# Official Journal C 399/28 O

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 399 |
| | |
| English edition | Information and Notices | Volume 5928 October 2016 |

ISSN 1977-091X

Official Journal

of the European Union

C 399

English edition

Information and Notices

Volume 5928 October 2016

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| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2016/C 399/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2016 to 30 September 2016(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |
| 2016/C 399/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2016 to 30 September 2016(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) | 9 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2016/C 399/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2016 to 30 September 2016(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

2016/C 399/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2016 to 30 September 2016(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)

9

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

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 28.10.2016 | EN | Official Journal of the European Union | C 399/1 |
| --- | --- | --- | --- |

28.10.2016

EN

Official Journal of the European Union

C 399/1

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2016 to 30 September 2016

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

(2016/C 399/01)

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

—

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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 9.9.2016 | CABOMETYX | cabozantinib | Ipsen Pharma
  65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France | EU/1/16/1136 | Film-coated tablet | L01XE26 | 13.9.2016 |
| 15.9.2016 | Inhixa | enoxaparin sodium | Techdow Europe AB
  Banérgatan 36, 75237 Uppsala, Sverige | EU/1/16/1132 | Solution for injection | B01AB05 | 19.9.2016 |
| 15.9.2016 | Mysildecard | sildenafil | Mylan S.A.S
  117 allée des Parcs, F-69800 Saint Priest, France | EU/1/16/1134 | Film-coated tablet | G04BE03 | 19.9.2016 |
| 15.9.2016 | Sialanar | glycopyrronium bromide | Proveca Limited
  Daresbury Innovation Centre, Keckwick Lane, Daresbury, Halton, Cheshire, WA4 4FS, United Kingdom | EU/1/16/1135 | Oral solution | A03AB02 | 19.9.2016 |
| 15.9.2016 | Tenofovir disoproxil Zentiva | tenofovir disoproxil | Zentiva, k.s.
  U Kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/16/1127 | Film-coated tablet | J05AF07 | 19.9.2016 |
| 15.9.2016 | Thorinane | enoxaparin sodium | Pharmathen S.A.
  6 Dervenakion, 15351 Pallini Attiki, Ελλάδα | EU/1/16/1131 | Solution for injection | B01AB05 | 19.9.2016 |
| 19.9.2016 | Truberzi | eluxadoline | Aptalis Pharma SAS
  5/6 Place de l’Iris — La Défense 5 92400 Courbevoie France | EU/1/16/1126 | Film-coated tablet | Pending | 21.9.2016 |

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

9.9.2016

CABOMETYX

cabozantinib

Ipsen Pharma

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

EU/1/16/1136

Film-coated tablet

L01XE26

13.9.2016

15.9.2016

Inhixa

enoxaparin sodium

Techdow Europe AB

Banérgatan 36, 75237 Uppsala, Sverige

EU/1/16/1132

Solution for injection

B01AB05

19.9.2016

15.9.2016

Mysildecard

sildenafil

Mylan S.A.S

117 allée des Parcs, F-69800 Saint Priest, France

EU/1/16/1134

Film-coated tablet

G04BE03

19.9.2016

15.9.2016

Sialanar

glycopyrronium bromide

Proveca Limited

Daresbury Innovation Centre, Keckwick Lane, Daresbury, Halton, Cheshire, WA4 4FS, United Kingdom

EU/1/16/1135

Oral solution

A03AB02

19.9.2016

15.9.2016

Tenofovir disoproxil Zentiva

tenofovir disoproxil

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/16/1127

Film-coated tablet

J05AF07

19.9.2016

15.9.2016

Thorinane

enoxaparin sodium

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

EU/1/16/1131

Solution for injection

B01AB05

19.9.2016

19.9.2016

Truberzi

eluxadoline

Aptalis Pharma SAS

5/6 Place de l’Iris — La Défense 5 92400 Courbevoie France

EU/1/16/1126

Film-coated tablet

Pending

21.9.2016

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

—

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 |
| --- | --- | --- | --- | --- |
| 2.9.2016 | Enzepi | Allergan Pharmaceuticals International Limited,
  Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland | EU/1/16/1113 | 6.9.2016 |
| 2.9.2016 | Extavia | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/08/454 | 6.9.2016 |
| 2.9.2016 | Kengrexal | Chiesi Farmaceutici S.P.A.
  Via Palermo 26/A, 43122 Parma, Italia | EU/1/15/994 | 6.9.2016 |
| 2.9.2016 | Ofev | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/14/979 | 6.9.2016 |
| 5.9.2016 | Nimvastid | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/09/525 | 7.9.2016 |
| 8.9.2016 | Betaferon | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/95/003 | 12.9.2016 |
| 8.9.2016 | Budesonide/Formoterol Teva Pharma B.V. | Teva Pharma B.V.
  Swensweg 5, 2031GA Haarlem, Nederland | EU/1/14/950 | 12.9.2016 |
| 8.9.2016 | Caprelsa | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/11/749 | 12.9.2016 |
| 8.9.2016 | DUAVIVE | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/14/960 | 12.9.2016 |
| 8.9.2016 | Insulatard | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/02/233 | 12.9.2016 |
| 8.9.2016 | Levetiracetam Actavis | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Ísland | EU/1/11/713 | 12.9.2016 |
| 8.9.2016 | Lucentis | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/06/374 | 12.9.2016 |
| 8.9.2016 | Panretin | Eisai Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom | EU/1/00/149 | 12.9.2016 |
| 8.9.2016 | Plegridy | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/14/934 | 12.9.2016 |
| 8.9.2016 | Protaphane | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/02/234 | 12.9.2016 |
| 9.9.2016 | Ameluz | Biofrontera Bioscience GmbH
  Hemmelrather Weg 201, D-51377 Leverkusen, Deutschland | EU/1/11/740 | 13.9.2016 |
| 9.9.2016 | Efavirenz Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/11/742 | 13.9.2016 |
| 9.9.2016 | Elaprase | Shire Human Genetic Therapies AB
  Vasagatan 7, 111 20 Stockholm, Sverige | EU/1/06/365 | 13.9.2016 |
| 9.9.2016 | Eurartesim | Sigma-Tau Industrie Farmaceutiche Riunite S.p.A
  Viale Shakespeare 47, 00144 Roma, Italia | EU/1/11/716 | 13.9.2016 |
| 9.9.2016 | Laventair | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/14/899 | 16.9.2016 |
| 9.9.2016 | Revlimid | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | EU/1/07/391 | 13.9.2016 |
| 9.9.2016 | Tandemact | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/06/366 | 13.9.2016 |
| 9.9.2016 | Tracleer | Actelion Registration Ltd
  Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | EU/1/02/220 | 13.9.2016 |
| 9.9.2016 | Velphoro | Vifor Fresenius Medical Care Renal Pharma France
  7-13 boulevard Paul-Emile Victor, 92521 Neuilly-sur-Seine, France | EU/1/14/943 | 15.9.2016 |
| 9.9.2016 | Xolair | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/05/319 | 13.9.2016 |
| 15.9.2016 | Arava | Sanofi-Aventis Deutschland GmbH
  D-65926 Frankfurt am Main, Deutschland | EU/1/99/118 | 19.9.2016 |
| 15.9.2016 | Arixtra | Aspen Pharma Trading Limited
  3016 Lake Drive Citywest Business Campus Dublin 24 Ireland | EU/1/02/206 | 19.9.2016 |
| 15.9.2016 | Evoltra | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/06/334 | 19.9.2016 |
| 15.9.2016 | Fosavance | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/05/310 | 19.9.2016 |
| 15.9.2016 | Ganfort | Allergan Pharmaceuticals Ireland, (514125)
  Castlebar Road, Westport, County Mayo, Ireland | EU/1/06/340 | 19.9.2016 |
| 15.9.2016 | Ibandronic Acid Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/10/642 | 19.9.2016 |
| 15.9.2016 | Intelence | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/08/468 | 19.9.2016 |
| 15.9.2016 | PANTECTA Control | Takeda GmbH, (HRB 701016)
  Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | EU/1/09/518 | 19.9.2016 |
| 15.9.2016 | Trulicity | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/14/956 | 19.9.2016 |
| 15.9.2016 | Zydelig | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/14/938 | 19.9.2016 |
| 16.9.2016 | Lamivudine Teva Pharma B.V. | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/596 | 20.9.2016 |
| 19.9.2016 | Adrovance | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/06/364 | 21.9.2016 |
| 19.9.2016 | Enbrel | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/99/126 | 21.9.2016 |
| 19.9.2016 | Fycompa | Eisai Europe Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom | EU/1/12/776 | 21.9.2016 |
| 19.9.2016 | Repaglinide Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, Harrow, HA1 4HF, United Kingdom | EU/1/11/743 | 21.9.2016 |
| 19.9.2016 | Soliris | Alexion Europe SAS
  1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France | EU/1/07/393 | 21.9.2016 |
| 19.9.2016 | Sovaldi | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/13/894 | 21.9.2016 |
| 19.9.2016 | Vantavo | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/09/572 | 21.9.2016 |
| 19.9.2016 | Zydelig | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/14/938 | 21.9.2016 |
| 22.9.2016 | Anoro | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/14/898 | 26.9.2016 |
| 22.9.2016 | Blincyto | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/15/1047 | 26.9.2016 |
| 22.9.2016 | EVARREST | Omrix Biopharmaceuticals N.V.
  Leonardo Da Vincilaan 15, B-1831 Diegem, België | EU/1/13/868 | 26.9.2016 |
| 22.9.2016 | Instanyl | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/09/531 | 26.9.2016 |
| 22.9.2016 | Leflunomide ratiopharm | ratiopharm GmbH
  Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/10/654 | 26.9.2016 |
| 22.9.2016 | Pregabalin Sandoz GmbH | Sandoz GmbH
  Biochemiestrasse 10, A-6250 Kundl, Österreich | EU/1/15/1012 | 26.9.2016 |
| 22.9.2016 | Saxenda | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/15/992 | 26.9.2016 |
| 22.9.2016 | Stayveer | Marklas Nederland B.V.
  Beneluxlaan 2b, NL-3446 GR Woerden, Nederland | EU/1/13/832 | 26.9.2016 |
| 22.9.2016 | Victoza | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/09/529 | 26.9.2016 |
| 22.9.2016 | Zelboraf | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/12/751 | 26.9.2016 |
| 26.9.2016 | Colobreathe | Forest Laboratories UK Ltd.
  Whiddon Valley Barnstaple, North Devon, EX32 8NS, United Kingdom | EU/1/11/747 | 28.9.2016 |
| 26.9.2016 | Tivicay | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/13/892 | 28.9.2016 |
| 30.9.2016 | Cometriq | Ipsen Pharma
  65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France | EU/1/13/890 | 4.10.2016 |
| 30.9.2016 | Moventig | Kyowa Kirin Limited
  Galabank Business Park, Galashiels, TD1 1QH, United Kingdom | EU/1/14/962 | 4.10.2016 |
| 30.9.2016 | Vantobra | PARI Pharma GmbH
  Moosstrasse 3, D-82319 Starnberg, Deutschland | EU/1/14/932 | 4.10.2016 |

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

2.9.2016

Enzepi

Allergan Pharmaceuticals International Limited,

Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland

EU/1/16/1113

6.9.2016

2.9.2016

Extavia

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/08/454

6.9.2016

2.9.2016

Kengrexal

Chiesi Farmaceutici S.P.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/15/994

6.9.2016

2.9.2016

Ofev

Boehringer Ingelheim International GmbH

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

EU/1/14/979

6.9.2016

5.9.2016

Nimvastid

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/525

7.9.2016

8.9.2016

Betaferon

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/95/003

12.9.2016

8.9.2016

Budesonide/Formoterol Teva Pharma B.V.

Teva Pharma B.V.

Swensweg 5, 2031GA Haarlem, Nederland

EU/1/14/950

12.9.2016

8.9.2016

Caprelsa

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/11/749

12.9.2016

8.9.2016

DUAVIVE

Pfizer Limited

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

EU/1/14/960

12.9.2016

8.9.2016

Insulatard

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/02/233

12.9.2016

8.9.2016

Levetiracetam Actavis

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Ísland

EU/1/11/713

12.9.2016

8.9.2016

Lucentis

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/06/374

12.9.2016

8.9.2016

Panretin

Eisai Limited

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

EU/1/00/149

12.9.2016

8.9.2016

Plegridy

Biogen Idec Limited

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

EU/1/14/934

12.9.2016

8.9.2016

Protaphane

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/02/234

12.9.2016

9.9.2016

Ameluz

Biofrontera Bioscience GmbH

Hemmelrather Weg 201, D-51377 Leverkusen, Deutschland

EU/1/11/740

13.9.2016

9.9.2016

Efavirenz Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/742

13.9.2016

9.9.2016

Elaprase

Shire Human Genetic Therapies AB

Vasagatan 7, 111 20 Stockholm, Sverige

EU/1/06/365

13.9.2016

9.9.2016

Eurartesim

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A

Viale Shakespeare 47, 00144 Roma, Italia

EU/1/11/716

13.9.2016

9.9.2016

Laventair

Glaxo Group Ltd

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

EU/1/14/899

16.9.2016

9.9.2016

Revlimid

Celgene Europe Limited

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

EU/1/07/391

13.9.2016

9.9.2016

Tandemact

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/06/366

13.9.2016

9.9.2016

Tracleer

Actelion Registration Ltd

Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom

EU/1/02/220

13.9.2016

9.9.2016

Velphoro

Vifor Fresenius Medical Care Renal Pharma France

7-13 boulevard Paul-Emile Victor, 92521 Neuilly-sur-Seine, France

EU/1/14/943

15.9.2016

9.9.2016

Xolair

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/05/319

13.9.2016

15.9.2016

Arava

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/99/118

19.9.2016

15.9.2016

Arixtra

Aspen Pharma Trading Limited

3016 Lake Drive Citywest Business Campus Dublin 24 Ireland

EU/1/02/206

19.9.2016

15.9.2016

Evoltra

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/06/334

19.9.2016

15.9.2016

Fosavance

Merck Sharp & Dohme Limited

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

EU/1/05/310

19.9.2016

15.9.2016

Ganfort

Allergan Pharmaceuticals Ireland, (514125)

Castlebar Road, Westport, County Mayo, Ireland

EU/1/06/340

19.9.2016

15.9.2016

Ibandronic Acid Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/10/642

19.9.2016

15.9.2016

Intelence

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/08/468

19.9.2016

15.9.2016

PANTECTA Control

Takeda GmbH, (HRB 701016)

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

EU/1/09/518

19.9.2016

15.9.2016

Trulicity

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/14/956

19.9.2016

15.9.2016

Zydelig

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/14/938

19.9.2016

16.9.2016

Lamivudine Teva Pharma B.V.

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/596

20.9.2016

19.9.2016

Adrovance

Merck Sharp & Dohme Limited

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

EU/1/06/364

21.9.2016

19.9.2016

Enbrel

Pfizer Limited

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

EU/1/99/126

21.9.2016

19.9.2016

Fycompa

Eisai Europe Limited

European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom

EU/1/12/776

21.9.2016

19.9.2016

Repaglinide Accord

Accord Healthcare Limited

Sage House, 319 Pinner Road, Harrow, HA1 4HF, United Kingdom

EU/1/11/743

21.9.2016

19.9.2016

Soliris

Alexion Europe SAS

1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France

EU/1/07/393

21.9.2016

19.9.2016

Sovaldi

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/13/894

21.9.2016

19.9.2016

Vantavo

Merck Sharp & Dohme Limited

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

EU/1/09/572

21.9.2016

19.9.2016

Zydelig

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/14/938

21.9.2016

22.9.2016

Anoro

Glaxo Group Ltd

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

EU/1/14/898

26.9.2016

22.9.2016

Blincyto

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/15/1047

26.9.2016

22.9.2016

EVARREST

Omrix Biopharmaceuticals N.V.

Leonardo Da Vincilaan 15, B-1831 Diegem, België

EU/1/13/868

26.9.2016

22.9.2016

Instanyl

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/09/531

26.9.2016

22.9.2016

Leflunomide ratiopharm

ratiopharm GmbH

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

EU/1/10/654

26.9.2016

22.9.2016

Pregabalin Sandoz GmbH

Sandoz GmbH

Biochemiestrasse 10, A-6250 Kundl, Österreich

EU/1/15/1012

26.9.2016

22.9.2016

Saxenda

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/15/992

26.9.2016

22.9.2016

Stayveer

Marklas Nederland B.V.

Beneluxlaan 2b, NL-3446 GR Woerden, Nederland

EU/1/13/832

26.9.2016

22.9.2016

Victoza

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/09/529

26.9.2016

22.9.2016

Zelboraf

Roche Registration Limited

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

EU/1/12/751

26.9.2016

26.9.2016

Colobreathe

Forest Laboratories UK Ltd.

Whiddon Valley Barnstaple, North Devon, EX32 8NS, United Kingdom

EU/1/11/747

28.9.2016

26.9.2016

Tivicay

ViiV Healthcare UK Limited

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

EU/1/13/892

28.9.2016

30.9.2016

Cometriq

Ipsen Pharma

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

EU/1/13/890

4.10.2016

30.9.2016

Moventig

Kyowa Kirin Limited

Galabank Business Park, Galashiels, TD1 1QH, United Kingdom

EU/1/14/962

4.10.2016

30.9.2016

Vantobra

PARI Pharma GmbH

Moosstrasse 3, D-82319 Starnberg, Deutschland

EU/1/14/932

4.10.2016

| — | Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) |
| --- | --- |

—

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 |
| --- | --- | --- | --- | --- |
| 19.9.2016 | PANTECTA Control | Takeda GmbH, (HRB 701016)
  Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | EU/1/09/518 | 21.9.2016 |

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

19.9.2016

PANTECTA Control

Takeda GmbH, (HRB 701016)

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

EU/1/09/518

21.9.2016

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

—

Issuing 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 | 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 22.9.2016 | ERAVAC | rabbit haemorrhagic disease vaccine (inactivated) | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, E-17170 Amer (Girona), España | EU/2/16/199 | Emulsion for injection | QI08AA | 26.9.2016 |

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

22.9.2016

ERAVAC

rabbit haemorrhagic disease vaccine (inactivated)

Laboratorios Hipra, S.A.

Avda. La Selva, 135, E-17170 Amer (Girona), España

EU/2/16/199

Emulsion for injection

QI08AA

26.9.2016

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

—

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 |
| --- | --- | --- | --- | --- |
| 19.9.2016 | Reconcile | Nexcyon Pharmaceuticals Ltd
  First Floor Denmark House, 143 High Street, Chalfont St Peter SL9 9QL, United Kingdom | EU/2/08/080 | 29.9.2016 |
| 28.9.2016 | Coliprotec F4 | Prevtec Microbia GmbH
  Geyerspergerstr 27, 80689 München, Deutschland | EU/2/14/180 | 30.9.2016 |

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

19.9.2016

Reconcile

Nexcyon Pharmaceuticals Ltd

First Floor Denmark House, 143 High Street, Chalfont St Peter SL9 9QL, United Kingdom

EU/2/08/080

29.9.2016

28.9.2016

Coliprotec F4

Prevtec Microbia GmbH

Geyerspergerstr 27, 80689 München, Deutschland

EU/2/14/180

30.9.2016

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

| European Medicines Agency |
| --- |
| 30 Churchill Place |
| Canary Wharf |
| London E14 5EU |
| United Kingdom |

European Medicines Agency

30 Churchill Place

Canary Wharf

London E14 5EU

United Kingdom

---

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

---

| 28.10.2016 | EN | Official Journal of the European Union | C 399/9 |
| --- | --- | --- | --- |

28.10.2016

EN

Official Journal of the European Union

C 399/9

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2016 to 30 September 2016

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

(2016/C 399/02)

| — | Issuing, maintenance or modification of a national marketing authorization |
| --- | --- |

—

Issuing, maintenance or modification of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | INN (International Non-Proprietary Name) | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- | --- |
| 8.9.2016 | Alkem Art 31 | Not applicable | See Annex II | See Annex II | 9.9.2016 |
| 22.9.2016 | Durogesic and associated names — Art 30 | fentanyl | See Annex III | See Annex III | 23.9.2016 |
| 22.9.2016 | Semler Art 31 | Not applicable | See Annex IV | See Annex IV | 23.9.2016 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorization

Member State concerned

Date of notification

8.9.2016

Alkem Art 31

Not applicable

See Annex II

See Annex II

9.9.2016

22.9.2016

Durogesic and associated names — Art 30

fentanyl

See Annex III

See Annex III

23.9.2016

22.9.2016

Semler Art 31

Not applicable

See Annex IV

See Annex IV

23.9.2016

| — | Refusal of a national marketing authorization |
| --- | --- |

—

Refusal of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | INN (International Non-Proprietary Name) | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- | --- |
| 22.9.2016 | Diclofenac epolamine 50 mg tablets — Art 29 | diclofenac | See Annex I | See Annex I | 23.9.2016 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorization

Member State concerned

Date of notification

22.9.2016

Diclofenac epolamine 50 mg tablets — Art 29

diclofenac

See Annex I

See Annex I

23.9.2016

| — | Suspension of a national marketing authorization |
| --- | --- |

—

Suspension of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | INN (International Non-Proprietary Name) | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- | --- |
| 8.9.2016 | Alkem Art 31 | Not applicable | See Annex II | See Annex II | 9.9.2016 |
| 22.9.2016 | Semler Art 31 | Not applicable | See Annex IV | See Annex IV | 23.9.2016 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorization

Member State concerned

Date of notification

8.9.2016

Alkem Art 31

Not applicable

See Annex II

See Annex II

9.9.2016

22.9.2016

Semler Art 31

Not applicable

See Annex IV

See Annex IV

23.9.2016

---

(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, applicants in the member states

| Member State EU/EEA | Applicant company name, address | Invented Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Czech Republic | ALTERGON ITALIA S.r.L
  Via dell’Industria
  83030 Pietradefusi, Avellino, ITALY | DICLOFENAC ALTERGON 50 MG TABLETY | 50 mg | tablet | Oral use |
| France | ALTERGON ITALIA S.r.L
  Via dell’Industria
  83030 Pietradefusi, Avellino, ITALY | DICLOFENAC ALTERGON | 50 mg | tablet | Oral use |
| Slovak Republic | ALTERGON ITALIA S.r.L
  Via dell’Industria
  83030 Pietradefusi, Avellino, ITALY | Diclofenac ALTERGON 50 mg | 50 mg | tablet | Oral use |
| United Kingdom | ALTERGON ITALIA S.r.L
  Via dell’Industria
  83030 Pietradefusi, Avellino, ITALY | DICLOFENAC EPOLAMINE ALTERGON 50 MG TABLETS | 50 mg | tablet | Oral use |

Member State EU/EEA

Applicant company name, address

Invented Name

Strength

Pharmaceutical form

Route of administration

Czech Republic

ALTERGON ITALIA S.r.L

Via dell’Industria

83030 Pietradefusi, Avellino, ITALY

DICLOFENAC ALTERGON 50 MG TABLETY

50 mg

tablet

Oral use

France

ALTERGON ITALIA S.r.L

Via dell’Industria

83030 Pietradefusi, Avellino, ITALY

DICLOFENAC ALTERGON

50 mg

tablet

Oral use

Slovak Republic

ALTERGON ITALIA S.r.L

Via dell’Industria

83030 Pietradefusi, Avellino, ITALY

Diclofenac ALTERGON 50 mg

50 mg

tablet

Oral use

United Kingdom

ALTERGON ITALIA S.r.L

Via dell’Industria

83030 Pietradefusi, Avellino, ITALY

DICLOFENAC EPOLAMINE ALTERGON 50 MG TABLETS

50 mg

tablet

Oral use

---

ANNEX II

List of nationally authorised medicinal products and marketing authorisation applications

