Use

PL - Poland

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 10 %

20 g/200 ml

Solution for infusion

Intravenous Use

PL - Poland

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 10 %

100 mg/ml

Solution for infusion

Intravenous Use

PT - Portugal

| Octapharma |
| --- |
| Produtos Farmaceuticos, Lda. |
| Paulo Castro |
| Rua da Graca, 14 |
| P-1170-169 Lisboa |
| Portugal |

Octapharma

Produtos Farmaceuticos, Lda.

Paulo Castro

Rua da Graca, 14

P-1170-169 Lisboa

Portugal

Octagam

50 mg/ml

Solution for infusion

Intravenous use

PT - Portugal

| Octapharma |
| --- |
| Produtos Farmaceuticos, Lda. |
| Paulo Castro |
| Rua da Graca, 14 |
| P-1170-169 Lisboa |
| Portugal |

Octapharma

Produtos Farmaceuticos, Lda.

Paulo Castro

Rua da Graca, 14

P-1170-169 Lisboa

Portugal

Octagam

100 mg/ml

Solution for infusion

Intravenous use

RO - Romania

| OCTAPHARMA (IP) Ltd. |
| --- |
| The Zenith Building 26 Spring Gardens |
| Manchester, M2 1AB |
| United Kingdom |

OCTAPHARMA (IP) Ltd.

The Zenith Building 26 Spring Gardens

Manchester, M2 1AB

United Kingdom

OCTAGAM

50 mg/ml

Solution for infusion

Intravenous use

RO - Romania

| OCTAPHARMA (IP) Ltd. |
| --- |
| The Zenith Building 26 Spring Gardens |
| Manchester, M2 1AB |
| United Kingdom |

OCTAPHARMA (IP) Ltd.

The Zenith Building 26 Spring Gardens

Manchester, M2 1AB

United Kingdom

OCTAGAM 10 %

100 mg/ml

Solution for infusion

Intravenous use

SE - Sweden

| Octapharma AB |
| --- |
| Olivier Clairotte |
| Elersvägen 40 |
| SE-11275 Stockholm |
| Sweden |

Octapharma AB

Olivier Clairotte

Elersvägen 40

SE-11275 Stockholm

Sweden

Octagem

50 mg/ml

Solution for infusion

Intravenous use

SE - Sweden

| Octapharma AB |
| --- |
| Olivier Clairotte |
| Elersvägen 40 |
| SE-11275 Stockholm |
| Sweden |

Octapharma AB

Olivier Clairotte

Elersvägen 40

SE-11275 Stockholm

Sweden

Octagem

100 mg/ml

Solution for infusion

Intravenous use

SI - Slovenia

| Zavod Republike Slovenije za transfuzijsko medicino |
| --- |
| Šlajmerjeva 6 |
| 1000 Ljubljana |
| Slovenija |

Zavod Republike Slovenije za transfuzijsko medicino

Šlajmerjeva 6

1000 Ljubljana

Slovenija

Octagam 50 mg/ml raztopina za infundiranje

50 mg/ ml

Solution for infusion

Intravenous use

SI - Slovenia

| Zavod Republike Slovenije za transfuzijsko medicino |
| --- |
| Šlajmerjeva 6 |
| 1000 Ljubljana |
| Slovenija |

Zavod Republike Slovenije za transfuzijsko medicino

Šlajmerjeva 6

1000 Ljubljana

Slovenija

Octagam 100 mg/ml raztopina za infundiranje

100 mg/ ml

Solution for infusion

Intravenous use

SK - Slovakia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam

20 ml 50 mg/ml

Solution for infusion

Intravenous use

SK - Slovakia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam

50 ml 50 mg/ml

Solution for infusion

Intravenous use

SK - Slovakia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam

100 ml 50 mg/ml

Solution for infusion

Intravenous use

SK - Slovakia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam

200 ml 50 mg/ml

Solution for infusion

Intravenous use

SK - Slovakia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 10 %

20 ml 100 mg/ml

Solution for infusion

Intravenous use

SK - Slovakia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 10 %

50 ml 100 mg/ml

Solution for infusion

Intravenous use

SK - Slovakia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 10 %

100 ml 100 mg/ml

Solution for infusion

Intravenous use

SK - Slovakia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 10 %

200 ml 100 mg/ml

Solution for infusion

Intravenous use

UK - United Kingdom

| Octapharma Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam Infusion

5 % w/v

Solution for infusion

Intravenous use

UK - United Kingdom

| Octapharma Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 10 % solution for Infusion

10 % w/v

Solution for infusion

Intravenous use

---

ANNEX V

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 |
| --- | --- | --- | --- | --- | --- |
| AT - Austria | Octapharma Pharmazeutika |
| Produktionsgesellschaft m.b.H. |
| Oberlaaerstraße 235 |
| A-1100 Wien |
| Austria |

Member State EU/EEA

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

AT - Austria

Octapharma Pharmazeutika

Produktionsgesellschaft m.b.H.

