# Official Journal C 293/2012

| | ISSN 1977-091X
  doi:10.3000/1977091X.C_2012.293.eng |
| --- | --- |
| Official Journal
  of the European Union | C 293 |
| | |
| English edition | Information and Notices | Volume 5528 September 2012 |

ISSN 1977-091X

doi:10.3000/1977091X.C_2012.293.eng

Official Journal

of the European Union

C 293

English edition

Information and Notices

Volume 5528 September 2012

---

| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2012/C 293/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2012 to 31 August 2012(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
  ) | 1 |
| 2012/C 293/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2012 to 31 August 2012(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

2012/C 293/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2012 to 31 August 2012(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

2012/C 293/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2012 to 31 August 2012(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

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

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 28.9.2012 | EN | Official Journal of the European Union | C 293/1 |
| --- | --- | --- | --- |

28.9.2012

EN

Official Journal of the European Union

C 293/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2012 to 31 August 2012

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

2012/C 293/01

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

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 03.08.2012 | Zoledronic acid medac | zoledronic acid | medac Gesellschaft für klinische Spezialpräparate mbH |
| Theaterstr. 6, D-22880 Wedel, Deutschland |

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

03.08.2012

Zoledronic acid medac

zoledronic acid

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstr. 6, D-22880 Wedel, Deutschland

EU/1/12/779/001-006

Concentrate for solution for infusion

M05BA08

07.08.2012

16.08.2012

Zoledronic acid Teva

zoledronic acid

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

TEVA Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/12/771/001-006

Concentrate for solution for infusion

M05BA08

20.08.2012

16.08.2012

Zoledronic acid Teva Pharma

zoledronic acid

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

TEVA Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/12/772/001-004

Solution for infusion

M05BA08

20.08.2012

23.08.2012

Cuprymina

Copper 64Cu chloride

| SPARKLE S.r.l. |
| --- |
| Contrada Calò snc, 73042 Casarano (LE) - Italia |

SPARKLE S.r.l.

Contrada Calò snc, 73042 Casarano (LE) - Italia

EU/1/12/784/001

Radiopharmaceutical precursor, solution

Pending

29.08.2012

23.08.2012

Jakavi

ruxolitinib

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

Novartis Europharm Limited

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

EU/1/12/773/001-003

Tablet

L01XE18

28.08.2012

23.08.2012

Zinforo

ceftaroline fosamil

| AstraZeneca AB |
| --- |
| S-151 85 Södertälje, Sverige |

AstraZeneca AB

S-151 85 Södertälje, Sverige

EU/1/12/785/001

powder for concentrate for solution for infusion

J01DI02

27.08.2012

23.08.2012

Zoledronic acid Mylan

zoledronic acid

| Mylan S.A.S |
| --- |
| 117 allée des Parcs,F-69 800 Saint Priest, France |

Mylan S.A.S

117 allée des Parcs,F-69 800 Saint Priest, France

EU/1/12/786/001-003

Concentrate for solution for infusion

M05BA08

27.08.2012

23.08.2012

Zyclara

imiquimod

| Meda AB |
| --- |
| Pipers väg 2A, 170 73 Solna, Svërige |

Meda AB

Pipers väg 2A, 170 73 Solna, Svërige

EU/1/12/783/001-003

Cream

D06BB10

27.08.2012

30.08.2012

Revestive

teduglutide

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

Nycomed Danmark ApS

Langebjerg 1, DK-4000 Roskilde, Danmark

EU/1/12/787/001

Powder and solvent for solution for injection

A16AX08

04.09.2012

—   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 |
| --- | --- | --- | --- | --- |
| 03.08.2012 | Hirobriz Breezhaler | Novartis Europharm Limited |
| Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

03.08.2012

Hirobriz Breezhaler

Novartis Europharm Limited

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

EU/1/09/594/001-010

07.08.2012

03.08.2012

INCRELEX

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

Ipsen Pharma

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

EU/1/07/402/001

07.08.2012

03.08.2012

Mabthera

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

Roche Registration Limited

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

EU/1/98/067/001-002

07.08.2012

03.08.2012

Olanzapine Mylan

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

Generics [UK] Limited

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

EU/1/08/475/001-060

07.08.2012

03.08.2012

Volibris

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

Glaxo Group Ltd

Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/08/451/001-004

07.08.2012

03.08.2012

Votrient

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

Glaxo Group Limited

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

EU/1/10/628/001-004

07.08.2012

03.08.2012

Yondelis

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

Pharma Mar, S.A.

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

EU/1/07/417/001-002

07.08.2012

08.08.2012

Kivexa

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

ViiV Healthcare UK Ltd

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

EU/1/04/298/001-003

10.08.2012

08.08.2012

Olanzapine Teva

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

Teva Pharma B.V.

Computerweg 10, DR Utrecht 3542, Nederland

EU/1/07/427/001-057

10.08.2012

22.08.2012

IDflu

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

Sanofi Pasteur SA

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

EU/1/08/507/001-006

23.08.2012

22.08.2012

Intanza

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

Sanofi Pasteur MSD SNC

8, rue Jonas Salk, Lyon 69007, France

EU/1/08/505/001-006

23.08.2012

23.08.2012

Adcirca

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

Eli Lilly Nederland B.V.

Grootslag 1-5, NL-3991 RA Houten, Nederland

EU/1/08/476/005-006

27.08.2012

23.08.2012

BeneFIX

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

Pfizer Limited

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

EU/1/97/047/004-008

28.08.2012

23.08.2012

Brinavess

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

Merck Sharp & Dohme Limited

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

EU/1/10/645/001-002

28.08.2012

23.08.2012

Copalia

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

Novartis Europharm Ltd

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

EU/1/06/372/001-039

28.08.2012

23.08.2012

Dafiro

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

Novartis Europharm Ltd

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

EU/1/06/371/001-039

28.08.2012

23.08.2012

Docetaxel Teva Pharma

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

Teva Pharma B.V.