Annex IA: Medicinal products recommended for maintenance and marketing authorisation applications for which bioequivalence vis-à-vis the EU reference medicinal product has been established

| Member State EU/EEA | Marketing Authorisation Holder | Applicant | Invented name | Active Substance | Strength | Pharmaceutical Form | Route of Administration |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Krka d.d., Novo mesto | | Cefuroxim Krka 250 mg Filmtabletten | Cefuroxime | 250 mg | Film-coated tablet | Oral use |
| Austria | Krka d.d., Novo mesto | | Cefuroxim Krka 500 mg Filmtabletten | Cefuroxime | 500 mg | Film-coated tablet | Oral use |
| Bulgaria | Krka d.d., Novo mesto | | Furocef 250 mg film-coated tablets | Cefuroxime | 250 mg | Film-coated tablet | Oral use |
| Bulgaria | Krka d.d., Novo mesto | | Furocef 500 mg film-coated tablets | Cefuroxime | 500 mg | Film-coated tablet | Oral use |
| Croatia | Krka — farma d.o.o. | | Furocef 250 mg film-coated tablets | Cefuroxime | 250 mg | Film-coated tablet | Oral use |
| Croatia | Krka — farma d.o.o. | | Furocef 500 mg film-coated tablets | Cefuroxime | 500 mg | Film-coated tablet | Oral use |
| Czech Republic | Krka d.d., Novo mesto | | Ricefan 250 mg | Cefuroxime | 250 mg | Film-coated tablet | Oral use |
| Czech Republic | Krka d.d., Novo mesto | | Ricefan 500 mg | Cefuroxime | 500 mg | Film-coated tablet | Oral use |
| Estonia | Krka d.d., Novo mesto | | FUROCEF | Cefuroxime | 250 mg | Film-coated tablet | Oral use |
| Estonia | Krka d.d., Novo mesto | | FUROCEF | Cefuroxime | 500 mg | Film-coated tablet | Oral use |
| France | Krka d.d., Novo mesto | | CEFUROXIME KRKA 250 mg, comprimé pelliculé | Cefuroxime | 250 mg | Film-coated tablet | Oral use |
| France | Krka d.d., Novo mesto | | CEFUROXIME KRKA 500 mg, comprimé pelliculé | Cefuroxime | 500 mg | Film-coated tablet | Oral use |
| Germany | Alkem Pharma GmbH | | Cefuroxim Alkem 250 mg Filmtabletten | Cefuroxime axetil | 250 mg | Film-coated tablet | Oral use |
| Germany | Alkem Pharma GmbH | | Cefuroxim Alkem 500 mg Filmtabletten | Cefuroxime axetil | 500 mg | Film-coated tablet | Oral use |
| Hungary | Krka d.d., Novo mesto | | Furocef Krka 250 mg tablets | Cefuroxime | 250 mg | Tablet | Oral use |
| Hungary | Krka d.d., Novo mesto | | Furocef Krka 500 mg tablets | Cefuroxime | 500 mg | Tablet | Oral use |
| Latvia | Krka d.d., Novo mesto | | Ricefan 250 mg film-coated tablets | Cefuroxime | 250 mg | Film-coated tablet | Oral use |
| Latvia | Krka d.d., Novo mesto | | Ricefan 500 mg film-coated tablets | Cefuroxime | 500 mg | Film-coated tablet | Oral use |
| Lithuania | Krka d.d., Novo mesto | | Ricefan | Cefuroxime | 250 mg | Film-coated tablet | Oral use |
| Lithuania | Krka d.d., Novo mesto | | Ricefan | Cefuroxime | 500 mg | Film-coated tablet | Oral use |
| Lithuania | | SIA Ingen Pharma | Cefuroxime Ingen Pharma | Cefuroxime | 250 mg | Film-coated tablet | Oral use |
| Lithuania | | SIA Ingen Pharma | Cefuroxime Ingen Pharma | Cefuroxime | 500 mg | Film-coated tablet | Oral use |
| Poland | Krka d.d., Novo mesto | | Furocef | Cefuroxime | 250 mg | Film-coated tablet | Oral use |
| Poland | Krka d.d., Novo mesto | | Furocef | Cefuroxime | 500 mg | Film-coated tablet | Oral use |
| Portugal | Krka d.d., Novo mesto | | Cefuroxima Krka | Cefuroxime axetil | 250 mg | Film-coated tablet | Oral use |
| Portugal | Krka d.d., Novo mesto | | Cefuroxima Krka | Cefuroxime axetil | 500 mg | Film-coated tablet | Oral use |
| Romania | Krka d.d., Novo mesto | | CEFUROXIME KRKA 250 mg, comprimate | Cefuroxime | 250 mg | Film-coated tablet | Oral use |
| Romania | Krka d.d., Novo mesto | | CEFUROXIME KRKA 500 mg, comprimate | Cefuroxime | 500 mg | Film-coated tablet | Oral use |
| Slovak Republic | Krka d.d., Novo mesto | | Furocef 250 mg filmom obalené tablety | Cefuroxime | 250 mg | Film-coated tablet | Oral use |
| Slovak Republic | Krka d.d., Novo mesto | | Furocef 500 mg filmom obalené tablety | Cefuroxime | 500 mg | Film-coated tablet | Oral use |
| Slovenia | Krka d.d., Novo mesto | | Ricefan | Cefuroxime | 250 mg | Film-coated tablet | Oral use |
| Slovenia | Krka d.d., Novo mesto | | Ricefan | Cefuroxime | 500 mg | Film-coated tablet | Oral use |
| Spain | Alkem Pharma GmbH | | Cefuroxima 500 mg comprimidos recubiertos con película | Cefuroxime axetil | 500 mg | Film-coated tablet | Oral use |
| Spain | Alkem Pharma GmbH | | Cefuroxima Alkem 250 mg comprimidos recubiertos con película | Cefuroxime axetil | 250 mg | Film-coated tablet | Oral use |
| Spain | Krka d.d., Novo mesto | | Cefuroxima KRKA 250 mg comprimidos recubiertos con película | Cefuroxime | 250 mg | Film-coated tablet | Oral use |
| Spain | Krka d.d., Novo mesto | | Cefuroxima KRKA 500 mg comprimidos recubiertos con película | Cefuroxime | 500 mg | Film-coated tablet | Oral use |
| United Kingdom | Alkem Pharma GmbH | | Cefuroxime 250 mg film-coated tablets | Cefuroxime axetil | 250 mg | Film-coated tablet | Oral use |
| United Kingdom | Alkem Pharma GmbH | | Cefuroxime 500 mg film-coated tablets | Cefuroxime axetil | 500 mg | Film-coated tablet | Oral use |

Member State EU/EEA

Marketing Authorisation Holder

Applicant

Invented name

Active Substance

Strength

Pharmaceutical Form

Route of Administration

Austria

Krka d.d., Novo mesto

Cefuroxim Krka 250 mg Filmtabletten

Cefuroxime

250 mg

Film-coated tablet

Oral use

Austria

Krka d.d., Novo mesto

Cefuroxim Krka 500 mg Filmtabletten

Cefuroxime

500 mg

Film-coated tablet

Oral use

Bulgaria

Krka d.d., Novo mesto

Furocef 250 mg film-coated tablets

Cefuroxime

250 mg

Film-coated tablet

Oral use

Bulgaria

Krka d.d., Novo mesto

Furocef 500 mg film-coated tablets

Cefuroxime

500 mg

Film-coated tablet

Oral use

Croatia

Krka — farma d.o.o.

Furocef 250 mg film-coated tablets

Cefuroxime

250 mg

Film-coated tablet

Oral use

Croatia

Krka — farma d.o.o.

Furocef 500 mg film-coated tablets

Cefuroxime

500 mg

Film-coated tablet

Oral use

Czech Republic

Krka d.d., Novo mesto

Ricefan 250 mg

Cefuroxime

250 mg

Film-coated tablet

Oral use

Czech Republic

Krka d.d., Novo mesto

Ricefan 500 mg

Cefuroxime

500 mg

Film-coated tablet

Oral use

Estonia

Krka d.d., Novo mesto

FUROCEF

Cefuroxime

250 mg

Film-coated tablet

Oral use

Estonia

Krka d.d., Novo mesto

FUROCEF

Cefuroxime

500 mg

Film-coated tablet

Oral use

France

Krka d.d., Novo mesto

CEFUROXIME KRKA 250 mg, comprimé pelliculé

Cefuroxime

250 mg

Film-coated tablet

Oral use

France

Krka d.d., Novo mesto

CEFUROXIME KRKA 500 mg, comprimé pelliculé

Cefuroxime

500 mg

Film-coated tablet

Oral use

Germany

Alkem Pharma GmbH

Cefuroxim Alkem 250 mg Filmtabletten

Cefuroxime axetil

250 mg

Film-coated tablet

Oral use

Germany

Alkem Pharma GmbH

Cefuroxim Alkem 500 mg Filmtabletten

Cefuroxime axetil

500 mg

Film-coated tablet

Oral use

Hungary

Krka d.d., Novo mesto

Furocef Krka 250 mg tablets

Cefuroxime

250 mg

Tablet

Oral use

Hungary

Krka d.d., Novo mesto

Furocef Krka 500 mg tablets

Cefuroxime

500 mg

Tablet

Oral use

Latvia

Krka d.d., Novo mesto

Ricefan 250 mg film-coated tablets

Cefuroxime

250 mg

Film-coated tablet

Oral use

Latvia

Krka d.d., Novo mesto

Ricefan 500 mg film-coated tablets

Cefuroxime

500 mg

Film-coated tablet

Oral use

Lithuania

Krka d.d., Novo mesto

Ricefan

Cefuroxime

250 mg

Film-coated tablet

Oral use

Lithuania

Krka d.d., Novo mesto

Ricefan

Cefuroxime

500 mg

Film-coated tablet

Oral use

Lithuania

SIA Ingen Pharma

Cefuroxime Ingen Pharma

Cefuroxime

250 mg

Film-coated tablet

Oral use

Lithuania

SIA Ingen Pharma

Cefuroxime Ingen Pharma

Cefuroxime

500 mg

Film-coated tablet

Oral use

Poland

Krka d.d., Novo mesto

Furocef

Cefuroxime

250 mg

Film-coated tablet

Oral use

Poland

Krka d.d., Novo mesto

Furocef

Cefuroxime

500 mg

Film-coated tablet

Oral use

Portugal

Krka d.d., Novo mesto

Cefuroxima Krka

Cefuroxime axetil

250 mg

Film-coated tablet

Oral use

Portugal

Krka d.d., Novo mesto

Cefuroxima Krka

Cefuroxime axetil

500 mg

Film-coated tablet

Oral use

Romania

Krka d.d., Novo mesto

CEFUROXIME KRKA 250 mg, comprimate

Cefuroxime

250 mg

Film-coated tablet

Oral use

Romania

Krka d.d., Novo mesto

CEFUROXIME KRKA 500 mg, comprimate

Cefuroxime

500 mg

Film-coated tablet

Oral use

Slovak Republic

Krka d.d., Novo mesto

Furocef 250 mg filmom obalené tablety

Cefuroxime

250 mg

Film-coated tablet

Oral use

Slovak Republic

Krka d.d., Novo mesto

Furocef 500 mg filmom obalené tablety

Cefuroxime

500 mg

Film-coated tablet

Oral use

Slovenia

Krka d.d., Novo mesto

Ricefan

Cefuroxime

250 mg

Film-coated tablet

Oral use

Slovenia

Krka d.d., Novo mesto

Ricefan

Cefuroxime

500 mg

Film-coated tablet

Oral use

Spain

Alkem Pharma GmbH

Cefuroxima 500 mg comprimidos recubiertos con película

Cefuroxime axetil

500 mg

Film-coated tablet

Oral use

Spain

Alkem Pharma GmbH

Cefuroxima Alkem 250 mg comprimidos recubiertos con película

Cefuroxime axetil

250 mg

Film-coated tablet

Oral use

Spain

Krka d.d., Novo mesto

Cefuroxima KRKA 250 mg comprimidos recubiertos con película

Cefuroxime

250 mg

Film-coated tablet

Oral use

Spain

Krka d.d., Novo mesto

Cefuroxima KRKA 500 mg comprimidos recubiertos con película

Cefuroxime

500 mg

Film-coated tablet

Oral use

United Kingdom

Alkem Pharma GmbH

Cefuroxime 250 mg film-coated tablets

Cefuroxime axetil

250 mg

Film-coated tablet

Oral use

United Kingdom

Alkem Pharma GmbH

Cefuroxime 500 mg film-coated tablets

Cefuroxime axetil

500 mg

Film-coated tablet

Oral use

Annex IB: Products for which the marketing authorisations are recommended for suspension and marketing authorisation applications which do not satisfy the criteria for authorisation

| Member State EU/EEA | Marketing Authorisation Holder | Applicant | Invented name | Active Substance | Strength | Pharmaceutical Form | Route of Administration |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Czech Republic | Alkem Pharma GmbH | | Riluzole Alkem 50 mg potahované tablety | Riluzole | 50 mg | Film-coated tablet | Oral use |
| Denmark | | Orion Corporation | Ibuprofen Orion | Ibuprofen | 200 mg | Film-coated tablet | Oral use |
| Denmark | | Orion Corporation | Ibuprofen Orion | Ibuprofen | 400 mg | Film-coated tablet | Oral use |
| Denmark | | Orion Corporation | Ibuprofen Orion | Ibuprofen | 600 mg | Film-coated tablet | Oral use |
| Germany | Alkem Pharma GmbH | | Riluzol Alkem 50 mg Filmtabletten | Riluzole | 50 mg | Film-coated tablet | Oral use |
| Spain | Alkem Pharma GmbH | | Riluzole 50 mg comprimidos recubiertos con película EFG | Riluzole | 50 mg | Film-coated tablet | Oral use |
| Sweden | | Orion Corporation | Ibuprofen Orion | Ibuprofen | 200 mg | Film-coated tablet | Oral use |
| Sweden | | Orion Corporation | Ibuprofen Orion | Ibuprofen | 400 mg | Film-coated tablet | Oral use |
| Sweden | | Orion Corporation | Ibuprofen Orion | Ibuprofen | 600 mg | Film-coated tablet | Oral use |
| United Kingdom | Alkem Pharma GmbH | | Riluzole alkem 50 mg film-coated tablets | Riluzole | 50 mg | Film-coated tablet | Oral use |