Oberlaaerstraße 235

A-1100 Wien

Austria

Octagam 100 mg/ml Infusionslösung

100 mg/ml

Solution for infusion

Intravenous Use

AT - Austria

| Octapharma Pharmazeutika |
| --- |
| Produktionsgesellschaft m.b.H. |
| Oberlaaerstraße 235 |
| A-1100 Wien |
| Austria |

Octapharma Pharmazeutika

Produktionsgesellschaft m.b.H.

Oberlaaerstraße 235

A-1100 Wien

Austria

Octagam 50 mg/ml Infusionslösung

50 mg/ml

Solution for infusion

Intravenous Use

BE - Belgium

| OCTAPHARMA BENELUX SA |
| --- |
| Rue de Stalle 63 |
| 1180 Bruxelles (Brussels) |
| Belgium |

OCTAPHARMA BENELUX SA

Rue de Stalle 63

1180 Bruxelles (Brussels)

Belgium

Octagam 10 %, solution pour perfusion

10 % (100 mg/ml)

Solution for infusion

Intravenous Use

BE - Belgium

| OCTAPHARMA BENELUX SA |
| --- |
| Rue de Stalle 63 |
| 1180 Bruxelles (Brussels) |
| Belgium |

OCTAPHARMA BENELUX SA

Rue de Stalle 63

1180 Bruxelles (Brussels)

Belgium

Octagam 50 mg/ml solution pour perfusion

50 mg/ml

Solution for infusion

Intravenous Use

BG - Bulgaria

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 10 %

100 mg/ml

Solution for infusion

Intravenous Use

CY - Cyprus

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam Infusion 10 %

10 %

Solution for infusion

Intravenous use

CY - Cyprus

| Hospitec Co Ltd |
| --- |
| 5 Thessalonikis, Block B |
| 2085 Nicosia |
| Cyprus |

Hospitec Co Ltd

5 Thessalonikis, Block B

2085 Nicosia

Cyprus

Octagam Infusion 5 %

5 %

Solution for infusion

Intravenous use

CZ - Czech Republic

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam

50 mg/ml

Solution for infusion

Intravenous Use

CZ - Czech Republic

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 10 %

100 mg/ml

Solution for infusion

Intravenous Use

DE - Germany

| OCTAPHARMA GmbH |
| --- |
| Elisabeth-Selbert-Str. 11 |
| 40764 Langenfeld |
| Germany |

OCTAPHARMA GmbH

Elisabeth-Selbert-Str. 11

40764 Langenfeld

Germany

Octagam 50 mg/ml

50 mg/ml

Solution for infusion

Intravenous Use

DE - Germany

| OCTAPHARMA GmbH |
| --- |
| Elisabeth-Selbert-Str. 11 |
| 40764 Langenfeld |
| Germany |

OCTAPHARMA GmbH

Elisabeth-Selbert-Str. 11

40764 Langenfeld

Germany

Octagam 5 %

50 mg/ml

Solution for infusion

Intravenous Use

DE - Germany

| OCTAPHARMA GmbH |
| --- |
| Elisabeth-Selbert-Str. 11 |
| 40764 Langenfeld |
| Germany |

OCTAPHARMA GmbH

Elisabeth-Selbert-Str. 11

40764 Langenfeld

Germany

Octagam 10 %

100 mg/ml

Solution for infusion

Intravenous Use

DK - Denmark

| Octapharma AB |
| --- |
| Elersvägen 40 |
| SE-11275 Stockholm |
| Sweden |

Octapharma AB

Elersvägen 40

SE-11275 Stockholm

Sweden

Octagam

50 mg/ml

Solution for infusion

Intravenous Use

DK - Denmark

| Octapharma AB |
| --- |
| Elersvägen 40 |
| SE-11275 Stockholm |
| Sweden |

Octapharma AB

Elersvägen 40

SE-11275 Stockholm

Sweden

Octagam

100 mg/ml

Solution for infusion

Intravenous Use

EL - Greece

| Octapharma Hellas SA |
| --- |
| 60, posidonos Ave. |
| 166 75 Glyfada Attiki |
| Greece |

Octapharma Hellas SA

60, posidonos Ave.