Computerweg 10, DR Utrecht 3542, Nederland

EU/1/10/662/001-002

27.08.2012

23.08.2012

Doribax

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

Janssen-Cilag International NV

Turnhoutseweg 30, B - 2340 Beerse, België

EU/1/08/467/001-002

27.08.2012

23.08.2012

Ecalta

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

Pfizer Limited

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

EU/1/07/416/002

28.08.2012

23.08.2012

Efficib

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

Merck Sharp & Dohme Ltd.

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

EU/1/08/457/001-016

28.08.2012

23.08.2012

Exforge HCT

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

Novartis Europharm Ltd

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

EU/1/09/569/001-060

28.08.2012

23.08.2012

Firazyr

| Shire Orphan Therapies GmbH |
| --- |
| Friedrichstrasse 149, D-10117 Berlin, Deutschland |

Shire Orphan Therapies GmbH

Friedrichstrasse 149, D-10117 Berlin, Deutschland

EU/1/08/461/001-002

27.08.2012

23.08.2012

Hepsera

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

Gilead Sciences International Limited

Cambridge, CB21 6GT, United Kingdom

EU/1/03/251/001-002

28.08.2012

23.08.2012

Humira

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

Abbott Laboratories Ltd

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

EU/1/03/256/001-010

28.08.2012

23.08.2012

Imprida HCT

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

Novartis Europharm Ltd

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

EU/1/09/570/001-060

28.08.2012

23.08.2012

Janumet

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

Merck Sharp & Dohme Ltd.

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

EU/1/08/455/001-016

28.08.2012

23.08.2012

Lysodren

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

Laboratoire HRA Pharma

15, rue Béranger, 75003 Paris, France

EU/1/04/273/001

27.08.2012

23.08.2012

Macugen

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

Pfizer Ltd

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

EU/1/05/325/002

29.08.2012

23.08.2012

Mepact

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

IDM PHARMA SAS

11-15 quai De Dion Bouton, 92816 Puteaux Cedex, France

EU/1/08/502/001

27.08.2012

23.08.2012

Neupro

| UCB Manufacturing Ireland Ltd. |
| --- |
| Shannon Industrial Estate, Co, Clare, Ireland |

UCB Manufacturing Ireland Ltd.

Shannon Industrial Estate, Co, Clare, Ireland

EU/1/05/331/001-055

27.08.2012

23.08.2012

Noxafil

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

Merck Sharp & Dohme Ltd.

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

EU/1/05/320/001

28.08.2012

23.08.2012

Olazax Disperzi

| Glenmark Pharmaceuticals s.r.o. |
| --- |
| City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika |

Glenmark Pharmaceuticals s.r.o.

City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika

EU/1/09/592/001-005

27.08.2012

23.08.2012

Panretin

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

Eisai Limited

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

EU/1/00/149/001

28.08.2012

23.08.2012

Rasilez

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

Novartis Europharm Ltd

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

EU/1/07/405/001-040

28.08.2012

23.08.2012

Reyataz

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

Bristol-Myers Squibb Pharma EEIG

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

EU/1/03/267/001-006

EU/1/03/267/008-010

28.08.2012

23.08.2012

Riprazo

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

Novartis Europharm Ltd

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

EU/1/07/409/001-040

28.08.2012

23.08.2012

Thalidomide Celgene

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

Celgene Europe Limited

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

EU/1/08/443/001

28.08.2012

23.08.2012

Vectibix

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

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/07/423/001-003

27.08.2012

23.08.2012

Velmetia

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

Merck Sharp & Dohme Ltd.

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

EU/1/08/456/001-016

28.08.2012

23.08.2012

Vfend

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

Pfizer Ltd

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

EU/1/02/212/001-026

28.08.2012

23.08.2012

Vfend

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

Pfizer Ltd

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

EU/1/02/212/001-026

28.08.2012

23.08.2012

Viramune

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

Boehringer Ingelheim International GmbH

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

EU/1/97/055/001-009

27.08.2012

23.08.2012

Xgeva

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

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/11/703/001-003

27.08.2012

23.08.2012

Zavesca

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

Actelion Registration Ltd

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

EU/1/02/238/001

27.08.2012

23.08.2012

Zebinix

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

BIAL - Portela & Ca, SA

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

EU/1/09/514/001-023

27.08.2012

23.08.2012

Zebinix

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

BIAL - Portela & Ca, SA

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

EU/1/09/514/001-020

27.08.2012

23.08.2012

Zostavax

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

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk, F-69007 Lyon, France

EU/1/06/341/001-013

27.08.2012

24.08.2012

FLUENZ

| MedImmune, LLC |
| --- |
| Lagelandseweg 78, 6545 CG Nijmegen, Nederland |

MedImmune, LLC

Lagelandseweg 78, 6545 CG Nijmegen, Nederland

EU/1/10/661/001-002

28.08.2012

27.08.2012

FLUENZ

| MedImmune, LLC |
| --- |
| Lagelandseweg 78, 6545 CG Nijmegen, Nederland |

MedImmune, LLC

Lagelandseweg 78, 6545 CG Nijmegen, Nederland

EU/1/10/661/002

29.08.2012

30.08.2012

Avastin

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

Roche Registration Limited

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

EU/1/04/300/001-002

04.09.2012

30.08.2012

Copalia HCT

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

Novartis Europharm Ltd

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

EU/1/09/575/001-060

03.09.2012

30.08.2012

Crixivan

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

Merck Sharp & Dohme Ltd

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

EU/1/96/024/010

03.09.2012

30.08.2012

Dafiro HCT

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

Novartis Europharm Ltd

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

EU/1/09/574/001-060

03.09.2012

30.08.2012

Enbrel

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

Pfizer Limited

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

EU/1/99/126/001-022

03.09.2012

30.08.2012

Evista

| DAIICHI SANKYO EUROPE GmbH |
| --- |
| Zielstattstrasse 48, 81379 München, Deutschland |

DAIICHI SANKYO EUROPE GmbH

Zielstattstrasse 48, 81379 München, Deutschland

EU/1/98/073/001-004

03.09.2012

30.08.2012

Exforge

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

Novartis Europharm Ltd

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

EU/1/06/370/001-039

03.09.2012

30.08.2012

Flebogamma DIF

| Instituto Grifols, S.A. |
| --- |
| Can Guasch, 2 - Parets del Vallès, 08150 Barcelona - Espaňa |

Instituto Grifols, S.A.