Member State EU/EEA

Marketing Authorisation Holder

Applicant

Invented name

Active Substance

Strength

Pharmaceutical Form

Route of Administration

Czech Republic

Alkem Pharma GmbH

Riluzole Alkem 50 mg potahované tablety

Riluzole

50 mg

Film-coated tablet

Oral use

Denmark

Orion Corporation

Ibuprofen Orion

Ibuprofen

200 mg

Film-coated tablet

Oral use

Denmark

Orion Corporation

Ibuprofen Orion

Ibuprofen

400 mg

Film-coated tablet

Oral use

Denmark

Orion Corporation

Ibuprofen Orion

Ibuprofen

600 mg

Film-coated tablet

Oral use

Germany

Alkem Pharma GmbH

Riluzol Alkem 50 mg Filmtabletten

Riluzole

50 mg

Film-coated tablet

Oral use

Spain

Alkem Pharma GmbH

Riluzole 50 mg comprimidos recubiertos con película EFG

Riluzole

50 mg

Film-coated tablet

Oral use

Sweden

Orion Corporation

Ibuprofen Orion

Ibuprofen

200 mg

Film-coated tablet

Oral use

Sweden

Orion Corporation

Ibuprofen Orion

Ibuprofen

400 mg

Film-coated tablet

Oral use

Sweden

Orion Corporation

Ibuprofen Orion

Ibuprofen

600 mg

Film-coated tablet

Oral use

United Kingdom

Alkem Pharma GmbH

Riluzole alkem 50 mg film-coated tablets

Riluzole

50 mg

Film-coated tablet

Oral use

---

ANNEX III

LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES

| Member State EU/EEA | Marketing authorisation holder | (Invented) Name | Strength | Pharmaceutical form | Route of administration | Content (concentration) |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Janssen-Cilag Pharma GmbH, 1020 Vienna, Vorgartenstraße 206B
  Austria | Durogesic | 12 μg/h | Transdermal patch | Transdermal use | 2,1  mg/5,25  cm2 which release 12,5 μg fentanyl per hour |
| Austria | Janssen-Cilag Pharma GmbH, 1020 Vienna, Vorgartenstraße 206B
  Austria | Durogesic | 25 μg/h | Transdermal patch | Transdermal use | 4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour |
| Austria | Janssen-Cilag Pharma GmbH, 1020 Vienna, Vorgartenstraße 206B
  Austria | Durogesic | 50 μg/h | Transdermal patch | Transdermal use | 8,4  mg/21 cm2 which release 50 μg fentanyl per hour |
| Austria | Janssen-Cilag Pharma GmbH, 1020 Vienna, Vorgartenstraße 206B
  Austria | Durogesic | 75 μg/h | Transdermal patch | Transdermal use | 12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour |
| Austria | Janssen-Cilag Pharma GmbH, 1020 Vienna, Vorgartenstraße 206B
  Austria | Durogesic | 100 μg/h | Transdermal patch | Transdermal use | 16,8  mg/42 cm2 which release 100 μg fentanyl per hour |
| Belgium | Janssen-Cilag N.V.
  Antwerpseweg 15-17
  B-2340 Beerse
  Belgium | Durogesic | 12 μg/h | Transdermal patch | Transdermal use | 2,1  mg/5,25  cm2 which release 12,5 μg fentanyl per hour |
| Belgium | Janssen-Cilag N.V.
  Antwerpseweg 15-17
  B-2340 Beerse
  Belgium | Durogesic | 25 μg/h | Transdermal patch | Transdermal use | 4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour |
| Belgium | Janssen-Cilag N.V.
  Antwerpseweg 15-17
  B-2340 Beerse
  Belgium | Durogesic | 50 μg/h | Transdermal patch | Transdermal use | 8,4  mg/21 cm2 which release 50 μg fentanyl per hour |
| Belgium | Janssen-Cilag N.V.
  Antwerpseweg 15-17
  B-2340 Beerse
  Belgium | Durogesic | 75 μg/h | Transdermal patch | Transdermal use | 12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour |
| Belgium | Janssen-Cilag N.V.
  Antwerpseweg 15-17
  B-2340 Beerse
  Belgium | Durogesic | 100 μg/h | Transdermal patch | Transdermal use | 16,8  mg/42 cm2 which release 100 μg fentanyl per hour |
| Croatia | Johnson & Johnson S.E. d.o.o. Oreškovićeva 6H, 10010 Zagreb, Croatia | Durogesic | 12 μg/h | Transdermal patch | Transdermal use | 2,1  mg/5,25  cm2 which release 12,5 μg fentanyl per hour |
| Croatia | Johnson & Johnson S.E. d.o.o. Oreškovićeva 6H, 10010 Zagreb, Croatia | Durogesic | 25 μg/h | Transdermal patch | Transdermal use | 4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour |
| Croatia | Johnson & Johnson S.E. d.o.o. Oreškovićeva 6H, 10010 Zagreb, Croatia | Durogesic | 50 μg/h | Transdermal patch | Transdermal use | 8,4  mg/21 cm2 which release 50 μg fentanyl per hour |
| Croatia | Johnson & Johnson S.E. d.o.o. Oreškovićeva 6H, 10010 Zagreb, Croatia | Durogesic | 75 μg/h | Transdermal patch | Transdermal use | 12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour |
| Croatia | Johnson & Johnson S.E. d.o.o. Oreškovićeva 6H, 10010 Zagreb, Croatia | Durogesic | 100 μg/h | Transdermal patch | Transdermal use | 16,8  mg/42 cm2 which release 100 μg fentanyl per hour |
| Cyprus | Janssen-Cilag International NV Turnhoutseweg 30
  2340 Beerse Belgium | Durogesic | 25 μg/h | Transdermal patch | Transdermal use | 4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour |
| Cyprus | Janssen-Cilag International NV Turnhoutseweg 30
  2340 Beerse Belgium | Durogesic | 50 μg/h | Transdermal patch | Transdermal use | 8,4  mg/21 cm2 which release 50 μg fentanyl per hour |
| Cyprus | Janssen-Cilag International NV Turnhoutseweg 30
  2340 Beerse Belgium | Durogesic | 100 μg/h | Transdermal patch | Transdermal use | 16,8  mg/42 cm2 which release 100 μg fentanyl per hour |
| Czech Republic | Janssen-Cilag s.r.o.,
  Karla Engliše 3201/6,
  Prague 5, 150 00
  Czech Republic | Durogesic 12 mcg/h | 12 μg/h | Transdermal patch | Transdermal use | 2,1  mg/5,25  cm2 which release 12,5 μg fentanyl per hour |
| Czech Republic | Janssen-Cilag s.r.o.,
  Karla Engliše 3201/6,
  Prague 5, 150 00
  Czech Republic | Durogesic 25 mcg/h | 25 μg/h | Transdermal patch | Transdermal use | 4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour |
| Czech Republic | Janssen-Cilag s.r.o.,
  Karla Engliše 3201/6,
  Prague 5, 150 00
  Czech Republic | Durogesic 50 mcg/h | 50 μg/h | Transdermal patch | Transdermal use | 8,4  mg/21 cm2 which release 50 μg fentanyl per hour |
| Czech Republic | Janssen-Cilag s.r.o.,
  Karla Engliše 3201/6,
  Prague 5, 150 00
  Czech Republic | Durogesic 75 mcg/h | 75 μg/h | Transdermal patch | Transdermal use | 12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour |
| Czech Republic | Janssen-Cilag s.r.o.,
  Karla Engliše 3201/6,
  Prague 5, 150 00
  Czech Republic | Durogesic 100 mcg/h | 100 μg/h | Transdermal patch | Transdermal use | 16,8  mg/42 cm2 which release 100 μg fentanyl per hour |
| Denmark | Janssen Cilag A/S
  Bregnerødvej 133
  3460 Birkerød
  Denmark | Durogesic | 12 μg/h | Transdermal patch | Transdermal use | 2,1  mg/5,25  cm2 which release 12,5 μg fentanyl per hour |
| Denmark | Janssen Cilag A/S
  Bregnerødvej 133
  3460 Birkerød
  Denmark | Durogesic | 25 μg/h | Transdermal patch | Transdermal use | 4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour |
| Denmark | Janssen Cilag A/S
  Bregnerødvej 133
  3460 Birkerød
  Denmark | Durogesic | 50 μg/h | Transdermal patch | Transdermal use | 8,4  mg/21 cm2 which release 50 μg fentanyl per hour |
| Denmark | Janssen Cilag A/S
  Bregnerødvej 133
  3460 Birkerød
  Denmark | Durogesic | 75 μg/h | Transdermal patch | Transdermal use | 12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour |
| Denmark | Janssen Cilag A/S
  Bregnerødvej 133
  3460 Birkerød
  Denmark | Durogesic | 100 μg/h | Transdermal patch | Transdermal use | 16,8  mg/42 cm2 which release 100 μg fentanyl per hour |
| Finland | Janssen-Cilag Oy, Vaisalantie 2, 02130 Espoo
  Finland | Durogesic | 12 μg/h | Transdermal patch | Transdermal use | 2,1  mg/5,25  cm2 which release 12,5 μg fentanyl per hour |
| Finland | Janssen-Cilag Oy, Vaisalantie 2, 02130 Espoo
  Finland | Durogesic | 25 μg/h | Transdermal patch | Transdermal use | 4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour |
| Finland | Janssen-Cilag Oy, Vaisalantie 2, 02130 Espoo
  Finland | Durogesic | 50 μg/h | Transdermal patch | Transdermal use | 8,4  mg/21 cm2 which release 50 μg fentanyl per hour |
| Finland | Janssen-Cilag Oy, Vaisalantie 2, 02130 Espoo
  Finland | Durogesic | 75 μg/h | Transdermal patch | Transdermal use | 12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour |
| Finland | Janssen-Cilag Oy, Vaisalantie 2, 02130 Espoo
  Finland | Durogesic | 100 μg/h | Transdermal patch | Transdermal use | 16,8  mg/42 cm2 which release 100 μg fentanyl per hour |
| France | JANSSEN-CILAG
  1, rue Camille Desmoulins
  TSA 91003
  92787 ISSY-LES-MOULINEAUX Cedex 9
  France | Durogesic 12 microgrammes/heure, dispositif transdermique | 12 μg/h | Transdermal patch | Transdermal use | 2,1  mg/5,25  cm2 which release 12,5 μg fentanyl per hour |
| France | JANSSEN-CILAG
  1, rue Camille Desmoulins
  TSA 91003
  92787 ISSY-LES-MOULINEAUX Cedex 9
  France | Durogesic 25 microgrammes/heure, dispositif transdermique | 25 μg/h | Transdermal patch | Transdermal use | 4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour |
| France | JANSSEN-CILAG
  1, rue Camille Desmoulins
  TSA 91003
  92787 ISSY-LES-MOULINEAUX Cedex 9
  France | Durogesic 50 microgrammes/heure, dispositif transdermique | 50 μg/h | Transdermal patch | Transdermal use | 8,4  mg/21 cm2 which release 50 μg fentanyl per hour |
| France | JANSSEN-CILAG
  1, rue Camille Desmoulins
  TSA 91003
  92787 ISSY-LES-MOULINEAUX Cedex 9
  France | Durogesic 75 microgrammes/heure, dispositif transdermique | 75 μg/h | Transdermal patch | Transdermal use | 12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour |
| France | JANSSEN-CILAG
  1, rue Camille Desmoulins
  TSA 91003
  92787 ISSY-LES-MOULINEAUX Cedex 9
  France | Durogesic 100 microgrammes/heure, dispositif transdermique | 100 μg/h | Transdermal patch | Transdermal use | 16,8  mg/42 cm2 which release 100 μg fentanyl per hour |
| Germany | JANSSEN-CILAG GmbH
  Johnson & Johnson Platz 1
  41470 Neuss, Germany | Durogesic SMAT | 12 μg/h | Transdermal patch | Transdermal use | 2,1  mg/5,25  cm2 which release 12,5 μg fentanyl per hour |
| Germany | JANSSEN-CILAG GmbH
  Johnson & Johnson Platz 1
  41470 Neuss, Germany | Durogesic SMAT | 25 μg/h | Transdermal patch | Transdermal use | 4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour |
| Germany | JANSSEN-CILAG GmbH
  Johnson & Johnson Platz 1
  41470 Neuss, Germany | Durogesic SMAT | 50 μg/h | Transdermal patch | Transdermal use | 8,4  mg/21 cm2 which release 50 μg fentanyl per hour |
| Germany | JANSSEN-CILAG GmbH
  Johnson & Johnson Platz 1
  41470 Neuss, Germany | Durogesic SMAT | 75 μg/h | Transdermal patch | Transdermal use | 12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour |
| Germany | JANSSEN-CILAG GmbH
  Johnson & Johnson Platz 1
  41470 Neuss, Germany | Durogesic SMAT | 100 μg/h | Transdermal patch | Transdermal use | 16,8  mg/42 cm2 which release 100 μg fentanyl per hour |
| Greece | Janssen-Cilag Pharmaceutical S.A.C.I.
  56 Eirinis Ave.,
  151 21, Pefki,
  Greece | Durogesic | 12 μg/h | Transdermal patch | Transdermal use | 2,1  mg/5,25  cm2 which release 12,5 μg fentanyl per hour |
| Greece | Janssen-Cilag Pharmaceutical S.A.C.I.
  56 Eirinis Ave.,
  151 21, Pefki,
  Greece | Durogesic | 25 μg/h | Transdermal patch | Transdermal use | 4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour |
| Greece | Janssen-Cilag Pharmaceutical S.A.C.I.
  56 Eirinis Ave.,
  151 21, Pefki,
  Greece | Durogesic | 50 μg/h | Transdermal patch | Transdermal use | 8,4  mg/21 cm2 which release 50 μg fentanyl per hour |
| Greece | Janssen-Cilag Pharmaceutical S.A.C.I.
  56 Eirinis Ave.,
  151 21, Pefki,
  Greece | Durogesic | 75 μg/h | Transdermal patch | Transdermal use | 12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour |
| Greece | Janssen-Cilag Pharmaceutical S.A.C.I.
  56 Eirinis Ave.,
  151 21, Pefki,
  Greece | Durogesic | 100 μg/h | Transdermal patch | Transdermal use | 16,8  mg/42 cm2 which release 100 μg fentanyl per hour |
| Hungary | Janssen-Cilag Kft.
  1123 Budapest,
  Nagyenyed utca 8-14
  Magyarország
  Hungary | Durogesic 12 mikrogramm/óra transzdermális tapasz | 12 μg/h | Transdermal patch | Transdermal use | 2,1  mg/5,25  cm2 which release 12,5 μg fentanyl per hour |
| Hungary | Janssen-Cilag Kft.
  1123 Budapest,
  Nagyenyed utca 8-14
  Magyarország
  Hungary | Durogesic 25 mikrogramm/óra transzdermális tapasz | 25 μg/h | Transdermal patch | Transdermal use | 4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour |
| Hungary | Janssen-Cilag Kft.
  1123 Budapest,
  Nagyenyed utca 8-14
  Magyarország
  Hungary | Durogesic 50 mikrogramm/óra transzdermális tapasz | 50 μg/h | Transdermal patch | Transdermal use | 8,4  mg/21 cm2 which release 50 μg fentanyl per hour |
| Hungary | Janssen-Cilag Kft.
  1123 Budapest,
  Nagyenyed utca 8-14
  Magyarország
  Hungary | Durogesic 75 mikrogramm/óra transzdermális tapasz | 75 μg/h | Transdermal patch | Transdermal use | 12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour |
| Hungary | Janssen-Cilag Kft.
  1123 Budapest,
  Nagyenyed utca 8-14
  Magyarország
  Hungary | Durogesic 100 mikrogramm/óra transzdermális tapasz | 100 μg/h | Transdermal patch | Transdermal use | 16,8  mg/42 cm2 which release 100 μg fentanyl per hour |
| Iceland | Janssen-Cilag AB
  Box 7073
  192 07 Sollentuna
  Sweden | Durogesic | 12 μg/h | Transdermal patch | Transdermal use | 2,1  mg/5,25  cm2 which release 12,5 μg fentanyl per hour |
| Iceland | Janssen-Cilag AB
  Box 7073
  192 07 Sollentuna
  Sweden | Durogesic | 25 μg/h | Transdermal patch | Transdermal use | 4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour |
| Iceland | Janssen-Cilag AB
  Box 7073
  192 07 Sollentuna
  Sweden | Durogesic | 50 μg/h | Transdermal patch | Transdermal use | 8,4  mg/21 cm2 which release 50 μg fentanyl per hour |
| Iceland | Janssen-Cilag AB
  Box 7073
  192 07 Sollentuna
  Sweden | Durogesic | 75 μg/h | Transdermal patch | Transdermal use | 12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour |
| Iceland | Janssen-Cilag AB
  Box 7073
  192 07 Sollentuna
  Sweden | Durogesic | 100 μg/h | Transdermal patch | Transdermal use | 16,8  mg/42 cm2 which release 100 μg fentanyl per hour |
| Ireland | Janssen-Cilag Limited
  50-100 Holmers Farm Way
  High Wycombe
  Buckinghamshire
  HP12 4EG
  United Kingdom | Durogesic DTrans | 12 μg/h | Transdermal patch | Transdermal use | 2,1  mg/5,25  cm2 which release 12,5 μg fentanyl per hour |
| Ireland | Janssen-Cilag Limited
  50-100 Holmers Farm Way
  High Wycombe
  Buckinghamshire
  HP12 4EG
  United Kingdom | Durogesic DTrans | 25 μg/h | Transdermal patch | Transdermal use | 4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour |
| Ireland | Janssen-Cilag Limited
  50-100 Holmers Farm Way
  High Wycombe
  Buckinghamshire
  HP12 4EG
  United Kingdom | Durogesic DTrans | 50 μg/h | Transdermal patch | Transdermal use | 8,4  mg/21 cm2 which release 50 μg fentanyl per hour |
| Ireland | Janssen-Cilag Limited
  50-100 Holmers Farm Way
  High Wycombe
  Buckinghamshire
  HP12 4EG
  United Kingdom | Durogesic DTrans | 75 μg/h | Transdermal patch | Transdermal use | 12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour |
| Ireland | Janssen-Cilag Limited
  50-100 Holmers Farm Way
  High Wycombe
  Buckinghamshire
  HP12 4EG
  United Kingdom | Durogesic DTrans | 100 μg/h | Transdermal patch | Transdermal use | 16,8  mg/42 cm2 which release 100 μg fentanyl per hour |
| Italy | JANSSEN-CILAG SpA
  Via M. Buonarroti, 23
  20093 COLOGNO MONZESE (MI), Italy | Durogesic | 12 μg/h | Transdermal patch | Transdermal use | 2,1  mg/5,25  cm2 which release 12,5 μg fentanyl per hour |
| Italy | JANSSEN-CILAG SpA
  Via M. Buonarroti, 23
  20093 COLOGNO MONZESE (MI), Italy | Durogesic | 25 μg/h | Transdermal patch | Transdermal use | 4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour |
| Italy | JANSSEN-CILAG SpA
  Via M. Buonarroti, 23
  20093 COLOGNO MONZESE (MI), Italy | Durogesic | 50 μg/h | Transdermal patch | Transdermal use | 8,4  mg/21 cm2 which release 50 μg fentanyl per hour |
| Italy | JANSSEN-CILAG SpA
  Via M. Buonarroti, 23
  20093 COLOGNO MONZESE (MI), Italy | Durogesic | 75 μg/h | Transdermal patch | Transdermal use | 12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour |
| Italy | JANSSEN-CILAG SpA
  Via M. Buonarroti, 23
  20093 COLOGNO MONZESE (MI), Italy | Durogesic | 100 μg/h | Transdermal patch | Transdermal use | 16,8  mg/42 cm2 which release 100 μg fentanyl per hour |
| Luxembourg | Janssen-Cilag N.V.
  Antwerpseweg 15-17
  B-2340 Beerse
  Belgium | Durogesic | 12 μg/h | Transdermal patch | Transdermal use | 2,1  mg/5,25  cm2 which release 12,5 μg fentanyl per hour |
| Luxembourg | Janssen-Cilag N.V.
  Antwerpseweg 15-17
  B-2340 Beerse
  Belgium | Durogesic | 25 μg/h | Transdermal patch | Transdermal use | 4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour |
| Luxembourg | Janssen-Cilag N.V.
  Antwerpseweg 15-17
  B-2340 Beerse
  Belgium | Durogesic | 50 μg/h | Transdermal patch | Transdermal use | 8,4  mg/21 cm2 which release 50 μg fentanyl per hour |
| Luxembourg | Janssen-Cilag N.V.
  Antwerpseweg 15-17
  B-2340 Beerse
  Belgium | Durogesic | 75 μg/h | Transdermal patch | Transdermal use | 12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour |
| Luxembourg | Janssen-Cilag N.V.
  Antwerpseweg 15-17
  B-2340 Beerse
  Belgium | Durogesic | 100 μg/h | Transdermal patch | Transdermal use | 16,8  mg/42 cm2 which release 100 μg fentanyl per hour |
| Malta | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340
  Beerse
  Belgium | Durogesic DTrans | 12 μg/h | Transdermal patch | Transdermal use | 2,1  mg/5,25  cm2 which release 12,5 μg fentanyl per hour |
| Malta | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340
  Beerse
  Belgium | Durogesic DTrans | 25 μg/h | Transdermal patch | Transdermal use | 4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour |
| Malta | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340
  Beerse
  Belgium | Durogesic DTrans | 50 μg/h | Transdermal patch | Transdermal use | 8,4  mg/21 cm2 which release 50 μg fentanyl per hour |
| Malta | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340
  Beerse
  Belgium | Durogesic DTrans | 75 μg/h | Transdermal patch | Transdermal use | 12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour |
| Malta | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340
  Beerse
  Belgium | Durogesic DTrans | 100 μg/h | Transdermal patch | Transdermal use | 16,8  mg/42 cm2 which release 100 μg fentanyl per hour |
| Netherlands | Janssen-Cilag B.V.
  Dr. Paul Janssenweg 150
  5026 RH Tilburg
  PO Box 90240
  5000 LT Tilburg
  Netherlands | Durogesic 12 μg/uur | 12 μg/h | Transdermal patch | Transdermal use | 2,1  mg/5,25  cm2 which release 12,5 μg fentanyl per hour |
| Netherlands | Janssen-Cilag B.V.
  Dr. Paul Janssenweg 150
  5026 RH Tilburg
  PO Box 90240
  5000 LT Tilburg
  Netherlands | Durogesic 25 μg/uur | 25 μg/h | Transdermal patch | Transdermal use | 4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour |
| Netherlands | Janssen-Cilag B.V.
  Dr. Paul Janssenweg 150
  5026 RH Tilburg
  PO Box 90240
  5000 LT Tilburg
  Netherlands | Durogesic 50 μg/uur | 50 μg/h | Transdermal patch | Transdermal use | 8,4  mg/21 cm2 which release 50 μg fentanyl per hour |
| Netherlands | Janssen-Cilag B.V.
  Dr. Paul Janssenweg 150
  5026 RH Tilburg
  PO Box 90240
  5000 LT Tilburg
  Netherlands | Durogesic 75 μg/uur | 75 μg/h | Transdermal patch | Transdermal use | 12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour |
| Netherlands | Janssen-Cilag B.V.
  Dr. Paul Janssenweg 150
  5026 RH Tilburg
  PO Box 90240
  5000 LT Tilburg
  Netherlands | Durogesic 100 μg/uur | 100 μg/h | Transdermal patch | Transdermal use | 16,8  mg/42 cm2 which release 100 μg fentanyl per hour |
| Norway | Janssen-Cilag AS
  Drammensveien 288
  NO-0283 Oslo
  Norway | Durogesic | 12 μg/h | Transdermal patch | Transdermal use | 2,1  mg/5,25  cm2 which release 12,5 μg fentanyl per hour |
| Norway | Janssen-Cilag AS
  Drammensveien 288
  NO-0283 Oslo
  Norway | Durogesic | 25 μg/h | Transdermal patch | Transdermal use | 4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour |
| Norway | Janssen-Cilag AS
  Drammensveien 288
  NO-0283 Oslo
  Norway | Durogesic | 50 μg/h | Transdermal patch | Transdermal use | 8,4  mg/21 cm2 which release 50 μg fentanyl per hour |
| Norway | Janssen-Cilag AS
  Drammensveien 288
  NO-0283 Oslo
  Norway | Durogesic | 75 μg/h | Transdermal patch | Transdermal use | 12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour |
| Norway | Janssen-Cilag AS
  Drammensveien 288
  NO-0283 Oslo
  Norway | Durogesic | 100 μg/h | Transdermal patch | Transdermal use | 16,8  mg/42 cm2 which release 100 μg fentanyl per hour |
| Poland | Janssen-Cilag International NV
  Turnhoutseweg 30
  B-2340 Beerse
  Belgium | Durogesic | 12 μg/h | Transdermal patch | Transdermal use | 2,1  mg/5,25  cm2 which release 12,5 μg fentanyl per hour |
| Poland | Janssen-Cilag International NV
  Turnhoutseweg 30
  B-2340 Beerse
  Belgium | Durogesic | 25 μg/h | Transdermal patch | Transdermal use | 4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour |
| Poland | Janssen-Cilag International NV
  Turnhoutseweg 30
  B-2340 Beerse
  Belgium | Durogesic | 50 μg/h | Transdermal patch | Transdermal use | 8,4  mg/21 cm2 which release 50 μg fentanyl per hour |
| Poland | Janssen-Cilag International NV
  Turnhoutseweg 30
  B-2340 Beerse
  Belgium | Durogesic | 75 μg/h | Transdermal patch | Transdermal use | 12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour |
| Poland | Janssen-Cilag International NV
  Turnhoutseweg 30
  B-2340 Beerse
  Belgium | Durogesic | 100 μg/h | Transdermal patch | Transdermal use | 16,8  mg/42 cm2 which release 100 μg fentanyl per hour |
| Portugal | Janssen Farmacêutica Portugal, Lda.
  Estrada Consiglieri Pedroso, 69 A
  Queluz de Baixo
  2734-503 Barcarena
  Portugal | Durogesic | 12 μg/h | Transdermal patch | Transdermal use | 2,1  mg/5,25  cm2 which release 12,5 μg fentanyl per hour |
| Portugal | Janssen Farmacêutica Portugal, Lda.
  Estrada Consiglieri Pedroso, 69 A
  Queluz de Baixo
  2734-503 Barcarena
  Portugal | Durogesic | 25 μg/h | Transdermal patch | Transdermal use | 4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour |
| Portugal | Janssen Farmacêutica Portugal, Lda.
  Estrada Consiglieri Pedroso, 69 A
  Queluz de Baixo
  2734-503 Barcarena
  Portugal | Durogesic | 50 μg/h | Transdermal patch | Transdermal use | 8,4  mg/21 cm2 which release 50 μg fentanyl per hour |
| Portugal | Janssen Farmacêutica Portugal, Lda.
  Estrada Consiglieri Pedroso, 69 A
  Queluz de Baixo
  2734-503 Barcarena
  Portugal | Durogesic | 75 μg/h | Transdermal patch | Transdermal use | 12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour |
| Portugal | Janssen Farmacêutica Portugal, Lda.
  Estrada Consiglieri Pedroso, 69 A
  Queluz de Baixo
  2734-503 Barcarena
  Portugal | Durogesic | 100 μg/h | Transdermal patch | Transdermal use | 16,8  mg/42 cm2 which release 100 μg fentanyl per hour |
| Slovenia | Johnson & Johnson d.o.o.
  Šmartinska cesta 53,
  1000 Ljubljana
  Slovenia | Durogesic | 12 μg/h | Transdermal patch | Transdermal use | 2,1  mg/5,25  cm2 which release 12,5 μg fentanyl per hour |
| Slovenia | Johnson & Johnson d.o.o.
  Šmartinska cesta 53,
  1000 Ljubljana
  Slovenia | Durogesic | 25 μg/h | Transdermal patch | Transdermal use | 4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour |
| Slovenia | Johnson & Johnson d.o.o.
  Šmartinska cesta 53,
  1000 Ljubljana
  Slovenia | Durogesic | 50 μg/h | Transdermal patch | Transdermal use | 8,4  mg/21 cm2 which release 50 μg fentanyl per hour |
| Slovenia | Johnson & Johnson d.o.o.
  Šmartinska cesta 53,
  1000 Ljubljana
  Slovenia | Durogesic | 75 μg/h | Transdermal patch | Transdermal use | 12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour |
| Slovenia | Johnson & Johnson d.o.o.
  Šmartinska cesta 53,
  1000 Ljubljana
  Slovenia | Durogesic | 100 μg/h | Transdermal patch | Transdermal use | 16,8  mg/42 cm2 which release 100 μg fentanyl per hour |
| Spain | JANSSEN-CILAG, S.A.
  Paseo de Las Doce Estrellas, 5-7
  28042, Madrid
  Spain | Durogesic Matrix | 12 μg/h | Transdermal patch | Transdermal use | 2,1  mg/5,25  cm2 which release 12,5 μg fentanyl per hour |
| Spain | JANSSEN-CILAG, S.A.
  Paseo de Las Doce Estrellas, 5-7
  28042, Madrid
  Spain | Durogesic Matrix | 25 μg/h | Transdermal patch | Transdermal use | 4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour |
| Spain | JANSSEN-CILAG, S.A.
  Paseo de Las Doce Estrellas, 5-7
  28042, Madrid
  Spain | Durogesic Matrix | 50 μg/h | Transdermal patch | Transdermal use | 8,4  mg/21 cm2 which release 50 μg fentanyl per hour |
| Spain | JANSSEN-CILAG, S.A.
  Paseo de Las Doce Estrellas, 5-7
  28042, Madrid
  Spain | Durogesic Matrix | 75 μg/h | Transdermal patch | Transdermal use | 12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour |
| Spain | JANSSEN-CILAG, S.A.
  Paseo de Las Doce Estrellas, 5-7
  28042, Madrid
  Spain | Durogesic Matrix | 100 μg/h | Transdermal patch | Transdermal use | 16,8  mg/42 cm2 which release 100 μg fentanyl per hour |
| Sweden | Janssen-Cilag AB
  Box 7073
  192 07 Sollentuna
  Sweden | Durogesic | 12 μg/h | Transdermal patch | Transdermal use | 2,1  mg/5,25  cm2 which release 12,5 μg fentanyl per hour |
| Sweden | Janssen-Cilag AB
  Box 7073
  192 07 Sollentuna
  Sweden | Durogesic | 25 μg/h | Transdermal patch | Transdermal use | 4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour |
| Sweden | Janssen-Cilag AB
  Box 7073
  192 07 Sollentuna
  Sweden | Durogesic | 50 μg/h | Transdermal patch | Transdermal use | 8,4  mg/21 cm2 which release 50 μg fentanyl per hour |
| Sweden | Janssen-Cilag AB
  Box 7073
  192 07 Sollentuna
  Sweden | Durogesic | 75 μg/h | Transdermal patch | Transdermal use | 12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour |
| Sweden | Janssen-Cilag AB
  Box 7073
  192 07 Sollentuna
  Sweden | Durogesic | 100 μg/h | Transdermal patch | Transdermal use | 16,8  mg/42 cm2 which release 100 μg fentanyl per hour |
| United Kingdom | Janssen-Cilag Limited
  50-100 Holmers Farm Way
  High Wycombe
  Buckinghamshire
  HP12 4EG
  United Kingdom | Durogesic DTrans | 12 μg/h | Transdermal patch | Transdermal use | 2,1  mg/5,25  cm2 which release 12,5 μg fentanyl per hour |
| United Kingdom | Janssen-Cilag Limited
  50-100 Holmers Farm Way
  High Wycombe
  Buckinghamshire
  HP12 4EG
  United Kingdom | Durogesic DTrans | 25 μg/h | Transdermal patch | Transdermal use | 4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour |
| United Kingdom | Janssen-Cilag Limited
  50-100 Holmers Farm Way
  High Wycombe
  Buckinghamshire
  HP12 4EG
  United Kingdom | Durogesic DTrans | 50 μg/h | Transdermal patch | Transdermal use | 8,4  mg/21 cm2 which release 50 μg fentanyl per hour |
| United Kingdom | Janssen-Cilag Limited
  50-100 Holmers Farm Way
  High Wycombe
  Buckinghamshire
  HP12 4EG
  United Kingdom | Durogesic DTrans | 75 μg/h | Transdermal patch | Transdermal use | 12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour |
| United Kingdom | Janssen-Cilag Limited
  50-100 Holmers Farm Way
  High Wycombe
  Buckinghamshire
  HP12 4EG
  United Kingdom | Durogesic DTrans | 100 μg/h | Transdermal patch | Transdermal use | 16,8  mg/42 cm2 which release 100 μg fentanyl per hour |

Member State EU/EEA

Marketing authorisation holder

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Content (concentration)

Austria

Janssen-Cilag Pharma GmbH, 1020 Vienna, Vorgartenstraße 206B

Austria

Durogesic

12 μg/h

Transdermal patch

Transdermal use

2,1  mg/5,25  cm2 which release 12,5 μg fentanyl per hour

Austria

Janssen-Cilag Pharma GmbH, 1020 Vienna, Vorgartenstraße 206B

Austria

Durogesic

25 μg/h

Transdermal patch

Transdermal use

4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour

Austria

Janssen-Cilag Pharma GmbH, 1020 Vienna, Vorgartenstraße 206B

Austria

Durogesic

50 μg/h

Transdermal patch

Transdermal use

8,4  mg/21 cm2 which release 50 μg fentanyl per hour

Austria

Janssen-Cilag Pharma GmbH, 1020 Vienna, Vorgartenstraße 206B

Austria

Durogesic

75 μg/h

Transdermal patch

Transdermal use

12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour

Austria

Janssen-Cilag Pharma GmbH, 1020 Vienna, Vorgartenstraße 206B

Austria

Durogesic

100 μg/h

Transdermal patch

Transdermal use

16,8  mg/42 cm2 which release 100 μg fentanyl per hour

Belgium

Janssen-Cilag N.V.

Antwerpseweg 15-17

B-2340 Beerse

Belgium

Durogesic

12 μg/h

Transdermal patch

Transdermal use

2,1  mg/5,25  cm2 which release 12,5 μg fentanyl per hour

Belgium

Janssen-Cilag N.V.

Antwerpseweg 15-17

B-2340 Beerse

Belgium

Durogesic

25 μg/h

Transdermal patch

Transdermal use

4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour

Belgium

Janssen-Cilag N.V.

Antwerpseweg 15-17

B-2340 Beerse

Belgium

Durogesic

50 μg/h

Transdermal patch

Transdermal use

8,4  mg/21 cm2 which release 50 μg fentanyl per hour

Belgium

Janssen-Cilag N.V.

Antwerpseweg 15-17

B-2340 Beerse

Belgium

Durogesic

75 μg/h

Transdermal patch

Transdermal use

12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour

Belgium

Janssen-Cilag N.V.

Antwerpseweg 15-17

B-2340 Beerse

Belgium

Durogesic

100 μg/h

Transdermal patch

Transdermal use

16,8  mg/42 cm2 which release 100 μg fentanyl per hour

Croatia

Johnson & Johnson S.E. d.o.o. Oreškovićeva 6H, 10010 Zagreb, Croatia

Durogesic

12 μg/h

Transdermal patch

Transdermal use

2,1  mg/5,25  cm2 which release 12,5 μg fentanyl per hour

Croatia

Johnson & Johnson S.E. d.o.o. Oreškovićeva 6H, 10010 Zagreb, Croatia

Durogesic

25 μg/h

Transdermal patch

Transdermal use

4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour

Croatia

Johnson & Johnson S.E. d.o.o. Oreškovićeva 6H, 10010 Zagreb, Croatia

Durogesic

50 μg/h

Transdermal patch

Transdermal use

8,4  mg/21 cm2 which release 50 μg fentanyl per hour

Croatia

Johnson & Johnson S.E. d.o.o. Oreškovićeva 6H, 10010 Zagreb, Croatia

Durogesic

75 μg/h

Transdermal patch

Transdermal use

12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour

Croatia

Johnson & Johnson S.E. d.o.o. Oreškovićeva 6H, 10010 Zagreb, Croatia

Durogesic

100 μg/h

Transdermal patch

Transdermal use

16,8  mg/42 cm2 which release 100 μg fentanyl per hour

Cyprus

Janssen-Cilag International NV Turnhoutseweg 30

2340 Beerse Belgium

Durogesic

25 μg/h

Transdermal patch

Transdermal use

4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour

Cyprus

Janssen-Cilag International NV Turnhoutseweg 30

2340 Beerse Belgium

Durogesic

50 μg/h

Transdermal patch

Transdermal use

8,4  mg/21 cm2 which release 50 μg fentanyl per hour

Cyprus

Janssen-Cilag International NV Turnhoutseweg 30

2340 Beerse Belgium

Durogesic

100 μg/h

Transdermal patch

Transdermal use

16,8  mg/42 cm2 which release 100 μg fentanyl per hour

Czech Republic

Janssen-Cilag s.r.o.,

Karla Engliše 3201/6,

Prague 5, 150 00

Czech Republic

Durogesic 12 mcg/h

12 μg/h

Transdermal patch

Transdermal use

2,1  mg/5,25  cm2 which release 12,5 μg fentanyl per hour

Czech Republic

Janssen-Cilag s.r.o.,

Karla Engliše 3201/6,

Prague 5, 150 00

Czech Republic

Durogesic 25 mcg/h

25 μg/h

Transdermal patch

Transdermal use

4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour

Czech Republic

Janssen-Cilag s.r.o.,

Karla Engliše 3201/6,

Prague 5, 150 00

Czech Republic

Durogesic 50 mcg/h

50 μg/h

Transdermal patch

Transdermal use

8,4  mg/21 cm2 which release 50 μg fentanyl per hour

Czech Republic

Janssen-Cilag s.r.o.,

Karla Engliše 3201/6,

Prague 5, 150 00

Czech Republic

Durogesic 75 mcg/h

75 μg/h

Transdermal patch

Transdermal use

12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour

Czech Republic

Janssen-Cilag s.r.o.,

Karla Engliše 3201/6,

Prague 5, 150 00

Czech Republic

Durogesic 100 mcg/h

100 μg/h

Transdermal patch

Transdermal use

16,8  mg/42 cm2 which release 100 μg fentanyl per hour

Denmark

Janssen Cilag A/S

Bregnerødvej 133

3460 Birkerød

Denmark

Durogesic

12 μg/h

Transdermal patch

Transdermal use

2,1  mg/5,25  cm2 which release 12,5 μg fentanyl per hour

Denmark

Janssen Cilag A/S

Bregnerødvej 133

3460 Birkerød

Denmark

Durogesic

25 μg/h

Transdermal patch

Transdermal use

4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour

Denmark

Janssen Cilag A/S

Bregnerødvej 133

3460 Birkerød

Denmark

Durogesic

50 μg/h

Transdermal patch

Transdermal use

8,4  mg/21 cm2 which release 50 μg fentanyl per hour

Denmark

Janssen Cilag A/S

Bregnerødvej 133

3460 Birkerød

Denmark

Durogesic

75 μg/h

Transdermal patch

Transdermal use

12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour

Denmark

Janssen Cilag A/S

Bregnerødvej 133

3460 Birkerød

Denmark

Durogesic

100 μg/h

Transdermal patch

Transdermal use

16,8  mg/42 cm2 which release 100 μg fentanyl per hour

Finland

Janssen-Cilag Oy, Vaisalantie 2, 02130 Espoo

Finland

Durogesic

12 μg/h

Transdermal patch

Transdermal use

2,1  mg/5,25  cm2 which release 12,5 μg fentanyl per hour

Finland

Janssen-Cilag Oy, Vaisalantie 2, 02130 Espoo

Finland

Durogesic

25 μg/h

Transdermal patch

Transdermal use

4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour

Finland

Janssen-Cilag Oy, Vaisalantie 2, 02130 Espoo

Finland

Durogesic

50 μg/h

Transdermal patch

Transdermal use

8,4  mg/21 cm2 which release 50 μg fentanyl per hour

Finland

Janssen-Cilag Oy, Vaisalantie 2, 02130 Espoo

Finland

Durogesic

75 μg/h

Transdermal patch

Transdermal use

12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour

Finland

Janssen-Cilag Oy, Vaisalantie 2, 02130 Espoo

Finland

Durogesic

100 μg/h

Transdermal patch

Transdermal use

16,8  mg/42 cm2 which release 100 μg fentanyl per hour

France

JANSSEN-CILAG

1, rue Camille Desmoulins

TSA 91003

92787 ISSY-LES-MOULINEAUX Cedex 9

France

Durogesic 12 microgrammes/heure, dispositif transdermique

12 μg/h

Transdermal patch

Transdermal use

2,1  mg/5,25  cm2 which release 12,5 μg fentanyl per hour

France

JANSSEN-CILAG

1, rue Camille Desmoulins

TSA 91003

92787 ISSY-LES-MOULINEAUX Cedex 9

France

Durogesic 25 microgrammes/heure, dispositif transdermique

25 μg/h

Transdermal patch

Transdermal use

4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour

France

JANSSEN-CILAG

1, rue Camille Desmoulins

TSA 91003

92787 ISSY-LES-MOULINEAUX Cedex 9

France

Durogesic 50 microgrammes/heure, dispositif transdermique

50 μg/h

Transdermal patch

Transdermal use

8,4  mg/21 cm2 which release 50 μg fentanyl per hour

France

JANSSEN-CILAG

1, rue Camille Desmoulins

TSA 91003

92787 ISSY-LES-MOULINEAUX Cedex 9

France

Durogesic 75 microgrammes/heure, dispositif transdermique

75 μg/h

Transdermal patch

Transdermal use

12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour

France

JANSSEN-CILAG

1, rue Camille Desmoulins

TSA 91003

92787 ISSY-LES-MOULINEAUX Cedex 9

France

Durogesic 100 microgrammes/heure, dispositif transdermique

100 μg/h

Transdermal patch

Transdermal use

16,8  mg/42 cm2 which release 100 μg fentanyl per hour

Germany

JANSSEN-CILAG GmbH

Johnson & Johnson Platz 1

41470 Neuss, Germany

Durogesic SMAT

12 μg/h

Transdermal patch

Transdermal use

2,1  mg/5,25  cm2 which release 12,5 μg fentanyl per hour

Germany

JANSSEN-CILAG GmbH

Johnson & Johnson Platz 1

41470 Neuss, Germany

Durogesic SMAT

25 μg/h

Transdermal patch

Transdermal use

4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour

Germany

JANSSEN-CILAG GmbH

Johnson & Johnson Platz 1

41470 Neuss, Germany

Durogesic SMAT

50 μg/h

Transdermal patch

Transdermal use

8,4  mg/21 cm2 which release 50 μg fentanyl per hour

Germany

JANSSEN-CILAG GmbH

Johnson & Johnson Platz 1

41470 Neuss, Germany

Durogesic SMAT

75 μg/h

Transdermal patch

Transdermal use

12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour

Germany

JANSSEN-CILAG GmbH

Johnson & Johnson Platz 1

41470 Neuss, Germany

Durogesic SMAT

100 μg/h

Transdermal patch

Transdermal use

16,8  mg/42 cm2 which release 100 μg fentanyl per hour

Greece

Janssen-Cilag Pharmaceutical S.A.C.I.