166 75 Glyfada Attiki

Greece

Octagam

5 % (W/V)

Solution for infusion

Intravenous Use

EL - Greece

| Octapharma Hellas SA |
| --- |
| 60, posidonos Ave. |
| 166 75 Glyfada Attiki |
| Greece |

Octapharma Hellas SA

60, posidonos Ave.

166 75 Glyfada Attiki

Greece

Octagam

10 % (100 MG/ML)

Solution for infusion

Intravenous Use

ES - Spain

| OCTAPHARMA, S.A. |
| --- |
| C/ Velázquez, 150 |
| 28002 Madrid |
| ESPAÑA |

OCTAPHARMA, S.A.

C/ Velázquez, 150

28002 Madrid

ESPAÑA

Octagamocta 100 mg/ml solución para perfusión

100 mg/ml

Solution for infusion

Intravenous use

ES - Spain

| OCTAPHARMA, S.A. |
| --- |
| C/ Velázquez, 150 |
| 28002 Madrid |
| ESPAÑA |

OCTAPHARMA, S.A.

C/ Velázquez, 150

28002 Madrid

ESPAÑA

Octagamocta 50 mg/ml solución para perfusión

50 mg/ml

Solution for infusion

Intravenous use

ET - Estonia

| Octapharma AB |
| --- |
| Elersvägen 40 |
| SE-11275 Stockholm |
| Sweden |

Octapharma AB

Elersvägen 40

SE-11275 Stockholm

Sweden

Octagam

50 mg/ml

Solution for infusion

Intravenous Use

ET - Estonia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 10 %

100 mg/1 ml

Solution for infusion

Intravenous Use

FI - Finland

| Octapharma AB |
| --- |
| Elersvägen 40 |
| SE-11275 Stockholm |
| Sweden |

Octapharma AB

Elersvägen 40

SE-11275 Stockholm

Sweden

Octagam

50 mg/ml

100 mg/ml

Solution for infusion

Intravenous Use

FR - France

| Octapharma France SAS |
| --- |
| 62Bis Avenue André Morizet |
| F- 92100 Boulogne |
| Billancourt |
| France |

Octapharma France SAS

62Bis Avenue André Morizet

F- 92100 Boulogne

Billancourt

France

Octagam 100 mg/ml, solution pour perfusion

100 mg/ml

Solution for infusion

Intravenous Use

FR - France

| Octapharma France SAS |
| --- |
| 62Bis Avenue André Morizet |
| F- 92100 Boulogne |
| Billancourt |
| France |

Octapharma France SAS

62Bis Avenue André Morizet

F- 92100 Boulogne

Billancourt

France

Octagam 50 mg/ml, solution pour perfusion

50 mg/ml

Solution for infusion

Intravenous Use

HU - Hungary

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 50 mg/ml oldatos infúzió

50 mg/ml

Solution for infusion

Intravenous Use

HU - Hungary

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 100 mg/ml oldatos infúzió

100 mg/ml

Solution for infusion

Intravenous Use

IS - Iceland

| Octapharma AB |
| --- |
| Nordenflychtsvägen 55 |
| SE-112 75 Stockholm |
| Sweden |

Octapharma AB

Nordenflychtsvägen 55

SE-112 75 Stockholm

Sweden

Octagam 5 %

50 mg/ml

Solution for infusion

Intravenous Use

IS - Iceland

| Octapharma AB |
| --- |
| Nordenflychtsvägen 55 |
| SE-112 75 Stockholm |
| Sweden |

Octapharma AB

Nordenflychtsvägen 55

SE-112 75 Stockholm

Sweden

Octagam 10 %

100 mg/ml

Solution for infusion

Intravenous Use

IT - Italy

| Octapharma Ltd |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma Ltd

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam

5 %

Solution for infusion

Intravenous Use

IT – Italy

| Octapharma Italy S.p.A |
| --- |
| Via Cisanello 145 |
| 56100 Pisa |
| Italy |

Octapharma Italy S.p.A

Via Cisanello 145

56100 Pisa

Italy

Gamten

10 %

Solution for infusion

Intravenous Use

LT - Lithuania

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam

100 mg/ml

Solution for infusion

Intravenous Use

LU - Luxembourg

| OCTAPHARMA BENELUX SA |
| --- |
| Rue de Stalle 63 |
| 1180 Bruxelles (Brussels) |
| Belgium |