Can Guasch, 2 - Parets del Vallès, 08150 Barcelona - Espaňa

EU/1/07/404/001-008

04.09.2012

30.08.2012

Gliolan

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

medac Gesellschaft für klinische Spezialpräparate mbH

Fehlandtstrasse 3, D-20354 Hamburg - Deutschland

EU/1/07/413/001-003

04.09.2012

30.08.2012

Imprida

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

Novartis Europharm Ltd

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

EU/1/06/373/001-039

03.09.2012

30.08.2012

INCRELEX

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

Ipsen Pharma

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

EU/1/07/402/001

04.09.2012

30.08.2012

Irbesartan Zentiva

| Sanofi |
| --- |
| 54, rue La Boétie, 75008 Paris, France |

Sanofi

54, rue La Boétie, 75008 Paris, France

EU/1/06/376/001-039

03.09.2012

30.08.2012

Januvia

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

Merck Sharp & Dohme Ltd

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

EU/1/07/383/001-018

03.09.2012

30.08.2012

Kaletra

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

Abbott Laboratories

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

EU/1/01/172/001-008

03.09.2012

30.08.2012

Leganto

| UCB Manufacturing Ireland Ltd. |
| --- |
| Shannon Industrial Estate, Co, Clare, Ireland |

UCB Manufacturing Ireland Ltd.

Shannon Industrial Estate, Co, Clare, Ireland

EU/1/11/695/001-055

04.09.2012

30.08.2012

Methylthioninium chloride Proveblue

| Provepharm S.A.S. |
| --- |
| Technopole de Chateau Gombert, 45 rue Frederic Joliot Curie, FR-13013 Marseille |

Provepharm S.A.S.

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

EU/1/11/682/001

04.09.2012

30.08.2012

Modigraf

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

Astellas Pharma Europe B.V.

Elisabethhof 19, 2353 EW Leiderdorp, Nederland

EU/1/09/523/001-002

03.09.2012

30.08.2012

Multaq

| Sanofi |
| --- |
| 54, rue La Boétie, 75008 Paris, France |

Sanofi

54, rue La Boétie, 75008 Paris, France

EU/1/09/591/001-004

03.09.2012

30.08.2012

Olanzapine Glenmark Europe

| Glenmark Generics (Europe) Limited |
| --- |
| Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HA3 OBU, United Kingdom |

Glenmark Generics (Europe) Limited

Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HA3 OBU, United Kingdom

EU/1/09/588/001-012

03.09.2012

30.08.2012

Optruma

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

Eli Lilly Nederland B.V.

Grootslag 1-5, 3991 RA Houten, Nederland

EU/1/98/074/001-004

03.09.2012

30.08.2012

Pradaxa

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

Boehringer Ingelheim International GmbH

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

EU/1/08/442/001-014

EU/1/08/442/017-019

05.09.2012

30.08.2012

Pravafenix

| LABORATOIRES SMB SA |
| --- |
| 26-28 rue de la Pastorale, 1080 Bruxelles, Belgique / 26-28 Herdersliedstraat, 1080 Brussel, België |

LABORATOIRES SMB SA

26-28 rue de la Pastorale, 1080 Bruxelles, Belgique / 26-28 Herdersliedstraat, 1080 Brussel, België

EU/1/11/679/001-006

04.09.2012

30.08.2012

Protopic

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

Astellas Pharma Europe B.V.

Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland

EU/1/02/201/001-006

03.09.2012

30.08.2012

ReFacto AF

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

Pfizer Limited

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

EU/1/99/103/001-008

03.09.2012

30.08.2012

Ristaben

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

Merck Sharp & Dohme Ltd.

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

EU/1/10/621/001-018

04.09.2012

30.08.2012

Ristfor

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

Merck Sharp & Dohme Ltd.

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

EU/1/10/620/001-016

04.09.2012

30.08.2012

Sprycel

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

Bristol-Myers Squibb Pharma EEIG

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

EU/1/06/363/001-015

03.09.2012

30.08.2012

Telmisartan Teva

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

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/09/610/061-062

03.09.2012

30.08.2012

Tygacil

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

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom

EU/1/06/336/001

03.09.2012

30.08.2012

Vedrop

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

Orphan Europe SARL

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

EU/1/09/533/001-003

04.09.2012

30.08.2012

Votrient

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

Glaxo Group Limited

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

EU/1/10/628/001-004

04.09.2012

30.08.2012

Zytiga

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

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/11/714/001

04.09.2012

—   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 |
| --- | --- | --- | --- | --- |
| 08.08.2012 | MabCampath | Genzyme Europe B.V. |
| Gooimeer 10, NL-1411 DD Naarden, Nederland |

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

08.08.2012

MabCampath

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/01/193/001-002

10.08.2012

23.08.2012

Zerene

| Meda AB |
| --- |
| Pipers väg 2A, Solna 170 09, Sverige |

Meda AB

Pipers väg 2A, Solna 170 09, Sverige

EU/1/99/099/001-006

27.08.2012

30.08.2012

Riprazo HCT

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

Novartis Europharm Limited

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

EU/1/11/680/001-080

03.09.2012

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 16.08.2012 | Inflacam | Chanelle Pharmaceuticals Manufacturing Limited |
| Loughrea, Co. Galway, IRELAND |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

16.08.2012

Inflacam

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, IRELAND

EU/2/11/134/001-017

20.08.2012

30.08.2012

Dexdomitor

| Orion Corporation |
| --- |
| Orionintie 1, FIN-02200 Espoo, Suomi |

Orion Corporation

Orionintie 1, FIN-02200 Espoo, Suomi

EU/2/02/033/001-004

03.09.2012

30.08.2012

Nobivac Bb

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

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/02/034/001

03.09.2012

30.08.2012

Suvaxyn Aujeszky 783 +O/W

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

Pfizer Limited

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

EU/2/98/009/001-006

03.09.2012

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

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

The European Medicines Agency

7, Westferry Circus,

Canary Wharf

UK - LONDON E14 4H

---

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

---

| 28.9.2012 | EN | Official Journal of the European Union | C 293/9 |
| --- | --- | --- | --- |