56 Eirinis Ave.,

151 21, Pefki,

Greece

Durogesic

12 μg/h

Transdermal patch

Transdermal use

2,1  mg/5,25  cm2 which release 12,5 μg fentanyl per hour

Greece

Janssen-Cilag Pharmaceutical S.A.C.I.

56 Eirinis Ave.,

151 21, Pefki,

Greece

Durogesic

25 μg/h

Transdermal patch

Transdermal use

4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour

Greece

Janssen-Cilag Pharmaceutical S.A.C.I.

56 Eirinis Ave.,

151 21, Pefki,

Greece

Durogesic

50 μg/h

Transdermal patch

Transdermal use

8,4  mg/21 cm2 which release 50 μg fentanyl per hour

Greece

Janssen-Cilag Pharmaceutical S.A.C.I.

56 Eirinis Ave.,

151 21, Pefki,

Greece

Durogesic

75 μg/h

Transdermal patch

Transdermal use

12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour

Greece

Janssen-Cilag Pharmaceutical S.A.C.I.

56 Eirinis Ave.,

151 21, Pefki,

Greece

Durogesic

100 μg/h

Transdermal patch

Transdermal use

16,8  mg/42 cm2 which release 100 μg fentanyl per hour

Hungary

Janssen-Cilag Kft.

1123 Budapest,

Nagyenyed utca 8-14

Magyarország

Hungary

Durogesic 12 mikrogramm/óra transzdermális tapasz

12 μg/h

Transdermal patch

Transdermal use

2,1  mg/5,25  cm2 which release 12,5 μg fentanyl per hour

Hungary

Janssen-Cilag Kft.

1123 Budapest,

Nagyenyed utca 8-14

Magyarország

Hungary

Durogesic 25 mikrogramm/óra transzdermális tapasz

25 μg/h

Transdermal patch

Transdermal use

4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour

Hungary

Janssen-Cilag Kft.

1123 Budapest,

Nagyenyed utca 8-14

Magyarország

Hungary

Durogesic 50 mikrogramm/óra transzdermális tapasz

50 μg/h

Transdermal patch

Transdermal use

8,4  mg/21 cm2 which release 50 μg fentanyl per hour

Hungary

Janssen-Cilag Kft.

1123 Budapest,

Nagyenyed utca 8-14

Magyarország

Hungary

Durogesic 75 mikrogramm/óra transzdermális tapasz

75 μg/h

Transdermal patch

Transdermal use

12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour

Hungary

Janssen-Cilag Kft.

1123 Budapest,

Nagyenyed utca 8-14

Magyarország

Hungary

Durogesic 100 mikrogramm/óra transzdermális tapasz

100 μg/h

Transdermal patch

Transdermal use

16,8  mg/42 cm2 which release 100 μg fentanyl per hour

Iceland

Janssen-Cilag AB

Box 7073

192 07 Sollentuna

Sweden

Durogesic

12 μg/h

Transdermal patch

Transdermal use

2,1  mg/5,25  cm2 which release 12,5 μg fentanyl per hour

Iceland

Janssen-Cilag AB

Box 7073

192 07 Sollentuna

Sweden

Durogesic

25 μg/h

Transdermal patch

Transdermal use

4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour

Iceland

Janssen-Cilag AB

Box 7073

192 07 Sollentuna

Sweden

Durogesic

50 μg/h

Transdermal patch

Transdermal use

8,4  mg/21 cm2 which release 50 μg fentanyl per hour

Iceland

Janssen-Cilag AB

Box 7073

192 07 Sollentuna

Sweden

Durogesic

75 μg/h

Transdermal patch

Transdermal use

12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour

Iceland

Janssen-Cilag AB

Box 7073

192 07 Sollentuna

Sweden

Durogesic

100 μg/h

Transdermal patch

Transdermal use

16,8  mg/42 cm2 which release 100 μg fentanyl per hour

Ireland

Janssen-Cilag Limited

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

United Kingdom

Durogesic DTrans

12 μg/h

Transdermal patch

Transdermal use

2,1  mg/5,25  cm2 which release 12,5 μg fentanyl per hour

Ireland

Janssen-Cilag Limited

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

United Kingdom

Durogesic DTrans

25 μg/h

Transdermal patch

Transdermal use

4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour

Ireland

Janssen-Cilag Limited

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

United Kingdom

Durogesic DTrans

50 μg/h

Transdermal patch

Transdermal use

8,4  mg/21 cm2 which release 50 μg fentanyl per hour

Ireland

Janssen-Cilag Limited

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

United Kingdom

Durogesic DTrans

75 μg/h

Transdermal patch

Transdermal use

12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour

Ireland

Janssen-Cilag Limited

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

United Kingdom

Durogesic DTrans

100 μg/h

Transdermal patch

Transdermal use

16,8  mg/42 cm2 which release 100 μg fentanyl per hour

Italy

JANSSEN-CILAG SpA

Via M. Buonarroti, 23

20093 COLOGNO MONZESE (MI), Italy

Durogesic

12 μg/h

Transdermal patch

Transdermal use

2,1  mg/5,25  cm2 which release 12,5 μg fentanyl per hour

Italy

JANSSEN-CILAG SpA

Via M. Buonarroti, 23

20093 COLOGNO MONZESE (MI), Italy

Durogesic

25 μg/h

Transdermal patch

Transdermal use

4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour

Italy

JANSSEN-CILAG SpA

Via M. Buonarroti, 23

20093 COLOGNO MONZESE (MI), Italy

Durogesic

50 μg/h

Transdermal patch

Transdermal use

8,4  mg/21 cm2 which release 50 μg fentanyl per hour

Italy

JANSSEN-CILAG SpA

Via M. Buonarroti, 23

20093 COLOGNO MONZESE (MI), Italy

Durogesic

75 μg/h

Transdermal patch

Transdermal use

12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour

Italy

JANSSEN-CILAG SpA

Via M. Buonarroti, 23

20093 COLOGNO MONZESE (MI), Italy

Durogesic

100 μg/h

Transdermal patch

Transdermal use

16,8  mg/42 cm2 which release 100 μg fentanyl per hour

Luxembourg

Janssen-Cilag N.V.

Antwerpseweg 15-17

B-2340 Beerse

Belgium

Durogesic

12 μg/h

Transdermal patch

Transdermal use

2,1  mg/5,25  cm2 which release 12,5 μg fentanyl per hour

Luxembourg

Janssen-Cilag N.V.

Antwerpseweg 15-17

B-2340 Beerse

Belgium

Durogesic

25 μg/h

Transdermal patch

Transdermal use

4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour

Luxembourg

Janssen-Cilag N.V.

Antwerpseweg 15-17

B-2340 Beerse

Belgium

Durogesic

50 μg/h

Transdermal patch

Transdermal use

8,4  mg/21 cm2 which release 50 μg fentanyl per hour

Luxembourg

Janssen-Cilag N.V.

Antwerpseweg 15-17

B-2340 Beerse

Belgium

Durogesic

75 μg/h

Transdermal patch

Transdermal use

12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour

Luxembourg

Janssen-Cilag N.V.

Antwerpseweg 15-17

B-2340 Beerse

Belgium

Durogesic

100 μg/h

Transdermal patch

Transdermal use

16,8  mg/42 cm2 which release 100 μg fentanyl per hour

Malta

Janssen-Cilag International NV

Turnhoutseweg 30, 2340

Beerse

Belgium

Durogesic DTrans

12 μg/h

Transdermal patch

Transdermal use

2,1  mg/5,25  cm2 which release 12,5 μg fentanyl per hour

Malta

Janssen-Cilag International NV

Turnhoutseweg 30, 2340

Beerse

Belgium

Durogesic DTrans

25 μg/h

Transdermal patch

Transdermal use

4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour

Malta

Janssen-Cilag International NV

Turnhoutseweg 30, 2340

Beerse

Belgium

Durogesic DTrans

50 μg/h

Transdermal patch

Transdermal use

8,4  mg/21 cm2 which release 50 μg fentanyl per hour

Malta

Janssen-Cilag International NV

Turnhoutseweg 30, 2340

Beerse

Belgium

Durogesic DTrans

75 μg/h

Transdermal patch

Transdermal use

12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour

Malta

Janssen-Cilag International NV

Turnhoutseweg 30, 2340

Beerse

Belgium

Durogesic DTrans

100 μg/h

Transdermal patch

Transdermal use

16,8  mg/42 cm2 which release 100 μg fentanyl per hour

Netherlands

Janssen-Cilag B.V.

Dr. Paul Janssenweg 150

5026 RH Tilburg

PO Box 90240

5000 LT Tilburg

Netherlands

Durogesic 12 μg/uur

12 μg/h

Transdermal patch

Transdermal use

2,1  mg/5,25  cm2 which release 12,5 μg fentanyl per hour

Netherlands

Janssen-Cilag B.V.

Dr. Paul Janssenweg 150

5026 RH Tilburg

PO Box 90240

5000 LT Tilburg

Netherlands

Durogesic 25 μg/uur

25 μg/h

Transdermal patch

Transdermal use

4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour

Netherlands

Janssen-Cilag B.V.

Dr. Paul Janssenweg 150

5026 RH Tilburg

PO Box 90240

5000 LT Tilburg

Netherlands

Durogesic 50 μg/uur

50 μg/h

Transdermal patch

Transdermal use

8,4  mg/21 cm2 which release 50 μg fentanyl per hour

Netherlands

Janssen-Cilag B.V.

Dr. Paul Janssenweg 150

5026 RH Tilburg

PO Box 90240

5000 LT Tilburg

Netherlands

Durogesic 75 μg/uur

75 μg/h

Transdermal patch

Transdermal use

12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour

Netherlands

Janssen-Cilag B.V.

Dr. Paul Janssenweg 150

5026 RH Tilburg

PO Box 90240

5000 LT Tilburg

Netherlands

Durogesic 100 μg/uur

100 μg/h

Transdermal patch

Transdermal use

16,8  mg/42 cm2 which release 100 μg fentanyl per hour

Norway

Janssen-Cilag AS

Drammensveien 288

NO-0283 Oslo

Norway

Durogesic

12 μg/h

Transdermal patch

Transdermal use

2,1  mg/5,25  cm2 which release 12,5 μg fentanyl per hour

Norway

Janssen-Cilag AS

Drammensveien 288

NO-0283 Oslo

Norway

Durogesic

25 μg/h

Transdermal patch

Transdermal use

4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour

Norway

Janssen-Cilag AS

Drammensveien 288

NO-0283 Oslo

Norway

Durogesic

50 μg/h

Transdermal patch

Transdermal use

8,4  mg/21 cm2 which release 50 μg fentanyl per hour

Norway

Janssen-Cilag AS

Drammensveien 288

NO-0283 Oslo

Norway

Durogesic

75 μg/h

Transdermal patch

Transdermal use

12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour

Norway

Janssen-Cilag AS

Drammensveien 288

NO-0283 Oslo

Norway

Durogesic

100 μg/h

Transdermal patch

Transdermal use

16,8  mg/42 cm2 which release 100 μg fentanyl per hour

Poland

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

Durogesic

12 μg/h

Transdermal patch

Transdermal use

2,1  mg/5,25  cm2 which release 12,5 μg fentanyl per hour

Poland

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

Durogesic

25 μg/h

Transdermal patch

Transdermal use

4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour

Poland

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

Durogesic

50 μg/h

Transdermal patch

Transdermal use

8,4  mg/21 cm2 which release 50 μg fentanyl per hour

Poland

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

Durogesic

75 μg/h

Transdermal patch

Transdermal use

12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour

Poland

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

Durogesic

100 μg/h

Transdermal patch

Transdermal use

16,8  mg/42 cm2 which release 100 μg fentanyl per hour

Portugal

Janssen Farmacêutica Portugal, Lda.

Estrada Consiglieri Pedroso, 69 A

Queluz de Baixo

2734-503 Barcarena

Portugal

Durogesic

12 μg/h

Transdermal patch

Transdermal use

2,1  mg/5,25  cm2 which release 12,5 μg fentanyl per hour

Portugal

Janssen Farmacêutica Portugal, Lda.

Estrada Consiglieri Pedroso, 69 A

Queluz de Baixo

2734-503 Barcarena

Portugal

Durogesic

25 μg/h

Transdermal patch

Transdermal use

4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour

Portugal

Janssen Farmacêutica Portugal, Lda.

Estrada Consiglieri Pedroso, 69 A

Queluz de Baixo

2734-503 Barcarena

Portugal

Durogesic

50 μg/h

Transdermal patch

Transdermal use

8,4  mg/21 cm2 which release 50 μg fentanyl per hour

Portugal

Janssen Farmacêutica Portugal, Lda.

Estrada Consiglieri Pedroso, 69 A

Queluz de Baixo

2734-503 Barcarena

Portugal

Durogesic

75 μg/h

Transdermal patch

Transdermal use

12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour

Portugal

Janssen Farmacêutica Portugal, Lda.

Estrada Consiglieri Pedroso, 69 A

Queluz de Baixo

2734-503 Barcarena

Portugal

Durogesic

100 μg/h

Transdermal patch

Transdermal use

16,8  mg/42 cm2 which release 100 μg fentanyl per hour

Slovenia

Johnson & Johnson d.o.o.

Šmartinska cesta 53,

1000 Ljubljana

Slovenia

Durogesic

12 μg/h

Transdermal patch

Transdermal use

2,1  mg/5,25  cm2 which release 12,5 μg fentanyl per hour

Slovenia

Johnson & Johnson d.o.o.

Šmartinska cesta 53,

1000 Ljubljana

Slovenia

Durogesic

25 μg/h

Transdermal patch

Transdermal use

4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour

Slovenia

Johnson & Johnson d.o.o.

Šmartinska cesta 53,

1000 Ljubljana

Slovenia

Durogesic

50 μg/h

Transdermal patch

Transdermal use

8,4  mg/21 cm2 which release 50 μg fentanyl per hour

Slovenia

Johnson & Johnson d.o.o.

Šmartinska cesta 53,

1000 Ljubljana

Slovenia

Durogesic

75 μg/h

Transdermal patch

Transdermal use

12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour

Slovenia

Johnson & Johnson d.o.o.

Šmartinska cesta 53,

1000 Ljubljana

Slovenia

Durogesic

100 μg/h

Transdermal patch

Transdermal use

16,8  mg/42 cm2 which release 100 μg fentanyl per hour

Spain

JANSSEN-CILAG, S.A.

Paseo de Las Doce Estrellas, 5-7

28042, Madrid

Spain

Durogesic Matrix

12 μg/h

Transdermal patch

Transdermal use

2,1  mg/5,25  cm2 which release 12,5 μg fentanyl per hour

Spain

JANSSEN-CILAG, S.A.

Paseo de Las Doce Estrellas, 5-7

28042, Madrid

Spain

Durogesic Matrix

25 μg/h

Transdermal patch

Transdermal use

4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour

Spain

JANSSEN-CILAG, S.A.

Paseo de Las Doce Estrellas, 5-7

28042, Madrid

Spain

Durogesic Matrix

50 μg/h

Transdermal patch

Transdermal use

8,4  mg/21 cm2 which release 50 μg fentanyl per hour

Spain

JANSSEN-CILAG, S.A.

Paseo de Las Doce Estrellas, 5-7

28042, Madrid

Spain

Durogesic Matrix

75 μg/h

Transdermal patch

Transdermal use

12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour

Spain

JANSSEN-CILAG, S.A.

Paseo de Las Doce Estrellas, 5-7

28042, Madrid

Spain

Durogesic Matrix

100 μg/h

Transdermal patch

Transdermal use

16,8  mg/42 cm2 which release 100 μg fentanyl per hour

Sweden

Janssen-Cilag AB

Box 7073

192 07 Sollentuna

Sweden

Durogesic

12 μg/h

Transdermal patch

Transdermal use

2,1  mg/5,25  cm2 which release 12,5 μg fentanyl per hour

Sweden

Janssen-Cilag AB

Box 7073

192 07 Sollentuna

Sweden

Durogesic

25 μg/h

Transdermal patch

Transdermal use

4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour

Sweden

Janssen-Cilag AB

Box 7073

192 07 Sollentuna

Sweden

Durogesic

50 μg/h

Transdermal patch

Transdermal use

8,4  mg/21 cm2 which release 50 μg fentanyl per hour

Sweden

Janssen-Cilag AB

Box 7073

192 07 Sollentuna

Sweden

Durogesic

75 μg/h

Transdermal patch

Transdermal use

12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour

Sweden

Janssen-Cilag AB

Box 7073

192 07 Sollentuna

Sweden

Durogesic

100 μg/h

Transdermal patch

Transdermal use

16,8  mg/42 cm2 which release 100 μg fentanyl per hour

United Kingdom

Janssen-Cilag Limited

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

United Kingdom

Durogesic DTrans

12 μg/h

Transdermal patch

Transdermal use

2,1  mg/5,25  cm2 which release 12,5 μg fentanyl per hour

United Kingdom

Janssen-Cilag Limited

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

United Kingdom

Durogesic DTrans

25 μg/h

Transdermal patch

Transdermal use

4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour

United Kingdom

Janssen-Cilag Limited

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

United Kingdom

Durogesic DTrans

50 μg/h

Transdermal patch

Transdermal use

8,4  mg/21 cm2 which release 50 μg fentanyl per hour

United Kingdom

Janssen-Cilag Limited

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

United Kingdom

Durogesic DTrans

75 μg/h

Transdermal patch

Transdermal use

12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour

United Kingdom

Janssen-Cilag Limited

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

United Kingdom

Durogesic DTrans

100 μg/h

Transdermal patch

Transdermal use

16,8  mg/42 cm2 which release 100 μg fentanyl per hour

---

ANNEX IV

List of nationally authorised medicinal products and marketing authorisation applications

Annex IA: Medicinal products recommended for maintenance and marketing authorisation applications for which bioequivalence vis-à-vis the EU reference medicinal product has been established

| Member State EU/EEA | Marketing Authorisation Holder | Applicant | Invented name | Active Substance | Strength | Pharmaceutical Form | Route of Administration |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | | Lupin (Europe) Ltd | Abacavir/Lamivudin Aristo 600 mg/300 mg Filmtabletten | abacavir/lamivudine | 600 mg/300 mg | Film-coated tablet | Oral use |
| Austria | | Lupin (Europe) Ltd | Abacavir/Lamivudin Sandoz 600 mg/300 mg — Filmtabletten | abacavir/lamivudine | 600 mg/300 mg | Film-coated tablet | Oral use |
| Belgium | | Lupin (Europe) Ltd | Abacavir/Lamivudin Sandoz | abacavir/lamivudine | 600 mg/300 mg | Film-coated tablet | Oral use |
| Belgium | | Mylan bvba | Abacavir/Lamivudin Mylan | abacavir/lamivudine | 600 mg/300 mg | Film-coated tablet | Oral use |
| Bulgaria | Sandoz d.d. | | Abacavir/Lamivudin Sandoz | abacavir/lamivudine | 600 mg/300 mg | Film-coated tablet | Oral use |
| Croatia | | Lupin (Europe) Ltd | Abakavir/Lamivudin Sandoz 600 mg/300 mg filmom obložene tablete | abacavir/lamivudine | 600 mg/300 mg | Film-coated tablet | Oral use |
| Cyprus | | Lupin (Europe) Ltd | Abacavir/Lamivudine Sandoz | abacavir/lamivudine | 600 mg/300 mg | Film-coated tablet | Oral use |
| Denmark | | Lupin (Europe) Ltd | Abacavir/Lamivudine Sandoz | abacavir/lamivudine | 600 mg/300 mg | Film-coated tablet | Oral use |
| Denmark | | Mylan AB | Abacavir/Lamivudine Mylan | abacavir/lamivudine | 600 mg/300 mg | Film-coated tablet | Oral use |
| Estonia | | Lupin (Europe) Ltd | ABACAVIR/LAMIVUDINE SANDOZ | abacavir/lamivudine | 600 mg/300 mg | Film-coated tablet | Oral use |
| Finland | | Lupin (Europe) Ltd | Abacavir/Lamivudine Sandoz | abacavir/lamivudine | 600 mg/300 mg | Film-coated tablet | Oral use |
| Finland | | Mylan AB | Abacavir/Lamivudine Mylan | abacavir/lamivudine | 600 mg/300 mg | Film-coated tablet | Oral use |
| France | | Venipharm | BAMIVENI | abacavir/lamivudine | 600 mg/300 mg | Film-coated tablet | Oral use |
| France | | Venipharm | BAMIVUDINE | abacavir/lamivudine | 600 mg/300 mg | Film-coated tablet | Oral use |
| France | | Venipharm | VIRAMUDINE | abacavir/lamivudine | 600 mg/300 mg | Film-coated tablet | Oral use |
| Germany | | Lupin (Europe) Ltd | Abacavir/Lamivudin 600 mg/300 mg Filmtabletten | abacavir/lamivudine | 600 mg/300 mg | Film-coated tablet | Oral use |
| Germany | | Lupin (Europe) Ltd | Abacavir/Lamivudine Hormosan 600 mg/300 mg Filmtabletten | abacavir/lamivudine | 600 mg/300 mg | Film-coated tablet | Oral use |
| Germany | | Lupin (Europe) Ltd | Abacavir/Lamivudin HEXAL 600 mg/300 mg Filmtabletten | abacavir/lamivudine | 600 mg/300 mg | Film-coated tablet | Oral use |
| Germany | | Lupin (Europe) Ltd | Abacavir/Lamivudin Aristo 600 mg/300 mg Filmtabletten | abacavir/lamivudine | 600 mg/300 mg | Film-coated tablet | Oral use |
| Germany | | Lupin (Europe) Ltd | Abacavir/Lamivudin Klinge 600 mg/300 mg Filmtabletten | abacavir/lamivudine | 600 mg/300 mg | Film-coated tablet | Oral use |
| Ireland | | Generics (UK) Limited | Abacavir/Lamivudine | abacavir/lamivudine | 600 mg/300 mg | Film-coated tablet | Oral use |
| Ireland | | Lupin (Europe) Ltd | Abacavir/Lamivudine Rowex | abacavir/lamivudine | 600 mg/300 mg | Film-coated tablet | Oral use |
| Italy | | Lupin (Europe) Ltd | ABACAVIR E LAMIVUDINA LUPIN | abacavir/lamivudine | 600 mg/300 mg | Film-coated tablet | Oral use |
| Italy | | Lupin (Europe) Ltd | ABACAVIR E LAMIVUDINA SANDOZ | abacavir/lamivudine | 600 mg/300 mg | Film-coated tablet | Oral use |
| Italy | | Lupin (Europe) Ltd | ABACAVIR E LAMIVUDINA MYLAN | abacavir/lamivudine | 600 mg/300 mg | Film-coated tablet | Oral use |
| Italy | | Lupin (Europe) Ltd | ABACAVIR E LAMIVUDINA ARISTO | abacavir/lamivudine | 600 mg/300 mg | Film-coated tablet | Oral use |
| Lithuania | | Lupin (Europe) Ltd | Abacavir/Lamivudine Sandoz 600 mg/300 mg plėvele dengtos tabletės | abacavir/lamivudine | 600 mg/300 mg | Film-coated tablet | Oral use |
| Norway | | Mylan AB | Abacavir/Lamivudin Mylan | abacavir/lamivudine | 600 mg/300 mg | Film-coated tablet | Oral use |
| Poland | | Lupin (Europe) Ltd | Abacavir+Lamivudine Sandoz | abacavir/lamivudine | 600 mg/300 mg | Film-coated tablet | Oral use |
| Poland | | Lupin (Europe) Ltd | Abacavir + Lamivudine Mylan | abacavir/lamivudine | 600 mg/300 mg | Film-coated tablet | Oral use |
| Portugal | | Lupin (Europe) Ltd | Abacavir + Lamivudina Lupin | abacavir/lamivudine | 600 mg/300 mg | Film-coated tablet | Oral use |
| Portugal | | Lupin (Europe) Ltd | Abacavir + Lamivudina Sandoz | abacavir/lamivudine | 600 mg/300 mg | Film-coated tablet | Oral use |
| Portugal | | Mylan, Lda. | Abacavir + Lamivudina Mylan | abacavir/lamivudine | 600 mg/300 mg | Film-coated tablet | Oral use |
| Romania | | Lupin (Europe) Ltd | Abacavir/lamivudină Sandoz 600 mg/300 mg, film-coated tablets | abacavir/lamivudine | 600 mg/300 mg | Film-coated tablet | Oral use |
| Slovenia | | Lupin (Europe) Ltd | Abakavir/lamivudin Sandoz 600 mg/300 mg filmsko obložene tablete | abacavir/lamivudine | 600 mg/300 mg | Film-coated tablet | Oral use |
| Spain | | Lupin (Europe) Ltd | Abacavir/Lamivudina Amneal 600 mg/300 mg comprimidos recubiertos con película EFG | abacavir/lamivudine | 600 mg/300 mg | Film-coated tablet | Oral use |
| Spain | | Lupin (Europe) Ltd | Abacavir/Lamivudina Aristo 600 mg/300 mg comprimidos recubiertos con película EFG | abacavir/lamivudine | 600 mg/300 mg | Film-coated tablet | Oral use |
| Spain | | Sandoz B.V. | Abacavir/Lamivudina Sandoz 600 mg/300 mg comprimimidos recubiertos con película EFG | abacavir/lamivudine | 600 mg/300 mg | Film-coated tablet | Oral use |
| Spain | Mylan Pharmaceuticals, S.L. | | Abacavir/Lamivudina Mylan 600 mg/300 mg comprimidos recubiertos con película EFG | abacavir/lamivudine | 600 mg/300 mg | Film-coated tablet | Oral use |
| Sweden | | Lupin (Europe) Ltd | Abacavir/Lamivudine Sandoz | abacavir/lamivudine | 600 mg/300 mg | Film-coated tablet | Oral use |
| Sweden | | Mylan AB | Abacavir/Lamivudine Mylan | abacavir/lamivudine | 600 mg/300 mg | Film-coated tablet | Oral use |
| The Netherlands | | Lupin (Europe) Ltd | Abacavir/Lamivudine Aristo | abacavir/lamivudine | 600 mg/300 mg | Film-coated tablet | Oral use |
| The Netherlands | | Lupin (Europe) Ltd | Abacavir/Lamivudine Lupin | abacavir/lamivudine | 600 mg/300 mg | Film-coated tablet | Oral use |
| The Netherlands | | Lupin (Europe) Ltd | Abacavir/Lamivudine Lupin | abacavir/lamivudine | 600 mg/300 mg | Film-coated tablet | Oral use |
| United Kingdom | | Aristo Pharma GmbH | Abacavir/lamivudine 600 mg/300 mg film-coated tablets | abacavir/lamivudine | 600 mg/300 mg | Tablet | Oral use |
| United Kingdom | | Lupin (Europe) Ltd | Abacavir/lamivudine 600 mg/300 mg film-coated tablets | abacavir/lamivudine | 600 mg/300 mg | Film-coated tablet | Oral use |
| United Kingdom | | Lupin (Europe) Ltd | Abacavir/lamivudine 600 mg/300 mg film-coated tablets | abacavir/lamivudine | 600 mg/300 mg | Film-coated tablet | Oral use |
| United Kingdom | | Generics (UK) Limited | Abacavir/lamivudine 600 mg/300 mg film-coated tablets | abacavir/lamivudine | 600 mg/300 mg | Film-coated tablet | Oral use |

Member State EU/EEA

Marketing Authorisation Holder

Applicant

Invented name

Active Substance

Strength

Pharmaceutical Form

Route of Administration

Austria

Lupin (Europe) Ltd

Abacavir/Lamivudin Aristo 600 mg/300 mg Filmtabletten

abacavir/lamivudine

600 mg/300 mg

Film-coated tablet

Oral use

Austria

Lupin (Europe) Ltd

Abacavir/Lamivudin Sandoz 600 mg/300 mg — Filmtabletten

abacavir/lamivudine

600 mg/300 mg

Film-coated tablet

Oral use

Belgium

Lupin (Europe) Ltd

Abacavir/Lamivudin Sandoz

abacavir/lamivudine

600 mg/300 mg

Film-coated tablet

Oral use

Belgium

Mylan bvba

Abacavir/Lamivudin Mylan

abacavir/lamivudine

600 mg/300 mg

Film-coated tablet

Oral use

Bulgaria

Sandoz d.d.