OCTAPHARMA BENELUX SA

Rue de Stalle 63

1180 Bruxelles (Brussels)

Belgium

Octagam

5 %

Solution for infusion

Intravenous use

LU - Luxembourg

| OCTAPHARMA BENELUX SA |
| --- |
| Rue de Stalle 63 |
| 1180 Bruxelles (Brussels) |
| Belgium |

OCTAPHARMA BENELUX SA

Rue de Stalle 63

1180 Bruxelles (Brussels)

Belgium

Octagam-10

10 %

Solution for infusion

Intravenous use

LV - Latvia

| Octapharma AB |
| --- |
| Elesvagen 40 |
| Stockholm, S-112 75 |
| Sweden |

Octapharma AB

Elesvagen 40

Stockholm, S-112 75

Sweden

Octagam 50 mg/ml solution for infusion

1 g/20 ml

Solution for infusion

Intravenous Use

LV - Latvia

| Octapharma AB |
| --- |
| Elesvagen 40 |
| Stockholm, S-112 75 |
| Sweden |

Octapharma AB

Elesvagen 40

Stockholm, S-112 75

Sweden

Octagam 50 mg/ml solution for infusion

2,5 g/50 ml

Solution for infusion

Intravenous Use

LV - Latvia

| Octapharma AB |
| --- |
| Elesvagen 40 |
| Stockholm, S-112 75 |
| Sweden |

Octapharma AB

Elesvagen 40

Stockholm, S-112 75

Sweden

Octagam 50 mg/ml solution for infusion

5 g/100 ml

Solution for infusion

Intravenous Use

LV - Latvia

| Octapharma AB |
| --- |
| Elesvagen 40 |
| Stockholm, S-112 75 |
| Sweden |

Octapharma AB

Elesvagen 40

Stockholm, S-112 75

Sweden

Octagam 50 mg/ml solution for infusion

10 g/200 ml

Solution for infusion

Intravenous Use

LV - Latvia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 100 mg/ml solution for infusion, 2 g/20 ml

2 g/20 ml

Solution for infusion

Intravenous Use

LV - Latvia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 100 mg/ml solution for infusion, 5 g/50 ml

5 g/50 ml

Solution for infusion

Intravenous Use

LV - Latvia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 100 mg/ml solution for infusion, 10 g/100 ml

10 g/100 ml

Solution for infusion

Intravenous Use

LV - Latvia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 100 mg/ml solution for infusion, 20 g/200 ml

20 g/200 ml

Solution for infusion

Intravenous Use

MT - Malta

| Octapharma (IP) Limited, |
| --- |
| The Zenith Building, |
| 26 Spring Gardens, Manchester M2 1AB, |
| United Kingdom |

Octapharma (IP) Limited,

The Zenith Building,

26 Spring Gardens, Manchester M2 1AB,

United Kingdom

Octagam 10 %, solution for infusion

1 ml contains: protein 100 mg (of which ≥ 95 % is human Immunoglobulin G), IgA ≤ 0,4 mg, IgM ≤ 0,3 mg

Solution for infusion

Intravenous use

NL - Netherlands

| Octapharma GmbH |
| --- |
| Elisabeth-Selbert-Str. 11 |
| 40764 Langenfeld |
| Germany |

Octapharma GmbH

Elisabeth-Selbert-Str. 11

40764 Langenfeld

Germany

Octagam 10 %

100 mg/ml

Solution for infusion

Intravenous Use

NL - Netherlands

| Octapharma GmbH |
| --- |
| Elisabeth-Selbert-Str. 11 |
| 40764 Langenfeld |
| Germany |