28.9.2012

EN

Official Journal of the European Union

C 293/9

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2012 to 31 August 2012

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

2012/C 293/02

—   Issuing, maintenance or modification of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 23/8/2012 | Zinnat and associated names | See Annex | See Annex | 27/8/2012 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

23/8/2012

Zinnat and associated names

See Annex

See Annex

27/8/2012

---

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

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

---

ANNEX

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

| Member State
  (EU/EEA) | Marketing Authorisation Holder | Invented name | Strength | Pharmaceutical Form | Route of administration | Content
  (concentration) |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6, |
| A-1140 Wien |
| AUSTRIA |

Member State

(EU/EEA)

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Content

(concentration)

Austria

GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6,

A-1140 Wien

AUSTRIA

Zinnat 125 mg/5 ml – Granulat zur Herstellung einer Suspension zum Einnehmen

125 mg/5 ml

Granules for Oral Suspension

Oral use

125 mg/5 ml

Austria

| GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6, |
| --- |
| A-1140 Wien |
| AUSTRIA |

GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6,

A-1140 Wien

AUSTRIA

Zinnat 250 mg – Granulat

250 mg

Granules

Oral use

N/A

Austria

| GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6, |
| --- |
| A-1140 Wien |
| AUSTRIA |

GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6,

A-1140 Wien

AUSTRIA

Zinnat 250 mg/5 ml – Granulat zur Herstellung einer Suspension zum Einnehmen

250 mg/5 ml

Granules for Oral Suspension

Oral use

250 mg/5 ml

Austria

| GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6, |
| --- |
| A-1140 Wien |
| AUSTRIA |

GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6,

A-1140 Wien

AUSTRIA

Zinnat 250 mg – Filmtabletten

250 mg

Film-coated Tablets

Oral use

N/A

Austria

| GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6, |
| --- |
| A-1140 Wien |
| AUSTRIA |

GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6,

A-1140 Wien

AUSTRIA

Zinnat 500 mg – Filmtabletten

500 mg

Film-coated Tablets

Oral use

N/A

Belgium

| GlaxoSmithKline s.a./n.v. Rue du Tilleul 13 |
| --- |
| 1332 Genval |
| BELGIUM |

GlaxoSmithKline s.a./n.v. Rue du Tilleul 13

1332 Genval

BELGIUM

Zinnat

250 mg/5 ml

Granules for Oral Suspension

Oral use

250 mg/5 ml

Belgium

| GlaxoSmithKline s.a./n.v. Rue du Tilleul 13 |
| --- |
| 1332 Genval |
| BELGIUM |

GlaxoSmithKline s.a./n.v. Rue du Tilleul 13

1332 Genval

BELGIUM

Zinnat

250 mg

Film-coated Tablets

Oral use

N/A

Belgium

| GlaxoSmithKline s.a./n.v. Rue du Tilleul 13 |
| --- |
| 1332 Genval |
| BELGIUM |

GlaxoSmithKline s.a./n.v. Rue du Tilleul 13

1332 Genval

BELGIUM

Zinnat

500 mg

Film-coated Tablets

Oral use

N/A

Bulgaria

GlaxoSmithKline EOOD, Ivan Vazov complex, Dimitar Manov Str., bld 10, 1408 Sofia, BULGARIA

Zinnat

125 mg/5 ml

Granules for Oral Suspension

Oral use

125 mg/5 ml

Bulgaria

| Glaxo Group Ltd., Greenford road, Greenford, Middlesex, UB6 0NN, |
| --- |
| UNITED KINGDOM |

Glaxo Group Ltd., Greenford road, Greenford, Middlesex, UB6 0NN,

UNITED KINGDOM

Zinnat

250 mg/5 ml

Granules for Oral Suspension

Oral use

250 mg/5 ml

Bulgaria

GlaxoSmithKline EOOD, Ivan Vazov complex, Dimitar Manov Str., bld 10, 1408 Sofia, BULGARIA

Zinnat

250 mg

Film-coated Tablets

Oral use

N/A

Bulgaria

GlaxoSmithKline EOOD, Ivan Vazov complex, Dimitar Manov Str., bld 10, 1408 Sofia, BULGARIA

Zinnat

500 mg

Film-coated Tablets

Oral use

N/A

Cyprus

| Glaxo Group Limited |
| --- |
| Berkeley Avenue |
| Greenford |
| Middlesex UB6 0NN |
| UNITED KINGDOM |

Glaxo Group Limited

Berkeley Avenue

Greenford

Middlesex UB6 0NN

UNITED KINGDOM

Zinnat

250 mg/5 ml

Granules for Oral Suspension

Oral use

250 mg/5 ml

Cyprus

| Glaxo Group Limited |
| --- |
| Berkeley Avenue |
| Greenford |
| Middlesex UB6 0NN |
| UNITED KINGDOM |

Glaxo Group Limited

Berkeley Avenue

Greenford

Middlesex UB6 0NN

UNITED KINGDOM

Zinnat

250 mg

Film-coated Tablets

Oral use

N/A

Cyprus

| Glaxo Group Limited |
| --- |
| Berkeley Avenue |
| Greenford |
| Middlesex UB6 0NN |
| UNITED KINGDOM |

Glaxo Group Limited

Berkeley Avenue

Greenford

Middlesex UB6 0NN

UNITED KINGDOM

Zinnat

500 mg

Film-coated Tablets

Oral use

N/A

Czech Republic

| Glaxo Group Ltd., |
| --- |
| Glaxo Welcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN |
| ENGLAND |

Glaxo Group Ltd.,

Glaxo Welcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN

ENGLAND

Zinnat 125 mg

125 mg/5 ml

Granules for Oral Suspension

Oral use

125 mg/5 ml

Czech Republic

| Glaxo Group Ltd., |
| --- |
| Glaxo Welcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN |
| ENGLAND |