Abacavir/Lamivudin Sandoz

abacavir/lamivudine

600 mg/300 mg

Film-coated tablet

Oral use

Croatia

Lupin (Europe) Ltd

Abakavir/Lamivudin Sandoz 600 mg/300 mg filmom obložene tablete

abacavir/lamivudine

600 mg/300 mg

Film-coated tablet

Oral use

Cyprus

Lupin (Europe) Ltd

Abacavir/Lamivudine Sandoz

abacavir/lamivudine

600 mg/300 mg

Film-coated tablet

Oral use

Denmark

Lupin (Europe) Ltd

Abacavir/Lamivudine Sandoz

abacavir/lamivudine

600 mg/300 mg

Film-coated tablet

Oral use

Denmark

Mylan AB

Abacavir/Lamivudine Mylan

abacavir/lamivudine

600 mg/300 mg

Film-coated tablet

Oral use

Estonia

Lupin (Europe) Ltd

ABACAVIR/LAMIVUDINE SANDOZ

abacavir/lamivudine

600 mg/300 mg

Film-coated tablet

Oral use

Finland

Lupin (Europe) Ltd

Abacavir/Lamivudine Sandoz

abacavir/lamivudine

600 mg/300 mg

Film-coated tablet

Oral use

Finland

Mylan AB

Abacavir/Lamivudine Mylan

abacavir/lamivudine

600 mg/300 mg

Film-coated tablet

Oral use

France

Venipharm

BAMIVENI

abacavir/lamivudine

600 mg/300 mg

Film-coated tablet

Oral use

France

Venipharm

BAMIVUDINE

abacavir/lamivudine

600 mg/300 mg

Film-coated tablet

Oral use

France

Venipharm

VIRAMUDINE

abacavir/lamivudine

600 mg/300 mg

Film-coated tablet

Oral use

Germany

Lupin (Europe) Ltd

Abacavir/Lamivudin 600 mg/300 mg Filmtabletten

abacavir/lamivudine

600 mg/300 mg

Film-coated tablet

Oral use

Germany

Lupin (Europe) Ltd

Abacavir/Lamivudine Hormosan 600 mg/300 mg Filmtabletten

abacavir/lamivudine

600 mg/300 mg

Film-coated tablet

Oral use

Germany

Lupin (Europe) Ltd

Abacavir/Lamivudin HEXAL 600 mg/300 mg Filmtabletten

abacavir/lamivudine

600 mg/300 mg

Film-coated tablet

Oral use

Germany

Lupin (Europe) Ltd

Abacavir/Lamivudin Aristo 600 mg/300 mg Filmtabletten

abacavir/lamivudine

600 mg/300 mg

Film-coated tablet

Oral use

Germany

Lupin (Europe) Ltd

Abacavir/Lamivudin Klinge 600 mg/300 mg Filmtabletten

abacavir/lamivudine

600 mg/300 mg

Film-coated tablet

Oral use

Ireland

Generics (UK) Limited

Abacavir/Lamivudine

abacavir/lamivudine

600 mg/300 mg

Film-coated tablet

Oral use

Ireland

Lupin (Europe) Ltd

Abacavir/Lamivudine Rowex

abacavir/lamivudine

600 mg/300 mg

Film-coated tablet

Oral use

Italy

Lupin (Europe) Ltd

ABACAVIR E LAMIVUDINA LUPIN

abacavir/lamivudine

600 mg/300 mg

Film-coated tablet

Oral use

Italy

Lupin (Europe) Ltd

ABACAVIR E LAMIVUDINA SANDOZ

abacavir/lamivudine

600 mg/300 mg

Film-coated tablet

Oral use

Italy

Lupin (Europe) Ltd

ABACAVIR E LAMIVUDINA MYLAN

abacavir/lamivudine

600 mg/300 mg

Film-coated tablet

Oral use

Italy

Lupin (Europe) Ltd

ABACAVIR E LAMIVUDINA ARISTO

abacavir/lamivudine

600 mg/300 mg

Film-coated tablet

Oral use

Lithuania

Lupin (Europe) Ltd

Abacavir/Lamivudine Sandoz 600 mg/300 mg plėvele dengtos tabletės

abacavir/lamivudine

600 mg/300 mg

Film-coated tablet

Oral use

Norway

Mylan AB

Abacavir/Lamivudin Mylan

abacavir/lamivudine

600 mg/300 mg

Film-coated tablet

Oral use

Poland

Lupin (Europe) Ltd

Abacavir+Lamivudine Sandoz

abacavir/lamivudine

600 mg/300 mg

Film-coated tablet

Oral use

Poland

Lupin (Europe) Ltd

Abacavir + Lamivudine Mylan

abacavir/lamivudine

600 mg/300 mg

Film-coated tablet

Oral use

Portugal

Lupin (Europe) Ltd

Abacavir + Lamivudina Lupin

abacavir/lamivudine

600 mg/300 mg

Film-coated tablet

Oral use

Portugal

Lupin (Europe) Ltd

Abacavir + Lamivudina Sandoz

abacavir/lamivudine

600 mg/300 mg

Film-coated tablet

Oral use

Portugal

Mylan, Lda.

Abacavir + Lamivudina Mylan

abacavir/lamivudine

600 mg/300 mg

Film-coated tablet

Oral use

Romania

Lupin (Europe) Ltd

Abacavir/lamivudină Sandoz 600 mg/300 mg, film-coated tablets

abacavir/lamivudine

600 mg/300 mg

Film-coated tablet

Oral use

Slovenia

Lupin (Europe) Ltd

Abakavir/lamivudin Sandoz 600 mg/300 mg filmsko obložene tablete

abacavir/lamivudine

600 mg/300 mg

Film-coated tablet

Oral use

Spain

Lupin (Europe) Ltd

Abacavir/Lamivudina Amneal 600 mg/300 mg comprimidos recubiertos con película EFG

abacavir/lamivudine

600 mg/300 mg

Film-coated tablet

Oral use

Spain

Lupin (Europe) Ltd

Abacavir/Lamivudina Aristo 600 mg/300 mg comprimidos recubiertos con película EFG

abacavir/lamivudine

600 mg/300 mg

Film-coated tablet

Oral use

Spain

Sandoz B.V.

Abacavir/Lamivudina Sandoz 600 mg/300 mg comprimimidos recubiertos con película EFG

abacavir/lamivudine

600 mg/300 mg

Film-coated tablet

Oral use

Spain

Mylan Pharmaceuticals, S.L.

Abacavir/Lamivudina Mylan 600 mg/300 mg comprimidos recubiertos con película EFG

abacavir/lamivudine

600 mg/300 mg

Film-coated tablet

Oral use

Sweden

Lupin (Europe) Ltd

Abacavir/Lamivudine Sandoz

abacavir/lamivudine

600 mg/300 mg

Film-coated tablet

Oral use

Sweden

Mylan AB

Abacavir/Lamivudine Mylan

abacavir/lamivudine

600 mg/300 mg

Film-coated tablet

Oral use

The Netherlands

Lupin (Europe) Ltd

Abacavir/Lamivudine Aristo

abacavir/lamivudine

600 mg/300 mg

Film-coated tablet

Oral use

The Netherlands

Lupin (Europe) Ltd

Abacavir/Lamivudine Lupin

abacavir/lamivudine

600 mg/300 mg

Film-coated tablet

Oral use

The Netherlands

Lupin (Europe) Ltd

Abacavir/Lamivudine Lupin

abacavir/lamivudine

600 mg/300 mg

Film-coated tablet

Oral use

United Kingdom

Aristo Pharma GmbH

Abacavir/lamivudine 600 mg/300 mg film-coated tablets

abacavir/lamivudine

600 mg/300 mg

Tablet

Oral use

United Kingdom

Lupin (Europe) Ltd

Abacavir/lamivudine 600 mg/300 mg film-coated tablets

abacavir/lamivudine

600 mg/300 mg

Film-coated tablet

Oral use

United Kingdom

Lupin (Europe) Ltd

Abacavir/lamivudine 600 mg/300 mg film-coated tablets

abacavir/lamivudine

600 mg/300 mg

Film-coated tablet

Oral use

United Kingdom

Generics (UK) Limited

Abacavir/lamivudine 600 mg/300 mg film-coated tablets

abacavir/lamivudine

600 mg/300 mg

Film-coated tablet

Oral use

Annex IB: Products for which the marketing authorisations are recommended for suspension and marketing authorisation applications which do not satisfy the criteria for authorisation