Octapharma GmbH

Elisabeth-Selbert-Str. 11

40764 Langenfeld

Germany

Octagam 5 %

50 mg/ml

Solution for infusion

Intravenous Use

NO - Norway

| Octapharma AG |
| --- |
| Seidenstraße 2 |
| CH-8853 Lachen |
| Switzerland |

Octapharma AG

Seidenstraße 2

CH-8853 Lachen

Switzerland

Octagam

50 mg/ml

Solution for infusion

Intravenous Use

NO - Norway

| Octapharma AG |
| --- |
| Seidenstraße 2 |
| CH-8853 Lachen |
| Switzerland |

Octapharma AG

Seidenstraße 2

CH-8853 Lachen

Switzerland

Octagam

100 mg/ml

Solution for infusion

Intravenous Use

PL - Poland

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam

2,5 g/50 ml

Solution for infusion

Intravenous Use

PL - Poland

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam

5 g/100 ml

Solution for infusion

Intravenous Use

PL - Poland

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam

10 g/200 ml

Solution for infusion

Intravenous Use

PL - Poland

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 10 %

100 mg/ml

Solution for infusion

Intravenous Use

PT - Portugal

| Octapharma |
| --- |
| Produtos Farmaceuticos, Lda. |
| Rua dos Lagares D'el Rei, 21C r/c Dto. |
| P-1170-268 Lisboa |
| Portugal |

Octapharma

Produtos Farmaceuticos, Lda.

Rua dos Lagares D'el Rei, 21C r/c Dto.

P-1170-268 Lisboa

Portugal

Octagam

50 mg/ml

Solution for infusion

Intravenous use

PT - Portugal

| Octapharma |
| --- |
| Produtos Farmaceuticos, Lda. |
| Rua dos Lagares D'el Rei, 21C r/c Dto. |
| P-1170-268 Lisboa |
| Portugal |

Octapharma

Produtos Farmaceuticos, Lda.

Rua dos Lagares D'el Rei, 21C r/c Dto.

P-1170-268 Lisboa

Portugal

Octagam

100 mg/ml

Solution for infusion

Intravenous use

RO - Romania

| OCTAPHARMA (IP) Ltd. |
| --- |
| The Zenith Building 26 Spring Gardens |
| Manchester, M2 1AB |
| United Kingdom |

OCTAPHARMA (IP) Ltd.

The Zenith Building 26 Spring Gardens

Manchester, M2 1AB

United Kingdom

Octagam

50 mg/ml

Solution for infusion

Intravenous use

RO - Romania

| OCTAPHARMA (IP) Ltd. |
| --- |
| The Zenith Building 26 Spring Gardens |
| Manchester, M2 1AB |
| United Kingdom |

OCTAPHARMA (IP) Ltd.

The Zenith Building 26 Spring Gardens

Manchester, M2 1AB

United Kingdom

Octagam 10 %

100 mg/ml

Solution for infusion

Intravenous use

SE - Sweden

| Octapharma AB |
| --- |
| Elersvägen 40 |
| 112 75 Stockholm |
| Sweden |

Octapharma AB

Elersvägen 40

112 75 Stockholm

Sweden

Octagam

50 mg/ml

Solution for infusion

Intravenous use

SE - Sweden

| Octapharma AB |
| --- |
| Elersvägen 40 |
| 112 75 Stockholm |
| Sweden |

Octapharma AB

Elersvägen 40

112 75 Stockholm

Sweden

Octagam

100 mg/ml

Solution for infusion

Intravenous use

SI - Slovenia

| Zavod Republike Slovenije za transfuzijsko medicino |
| --- |
| Šlajmerjeva 6 |
| 1000 Ljubljana |
| Slovenija |

Zavod Republike Slovenije za transfuzijsko medicino

Šlajmerjeva 6

1000 Ljubljana

Slovenija

Octagam 50 mg/ml raztopina za infundiranje

50 mg/ ml

Solution for infusion

Intravenous use

SI - Slovenia

| Zavod Republike Slovenije za transfuzijsko medicino |
| --- |
| Šlajmerjeva 6 |
| 1000 Ljubljana |
| Slovenija |

Zavod Republike Slovenije za transfuzijsko medicino

Šlajmerjeva 6

1000 Ljubljana

Slovenija

Octagam 100 mg/ml raztopina za infundiranje

100 mg/ ml

Solution for infusion

Intravenous use

SK - Slovakia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam

50 mg/ml

Solution for infusion

Intravenous use

SK - Slovakia

| Octapharma (IP) Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma (IP) Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 10 %

100 mg/ml

Solution for infusion

Intravenous use

UK - United Kingdom

| Octapharma Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam Infusion

5 % w/v

Solution for infusion

Intravenous use

UK - United Kingdom

| Octapharma Limited |
| --- |
| The Zenith Building |
| 26 Spring Gardens |
| Manchester M2 1AB |
| United Kingdom |

Octapharma Limited

The Zenith Building

26 Spring Gardens

Manchester M2 1AB

United Kingdom

Octagam 10 % solution for Infusion

10 % w/v

Solution for infusion

Intravenous use

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