Glaxo Group Ltd.,

Glaxo Welcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN

ENGLAND

Zinnat 250 mg

250 mg/5 ml

Granules for Oral Suspension

Oral use

250 mg/5 ml

Czech Republic

| Glaxo Group Ltd., |
| --- |
| Glaxo Welcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN |
| ENGLAND |

Glaxo Group Ltd.,

Glaxo Welcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN

ENGLAND

Zinnat 125 mg

125 mg

Film-coated Tablets

Oral use

N/A

Czech Republic

| Glaxo Group Ltd., |
| --- |
| Glaxo Welcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN |
| ENGLAND |

Glaxo Group Ltd.,

Glaxo Welcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN

ENGLAND

Zinnat 250 mg

250 mg

Film-coated Tablets

Oral use

N/A

Czech Republic

| Glaxo Group Ltd., |
| --- |
| Glaxo Welcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN |
| ENGLAND |

Glaxo Group Ltd.,

Glaxo Welcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN

ENGLAND

Zinnat 500 mg

500 mg

Film-coated Tablets

Oral use

N/A

Denmark

| GlaxoSmithKline Pharma A/S |
| --- |
| Nykaer 68, 2605 Broendby |
| DENMARK |

GlaxoSmithKline Pharma A/S

Nykaer 68, 2605 Broendby

DENMARK

Zinnat

125 mg/5 ml (25 mg/ml)

Granules for Oral Suspension

Oral use

125 mg/5 ml

Denmark

| GlaxoSmithKline Pharma A/S |
| --- |
| Nykaer 68, 2605 Broendby |
| DENMARK |

GlaxoSmithKline Pharma A/S

Nykaer 68, 2605 Broendby

DENMARK

Zinnat

125 mg

Film-coated Tablets

Oral use

N/A

Denmark

| GlaxoSmithKline Pharma A/S |
| --- |
| Nykaer 68, 2605 Broendby |
| DENMARK |

GlaxoSmithKline Pharma A/S

Nykaer 68, 2605 Broendby

DENMARK

Zinnat

250 mg

Film-coated Tablets

Oral use

N/A

Denmark

| GlaxoSmithKline Pharma A/S |
| --- |
| Nykaer 68, 2605 Broendby |
| DENMARK |

GlaxoSmithKline Pharma A/S

Nykaer 68, 2605 Broendby

DENMARK

Zinnat

500 mg

Film-coated Tablets

Oral use

N/A

Estonia

| Glaxo Group Ltd. |
| --- |
| Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN |
| UNITED KINGDOM |

Glaxo Group Ltd.

Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN

UNITED KINGDOM

Zinnat

25 mg/1 ml

Granules for Oral Suspension

Oral use

25 mg/1 ml

Estonia

| Glaxo Group Ltd. |
| --- |
| Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN |
| UNITED KINGDOM |

Glaxo Group Ltd.

Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN

UNITED KINGDOM

Zinnat

250 mg

Film-coated Tablet

Oral use

N/A

Estonia

| Glaxo Group Ltd. |
| --- |
| Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN |
| UNITED KINGDOM |

Glaxo Group Ltd.

Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN

UNITED KINGDOM

Zinnat

500 mg

Film-coated Tablet

Oral use

N/A

Finland

| GlaxoSmithKline Oy |
| --- |
| P.O.Box 24 (Piispansilta 9 A), FI-02231 Espoo, FINLAND |

GlaxoSmithKline Oy

P.O.Box 24 (Piispansilta 9 A), FI-02231 Espoo, FINLAND

Zinnat

50 mg/ml

Granules for Oral Suspension

Oral use

N/A

Finland

Glaxo Operations UK Ltd, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, UNITED KINGDOM

Zinnat

125 mg

Film-coated Tablets

Oral use

N/A

Finland

Glaxo Operations UK Ltd, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, UNITED KINGDOM

Zinnat

250 mg

Film-coated Tablets

Oral use

N/A

France

| Laboratoire GlaxoSmithKline |
| --- |
| 100, route de Versailles – 78163 Marly-le-Roi Cedex |
| FRANCE |

Laboratoire GlaxoSmithKline

100, route de Versailles – 78163 Marly-le-Roi Cedex

FRANCE

Zinnat 125 mg/5 ml Enfants et Nourrissons

125 mg/5 ml

Granules for Oral Suspension

Oral use

125 mg/5 ml

France

| Laboratoire GlaxoSmithKline |
| --- |
| 100, route de Versailles – 78163 Marly-le-Roi Cedex |
| FRANCE |

Laboratoire GlaxoSmithKline

100, route de Versailles – 78163 Marly-le-Roi Cedex

FRANCE

Zinnat

125 mg

Film-coated Tablets

Oral use

N/A

France

| Laboratoire GlaxoSmithKline |
| --- |
| 100, route de Versailles – 78163 Marly-le-Roi Cedex |
| FRANCE |

Laboratoire GlaxoSmithKline

100, route de Versailles – 78163 Marly-le-Roi Cedex

FRANCE

Zinnat

250 mg

Film-coated Tablets

Oral use

N/A

France

| Laboratoire GlaxoSmithKline |
| --- |
| 100, route de Versailles – 78163 Marly-le-Roi Cedex |
| FRANCE |

Laboratoire GlaxoSmithKline

100, route de Versailles – 78163 Marly-le-Roi Cedex

FRANCE

Zinnat

500 mg

Film-coated Tablets

Oral use

N/A

France

| Laboratoire GlaxoSmithKline |
| --- |
| 100, route de Versailles – 78163 Marly-le-Roi Cedex |
| FRANCE |

Laboratoire GlaxoSmithKline

100, route de Versailles – 78163 Marly-le-Roi Cedex

FRANCE

Zinnat 125 mg Enfants et Nourrissons

125 mg

Granules for Oral Suspension in sachet

Oral use

N/A

Germany

| GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11 |
| --- |
| 80339 München |
| GERMANY |

GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11

80339 München

GERMANY

Zinnat -Trockensaft

125 mg/5 ml (25 mg/ml)