| Member State EU/EEA | Marketing Authorisation Holder | Applicant | Invented name | Active Substance | Strength | Pharmaceutical Form | Route of Administration |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Belgium | | Sandoz NV | Erlotinib Sandoz | erlotinib | 25 mg | Film-coated tablet | Oral use |
| Belgium | | Sandoz NV | Erlotinib Sandoz | erlotinib | 100 mg | Film-coated tablet | Oral use |
| Belgium | | Sandoz NV | Erlotinib Sandoz | erlotinib | 150 mg | Film-coated tablet | Oral use |
| Belgium | | Teva Pharma Belgium NV | Erlotinib Ratiopharm | erlotinib | 25 mg | Film-coated tablet | Oral use |
| Belgium | | Teva Pharma Belgium NV | Erlotinib Ratiopharm | erlotinib | 100 mg | Film-coated tablet | Oral use |
| Belgium | | Teva Pharma Belgium NV | Erlotinib Ratiopharm | erlotinib | 150 mg | Film-coated tablet | Oral use |
| Belgium | | Accord Healthcare Ltd | Saquinavir Accord | saquinavir | 500 mg | Film-coated tablet | Oral use |
| Belgium | Teva Pharma Belgium NV | | Atovaquone/Proguanil Teva | atovaquone/proguanil | 62,5  mg/25 mg | Film-coated tablet | Oral use |
| Belgium | Teva Pharma Belgium NV | | Atovaquone/Proguanil Teva | atovaquone/proguanil | 250 mg/100 mg | Film-coated tablet | Oral use |
| Belgium | Sandoz NV | | Malaprotec | atovaquone/proguanil | 62,5  mg/25 mg | Film-coated tablet | Oral use |
| Belgium | Sandoz NV | | Malaprotec | atovaquone/proguanil | 250 mg/100 mg | Film-coated tablet | Oral use |
| Belgium | Sandoz NV | | Saquinavir Sandoz | saquinavir | 500 mg | Film-coated tablet | Oral use |
| Bulgaria | | Teva B.V. | Erlotinib Teva Pharma B.V | erlotinib | 100 mg | Film-coated tablet | Oral use |
| Bulgaria | | Teva B.V. | Erlotinib Teva Pharma B.V | erlotinib | 150 mg | Film-coated tablet | Oral use |
| Bulgaria | | Sandoz B.V. | Erlotinib Sandoz | erlotinib | 100 mg | Film-coated tablet | Oral use |
| Bulgaria | | Sandoz B.V. | Erlotinib Sandoz | erlotinib | 150 mg | Film-coated tablet | Oral use |
| Bulgaria | | Accord Healthcare Limited | Saquinavir Accord | saquinavir | 500 mg | Film-coated tablet | Oral use |
| Croatia | | Sandoz B.V. | Erlotinib Sandoz 25 mg filmom obložene tablete | erlotinib | 25 mg | Film-coated tablet | Oral use |
| Croatia | | Sandoz B.V. | Erlotinib Sandoz 100 mg filmom obložene tablete | erlotinib | 100 mg | Film-coated tablet | Oral use |
| Croatia | | Sandoz B.V. | Erlotinib Sandoz 150 mg filmom obložene tablete | erlotinib | 150 mg | Film-coated tablet | Oral use |
| Croatia | | Teva B.V. | Erlotinib Pliva Hrvatska 25 mg filmom obložene tablete | erlotinib | 25 mg | Film-coated tablet | Oral use |
| Croatia | | Teva B.V. | Erlotinib Pliva Hrvatska 100 mg filmom obložene tablete | erlotinib | 100 mg | Film-coated tablet | Oral use |
| Croatia | | Teva B.V. | Erlotinib Pliva Hrvatska 150 mg filmom obložene tablete | erlotinib | 150 mg | Film-coated tablet | Oral use |
| Croatia | | Edicta Pharm d.o.o. | Edinib 25 mg filmom obložene tablete | erlotinib | 25 mg | Film-coated tablet | Oral use |
| Croatia | | Edicta Pharm d.o.o. | Edinib 100 mg filmom obložene tablete | erlotinib | 100 mg | Film-coated tablet | Oral use |
| Croatia | | Edicta Pharm d.o.o. | Edinib 150 mg filmom obložene tablete | erlotinib | 150 mg | Film-coated tablet | Oral use |
| Cyprus | | Sandoz B.V. | Erlotinib Hydrochloride Sandoz | erlotinib | 150 mg | Film-coated tablet | Oral use |
| Cyprus | | Accord Healthcare Ltd | Saquinavir Accord | saquinavir | 500 mg | Film-coated tablet | Oral use |
| Czech Republic | | Sandoz B.V. | Erlotinib Sandoz 25 mg | erlotinib | 25 mg | Film-coated tablet | Oral use |
| Czech Republic | | Sandoz B.V. | Erlotinib Sandoz 100 mg | erlotinib | 100 mg | Film-coated tablet | Oral use |
| Czech Republic | | Sandoz B.V. | Erlotinib Sandoz 150 mg | erlotinib | 150 mg | Film-coated tablet | Oral use |
| Czech Republic | | Vipharm S.A. | Erlotinib Vipharm 25 mg potahovane tablety | erlotinib | 25 mg | Film-coated tablet | Oral use |
| Czech Republic | | Vipharm S.A. | Erlotinib Vipharm 100 mg potahovane tablety | erlotinib | 100 mg | Film-coated tablet | Oral use |
| Czech Republic | | Vipharm S.A. | Erlotinib Vipharm 150 mg potahovane tablety | erlotinib | 150 mg | Film-coated tablet | Oral use |
| Denmark | | Sandoz B.V. | Erlotinib Sandoz | erlotinib | 25 mg | Film-coated tablet | Oral use |
| Denmark | | Sandoz B.V. | Erlotinib Sandoz | erlotinib | 100 mg | Film-coated tablet | Oral use |
| Denmark | | Sandoz B.V. | Erlotinib Sandoz | erlotinib | 150 mg | Film-coated tablet | Oral use |
| Denmark | Orifarm Generics A/S | | Atovaquone/Proguanil Orifarm | atovaquone/proguanil | 250 mg/100 mg | Film-coated tablet | Oral use |
| Denmark | ratiopharm GmBH | | Atovaquone/Proguanil ratiopharm | atovaquone/proguanil | 250 mg/100 mg | Film-coated tablet | Oral use |
| Denmark | Sandoz A/S | | Horisto | atovaquone/proguanil | 62,5  mg/25 mg | Film-coated tablet | Oral use |
| Denmark | Sandoz A/S | | Horisto | atovaquone/proguanil | 250 mg/100 mg | Film-coated tablet | Oral use |
| Denmark | Mylan AB | | Eletriptan Mylan | eletriptan | 40 mg | Film-coated tablet | Oral use |
| Estonia | | Sandoz B.V. | Erlotinib Sandoz | erlotinib | 25 mg | Film-coated tablet | Oral use |
| Estonia | | Sandoz B.V. | Erlotinib Sandoz | erlotinib | 100 mg | Film-coated tablet | Oral use |
| Estonia | | Sandoz B.V. | Erlotinib Sandoz | erlotinib | 150 mg | Film-coated tablet | Oral use |
| Estonia | | Teva B.V. | ERLOTINIB TEVA GENERICS | erlotinib | 100 mg | Film-coated tablet | Oral use |
| Estonia | | Teva B.V. | ERLOTINIB TEVA GENERICS | erlotinib | 150 mg | Film-coated tablet | Oral use |
| Finland | ratiopharm GmbH | | Atovaquone/Proguanil ratiopharm | atovaquone/proguanil | 250 mg/100 mg | Film-coated tablet | Oral use |
| Finland | Sandoz A/S | | Rumbabor | atovaquone/proguanil | 62,5  mg/25 mg | Film-coated tablet | Oral use |
| Finland | Sandoz A/S | | Rumbabor | atovaquone/proguanil | 250 mg/100 mg | Film-coated tablet | Oral use |
| Finland | Mylan AB | | Eletriptan Mylan | eletriptan | 40 mg | Film-coated tablet | Oral use |
| France | | Sandoz B.V. | Erlotinib Sandoz | erlotinib | 25 mg | Film-coated tablet | Oral use |
| France | | Sandoz B.V. | Erlotinib Sandoz | erlotinib | 100 mg | Film-coated tablet | Oral use |
| France | | Sandoz B.V. | Erlotinib Sandoz | erlotinib | 150 mg | Film-coated tablet | Oral use |
| France | | Teva B.V. | Erlotinib Teva Pharma | erlotinib | 25 mg | Film-coated tablet | Oral use |
| France | | Teva B.V. | Erlotinib Teva Pharma | erlotinib | 100 mg | Film-coated tablet | Oral use |
| France | | Teva B.V. | Erlotinib Teva Pharma | erlotinib | 150 mg | Film-coated tablet | Oral use |
| France | | Sandoz B.V. | SAQUINAVIR SANDOZ | saquinavir | 500 mg | Film-coated tablet | Oral use |
| France | | Medipha Sante | AMOXICILLINE MEDIPHA 1 g | amoxicillin | 1 g | Orodispersible tablet | Oral use |
| France | Medipha Sante | | Amoxicilline Authou | amoxicillin | 1 g | Orodispersible tablet | Oral use |
| France | Sandoz | | Atovaquone/Proguanil Sandoz ENFANTS | atovaquone/proguanil | 62,5  mg/25 mg | Film-coated tablet | Oral use |
| France | Sandoz | | Atovaquone/Proguanil Sandoz | atovaquone/proguanil | 250 mg/100 mg | Film-coated tablet | Oral use |
| France | Teva Sante | | Atovaquone/Proguanil Teva ENFANTS | atovaquone/proguanil | 62,5  mg/25 mg | Film-coated tablet | Oral use |
| France | Teva Sante | | Atovaquone/Proguanil Teva | atovaquone/proguanil | 250 mg/100 mg | Film-coated tablet | Oral use |
| France | Venipharm | | EBACHOI | ebastine | 10 mg | Orodispersible tablet | Oral use |
| France | Venipharm | | EBARREN | ebastine | 10 mg | Film-coated tablet | Oral use |
| France | Biogaran | | EBASTINE BIOGARAN | ebastine | 10 mg | Film-coated tablet | Oral use |
| France | Biogaran | | EBASTINE BIOGARAN | ebastine | 10 mg | Orodispersible tablet | Oral use |
| France | Mylan SAS | | EBASTINE MYLAN | ebastine | 10 mg | Orodispersible tablet | Oral use |
| France | Mylan SAS | | EBASTINE MYLAN | ebastine | 10 mg | Film-coated tablet | Oral use |
| France | Sanofi Aventis France | | EBASTINE ZENTIVA | ebastine | 10 mg | Film-coated tablet | Oral use |
| France | Sanofi Aventis France | | EBASTINE ZENTIVA | ebastine | 10 mg | Orodispersible tablet | Oral use |
| France | Venipharm | | EBONDE | ebastine | 10 mg | Film-coated tablet | Oral use |
| France | Venipharm | | EBONTAN | ebastine | 10 mg | Orodispersible tablet | Oral use |
| France | Venipharm | | EBOUDA | ebastine | 10 mg | Film-coated tablet | Oral use |
| France | Mylan SAS | | Eletriptan Mylan | eletriptan | 20 mg | Film-coated tablet | Oral use |
| France | Mylan SAS | | Eletriptan Mylan | eletriptan | 40 mg | Film-coated tablet | Oral use |
| France | Medipha Sante | | Tramadol/Paracétamol Nialex | tramadol/paracetamol | 37,5  mg/325 mg | Film-coated tablet | Oral use |
| France | Zydus France | | Tramadol/Paracétamol Zydus France | tramadol/paracetamol | 37,5  mg/325 mg | Film-coated tablet | Oral use |
| Germany | | Pharma Resources GmbH | Etoricoxib PhaRes 30 mg Filmtabletten | etoricoxib | 30 mg | Film-coated tablet | Oral use |
| Germany | | Pharma Resources GmbH | Etoricoxib PhaRes 60 mg Filmtabletten | etoricoxib | 60 mg | Film-coated tablet | Oral use |
| Germany | | Pharma Resources GmbH | Etoricoxib PhaRes 90 mg Filmtabletten | etoricoxib | 90 mg | Film-coated tablet | Oral use |
| Germany | | Pharma Resources GmbH | Etoricoxib PhaRes 120 mg Filmtabletten | etoricoxib | 120 mg | Film-coated tablet | Oral use |
| Germany | | Bristol Laboratories Ltd. | Celecoxib axcount 100 mg Hartkapseln | celecoxib | 100 mg | Capsule, hard | Oral use |
| Germany | | Bristol Laboratories Ltd. | Celecoxib axcount 200 mg Hartkapseln | celecoxib | 200 mg | Capsule, hard | Oral use |
| Germany | | Micro Labs GmbH | Amoxicillin Micro Labs 250 mg | amoxicillin | 250 mg | Film-coated tablet | Oral use |
| Germany | | Micro Labs GmbH | Amoxicillin Micro Labs 500 mg | amoxicillin | 500 mg | Film-coated tablet | Oral use |
| Germany | | Micro Labs GmbH | Amoxicillin Micro Labs 750 mg | amoxicillin | 750 mg | Film-coated tablet | Oral use |
| Germany | | Micro Labs GmbH | Amoxicillin Micro Labs 1 000  mg | amoxicillin | 1 000  mg | Film-coated tablet | Oral use |
| Germany | | Micro Labs GmbH | Rasagilin Micro Labs 1 mg Tabletten | rasagiline | 1 mg | Film-coated tablet | Oral use |
| Germany | | Lupin (Europe) Ltd | Duloxetin-Hormosan 60 mg magensaftresistente Hartkapseln | duloxetine | 60 mg | Capsule, hard | Oral use |
| Germany | | Lupin (Europe) Ltd | Duloxetin-Hormosan 40 mg magensaftresistente Hartkapseln | duloxetine | 40 mg | Capsule, hard | Oral use |
| Germany | | Lupin (Europe) Ltd | Duloxetin-Hormosan 30 mg magensaftresistente Hartkapseln | duloxetine | 30 mg | Capsule, hard | Oral use |
| Germany | | Lupin (Europe) Ltd | Duloxetin-Hormosan 20 mg magensaftresistente Hartkapseln | duloxetine | 20 mg | Capsule, hard | Oral use |
| Germany | | Micro Labs GmbH | Irbesartan/Hydrochlorothiazide Micro Labs 150 mg/12,5  mg Filmtabletten | irbesartan/hydrochlorothiazide | 150 mg/12,5  mg | Film-coated tablet | Oral use |
| Germany | | Micro Labs GmbH | Irbesartan/Hydrochlorothiazide Micro Labs 300 mg/12,5  mg Filmtabletten | irbesartan/hydrochlorothiazide | 300 mg/12,5  mg | Film-coated tablet | Oral use |
| Germany | | Micro Labs GmbH | Irbesartan/Hydrochlorothiazide Micro Labs 300 mg/25 mg Filmtabletten | irbesartan/hydrochlorothiazide | 300 mg/25 mg | Film-coated tablet | Oral use |
| Germany | | Sandoz B.V. | Erlotinib HEXAL 25 mg Filmtabletten | erlotinib | 25 mg | Film-coated tablet | Oral use |
| Germany | | Sandoz B.V. | Erlotinib HEXAL 100 mg Filmtabletten | erlotinib | 100 mg | Film-coated tablet | Oral use |
| Germany | | Sandoz B.V. | Erlotinib HEXAL 150 mg Filmtabletten | erlotinib | 150 mg | Film-coated tablet | Oral use |
| Germany | | Sandoz B.V. | Erlotinib — 1 A Pharma 25 mg Filmtabletten | erlotinib | 25 mg | Film-coated tablet | Oral use |
| Germany | | Sandoz B.V. | Erlotinib — 1 A Pharma 100 mg Filmtabletten | erlotinib | 100 mg | Film-coated tablet | Oral use |
| Germany | | Sandoz B.V. | Erlotinib — 1 A Pharma 150 mg Filmtabletten | erlotinib | 150 mg | Film-coated tablet | Oral use |
| Germany | | Teva B.V. | Erlotinib-ratiopharm 25 mg Filmtabletten | erlotinib | 25 mg | Film-coated tablet | Oral use |
| Germany | | Teva B.V. | Erlotinib-ratiopharm 100 mg Filmtabletten | erlotinib | 100 mg | Film-coated tablet | Oral use |
| Germany | | Teva B.V. | Erlotinib-ratiopharm 150 mg Filmtabletten | erlotinib | 150 mg | Film-coated tablet | Oral use |
| Germany | | Teva B.V. | Erlotinib-ratiopharm 25 mg Filmtabletten | erlotinib | 25 mg | Film-coated tablet | Oral use |
| Germany | | Teva B.V. | Erlotinib-ratiopharm 100 mg Filmtabletten | erlotinib | 100 mg | Film-coated tablet | Oral use |
| Germany | | Teva B.V. | Erlotinib-ratiopharm 150 mg Filmtabletten | erlotinib | 150 mg | Film-coated tablet | Oral use |
| Germany | | Teva B.V. | Erlotinib-ratiopharm 25 mg Filmtabletten | erlotinib | 25 mg | Film-coated tablet | Oral use |
| Germany | | Teva B.V. | Erlotinib-ratiopharm 100 mg Filmtabletten | erlotinib | 100 mg | Film-coated tablet | Oral use |
| Germany | | Teva B.V. | Erlotinib-ratiopharm 150 mg Filmtabletten | erlotinib | 150 mg | Film-coated tablet | Oral use |
| Germany | Hexal Aktiengesellschaft | | Saquinavir HEXAL 500 mg Filmtabletten | saquinavir | 500 mg | Film-coated tablet | Oral use |
| Germany | ratiopharm GmbH | | Atovaquon/Proguanilhydrochlorid-ratiopharm 62,5  mg/25 mg Filmtabletten | atovaquone/proguanil | 62,5  mg/25 mg | Film-coated tablet | Oral use |
| Germany | ratiopharm GmbH | | Atovaquon/Proguanilhydrochlorid-ratiopharm 250 mg/100 mg Filmtabletten | atovaquone/proguanil | 250 mg/100 mg | Film-coated tablet | Oral use |
| Germany | 1A Pharma GmbH | | Atovaquon/Proguanilhydrochlorid — 1 A Pharma 250 mg/100 mg Filmtabletten | atovaquone/proguanil | 250 mg/100 mg | Film-coated tablet | Oral use |
| Germany | 1A Pharma GmbH | | Atovaquon/Proguanilhydrochlorid — 1 A Pharma 62,5  mg/25 mg Filmtabletten | atovaquone/proguanil | 62,5  mg/25 mg | Film-coated tablet | Oral use |
| Germany | Hexal Aktiengesellschaft | | Malacomp HEXAL | atovaquone/proguanil | 250 mg/100 mg | Film-coated tablet | Oral use |
| Germany | Hexal Aktiengesellschaft | | Malacomp HEXAL junior | atovaquone/proguanil | 62,5  mg/25 mg | Film-coated tablet | Oral use |
| Germany | Hormosan Pharma Gesellschaft mit beschränkter Haftung | | Pregabalin-Hormosan 25 mg Hartkapseln | pregabalin | 25 mg | Capsule, hard | Oral use |
| Germany | Aristo Pharma GmbH | | Eprosartan Aristo 600 mg Filmtabletten | eprosartan | 600 mg | Film-coated tablet | Oral use |
| Germany | Glenmark Arzneimittel GmbH | | Celecoxib Glenmark 200 mg Hartkapseln | celecoxib | 200 mg | Capsule, hard | Oral use |
| Germany | Glenmark Arzneimittel GmbH | | Celecoxib Glenmark 100 mg Hartkapseln | celecoxib | 100 mg | Capsule, hard | Oral use |
| Greece | | Genepharm SA | ERLOTINIB/GENEPHARM | erlotinib | 25 mg | Film-coated tablet | Oral use |
| Greece | | Genepharm SA | ERLOTINIB/GENEPHARM | erlotinib | 100 mg | Film-coated tablet | Oral use |
| Greece | | Genepharm SA | ERLOTINIB/GENEPHARM | erlotinib | 150 mg | Film-coated tablet | Oral use |
| Hungary | | Vipharm S.A. | ERLOTINIB VIPHARM 100 mg filmtabletta | erlotinib | 100 mg | Film-coated tablet | Oral use |
| Hungary | | Vipharm S.A. | ERLOTINIB VIPHARM 150 mg filmtabletta | erlotinib | 150 mg | Film-coated tablet | Oral use |
| Hungary | | Vipharm S.A. | ERLOTINIB VIPHARM 25 mg filmtabletta | erlotinib | 25 mg | Film-coated tablet | Oral use |
| Hungary | | Sandoz B.V. | ERLOTINIB Sandoz 25 mg filmtabletta | erlotinib | 25 mg | Film-coated tablet | Oral use |
| Hungary | | Sandoz B.V. | ERLOTINIB Sandoz 100 mg filmtabletta | erlotinib | 100 mg | Film-coated tablet | Oral use |
| Hungary | | Sandoz B.V. | ERLOTINIB Sandoz 150 mg filmtabletta | erlotinib | 150 mg | Film-coated tablet | Oral use |
| Hungary | | Lupin (Europe) Ltd | Pregabalin Merck 25 mg kemény kapszula | pregabalin | 25 mg | Capsule, hard | Oral use |
| Iceland | Lyfis ehf. | | Celecoxib LYFIS | celecoxib | 100 mg | Capsule, hard | Oral use |
| Iceland | Lyfis ehf. | | Celecoxib LYFIS | celecoxib | 200 mg | Capsule, hard | Oral use |
| Ireland | | Sandoz B.V. | Erlotinib Rowex | erlotinib | 25 mg | Film-coated tablet | Oral use |
| Ireland | | Sandoz B.V. | Erlotinib Rowex | erlotinib | 100 mg | Film-coated tablet | Oral use |
| Ireland | | Sandoz B.V. | Erlotinib Rowex | erlotinib | 150 mg | Film-coated tablet | Oral use |
| Italy | | Teva B.V. | ERLOTINIB TEVA | erlotinib | 25 mg | Film-coated tablet | Oral use |
| Italy | | Teva B.V. | ERLOTINIB TEVA | erlotinib | 100 mg | Film-coated tablet | Oral use |
| Italy | | Teva B.V. | ERLOTINIB TEVA | erlotinib | 150 mg | Film-coated tablet | Oral use |
| Italy | | Sandoz B.V. | ERLOTINIB SANDOZ | erlotinib | 100 mg | Film-coated tablet | Oral use |
| Italy | | Sandoz B.V. | ERLOTINIB SANDOZ | erlotinib | 150 mg | Film-coated tablet | Oral use |
| Italy | Sandoz S.p.A. | | ATOVAQUONE E PROGUANILE SANDOZ | atovaquone/proguanil | 250 mg/100 mg | Film-coated tablet | Oral use |
| Italy | Sandoz S.p.A. | | ATOVAQUONE E PROGUANILE SANDOZ | atovaquone/proguanil | 62,5  mg/25 mg | Film-coated tablet | Oral use |
| Italy | Sandoz S.p.A. | | SAQUINAVIR SANDOZ | saquinavir | 500 mg | Film-coated tablet | Oral use |
| Italy | Mylan S.p.A. | | ELETRIPTAN MYLAN | eletriptan | 20 mg | Film-coated tablet | Oral use |
| Italy | Mylan S.p.A. | | ELETRIPTAN MYLAN | eletriptan | 40 mg | Film-coated tablet | Oral use |
| Latvia | | PharmaSwiss Česká republika s.r.o. | Erlotinib PharmaSwiss 25 mg film-coated tablets | erlotinib | 25 mg | Film-coated tablet | Oral use |
| Latvia | | PharmaSwiss Česká republika s.r.o. | Erlotinib PharmaSwiss 100 mg film-coated tablets | erlotinib | 100 mg | Film-coated tablet | Oral use |
| Latvia | | PharmaSwiss Česká republika s.r.o. | Erlotinib PharmaSwiss 150 mg film-coated tablets | erlotinib | 150 mg | Film-coated tablet | Oral use |
| Latvia | | Sandoz B.V. | Erlotinib Sandoz 25 mg film-coated tablets | erlotinib | 25 mg | Film-coated tablet | Oral use |
| Latvia | | Sandoz B.V. | Erlotinib Sandoz 100 mg film-coated tablets | erlotinib | 100 mg | Film-coated tablet | Oral use |
| Latvia | | Sandoz B.V. | Erlotinib Sandoz 150 mg film-coated tablets | erlotinib | 150 mg | Film-coated tablet | Oral use |
| Latvia | | Accord Healthcare Ltd | Saquinavir Accord 500 mg film-coated tablets | saquinavir | 500 mg | Film-coated tablet | Oral use |
| Lithuania | | PharmaSwiss Česká republika s.r.o. | Erlotinib PharmaSwiss | erlotinib | 25 mg | Film-coated tablet | Oral use |
| Lithuania | | PharmaSwiss Česká republika s.r.o. | Erlotinib PharmaSwiss | erlotinib | 100 mg | Film-coated tablet | Oral use |
| Lithuania | | PharmaSwiss Česká republika s.r.o. | Erlotinib PharmaSwiss | erlotinib | 150 mg | Film-coated tablet | Oral use |
| Lithuania | | Sandoz B.V. | Erlotinib Sandoz | erlotinib | 25 mg | Film-coated tablet | Oral use |
| Lithuania | | Sandoz B.V. | Erlotinib Sandoz | erlotinib | 100 mg | Film-coated tablet | Oral use |
| Lithuania | | Sandoz B.V. | Erlotinib Sandoz | erlotinib | 150 mg | Film-coated tablet | Oral use |
| Lithuania | | Teva B.V. | Erlotinib Teva Generics | erlotinib | 150 mg | Film-coated tablet | Oral use |
| Lithuania | | Accord Healthcare Ltd | Saquinavir Accord 500 mg plėvele dengtos tabletės | saquinavir | 500 mg | Film-coated tablet | Oral use |
| Luxembourg | | Sandoz S.A. | Saquinavir | saquinavir | 500 mg | Film-coated tablet | Oral use |
| Luxembourg | | Micro Labs GmbH | Irbesartan/Hydrochlorothiazide Micro Labs 150 mg/12,5  mg Filmtabletten | irbesartan/hydrochlorothiazide | 150 mg/12,5  mg | Film-coated tablet | Oral use |
| Luxembourg | | Micro Labs GmbH | Irbesartan/Hydrochlorothiazide Micro Labs 300 mg/12,5  mg Filmtabletten | irbesartan/hydrochlorothiazide | 300 mg/12,5  mg | Film-coated tablet | Oral use |
| Luxembourg | | Micro Labs GmbH | Irbesartan/Hydrochlorothiazide Micro Labs 300 mg/25 mg Filmtabletten | irbesartan/hydrochlorothiazide | 300 mg/25 mg | Film-coated tablet | Oral use |
| Luxembourg | | Teva B.V. | Erlotinib-ratiopharm 25 mg Filmtabletten | erlotinib | 25 mg | Film-coated tablet | Oral use |
| Luxembourg | | Teva B.V. | Erlotinib-ratiopharm 100 mg Filmtabletten | erlotinib | 100 mg | Film-coated tablet | Oral use |
| Luxembourg | | Teva B.V. | Erlotinib-ratiopharm 150 mg Filmtabletten | erlotinib | 150 mg | Film-coated tablet | Oral use |
| Luxembourg | | Teva B.V. | Erlotinib Ratiopharm | erlotinib | 25 mg | Film-coated tablet | Oral use |
| Luxembourg | | Teva B.V. | Erlotinib Ratiopharm | erlotinib | 100 mg | Film-coated tablet | Oral use |
| Luxembourg | | Teva B.V. | Erlotinib Ratiopharm | erlotinib | 150 mg | Film-coated tablet | Oral use |
| Luxembourg | | Micro Labs GmbH | Rasagilin Micro Labs 1 mg Tabletten | rasagiline | 1 mg | Film-coated tablet | Oral use |
| Luxembourg | Sandoz S.A. | | Malaprotec | atovaquone/proguanil | 62,5  mg/25 mg | Film-coated tablet | Oral use |
| Luxembourg | Sandoz S.A. | | Malaprotec | atovaquone/proguanil | 250 mg/100 mg | Film-coated tablet | Oral use |
| Luxembourg | ratiopharm GmbH | | Atovaquon/Proguanilhydrochlorid-ratiopharm 62,5  mg/25 mg Filmtabletten | atovaquone/proguanil | 62,5  mg/25 mg | Film-coated tablet | Oral use |
| Luxembourg | ratiopharm GmbH | | Atovaquon/Proguanilhydrochlorid-ratiopharm 250 mg/100 mg Filmtabletten | atovaquone/proguanil | 250 mg/100 mg | Film-coated tablet | Oral use |
| Malta | 1A Pharma GmbH | | Reprapog | atovaquone/proguanil | 62,5  mg/25 mg | Film-coated tablet | Oral use |
| Malta | 1A Pharma GmbH | | Reprapog | atovaquone/proguanil | 250 mg/100 mg | Film-coated tablet | Oral use |
| Norway | Mylan AB | | Eletriptan Mylan | eletriptan | 40 mg | Film-coated tablet | Oral use |
| Norway | Mylan AB | | Eletriptan Mylan | eletriptan | 20 mg | Film-coated tablet | Oral use |
| Norway | Orifarm Generics A/S | | Atovaquone/Proguanil Orifarm | atovaquone/proguanil | 250 mg/100 mg | Film-coated tablet | Oral use |
| Poland | | Sandoz B.V. | Erlotinib Sandoz | erlotinib | 25 mg | Film-coated tablet | Oral use |
| Poland | | Sandoz B.V. | Erlotinib Sandoz | erlotinib | 100 mg | Film-coated tablet | Oral use |
| Poland | | Sandoz B.V. | Erlotinib Sandoz | erlotinib | 150 mg | Film-coated tablet | Oral use |
| Poland | | Vipharm S.A. | Erlotinib Vipharm | erlotinib | 25 mg | Film-coated tablet | Oral use |
| Poland | | Vipharm S.A. | Erlotinib Vipharm | erlotinib | 100 mg | Film-coated tablet | Oral use |
| Poland | | Vipharm S.A. | Erlotinib Vipharm | erlotinib | 150 mg | Film-coated tablet | Oral use |
| Poland | Sandoz GmbH | | Saquinavir Sandoz | saquinavir | 500 mg | Film-coated tablet | Oral use |
| Portugal | | Brown & Burk UK, Ltd. | Amoxicilina Brown | amoxicillin | 250 mg | Film-coated tablet | Oral use |
| Portugal | | Brown & Burk UK, Ltd. | Amoxicilina Brown | amoxicillin | 500 mg | Film-coated tablet | Oral use |
| Portugal | | Brown & Burk UK, Ltd. | Amoxicilina Brown | amoxicillin | 750 mg | Film-coated tablet | Oral use |
| Portugal | | Brown & Burk UK, Ltd. | Amoxicilina Brown | amoxicillin | 1 000  mg | Film-coated tablet | Oral use |
| Portugal | | Teva Pharma — Produtos Farmacêuticos, Lda. | Erlotinib Zidrium | erlotinib | 25 mg | Film-coated tablet | Oral use |
| Portugal | | Teva Pharma — Produtos Farmacêuticos, Lda. | Erlotinib Zidrium | erlotinib | 100 mg | Film-coated tablet | Oral use |
| Portugal | | Teva Pharma — Produtos Farmacêuticos, Lda. | Erlotinib Zidrium | erlotinib | 150 mg | Film-coated tablet | Oral use |
| Portugal | | Sandoz B.V. | Erlotinib Sandoz | erlotinib | 25 mg | Film-coated tablet | Oral use |
| Portugal | | Sandoz B.V. | Erlotinib Sandoz | erlotinib | 100 mg | Film-coated tablet | Oral use |
| Portugal | | Sandoz B.V. | Erlotinib Sandoz | erlotinib | 150 mg | Film-coated tablet | Oral use |
| Portugal | | Hetero Europe, S.L. | Celecoxib Hetero | Celecoxib | 100 mg | Capsule, hard | Oral use |
| Portugal | | Hetero Europe, S.L. | Celecoxib Hetero | Celecoxib | 200 mg | Capsule, hard | Oral use |
| Portugal | | Lupin (Europe) Ltd | Pregabalina Merck | Pregabalin | 25 mg | Capsule, hard | Oral use |
| Portugal | Hetero Europe, S.L. | | Eprosartan Hetero | eprosartan | 600 mg | Film-coated tablet | Oral use |
| Portugal | Farmoz — Sociedade Técnico Medicinal, S.A. | | Saquinavir Farmoz | saquinavir | 500 mg | Film-coated tablet | Oral use |
| Portugal | Lupin (Europe) Ltd | | Pregabalina Lupin | pregabalin | 25 mg | Capsule, hard | Oral use |
| Romania | | PharmaSwiss Česká republika s.r.o. | Erlotinib PharmaSwiss 25 mg film-coated tablets | erlotinib | 25 mg | Film-coated tablet | Oral use |
| Romania | | PharmaSwiss Česká republika s.r.o. | Erlotinib PharmaSwiss 100 mg film-coated tablets | erlotinib | 100 mg | Film-coated tablet | Oral use |
| Romania | | PharmaSwiss Česká republika s.r.o. | Erlotinib PharmaSwiss 150 mg film-coated tablets | erlotinib | 150 mg | Film-coated tablet | Oral use |
| Romania | | Teva B.V. | Erlotinib Teva Pharma 25 mg, film-coated tablets | erlotinib | 25 mg | Film-coated tablet | Oral use |
| Romania | | Teva B.V. | Erlotinib Teva Pharma 100 mg, film-coated tablets | erlotinib | 100 mg | Film-coated tablet | Oral use |
| Romania | | Teva B.V. | Erlotinib Teva Pharma 150 mg, film-coated tablets | erlotinib | 150 mg | Film-coated tablet | Oral use |
| Romania | | Sandoz B.V. | Erlotinib Sandoz 25 mg, film-coated tablets | erlotinib | 25 mg | Film-coated tablet | Oral use |
| Romania | | Sandoz B.V. | Erlotinib Sandoz 100 mg, film-coated tablets | erlotinib | 100 mg | Film-coated tablet | Oral use |
| Romania | | Sandoz B.V. | Erlotinib Sandoz 150 mg, film-coated tablets | erlotinib | 150 mg | Film-coated tablet | Oral use |
| Slovakia | | Sandoz B.V. | Erlotinib Sandoz 100 mg, 150 mg | erlotinib | 100 mg | Film-coated tablet | Oral use |
| Slovakia | | Sandoz B.V. | Erlotinib Sandoz 100 mg, 150 mg | erlotinib | 150 mg | Film-coated tablet | Oral use |
| Slovakia | | Vipharm S.A. | Erlotinib Vipharm 25 mg, 100 mg, 150 mg | erlotinib | 25 mg | Film-coated tablet | Oral use |
| Slovakia | | Vipharm S.A. | Erlotinib Vipharm 25 mg, 100 mg, 150 mg | erlotinib | 100 mg | Film-coated tablet | Oral use |
| Slovakia | | Vipharm S.A. | Erlotinib Vipharm 25 mg, 100 mg, 150 mg | erlotinib | 150 mg | Film-coated tablet | Oral use |
| Slovakia | | PharmaSwiss Česká republika s.r.o. | ERLOTIB 25 mg, 100 mg, 150 mg | erlotinib | 25 mg | Film-coated tablet | Oral use |
| Slovakia | | PharmaSwiss Česká republika s.r.o. | ERLOTIB 25 mg, 100 mg, 150 mg | erlotinib | 100 mg | Film-coated tablet | Oral use |
| Slovakia | | PharmaSwiss Česká republika s.r.o. | ERLOTIB 25 mg, 100 mg, 150 mg | erlotinib | 150 mg | Film-coated tablet | Oral use |
| Slovenia | | Sandoz B.V. | Erlotinib Sandoz 25 mg flmsko obložene tablete | erlotinib | 25 mg | Film-coated tablet | Oral use |
| Slovenia | | Sandoz B.V. | Erlotinib Sandoz 100 mg filmsko obložene tablete | erlotinib | 100 mg | Film-coated tablet | Oral use |
| Slovenia | | Sandoz B.V. | Erlotinib Sandoz 150 mg filmsko obložene tablete | erlotinib | 150 mg | Film-coated tablet | Oral use |
| Spain | | Sandoz B.V. | Erlotinib Sandoz 25 mg, 100 mg and 150 mg comprimidos recubiertos con película EFG | erlotinib | 25 mg | Film-coated tablet | Oral use |
| Spain | | Sandoz B.V. | Erlotinib Sandoz 25 mg, 100 mg and 150 mg comprimidos recubiertos con película EFG | erlotinib | 100 mg | Film-coated tablet | Oral use |
| Spain | | Sandoz B.V. | Erlotinib Sandoz 25 mg, 100 mg and 150 mg comprimidos recubiertos con película EFG | erlotinib | 150 mg | Film-coated tablet | Oral use |
| Spain | | Brill Pharma, S.L. | Celecoxib Brill Pharma 100 mg and 200 mg cápsulas duras | celecoxib | 100 mg | Capsule, hard | Oral use |
| Spain | | Brill Pharma, S.L. | Celecoxib Brill Pharma 100 mg and 200 mg cápsulas duras | celecoxib | 200 mg | Capsule, hard | Oral use |
| Spain | | Accord Healthcare Ltd | Saquinavir Accord 500 mg comprimidos recubiertos con película EFG | saquinavir | 500 mg | Film-coated tablet | Oral use |
| Spain | Teva Pharma, S.L.U. | | Atovacuona/Hidrocloruro de Proguanil Teva 250 mg/100 mg comprimidos recubiertos con película EFG | atovaquone/proguanil | 250 mg/100 mg | Film-coated tablet | Oral use |
| Spain | Sandoz Farmaceutica, S.A. | | Atovacuona/Hidrocloruro de Proguanil Sandoz 250 mg/100 mg comprimidos recubiertos con película EFG | atovaquone/proguanil | 250 mg/100 mg | Film-coated tablet | Oral use |
| Spain | Pensa Pharma, S.A.U. | | Eprosartan Pensa 600 mg comprimidos recubiertos con película EFG | eprosartan | 600 mg | Film-coated tablet | Oral use |
| Spain | Industria Química Y Farmacéutica VIR, S.A. | | Celecoxib VIR 200 mg cápsulas duras EFG | celecoxib | 200 mg | Capsule, hard | Oral use |
| Sweden | | Sandoz B.V. | Erlotinib Sandoz | erlotinib | 25 mg | Film-coated tablet | Oral use |
| Sweden | | Sandoz B.V. | Erlotinib Sandoz | erlotinib | 100 mg | Film-coated tablet | Oral use |
| Sweden | | Sandoz B.V. | Erlotinib Sandoz | erlotinib | 150 mg | Film-coated tablet | Oral use |
| Sweden | Sandoz A/S | | Horisto | atovaquone/proguanil | 62,5  mg/25 mg | Film-coated tablet | Oral use |
| Sweden | Sandoz A/S | | Horisto | atovaquone/proguanil | 250 mg/100 mg | Film-coated tablet | Oral use |
| Sweden | Mylan AB | | Eletriptan Mylan | eletriptan | 20 mg | Film-coated tablet | Oral use |
| Sweden | Mylan AB | | Eletriptan Mylan | eletriptan | 40 mg | Film-coated tablet | Oral use |
| Sweden | Orifarm Generics A/S | | Atovaquone/Proguanil Orifarm | atovaquone/proguanil | 250 mg/100 mg | Film-coated tablet | Oral use |
| Sweden | Medical Valley Invest AB | | Celecoxib Medical Valley | celecoxib | 100 mg | Capsule, hard | Oral use |
| Sweden | Medical Valley Invest AB | | Celecoxib Medical Valley | celecoxib | 200 mg | Capsule, hard | Oral use |
| The Netherlands | | PharmaSwiss Česká republika s.r.o. | ERLOTIB | erlotinib | 25 mg | Film-coated tablet | Oral use |
| The Netherlands | | PharmaSwiss Česká republika s.r.o. | ERLOTIB | erlotinib | 100 mg | Film-coated tablet | Oral use |
| The Netherlands | | PharmaSwiss Česká republika s.r.o. | ERLOTIB | erlotinib | 150 mg | Film-coated tablet | Oral use |
| The Netherlands | | Sandoz B.V. | Erlotinib Sandoz | erlotinib | 25 mg | Film-coated tablet | Oral use |
| The Netherlands | | Sandoz B.V. | Erlotinib Sandoz | erlotinib | 100 mg | Film-coated tablet | Oral use |
| The Netherlands | | Sandoz B.V. | Erlotinib Sandoz | erlotinib | 150 mg | Film-coated tablet | Oral use |
| The Netherlands | | Sandoz B.V. | Erlotinib Sandoz | erlotinib | 25 mg | Film-coated tablet | Oral use |
| The Netherlands | | Sandoz B.V. | Erlotinib Sandoz | erlotinib | 100 mg | Film-coated tablet | Oral use |
| The Netherlands | | Sandoz B.V. | Erlotinib Sandoz | erlotinib | 150 mg | Film-coated tablet | Oral use |
| The Netherlands | | Accord Healthcare Ltd | Saquinavir Accord | saquinavir | 500 mg | Film-coated tablet | Oral use |
| The Netherlands | | Teva B.V. | Erlotinib PCH | erlotinib | 25 mg | Film-coated tablet | Oral use |
| The Netherlands | | Teva B.V. | Erlotinib PCH | erlotinib | 100 mg | Film-coated tablet | Oral use |
| The Netherlands | | Teva B.V. | Erlotinib PCH | erlotinib | 150 mg | Film-coated tablet | Oral use |
| The Netherlands | Teva Nederland B.V. | | Atovaquon/Proguanil HCl Teva | atovaquone/proguanil | 250 mg/100 mg | Film-coated tablet | Oral use |
| The Netherlands | Teva Nederland B.V. | | Atovaquon/Proguanil HCl Teva | atovaquone/proguanil | 62,5  mg/25 mg | Film-coated tablet | Oral use |
| The Netherlands | Sandoz B.V. | | Atovaquon/Proguanil HCl Sandoz | atovaquone/proguanil | 62,5  mg/25 mg | Film-coated tablet | Oral use |
| The Netherlands | Sandoz B.V. | | Atovaquon/Proguanil HCl Sandoz | atovaquone/proguanil | 250 mg/100 mg | Film-coated tablet | Oral use |
| The Netherlands | Sandoz B.V. | | Atovaquon/Proguanil HCl Sandoz | atovaquone/proguanil | 62,5  mg/25 mg | Film-coated tablet | Oral use |
| The Netherlands | Sandoz B.V. | | Atovaquon/Proguanil HCl Sandoz | atovaquone/proguanil | 250 mg/100 mg | Film-coated tablet | Oral use |
| The Netherlands | Sandoz B.V. | | Saquinavir Sandoz | saquinavir | 500 mg | Film-coated tablet | Oral use |
| The Netherlands | Sandoz B.V. | | Saquinavir Sandoz | saquinavir | 500 mg | Film-coated tablet | Oral use |
| The Netherlands | Hetero Europe, S.L. | | Celecoxib Hetero | celecoxib | 100 mg | Capsule, hard | Oral use |
| The Netherlands | Hetero Europe, S.L. | | Celecoxib Hetero | celecoxib | 200 mg | Capsule, hard | Oral use |
| United Kingdom | | Brown & Burk UK, Ltd. | ROSUVASTATIN 5 MG FILM-COATED TABLETS | rosuvastatin | 5 mg | Film-coated tablet | Oral use |
| United Kingdom | | Brown & Burk UK, Ltd. | ROSUVASTATIN 10 MG FILM-COATED TABLETS | rosuvastatin | 10 mg | Film-coated tablet | Oral use |
| United Kingdom | | Brown & Burk UK, Ltd. | ROSUVASTATIN 20 MG FILM-COATED TABLETS | rosuvastatin | 20 mg | Film-coated tablet | Oral use |
| United Kingdom | | Brown & Burk UK, Ltd. | ROSUVASTATIN 40 MG FILM-COATED TABLETS | rosuvastatin | 40 mg | Film-coated tablet | Oral use |
| United Kingdom | | Brown & Burk UK, Ltd. | TRAMADOL/PARACETAMOL BROWN & BURK 37,5 MG/325 MG FILM-COATED TABLETS | tramadol/paracetamol | 37,5  mg/325 mg | Film-coated tablet | Oral use |
| United Kingdom | | Brown & Burk UK, Ltd. | Irbesartan/Hydrochlorothiazide Brown & Burk 150 mg/12,5  mg Film-coated tablets | irbesartan/hydrochlorothiazide | 150 mg/12,5  mg | Film-coated tablet | Oral use |
| United Kingdom | | Brown & Burk UK, Ltd. | Irbesartan/Hydrochlorothiazide Brown & Burk 300 mg/12,5  mg Film-coated tablets | irbesartan/hydrochlorothiazide | 300 mg/12,5  mg | Film-coated tablet | Oral use |
| United Kingdom | | Brown & Burk UK, Ltd. | Irbesartan/Hydrochlorothiazide Brown & Burk 300 mg/25 mg Film-coated tablets | irbesartan/hydrochlorothiazide | 300 mg/25 mg | Film-coated tablet | Oral use |
| United Kingdom | | Brown & Burk UK, Ltd. | Rasagiline Brown & Burk 1 mg Tablets | rasagiline | 1 mg | Film-coated tablet | Oral use |
| United Kingdom | | Lupin (Europe) Ltd | Duloxetine Lupin 20 mg GR capsules | duloxetine | 20 mg | Capsule | Oral use |
| United Kingdom | | Lupin (Europe) Ltd | Duloxetine Lupin 30 mg GR capsules | duloxetine | 30 mg | Capsule | Oral use |
| United Kingdom | | Lupin (Europe) Ltd | Duloxetine Lupin 40 mg GR capsules | duloxetine | 40 mg | Capsule | Oral use |
| United Kingdom | | Lupin (Europe) Ltd | Duloxetine Lupin 60 mg GR capsules | duloxetine | 60 mg | Capsule | Oral use |
| United Kingdom | Teva UK Limited | | MAFAMOZ 250 MG/100 MG FILM-COATED TABLETS | atovaquone/proguanil | 250 mg/100 mg | Tablet | Oral use |
| United Kingdom | Teva UK Limited | | MAFAMOZ 62,5 MG/25 MG FILM-COATED TABLETS | atovaquone/proguanil | 62,5  mg/25 mg | Tablet | Oral use |
| United Kingdom | Sandoz Limited | | REPRAPOG 62,5 MG/25 MG FILM-COATED TABLETS | atovaquone/proguanil | 62,5  mg/25 mg | Film-coated tablet | Oral use |
| United Kingdom | Sandoz Limited | | REPRAPOG 250 MG/100 MG FILM-COATED TABLETS | atovaquone/proguanil | 250 mg/100 mg | Film-coated tablet | Oral use |
| United Kingdom | Brown & Burk UK Limited | | AMOXICILLIN SUGAR FREE 3 G POWDER FOR ORAL SUSPENSION SACHETS | amoxicillin | 3 443,35  mg | Powder for oral suspension | Oral use |
| United Kingdom | Hetero Europe, S.L. | | EPROSARTAN 300 MG FILM-COATED TABLETS | eprosartan | 300 mg | Film-coated tablet | Oral use |
| United Kingdom | Hetero Europe, S.L. | | EPROSARTAN 400 MG FILM-COATED TABLETS | eprosartan | 400 mg | Film-coated tablet | Oral use |
| United Kingdom | Hetero Europe, S.L. | | EPROSARTAN 600 MG FILM-COATED TABLETS | eprosartan | 600 mg | Film-coated tablet | Oral use |
| United Kingdom | Bristol Laboratories Limited | | CELECOXIB CAPSULES, HARD 100 MG | celecoxib | 100 mg | Capsule, hard | Oral use |
| United Kingdom | Bristol Laboratories Limited | | CELECOXIB CAPSULES, HARD 200 MG | celecoxib | 200 mg | Capsule, hard | Oral use |
| United Kingdom | Lupin (Europe) Ltd | | Pregabalin Lupin 25 mg hard capsules | pregabalin | 25 mg | Capsule, hard | Oral use |

Member State EU/EEA

Marketing Authorisation Holder

Applicant

Invented name

Active Substance

Strength

Pharmaceutical Form

Route of Administration

Belgium

Sandoz NV

Erlotinib Sandoz

erlotinib

25 mg

Film-coated tablet

Oral use

Belgium

Sandoz NV

Erlotinib Sandoz

erlotinib

100 mg

Film-coated tablet

Oral use

Belgium

Sandoz NV

Erlotinib Sandoz

erlotinib

150 mg

Film-coated tablet

Oral use

Belgium

Teva Pharma Belgium NV

Erlotinib Ratiopharm

erlotinib

25 mg

Film-coated tablet

Oral use

Belgium

Teva Pharma Belgium NV

Erlotinib Ratiopharm

erlotinib

100 mg

Film-coated tablet

Oral use

Belgium

Teva Pharma Belgium NV

Erlotinib Ratiopharm

erlotinib

150 mg

Film-coated tablet

Oral use

Belgium

Accord Healthcare Ltd

Saquinavir Accord

saquinavir

500 mg

Film-coated tablet

Oral use

Belgium

Teva Pharma Belgium NV

Atovaquone/Proguanil Teva

atovaquone/proguanil

62,5  mg/25 mg

Film-coated tablet

Oral use

Belgium

Teva Pharma Belgium NV

Atovaquone/Proguanil Teva

atovaquone/proguanil

250 mg/100 mg

Film-coated tablet

Oral use

Belgium

Sandoz NV

Malaprotec

atovaquone/proguanil

62,5  mg/25 mg

Film-coated tablet

Oral use

Belgium

Sandoz NV

Malaprotec

atovaquone/proguanil

250 mg/100 mg

Film-coated tablet

Oral use

Belgium

Sandoz NV

Saquinavir Sandoz

saquinavir

500 mg

Film-coated tablet

Oral use

Bulgaria

Teva B.V.

Erlotinib Teva Pharma B.V

erlotinib

100 mg

Film-coated tablet

Oral use

Bulgaria

Teva B.V.

Erlotinib Teva Pharma B.V

erlotinib

150 mg

Film-coated tablet

Oral use

Bulgaria

Sandoz B.V.

Erlotinib Sandoz

erlotinib

100 mg

Film-coated tablet

Oral use

Bulgaria

Sandoz B.V.

Erlotinib Sandoz

erlotinib

150 mg

Film-coated tablet

Oral use

Bulgaria

Accord Healthcare Limited

Saquinavir Accord

saquinavir

500 mg

Film-coated tablet

Oral use

Croatia

Sandoz B.V.

Erlotinib Sandoz 25 mg filmom obložene tablete

erlotinib

25 mg

Film-coated tablet

Oral use

Croatia

Sandoz B.V.

Erlotinib Sandoz 100 mg filmom obložene tablete

erlotinib

100 mg

Film-coated tablet

Oral use

Croatia

Sandoz B.V.

Erlotinib Sandoz 150 mg filmom obložene tablete

erlotinib

150 mg

Film-coated tablet

Oral use

Croatia

Teva B.V.

Erlotinib Pliva Hrvatska 25 mg filmom obložene tablete

erlotinib

25 mg

Film-coated tablet

Oral use

Croatia

Teva B.V.

Erlotinib Pliva Hrvatska 100 mg filmom obložene tablete

erlotinib

100 mg

Film-coated tablet

Oral use

Croatia

Teva B.V.

Erlotinib Pliva Hrvatska 150 mg filmom obložene tablete

erlotinib

150 mg

Film-coated tablet

Oral use

Croatia

Edicta Pharm d.o.o.

Edinib 25 mg filmom obložene tablete

erlotinib

25 mg

Film-coated tablet

Oral use

Croatia

Edicta Pharm d.o.o.

Edinib 100 mg filmom obložene tablete

erlotinib

100 mg

Film-coated tablet

Oral use

Croatia

Edicta Pharm d.o.o.

Edinib 150 mg filmom obložene tablete

erlotinib

150 mg

Film-coated tablet

Oral use

Cyprus

Sandoz B.V.

Erlotinib Hydrochloride Sandoz

erlotinib

150 mg

Film-coated tablet

Oral use

Cyprus

Accord Healthcare Ltd

Saquinavir Accord

saquinavir

500 mg

Film-coated tablet

Oral use

Czech Republic

Sandoz B.V.

Erlotinib Sandoz 25 mg

erlotinib

25 mg

Film-coated tablet

Oral use

Czech Republic

Sandoz B.V.

Erlotinib Sandoz 100 mg

erlotinib

100 mg

Film-coated tablet

Oral use

Czech Republic

Sandoz B.V.

Erlotinib Sandoz 150 mg

erlotinib

150 mg

Film-coated tablet

Oral use

Czech Republic

Vipharm S.A.

Erlotinib Vipharm 25 mg potahovane tablety

erlotinib

25 mg

Film-coated tablet

Oral use

Czech Republic

Vipharm S.A.

Erlotinib Vipharm 100 mg potahovane tablety

erlotinib

100 mg

Film-coated tablet

Oral use

Czech Republic

Vipharm S.A.

Erlotinib Vipharm 150 mg potahovane tablety

erlotinib

150 mg

Film-coated tablet

Oral use

Denmark

Sandoz B.V.

Erlotinib Sandoz

erlotinib

25 mg

Film-coated tablet

Oral use

Denmark

Sandoz B.V.

Erlotinib Sandoz

erlotinib

100 mg

Film-coated tablet

Oral use

Denmark

Sandoz B.V.

Erlotinib Sandoz

erlotinib

150 mg

Film-coated tablet

Oral use

Denmark

Orifarm Generics A/S

Atovaquone/Proguanil Orifarm

atovaquone/proguanil

250 mg/100 mg

Film-coated tablet

Oral use

Denmark

ratiopharm GmBH

Atovaquone/Proguanil ratiopharm

atovaquone/proguanil

250 mg/100 mg

Film-coated tablet

Oral use

Denmark

Sandoz A/S

Horisto

atovaquone/proguanil

62,5  mg/25 mg

Film-coated tablet

Oral use

Denmark

Sandoz A/S

Horisto

atovaquone/proguanil

250 mg/100 mg

Film-coated tablet

Oral use

Denmark

Mylan AB

Eletriptan Mylan

eletriptan

40 mg

Film-coated tablet

Oral use

Estonia

Sandoz B.V.

Erlotinib Sandoz

erlotinib

25 mg

Film-coated tablet

Oral use

Estonia

Sandoz B.V.

Erlotinib Sandoz

erlotinib

100 mg

Film-coated tablet

Oral use

Estonia

Sandoz B.V.

Erlotinib Sandoz

erlotinib

150 mg

Film-coated tablet

Oral use

Estonia

Teva B.V.

ERLOTINIB TEVA GENERICS

erlotinib

100 mg

Film-coated tablet

Oral use

Estonia

Teva B.V.

ERLOTINIB TEVA GENERICS

erlotinib

150 mg

Film-coated tablet

Oral use

Finland

ratiopharm GmbH

Atovaquone/Proguanil ratiopharm

atovaquone/proguanil

250 mg/100 mg

Film-coated tablet

Oral use

Finland

Sandoz A/S

Rumbabor

atovaquone/proguanil

62,5  mg/25 mg

Film-coated tablet

Oral use

Finland

Sandoz A/S

Rumbabor

atovaquone/proguanil

250 mg/100 mg

Film-coated tablet

Oral use

Finland

Mylan AB

Eletriptan Mylan

eletriptan

40 mg

Film-coated tablet

Oral use

France

Sandoz B.V.

Erlotinib Sandoz

erlotinib

25 mg

Film-coated tablet

Oral use

France

Sandoz B.V.

Erlotinib Sandoz

erlotinib

100 mg

Film-coated tablet

Oral use

France

Sandoz B.V.

Erlotinib Sandoz

erlotinib

150 mg

Film-coated tablet

Oral use

France

Teva B.V.

Erlotinib Teva Pharma

erlotinib

25 mg

Film-coated tablet

Oral use

France

Teva B.V.

Erlotinib Teva Pharma

erlotinib

100 mg

Film-coated tablet

Oral use

France

Teva B.V.

Erlotinib Teva Pharma

erlotinib

150 mg

Film-coated tablet

Oral use

France

Sandoz B.V.

SAQUINAVIR SANDOZ

saquinavir

500 mg

Film-coated tablet

Oral use

France

Medipha Sante

AMOXICILLINE MEDIPHA 1 g

amoxicillin

1 g

Orodispersible tablet

Oral use

France

Medipha Sante

Amoxicilline Authou

amoxicillin

1 g

Orodispersible tablet

Oral use

France

Sandoz

Atovaquone/Proguanil Sandoz ENFANTS

atovaquone/proguanil

62,5  mg/25 mg

Film-coated tablet

Oral use

France

Sandoz

Atovaquone/Proguanil Sandoz

atovaquone/proguanil

250 mg/100 mg

Film-coated tablet

Oral use

France

Teva Sante

Atovaquone/Proguanil Teva ENFANTS

atovaquone/proguanil

62,5  mg/25 mg

Film-coated tablet

Oral use

France

Teva Sante

Atovaquone/Proguanil Teva

atovaquone/proguanil

250 mg/100 mg

Film-coated tablet

Oral use

France

Venipharm

EBACHOI

ebastine

10 mg

Orodispersible tablet

Oral use

France

Venipharm

EBARREN

ebastine

10 mg

Film-coated tablet

Oral use

France

Biogaran

EBASTINE BIOGARAN

ebastine

10 mg

Film-coated tablet

Oral use

France

Biogaran

EBASTINE BIOGARAN

ebastine

10 mg

Orodispersible tablet

Oral use

France

Mylan SAS

EBASTINE MYLAN

ebastine

10 mg

Orodispersible tablet

Oral use

France

Mylan SAS

EBASTINE MYLAN

ebastine

10 mg

Film-coated tablet

Oral use

France

Sanofi Aventis France

EBASTINE ZENTIVA

ebastine

10 mg

Film-coated tablet

Oral use

France

Sanofi Aventis France

EBASTINE ZENTIVA

ebastine

10 mg

Orodispersible tablet

Oral use

France

Venipharm

EBONDE

ebastine

10 mg

Film-coated tablet

Oral use

France

Venipharm

EBONTAN

ebastine

10 mg

Orodispersible tablet

Oral use

France

Venipharm

EBOUDA

ebastine

10 mg

Film-coated tablet

Oral use

France

Mylan SAS

Eletriptan Mylan

eletriptan

20 mg

Film-coated tablet

Oral use

France

Mylan SAS

Eletriptan Mylan

eletriptan

40 mg

Film-coated tablet

Oral use

France

Medipha Sante

Tramadol/Paracétamol Nialex

tramadol/paracetamol

37,5  mg/325 mg

Film-coated tablet

Oral use

France

Zydus France

Tramadol/Paracétamol Zydus France

tramadol/paracetamol

37,5  mg/325 mg

Film-coated tablet

Oral use

Germany

Pharma Resources GmbH

Etoricoxib PhaRes 30 mg Filmtabletten

etoricoxib

30 mg

Film-coated tablet

Oral use

Germany

Pharma Resources GmbH

Etoricoxib PhaRes 60 mg Filmtabletten

etoricoxib

60 mg

Film-coated tablet

Oral use

Germany

Pharma Resources GmbH

Etoricoxib PhaRes 90 mg Filmtabletten

etoricoxib

90 mg

Film-coated tablet

Oral use

Germany

Pharma Resources GmbH

Etoricoxib PhaRes 120 mg Filmtabletten

etoricoxib

120 mg

Film-coated tablet

Oral use

Germany

Bristol Laboratories Ltd.

Celecoxib axcount 100 mg Hartkapseln

celecoxib

100 mg

Capsule, hard

Oral use

Germany

Bristol Laboratories Ltd.

Celecoxib axcount 200 mg Hartkapseln

celecoxib

200 mg

Capsule, hard

Oral use

Germany

Micro Labs GmbH

Amoxicillin Micro Labs 250 mg

amoxicillin

250 mg

Film-coated tablet

Oral use

Germany

Micro Labs GmbH

Amoxicillin Micro Labs 500 mg

amoxicillin

500 mg

Film-coated tablet

Oral use

Germany

Micro Labs GmbH

Amoxicillin Micro Labs 750 mg

amoxicillin

750 mg

Film-coated tablet

Oral use

Germany

Micro Labs GmbH

Amoxicillin Micro Labs 1 000  mg

amoxicillin

1 000  mg

Film-coated tablet

Oral use

Germany

Micro Labs GmbH

Rasagilin Micro Labs 1 mg Tabletten

rasagiline

1 mg

Film-coated tablet

Oral use

Germany

Lupin (Europe) Ltd

Duloxetin-Hormosan 60 mg magensaftresistente Hartkapseln

duloxetine

60 mg

Capsule, hard

Oral use

Germany

Lupin (Europe) Ltd

Duloxetin-Hormosan 40 mg magensaftresistente Hartkapseln

duloxetine

40 mg

Capsule, hard

Oral use

Germany

Lupin (Europe) Ltd

Duloxetin-Hormosan 30 mg magensaftresistente Hartkapseln

duloxetine

30 mg

Capsule, hard

Oral use

Germany

Lupin (Europe) Ltd

Duloxetin-Hormosan 20 mg magensaftresistente Hartkapseln

duloxetine

20 mg

Capsule, hard

Oral use

Germany

Micro Labs GmbH

Irbesartan/Hydrochlorothiazide Micro Labs 150 mg/12,5  mg Filmtabletten

irbesartan/hydrochlorothiazide

150 mg/12,5  mg

Film-coated tablet

Oral use

Germany

Micro Labs GmbH

Irbesartan/Hydrochlorothiazide Micro Labs 300 mg/12,5  mg Filmtabletten

irbesartan/hydrochlorothiazide

300 mg/12,5  mg

Film-coated tablet

Oral use

Germany

Micro Labs GmbH

Irbesartan/Hydrochlorothiazide Micro Labs 300 mg/25 mg Filmtabletten

irbesartan/hydrochlorothiazide

300 mg/25 mg

Film-coated tablet

Oral use

Germany

Sandoz B.V.

Erlotinib HEXAL 25 mg Filmtabletten

erlotinib

25 mg

Film-coated tablet

Oral use

Germany

Sandoz B.V.

Erlotinib HEXAL 100 mg Filmtabletten

erlotinib

100 mg

Film-coated tablet

Oral use

Germany

Sandoz B.V.

Erlotinib HEXAL 150 mg Filmtabletten

erlotinib

150 mg

Film-coated tablet

Oral use

Germany

Sandoz B.V.

Erlotinib — 1 A Pharma 25 mg Filmtabletten

erlotinib

25 mg

Film-coated tablet

Oral use

Germany

Sandoz B.V.

Erlotinib — 1 A Pharma 100 mg Filmtabletten

erlotinib

100 mg

Film-coated tablet

Oral use

Germany

Sandoz B.V.

Erlotinib — 1 A Pharma 150 mg Filmtabletten

erlotinib

150 mg

Film-coated tablet

Oral use

Germany

Teva B.V.

Erlotinib-ratiopharm 25 mg Filmtabletten

erlotinib

25 mg

Film-coated tablet

Oral use

Germany

Teva B.V.

Erlotinib-ratiopharm 100 mg Filmtabletten

erlotinib

100 mg

Film-coated tablet

Oral use

Germany

Teva B.V.

Erlotinib-ratiopharm 150 mg Filmtabletten

erlotinib

150 mg

Film-coated tablet

Oral use

Germany

Teva B.V.

Erlotinib-ratiopharm 25 mg Filmtabletten

erlotinib

25 mg

Film-coated tablet

Oral use

Germany

Teva B.V.

Erlotinib-ratiopharm 100 mg Filmtabletten

erlotinib

100 mg

Film-coated tablet

Oral use

Germany

Teva B.V.

Erlotinib-ratiopharm 150 mg Filmtabletten

erlotinib

150 mg

Film-coated tablet

Oral use

Germany

Teva B.V.

Erlotinib-ratiopharm 25 mg Filmtabletten

erlotinib

25 mg

Film-coated tablet

Oral use

Germany

Teva B.V.

Erlotinib-ratiopharm 100 mg Filmtabletten

erlotinib

100 mg

Film-coated tablet

Oral use

Germany

Teva B.V.

Erlotinib-ratiopharm 150 mg Filmtabletten

erlotinib

150 mg

Film-coated tablet

Oral use

Germany

Hexal Aktiengesellschaft

Saquinavir HEXAL 500 mg Filmtabletten

saquinavir

500 mg

Film-coated tablet

Oral use

Germany

ratiopharm GmbH

Atovaquon/Proguanilhydrochlorid-ratiopharm 62,5  mg/25 mg Filmtabletten

atovaquone/proguanil

62,5  mg/25 mg

Film-coated tablet

Oral use

Germany

ratiopharm GmbH

Atovaquon/Proguanilhydrochlorid-ratiopharm 250 mg/100 mg Filmtabletten

atovaquone/proguanil

250 mg/100 mg

Film-coated tablet

Oral use

Germany

1A Pharma GmbH

Atovaquon/Proguanilhydrochlorid — 1 A Pharma 250 mg/100 mg Filmtabletten

atovaquone/proguanil

250 mg/100 mg

Film-coated tablet

Oral use

Germany

1A Pharma GmbH

Atovaquon/Proguanilhydrochlorid — 1 A Pharma 62,5  mg/25 mg Filmtabletten

atovaquone/proguanil

62,5  mg/25 mg

Film-coated tablet

Oral use

Germany

Hexal Aktiengesellschaft

Malacomp HEXAL

atovaquone/proguanil

250 mg/100 mg

Film-coated tablet

Oral use

Germany

Hexal Aktiengesellschaft

Malacomp HEXAL junior

atovaquone/proguanil

62,5  mg/25 mg

Film-coated tablet

Oral use

Germany

Hormosan Pharma Gesellschaft mit beschränkter Haftung

Pregabalin-Hormosan 25 mg Hartkapseln

pregabalin

25 mg

Capsule, hard

Oral use

Germany

Aristo Pharma GmbH

Eprosartan Aristo 600 mg Filmtabletten

eprosartan

600 mg

Film-coated tablet

Oral use

Germany

Glenmark Arzneimittel GmbH

Celecoxib Glenmark 200 mg Hartkapseln

celecoxib

200 mg

Capsule, hard

Oral use

Germany

Glenmark Arzneimittel GmbH

Celecoxib Glenmark 100 mg Hartkapseln

celecoxib

100 mg

Capsule, hard

Oral use

Greece

Genepharm SA

ERLOTINIB/GENEPHARM

erlotinib

25 mg

Film-coated tablet

Oral use

Greece

Genepharm SA

ERLOTINIB/GENEPHARM

erlotinib

100 mg

Film-coated tablet

Oral use

Greece

Genepharm SA

ERLOTINIB/GENEPHARM

erlotinib

150 mg

Film-coated tablet

Oral use

Hungary

Vipharm S.A.

ERLOTINIB VIPHARM 100 mg filmtabletta

erlotinib

100 mg

Film-coated tablet

Oral use

Hungary

Vipharm S.A.