Granules for Oral Suspension

Oral use

125 mg/5 ml

Germany

| GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11 |
| --- |
| 80339 München |
| GERMANY |

GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11

80339 München

GERMANY

Zinnat

125 mg

Film-coated Tablets

Oral use

N/A

Germany

| GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11 |
| --- |
| 80339 München |
| GERMANY |

GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11

80339 München

GERMANY

Zinnat

250 mg

Film-coated Tablets

Oral use

N/A

Germany

| GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11 |
| --- |
| 80339 München |
| GERMANY |

GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11

80339 München

GERMANY

Zinnat

500 mg

Film-coated Tablets

Oral use

N/A

Germany

| GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11 |
| --- |
| 80339 München |
| GERMANY |

GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11

80339 München

GERMANY

Elobact 125 mg Dosier-Brief

125 mg

Granules for Oral Suspension

Oral use

N/A

Germany

| GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11 |
| --- |
| 80339 München |
| GERMANY |

GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11

80339 München

GERMANY

Elobact Trockensaft

125 mg/5 ml

Granules for Oral Suspension

Oral use

125 mg/5 ml

Germany

| GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11 |
| --- |
| 80339 München |
| GERMANY |

GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11

80339 München

GERMANY

Elobact 250 mg Dosier-Brief

250 mg

Granules for Oral Suspension

Oral use

N/A

Germany

| GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11 |
| --- |
| 80339 München |
| GERMANY |

GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11

80339 München

GERMANY

Elobact

125 mg

Film-coated Tablets

Oral use

N/A

Germany

| GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11 |
| --- |
| 80339 München |
| GERMANY |

GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11

80339 München

GERMANY

Elobact

250 mg

Film-coated Tablets

Oral use

N/A

Germany

| GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11 |
| --- |
| 80339 München |
| GERMANY |

GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11

80339 München

GERMANY

Elobact

500 mg

Film-coated Tablets

Oral use

N/A

Greece

| GlaxoSmithKline a.e.b.e, Leof. Kifissias 266, |
| --- |
| 152 32 Halandri, Athens |
| GREECE |

GlaxoSmithKline a.e.b.e, Leof. Kifissias 266,

152 32 Halandri, Athens

GREECE

Zinadol

250 mg/5 ml

Granules for Oral Suspension

Oral use

250 mg/5 ml

Greece

| GlaxoSmithKline a.e.b.e, Leof. Kifissias 266, |
| --- |
| 152 32 Halandri, Athens |
| GREECE |

GlaxoSmithKline a.e.b.e, Leof. Kifissias 266,

152 32 Halandri, Athens

GREECE

Zinadol

250 mg

Film-coated Tablets

Oral use

N/A

Greece

| GlaxoSmithKline a.e.b.e, Leof. Kifissias 266, |
| --- |
| 152 32 Halandri, Athens |
| GREECE |

GlaxoSmithKline a.e.b.e, Leof. Kifissias 266,

152 32 Halandri, Athens

GREECE

Zinadol

500 mg

Film-coated Tablets

Oral use

N/A

Hungary

| GlaxoSmithKline Kft. |
| --- |
| 1124 Bp, Csörsz u. 43. |
| HUNGARY |

GlaxoSmithKline Kft.

1124 Bp, Csörsz u. 43.

HUNGARY

Zinnat

125 mg/5 ml

Granules for Oral Suspension

Oral use

125 mg/5 ml

Hungary

| GlaxoSmithKline Kft. |
| --- |
| 1124 Bp, Csörsz u. 43. |
| HUNGARY |

GlaxoSmithKline Kft.

1124 Bp, Csörsz u. 43.

HUNGARY

Zinnat

125 mg

Film-coated Tablets

Oral use

N/A

Hungary

| GlaxoSmithKline Kft. |
| --- |
| 1124 Bp, Csörsz u. 43. |
| HUNGARY |

GlaxoSmithKline Kft.

1124 Bp, Csörsz u. 43.

HUNGARY

Zinnat

250 mg

Film-coated Tablets

Oral use

N/A

Hungary

| GlaxoSmithKline Kft. |
| --- |
| 1124 Bp, Csörsz u. 43. |
| HUNGARY |

GlaxoSmithKline Kft.

1124 Bp, Csörsz u. 43.

HUNGARY

Zinnat

500 mg

Film-coated Tablets

Oral use

N/A

Iceland

| GlaxoSmithKline ehf. |
| --- |
| Thverholt 14 |
| 105 Reykjavík. |
| ICELAND |

GlaxoSmithKline ehf.

Thverholt 14

105 Reykjavík.

ICELAND

Zinnat

250 mg/5 ml

(25 mg/ml)

Granules for Oral Suspension

Oral use

250 mg/5 ml

Iceland

| GlaxoSmithKline ehf. |
| --- |
| Thverholt 14 |
| 105 Reykjavík. |
| ICELAND |

GlaxoSmithKline ehf.

Thverholt 14

105 Reykjavík.

ICELAND

Zinnat

250 mg

Film-coated Tablets

Oral use

N/A

Ireland

| GlaxoSmithKline (Ireland) Limited |
| --- |
| Stonemasons Way, |
| Rathfarnham, |
| Dublin 16 |
| IRELAND |

GlaxoSmithKline (Ireland) Limited

Stonemasons Way,

Rathfarnham,

Dublin 16

IRELAND

Zinnat

125 mg/5 ml

Granules for Oral Suspension

Oral use

125 mg/5 ml

Ireland

| GlaxoSmithKline (Ireland) Limited |
| --- |
| Stonemasons Way, |
| Rathfarnham, |
| Dublin 16 |
| IRELAND |

GlaxoSmithKline (Ireland) Limited

Stonemasons Way,

Rathfarnham,

Dublin 16

IRELAND

Zinnat

250 mg/5 ml

Granules for Oral Suspension

Oral use

250 mg/5 ml

Ireland

| GlaxoSmithKline (Ireland) Limited |
| --- |
| Stonemasons Way, |
| Rathfarnham, |
| Dublin 16 |
| IRELAND |

GlaxoSmithKline (Ireland) Limited

Stonemasons Way,

Rathfarnham,

Dublin 16

IRELAND

Zinnat

125 mg

Film-coated Tablets

Oral use

N/A

Ireland

| GlaxoSmithKline (Ireland) Limited |
| --- |
| Stonemasons Way, |
| Rathfarnham, |
| Dublin 16 |
| IRELAND |

GlaxoSmithKline (Ireland) Limited

Stonemasons Way,

Rathfarnham,

Dublin 16

IRELAND

Zinnat

500 mg

Film-coated Tablets

Oral use

N/A

Italy

| GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – |
| --- |
| 37135 Verona |
| ITALY |

GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –

37135 Verona

ITALY

Zinnat

125 mg/5 ml

Granules for Oral Suspension

Oral use

125 mg/5 ml

Italy

| GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – |
| --- |
| 37135 Verona |
| ITALY |

GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –

37135 Verona

ITALY

Zinnat

250 mg

Granules for Oral Suspension

Oral use

N/A

Italy

| GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – |
| --- |
| 37135 Verona |
| ITALY |

GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –

37135 Verona

ITALY

Zinnat

250 mg/5 ml

Granules for Oral Suspension

Oral use

250 mg/5 ml

Italy

| GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – |
| --- |
| 37135 Verona |
| ITALY |

GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –

37135 Verona

ITALY

Zinnat

250 mg

Film-coated Tablets

Oral use

N/A

Italy

| GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – |
| --- |
| 37135 Verona |
| ITALY |

GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –

37135 Verona

ITALY

Zinnat

500 mg

Film-coated Tablets

Oral use

N/A

Italy

| GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – |
| --- |
| 37135 Verona |
| ITALY |

GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –

37135 Verona

ITALY

Zoref

125 mg/5 ml

Granules for Oral Suspension

Oral use

125 mg/5 ml

Italy

| GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – |
| --- |
| 37135 Verona |
| ITALY |

GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –

37135 Verona

ITALY

Zoref

250 mg/5 ml

Granules for Oral Suspension

Oral use

250 mg/5 ml

Italy

| GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – |
| --- |
| 37135 Verona |
| ITALY |

GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –

37135 Verona

ITALY

Zoref

250 mg

Film-coated Tablets

Oral use

N/A

Italy

| GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – |
| --- |
| 37135 Verona |
| ITALY |

GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –

37135 Verona

ITALY

Zoref

500 mg

Film-coated Tablets

Oral use

N/A

Italy

| Malesci Istituto Farmacobiologico S.p.A |
| --- |
| Via Lungo l’Ema 7, |
| 50012 Bagno A Ripoli |
| Firenze |
| ITALY |

Malesci Istituto Farmacobiologico S.p.A

Via Lungo l’Ema 7,

50012 Bagno A Ripoli

Firenze

ITALY

Oraxim

125 mg/5 ml

Granules for Oral Suspension

Oral use

125 mg/5 ml

Italy

| Malesci Istituto Farmacobiologico S.p.A |
| --- |
| Via Lungo l’Ema 7, |
| 50012 Bagno A Ripoli |
| Firenze |
| ITALY |

Malesci Istituto Farmacobiologico S.p.A

Via Lungo l’Ema 7,

50012 Bagno A Ripoli

Firenze

ITALY

Oraxim

250 mg

Granules for Oral Suspension

Oral use

N/A

Italy

| Malesci Istituto Farmacobiologico S.p.A |
| --- |
| Via Lungo l’Ema 7, |
| 50012 Bagno A Ripoli |
| Firenze |
| ITALY |

Malesci Istituto Farmacobiologico S.p.A

Via Lungo l’Ema 7,

50012 Bagno A Ripoli

Firenze

ITALY

Oraxim

125 mg/5 ml

Granules for Oral Suspension

Oral use

250 mg/5 ml

Italy

| Malesci Istituto Farmacobiologico S.p.A |
| --- |
| Via Lungo l’Ema 7, |
| 50012 Bagno A Ripoli |
| Firenze |
| ITALY |

Malesci Istituto Farmacobiologico S.p.A

Via Lungo l’Ema 7,

50012 Bagno A Ripoli

Firenze

ITALY

Oraxim

250 mg

Film-coated Tablets

Oral use

N/A

Italy

| Malesci Istituto Farmacobiologico S.p.A |
| --- |
| Via Lungo l’Ema 7, |
| 50012 Bagno A Ripoli |
| Firenze |
| ITALY |

Malesci Istituto Farmacobiologico S.p.A

Via Lungo l’Ema 7,

50012 Bagno A Ripoli

Firenze

ITALY

Oraxim

500 mg

Film-coated Tablets

Oral use

N/A

Latvia

| GlaxoSmithKline Latvia SIA, Bruņinieku 5, Rīga, LV-1001 |
| --- |
| LATVIA |

GlaxoSmithKline Latvia SIA, Bruņinieku 5, Rīga, LV-1001

LATVIA

Zinnat 25 mg/ml granulas iekšķīgi lietojamas suspensijas pagatavošanai

125 mg/5 ml

(25 mg/ml)

Granules for Oral Suspension

Oral use

125 mg/5 ml

Latvia

| GlaxoSmithKline Latvia SIA, Bruņinieku 5, Rīga, LV-1001 |
| --- |
| LATVIA |

GlaxoSmithKline Latvia SIA, Bruņinieku 5, Rīga, LV-1001

LATVIA

Zinnat 250 mg apvalkotās tabletes

250 mg

Film-coated Tablets

Oral use

N/A

Latvia

| GlaxoSmithKline Latvia SIA, Bruņinieku 5, Rīga, LV-1001 |
| --- |
| LATVIA |

GlaxoSmithKline Latvia SIA, Bruņinieku 5, Rīga, LV-1001

LATVIA

Zinnat 500 mg apvalkotās tabletes

500 mg

Film-coated Tablets

Oral use

N/A

Lithuania

| UAB ‘GlaxoSmithKline Lietuva’, |
| --- |
| A. Goštauto g. 40A, |
| LT-01112 Vilnius, LITHUANIA |