ERLOTINIB VIPHARM 150 mg filmtabletta

erlotinib

150 mg

Film-coated tablet

Oral use

Hungary

Vipharm S.A.

ERLOTINIB VIPHARM 25 mg filmtabletta

erlotinib

25 mg

Film-coated tablet

Oral use

Hungary

Sandoz B.V.

ERLOTINIB Sandoz 25 mg filmtabletta

erlotinib

25 mg

Film-coated tablet

Oral use

Hungary

Sandoz B.V.

ERLOTINIB Sandoz 100 mg filmtabletta

erlotinib

100 mg

Film-coated tablet

Oral use

Hungary

Sandoz B.V.

ERLOTINIB Sandoz 150 mg filmtabletta

erlotinib

150 mg

Film-coated tablet

Oral use

Hungary

Lupin (Europe) Ltd

Pregabalin Merck 25 mg kemény kapszula

pregabalin

25 mg

Capsule, hard

Oral use

Iceland

Lyfis ehf.

Celecoxib LYFIS

celecoxib

100 mg

Capsule, hard

Oral use

Iceland

Lyfis ehf.

Celecoxib LYFIS

celecoxib

200 mg

Capsule, hard

Oral use

Ireland

Sandoz B.V.

Erlotinib Rowex

erlotinib

25 mg

Film-coated tablet

Oral use

Ireland

Sandoz B.V.

Erlotinib Rowex

erlotinib

100 mg

Film-coated tablet

Oral use

Ireland

Sandoz B.V.

Erlotinib Rowex

erlotinib

150 mg

Film-coated tablet

Oral use

Italy

Teva B.V.

ERLOTINIB TEVA

erlotinib

25 mg

Film-coated tablet

Oral use

Italy

Teva B.V.

ERLOTINIB TEVA

erlotinib

100 mg

Film-coated tablet

Oral use

Italy

Teva B.V.

ERLOTINIB TEVA

erlotinib

150 mg

Film-coated tablet

Oral use

Italy

Sandoz B.V.

ERLOTINIB SANDOZ

erlotinib

100 mg

Film-coated tablet

Oral use

Italy

Sandoz B.V.

ERLOTINIB SANDOZ

erlotinib

150 mg

Film-coated tablet

Oral use

Italy

Sandoz S.p.A.

ATOVAQUONE E PROGUANILE SANDOZ

atovaquone/proguanil

250 mg/100 mg

Film-coated tablet

Oral use

Italy

Sandoz S.p.A.

ATOVAQUONE E PROGUANILE SANDOZ

atovaquone/proguanil

62,5  mg/25 mg

Film-coated tablet

Oral use

Italy

Sandoz S.p.A.

SAQUINAVIR SANDOZ

saquinavir

500 mg

Film-coated tablet

Oral use

Italy

Mylan S.p.A.

ELETRIPTAN MYLAN

eletriptan

20 mg

Film-coated tablet

Oral use

Italy

Mylan S.p.A.

ELETRIPTAN MYLAN

eletriptan

40 mg

Film-coated tablet

Oral use

Latvia

PharmaSwiss Česká republika s.r.o.

Erlotinib PharmaSwiss 25 mg film-coated tablets

erlotinib

25 mg

Film-coated tablet

Oral use

Latvia

PharmaSwiss Česká republika s.r.o.

Erlotinib PharmaSwiss 100 mg film-coated tablets

erlotinib

100 mg

Film-coated tablet

Oral use

Latvia

PharmaSwiss Česká republika s.r.o.

Erlotinib PharmaSwiss 150 mg film-coated tablets

erlotinib

150 mg

Film-coated tablet

Oral use

Latvia

Sandoz B.V.

Erlotinib Sandoz 25 mg film-coated tablets

erlotinib

25 mg

Film-coated tablet

Oral use

Latvia

Sandoz B.V.

Erlotinib Sandoz 100 mg film-coated tablets

erlotinib

100 mg

Film-coated tablet

Oral use

Latvia

Sandoz B.V.

Erlotinib Sandoz 150 mg film-coated tablets

erlotinib

150 mg

Film-coated tablet

Oral use

Latvia

Accord Healthcare Ltd

Saquinavir Accord 500 mg film-coated tablets

saquinavir

500 mg

Film-coated tablet

Oral use

Lithuania

PharmaSwiss Česká republika s.r.o.

Erlotinib PharmaSwiss

erlotinib

25 mg

Film-coated tablet

Oral use

Lithuania

PharmaSwiss Česká republika s.r.o.

Erlotinib PharmaSwiss

erlotinib

100 mg

Film-coated tablet

Oral use

Lithuania

PharmaSwiss Česká republika s.r.o.

Erlotinib PharmaSwiss

erlotinib

150 mg

Film-coated tablet

Oral use

Lithuania

Sandoz B.V.

Erlotinib Sandoz

erlotinib

25 mg

Film-coated tablet

Oral use

Lithuania

Sandoz B.V.

Erlotinib Sandoz

erlotinib

100 mg

Film-coated tablet

Oral use

Lithuania

Sandoz B.V.

Erlotinib Sandoz

erlotinib

150 mg

Film-coated tablet

Oral use

Lithuania

Teva B.V.

Erlotinib Teva Generics

erlotinib

150 mg

Film-coated tablet

Oral use

Lithuania

Accord Healthcare Ltd

Saquinavir Accord 500 mg plėvele dengtos tabletės

saquinavir

500 mg

Film-coated tablet

Oral use

Luxembourg

Sandoz S.A.

Saquinavir

saquinavir

500 mg

Film-coated tablet

Oral use

Luxembourg

Micro Labs GmbH

Irbesartan/Hydrochlorothiazide Micro Labs 150 mg/12,5  mg Filmtabletten

irbesartan/hydrochlorothiazide

150 mg/12,5  mg

Film-coated tablet

Oral use

Luxembourg

Micro Labs GmbH

Irbesartan/Hydrochlorothiazide Micro Labs 300 mg/12,5  mg Filmtabletten

irbesartan/hydrochlorothiazide

300 mg/12,5  mg

Film-coated tablet

Oral use

Luxembourg

Micro Labs GmbH

Irbesartan/Hydrochlorothiazide Micro Labs 300 mg/25 mg Filmtabletten

irbesartan/hydrochlorothiazide

300 mg/25 mg

Film-coated tablet

Oral use

Luxembourg

Teva B.V.

Erlotinib-ratiopharm 25 mg Filmtabletten

erlotinib

25 mg

Film-coated tablet

Oral use

Luxembourg

Teva B.V.

Erlotinib-ratiopharm 100 mg Filmtabletten

erlotinib

100 mg

Film-coated tablet

Oral use

Luxembourg

Teva B.V.

Erlotinib-ratiopharm 150 mg Filmtabletten

erlotinib

150 mg

Film-coated tablet

Oral use

Luxembourg

Teva B.V.

Erlotinib Ratiopharm

erlotinib

25 mg

Film-coated tablet

Oral use

Luxembourg

Teva B.V.

Erlotinib Ratiopharm

erlotinib

100 mg

Film-coated tablet

Oral use

Luxembourg

Teva B.V.

Erlotinib Ratiopharm

erlotinib

150 mg

Film-coated tablet

Oral use

Luxembourg

Micro Labs GmbH

Rasagilin Micro Labs 1 mg Tabletten

rasagiline

1 mg

Film-coated tablet

Oral use

Luxembourg

Sandoz S.A.

Malaprotec

atovaquone/proguanil

62,5  mg/25 mg

Film-coated tablet

Oral use

Luxembourg

Sandoz S.A.

Malaprotec

atovaquone/proguanil

250 mg/100 mg

Film-coated tablet

Oral use

Luxembourg

ratiopharm GmbH

Atovaquon/Proguanilhydrochlorid-ratiopharm 62,5  mg/25 mg Filmtabletten

atovaquone/proguanil

62,5  mg/25 mg

Film-coated tablet

Oral use

Luxembourg

ratiopharm GmbH

Atovaquon/Proguanilhydrochlorid-ratiopharm 250 mg/100 mg Filmtabletten

atovaquone/proguanil

250 mg/100 mg

Film-coated tablet

Oral use

Malta

1A Pharma GmbH

Reprapog

atovaquone/proguanil

62,5  mg/25 mg

Film-coated tablet

Oral use

Malta

1A Pharma GmbH

Reprapog

atovaquone/proguanil

250 mg/100 mg

Film-coated tablet

Oral use

Norway

Mylan AB

Eletriptan Mylan

eletriptan

40 mg

Film-coated tablet

Oral use

Norway

Mylan AB

Eletriptan Mylan

eletriptan

20 mg

Film-coated tablet

Oral use

Norway

Orifarm Generics A/S

Atovaquone/Proguanil Orifarm

atovaquone/proguanil

250 mg/100 mg

Film-coated tablet

Oral use

Poland

Sandoz B.V.

Erlotinib Sandoz

erlotinib

25 mg

Film-coated tablet

Oral use

Poland

Sandoz B.V.

Erlotinib Sandoz

erlotinib

100 mg

Film-coated tablet

Oral use

Poland

Sandoz B.V.

Erlotinib Sandoz

erlotinib

150 mg

Film-coated tablet

Oral use

Poland

Vipharm S.A.

Erlotinib Vipharm

erlotinib

25 mg

Film-coated tablet

Oral use

Poland

Vipharm S.A.

Erlotinib Vipharm

erlotinib

100 mg

Film-coated tablet

Oral use

Poland

Vipharm S.A.

Erlotinib Vipharm

erlotinib

150 mg

Film-coated tablet

Oral use

Poland

Sandoz GmbH

Saquinavir Sandoz

saquinavir

500 mg

Film-coated tablet

Oral use

Portugal

Brown & Burk UK, Ltd.

Amoxicilina Brown

amoxicillin

250 mg

Film-coated tablet

Oral use

Portugal

Brown & Burk UK, Ltd.

Amoxicilina Brown

amoxicillin

500 mg

Film-coated tablet

Oral use

Portugal

Brown & Burk UK, Ltd.

Amoxicilina Brown

amoxicillin

750 mg

Film-coated tablet

Oral use

Portugal

Brown & Burk UK, Ltd.

Amoxicilina Brown

amoxicillin

1 000  mg

Film-coated tablet

Oral use

Portugal

Teva Pharma — Produtos Farmacêuticos, Lda.

Erlotinib Zidrium

erlotinib

25 mg

Film-coated tablet

Oral use

Portugal

Teva Pharma — Produtos Farmacêuticos, Lda.

Erlotinib Zidrium

erlotinib

100 mg

Film-coated tablet

Oral use

Portugal

Teva Pharma — Produtos Farmacêuticos, Lda.

Erlotinib Zidrium

erlotinib

150 mg

Film-coated tablet

Oral use

Portugal

Sandoz B.V.

Erlotinib Sandoz

erlotinib

25 mg

Film-coated tablet

Oral use

Portugal

Sandoz B.V.

Erlotinib Sandoz

erlotinib

100 mg

Film-coated tablet

Oral use

Portugal

Sandoz B.V.

Erlotinib Sandoz

erlotinib

150 mg

Film-coated tablet

Oral use

Portugal

Hetero Europe, S.L.

Celecoxib Hetero

Celecoxib

100 mg

Capsule, hard

Oral use

Portugal

Hetero Europe, S.L.

Celecoxib Hetero

Celecoxib

200 mg

Capsule, hard

Oral use

Portugal

Lupin (Europe) Ltd

Pregabalina Merck

Pregabalin

25 mg

Capsule, hard

Oral use

Portugal

Hetero Europe, S.L.

Eprosartan Hetero

eprosartan

600 mg

Film-coated tablet

Oral use

Portugal

Farmoz — Sociedade Técnico Medicinal, S.A.

Saquinavir Farmoz

saquinavir

500 mg

Film-coated tablet

Oral use

Portugal

Lupin (Europe) Ltd

Pregabalina Lupin

pregabalin

25 mg

Capsule, hard

Oral use

Romania

PharmaSwiss Česká republika s.r.o.

Erlotinib PharmaSwiss 25 mg film-coated tablets

erlotinib

25 mg

Film-coated tablet

Oral use

Romania

PharmaSwiss Česká republika s.r.o.

Erlotinib PharmaSwiss 100 mg film-coated tablets

erlotinib

100 mg

Film-coated tablet

Oral use

Romania

PharmaSwiss Česká republika s.r.o.

Erlotinib PharmaSwiss 150 mg film-coated tablets

erlotinib

150 mg

Film-coated tablet

Oral use

Romania

Teva B.V.

Erlotinib Teva Pharma 25 mg, film-coated tablets

erlotinib

25 mg

Film-coated tablet

Oral use

Romania

Teva B.V.

Erlotinib Teva Pharma 100 mg, film-coated tablets

erlotinib

100 mg

Film-coated tablet

Oral use

Romania

Teva B.V.

Erlotinib Teva Pharma 150 mg, film-coated tablets

erlotinib

150 mg

Film-coated tablet

Oral use

Romania

Sandoz B.V.

Erlotinib Sandoz 25 mg, film-coated tablets

erlotinib

25 mg

Film-coated tablet

Oral use

Romania

Sandoz B.V.

Erlotinib Sandoz 100 mg, film-coated tablets

erlotinib

100 mg

Film-coated tablet

Oral use

Romania

Sandoz B.V.

Erlotinib Sandoz 150 mg, film-coated tablets

erlotinib

150 mg

Film-coated tablet

Oral use

Slovakia

Sandoz B.V.

Erlotinib Sandoz 100 mg, 150 mg

erlotinib

100 mg

Film-coated tablet

Oral use

Slovakia

Sandoz B.V.

Erlotinib Sandoz 100 mg, 150 mg

erlotinib

150 mg

Film-coated tablet

Oral use

Slovakia

Vipharm S.A.

Erlotinib Vipharm 25 mg, 100 mg, 150 mg

erlotinib

25 mg

Film-coated tablet

Oral use

Slovakia

Vipharm S.A.

Erlotinib Vipharm 25 mg, 100 mg, 150 mg

erlotinib

100 mg

Film-coated tablet

Oral use

Slovakia

Vipharm S.A.

Erlotinib Vipharm 25 mg, 100 mg, 150 mg

erlotinib

150 mg

Film-coated tablet

Oral use

Slovakia

PharmaSwiss Česká republika s.r.o.

ERLOTIB 25 mg, 100 mg, 150 mg

erlotinib

25 mg

Film-coated tablet

Oral use

Slovakia

PharmaSwiss Česká republika s.r.o.

ERLOTIB 25 mg, 100 mg, 150 mg

erlotinib

100 mg

Film-coated tablet

Oral use

Slovakia

PharmaSwiss Česká republika s.r.o.

ERLOTIB 25 mg, 100 mg, 150 mg

erlotinib

150 mg

Film-coated tablet

Oral use

Slovenia

Sandoz B.V.

Erlotinib Sandoz 25 mg flmsko obložene tablete

erlotinib

25 mg

Film-coated tablet

Oral use

Slovenia

Sandoz B.V.

Erlotinib Sandoz 100 mg filmsko obložene tablete

erlotinib

100 mg

Film-coated tablet

Oral use

Slovenia

Sandoz B.V.

Erlotinib Sandoz 150 mg filmsko obložene tablete

erlotinib

150 mg

Film-coated tablet

Oral use

Spain

Sandoz B.V.

Erlotinib Sandoz 25 mg, 100 mg and 150 mg comprimidos recubiertos con película EFG

erlotinib

25 mg

Film-coated tablet

Oral use

Spain

Sandoz B.V.

Erlotinib Sandoz 25 mg, 100 mg and 150 mg comprimidos recubiertos con película EFG

erlotinib

100 mg

Film-coated tablet

Oral use

Spain

Sandoz B.V.

Erlotinib Sandoz 25 mg, 100 mg and 150 mg comprimidos recubiertos con película EFG

erlotinib

150 mg

Film-coated tablet

Oral use

Spain

Brill Pharma, S.L.

Celecoxib Brill Pharma 100 mg and 200 mg cápsulas duras

celecoxib

100 mg

Capsule, hard

Oral use

Spain

Brill Pharma, S.L.

Celecoxib Brill Pharma 100 mg and 200 mg cápsulas duras

celecoxib

200 mg

Capsule, hard

Oral use

Spain

Accord Healthcare Ltd

Saquinavir Accord 500 mg comprimidos recubiertos con película EFG

saquinavir

500 mg

Film-coated tablet

Oral use

Spain

Teva Pharma, S.L.U.

Atovacuona/Hidrocloruro de Proguanil Teva 250 mg/100 mg comprimidos recubiertos con película EFG

atovaquone/proguanil

250 mg/100 mg

Film-coated tablet

Oral use

Spain

Sandoz Farmaceutica, S.A.

Atovacuona/Hidrocloruro de Proguanil Sandoz 250 mg/100 mg comprimidos recubiertos con película EFG

atovaquone/proguanil

250 mg/100 mg

Film-coated tablet

Oral use

Spain

Pensa Pharma, S.A.U.

Eprosartan Pensa 600 mg comprimidos recubiertos con película EFG

eprosartan

600 mg

Film-coated tablet

Oral use

Spain

Industria Química Y Farmacéutica VIR, S.A.

Celecoxib VIR 200 mg cápsulas duras EFG

celecoxib

200 mg

Capsule, hard

Oral use

Sweden

Sandoz B.V.

Erlotinib Sandoz

erlotinib

25 mg

Film-coated tablet

Oral use

Sweden

Sandoz B.V.

Erlotinib Sandoz

erlotinib

100 mg

Film-coated tablet

Oral use

Sweden

Sandoz B.V.

Erlotinib Sandoz

erlotinib

150 mg

Film-coated tablet

Oral use

Sweden

Sandoz A/S

Horisto

atovaquone/proguanil

62,5  mg/25 mg

Film-coated tablet

Oral use

Sweden

Sandoz A/S

Horisto

atovaquone/proguanil

250 mg/100 mg

Film-coated tablet

Oral use

Sweden

Mylan AB

Eletriptan Mylan

eletriptan

20 mg

Film-coated tablet

Oral use

Sweden

Mylan AB

Eletriptan Mylan

eletriptan

40 mg

Film-coated tablet

Oral use

Sweden

Orifarm Generics A/S

Atovaquone/Proguanil Orifarm

atovaquone/proguanil

250 mg/100 mg

Film-coated tablet

Oral use

Sweden

Medical Valley Invest AB

Celecoxib Medical Valley

celecoxib

100 mg

Capsule, hard

Oral use

Sweden

Medical Valley Invest AB

Celecoxib Medical Valley

celecoxib

200 mg

Capsule, hard

Oral use

The Netherlands

PharmaSwiss Česká republika s.r.o.

ERLOTIB

erlotinib

25 mg

Film-coated tablet

Oral use

The Netherlands

PharmaSwiss Česká republika s.r.o.

ERLOTIB

erlotinib

100 mg

Film-coated tablet

Oral use

The Netherlands

PharmaSwiss Česká republika s.r.o.

ERLOTIB

erlotinib

150 mg

Film-coated tablet

Oral use

The Netherlands

Sandoz B.V.

Erlotinib Sandoz

erlotinib

25 mg

Film-coated tablet

Oral use

The Netherlands

Sandoz B.V.

Erlotinib Sandoz

erlotinib

100 mg

Film-coated tablet

Oral use

The Netherlands

Sandoz B.V.

Erlotinib Sandoz

erlotinib

150 mg

Film-coated tablet

Oral use

The Netherlands

Sandoz B.V.

Erlotinib Sandoz

erlotinib

25 mg

Film-coated tablet

Oral use

The Netherlands

Sandoz B.V.

Erlotinib Sandoz

erlotinib

100 mg

Film-coated tablet

Oral use

The Netherlands

Sandoz B.V.

Erlotinib Sandoz

erlotinib

150 mg

Film-coated tablet

Oral use

The Netherlands

Accord Healthcare Ltd

Saquinavir Accord

saquinavir

500 mg

Film-coated tablet

Oral use

The Netherlands

Teva B.V.

Erlotinib PCH

erlotinib

25 mg

Film-coated tablet

Oral use

The Netherlands

Teva B.V.

Erlotinib PCH

erlotinib

100 mg

Film-coated tablet

Oral use

The Netherlands

Teva B.V.

Erlotinib PCH

erlotinib

150 mg

Film-coated tablet

Oral use

The Netherlands

Teva Nederland B.V.

Atovaquon/Proguanil HCl Teva

atovaquone/proguanil

250 mg/100 mg

Film-coated tablet

Oral use

The Netherlands

Teva Nederland B.V.

Atovaquon/Proguanil HCl Teva

atovaquone/proguanil

62,5  mg/25 mg

Film-coated tablet

Oral use

The Netherlands

Sandoz B.V.

Atovaquon/Proguanil HCl Sandoz

atovaquone/proguanil

62,5  mg/25 mg

Film-coated tablet

Oral use

The Netherlands

Sandoz B.V.

Atovaquon/Proguanil HCl Sandoz

atovaquone/proguanil

250 mg/100 mg

Film-coated tablet

Oral use

The Netherlands

Sandoz B.V.

Atovaquon/Proguanil HCl Sandoz

atovaquone/proguanil

62,5  mg/25 mg

Film-coated tablet

Oral use

The Netherlands

Sandoz B.V.

Atovaquon/Proguanil HCl Sandoz

atovaquone/proguanil

250 mg/100 mg

Film-coated tablet

Oral use

The Netherlands

Sandoz B.V.

Saquinavir Sandoz

saquinavir

500 mg

Film-coated tablet

Oral use

The Netherlands

Sandoz B.V.

Saquinavir Sandoz

saquinavir

500 mg

Film-coated tablet

Oral use

The Netherlands

Hetero Europe, S.L.

Celecoxib Hetero

celecoxib

100 mg

Capsule, hard

Oral use

The Netherlands

Hetero Europe, S.L.

Celecoxib Hetero

celecoxib

200 mg

Capsule, hard

Oral use

United Kingdom

Brown & Burk UK, Ltd.

ROSUVASTATIN 5 MG FILM-COATED TABLETS

rosuvastatin

5 mg

Film-coated tablet

Oral use

United Kingdom

Brown & Burk UK, Ltd.

ROSUVASTATIN 10 MG FILM-COATED TABLETS

rosuvastatin

10 mg

Film-coated tablet

Oral use

United Kingdom

Brown & Burk UK, Ltd.

ROSUVASTATIN 20 MG FILM-COATED TABLETS

rosuvastatin

20 mg

Film-coated tablet

Oral use

United Kingdom

Brown & Burk UK, Ltd.

ROSUVASTATIN 40 MG FILM-COATED TABLETS

rosuvastatin

40 mg

Film-coated tablet

Oral use

United Kingdom

Brown & Burk UK, Ltd.

TRAMADOL/PARACETAMOL BROWN & BURK 37,5 MG/325 MG FILM-COATED TABLETS

tramadol/paracetamol

37,5  mg/325 mg

Film-coated tablet

Oral use

United Kingdom

Brown & Burk UK, Ltd.

Irbesartan/Hydrochlorothiazide Brown & Burk 150 mg/12,5  mg Film-coated tablets

irbesartan/hydrochlorothiazide

150 mg/12,5  mg

Film-coated tablet

Oral use

United Kingdom

Brown & Burk UK, Ltd.

Irbesartan/Hydrochlorothiazide Brown & Burk 300 mg/12,5  mg Film-coated tablets

irbesartan/hydrochlorothiazide

300 mg/12,5  mg

Film-coated tablet

Oral use

United Kingdom

Brown & Burk UK, Ltd.

Irbesartan/Hydrochlorothiazide Brown & Burk 300 mg/25 mg Film-coated tablets

irbesartan/hydrochlorothiazide

300 mg/25 mg

Film-coated tablet

Oral use

United Kingdom

Brown & Burk UK, Ltd.

Rasagiline Brown & Burk 1 mg Tablets

rasagiline

1 mg

Film-coated tablet

Oral use

United Kingdom

Lupin (Europe) Ltd

Duloxetine Lupin 20 mg GR capsules

duloxetine

20 mg

Capsule

Oral use

United Kingdom

Lupin (Europe) Ltd

Duloxetine Lupin 30 mg GR capsules

duloxetine

30 mg

Capsule

Oral use

United Kingdom

Lupin (Europe) Ltd

Duloxetine Lupin 40 mg GR capsules

duloxetine

40 mg

Capsule

Oral use

United Kingdom

Lupin (Europe) Ltd

Duloxetine Lupin 60 mg GR capsules

duloxetine

60 mg

Capsule

Oral use

United Kingdom

Teva UK Limited

MAFAMOZ 250 MG/100 MG FILM-COATED TABLETS

atovaquone/proguanil

250 mg/100 mg

Tablet

Oral use

United Kingdom

Teva UK Limited

MAFAMOZ 62,5 MG/25 MG FILM-COATED TABLETS

atovaquone/proguanil

62,5  mg/25 mg

Tablet

Oral use

United Kingdom

Sandoz Limited

REPRAPOG 62,5 MG/25 MG FILM-COATED TABLETS

atovaquone/proguanil

62,5  mg/25 mg

Film-coated tablet

Oral use

United Kingdom

Sandoz Limited

REPRAPOG 250 MG/100 MG FILM-COATED TABLETS

atovaquone/proguanil

250 mg/100 mg

Film-coated tablet

Oral use

United Kingdom

Brown & Burk UK Limited

AMOXICILLIN SUGAR FREE 3 G POWDER FOR ORAL SUSPENSION SACHETS

amoxicillin

3 443,35  mg

Powder for oral suspension

Oral use

United Kingdom

Hetero Europe, S.L.

EPROSARTAN 300 MG FILM-COATED TABLETS

eprosartan

300 mg

Film-coated tablet

Oral use

United Kingdom

Hetero Europe, S.L.

EPROSARTAN 400 MG FILM-COATED TABLETS

eprosartan

400 mg

Film-coated tablet

Oral use

United Kingdom

Hetero Europe, S.L.

EPROSARTAN 600 MG FILM-COATED TABLETS

eprosartan

600 mg

Film-coated tablet

Oral use

United Kingdom

Bristol Laboratories Limited

CELECOXIB CAPSULES, HARD 100 MG

celecoxib

100 mg

Capsule, hard

Oral use

United Kingdom

Bristol Laboratories Limited

CELECOXIB CAPSULES, HARD 200 MG

celecoxib

200 mg

Capsule, hard

Oral use

United Kingdom

Lupin (Europe) Ltd

Pregabalin Lupin 25 mg hard capsules

pregabalin

25 mg

Capsule, hard

Oral use

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