UAB ‘GlaxoSmithKline Lietuva’,

A. Goštauto g. 40A,

LT-01112 Vilnius, LITHUANIA

Zinnat

125 mg/5 ml

Granules for Oral Suspension

Oral use

125 mg/5 ml

Lithuania

| UAB ‘GlaxoSmithKline Lietuva’, |
| --- |
| A. Goštauto g. 40A, |
| LT-01112 Vilnius, LITHUANIA |

UAB ‘GlaxoSmithKline Lietuva’,

A. Goštauto g. 40A,

LT-01112 Vilnius, LITHUANIA

Zinnat

125 mg

Film-coated Tablets

Oral use

N/A

Lithuania

| UAB ‘GlaxoSmithKline Lietuva’, |
| --- |
| A. Goštauto g. 40A, |
| LT-01112 Vilnius, LITHUANIA |

UAB ‘GlaxoSmithKline Lietuva’,

A. Goštauto g. 40A,

LT-01112 Vilnius, LITHUANIA

Zinnat

250 mg

Film-coated Tablets

Oral use

N/A

Lithuania

| UAB ‘GlaxoSmithKline Lietuva’, |
| --- |
| A. Goštauto g. 40A, |
| LT-01112 Vilnius, LITHUANIA |

UAB ‘GlaxoSmithKline Lietuva’,

A. Goštauto g. 40A,

LT-01112 Vilnius, LITHUANIA

Zinnat

500 mg

Film-coated Tablets

Oral use

N/A

Luxembourg

| GLAXOSMITHKLINE PHARMACEUTICALS SA |
| --- |
| 2-4-6, AVENUE PASCAL B-1330 WAVRE |

GLAXOSMITHKLINE PHARMACEUTICALS SA

2-4-6, AVENUE PASCAL B-1330 WAVRE

Zinnat

125 mg/5 ml

Granules for Oral Suspension

Oral use

125 mg/5 ml

Luxembourg

| GLAXOSMITHKLINE PHARMACEUTICALS SA |
| --- |
| 2-4-6, AVENUE PASCAL B-1330 WAVRE |

GLAXOSMITHKLINE PHARMACEUTICALS SA

2-4-6, AVENUE PASCAL B-1330 WAVRE

Zinnat

250 mg

Granules for Oral Suspension

Oral use

N/A

Luxembourg

| GLAXOSMITHKLINE PHARMACEUTICALS SA |
| --- |
| 2-4-6, AVENUE PASCAL B-1330 WAVRE |

GLAXOSMITHKLINE PHARMACEUTICALS SA

2-4-6, AVENUE PASCAL B-1330 WAVRE

Zinnat

250 mg/5 ml

Granules for Oral Suspension

Oral use

250 mg/5 ml

Luxembourg

| GLAXOSMITHKLINE PHARMACEUTICALS SA |
| --- |
| 2-4-6, AVENUE PASCAL B-1330 WAVRE |

GLAXOSMITHKLINE PHARMACEUTICALS SA

2-4-6, AVENUE PASCAL B-1330 WAVRE

Zinnat

125 mg

Film-coated Tablets

Oral use

N/A

Luxembourg

| GLAXOSMITHKLINE PHARMACEUTICALS SA |
| --- |
| 2-4-6, AVENUE PASCAL B-1330 WAVRE |

GLAXOSMITHKLINE PHARMACEUTICALS SA

2-4-6, AVENUE PASCAL B-1330 WAVRE

Zinnat

250 mg

Film-coated Tablets

Oral use

N/A

Luxembourg

| GLAXOSMITHKLINE PHARMACEUTICALS SA |
| --- |
| 2-4-6, AVENUE PASCAL B-1330 WAVRE |

GLAXOSMITHKLINE PHARMACEUTICALS SA

2-4-6, AVENUE PASCAL B-1330 WAVRE

Zinnat

500 mg

Film-coated Tablets

Oral use

N/A

Malta

GlaxoSmithKline (Ireland) Ltd. Stonemasons Way, Rathfarnham, Dublin 16 IRELAND

Zinnat

125 mg/5 ml

Granules for Oral Suspension

Oral use

125 mg/5 ml

Malta

GlaxoSmithKline (Ireland) Ltd. Stonemasons Way, Rathfarnham, Dublin 16 IRELAND

Zinnat

250 mg/5 ml

Granules for Oral Suspension

Oral use

250 mg/5 ml

Malta

| Glaxo Wellcome UK Limited |
| --- |
| Glaxo Wellcome House |
| Berkeley avenue |
| Greenford, Middlesex |
| United Kingdom |
| UB6 0NN |

Glaxo Wellcome UK Limited

Glaxo Wellcome House

Berkeley avenue

Greenford, Middlesex

United Kingdom

UB6 0NN

Zinnat

250 mg

Film-coated Tablets

Oral use

N/A

Malta

GlaxoSmithKline (Ireland) Ltd. Stonemasons Way, Rathfarnham, Dublin 16 IRELAND

Zinnat

500 mg

Film-coated Tablets

Oral use

N/A

Netherlands

| Glaxo Smith Kline B.V. |
| --- |
| Huis ter Heideweg 62 |
| 3705 LZ ZEIST |
| NETHERLANDS |

Glaxo Smith Kline B.V.

Huis ter Heideweg 62

3705 LZ ZEIST

NETHERLANDS

Zinnat

125 mg/5 ml

Granules for Oral Suspension

Oral use

125 mg/5 ml

Netherlands

| Glaxo Smith Kline B.V. |
| --- |
| Huis ter Heideweg 62 |
| 3705 LZ ZEIST |
| NETHERLANDS |

Glaxo Smith Kline B.V.

Huis ter Heideweg 62

3705 LZ ZEIST

NETHERLANDS

Zinnat

125 mg

Film-coated Tablets

Oral use

N/A

Netherlands

| Glaxo Smith Kline B.V. |
| --- |
| Huis ter Heideweg 62 |
| 3705 LZ ZEIST |
| NETHERLANDS |

Glaxo Smith Kline B.V.

Huis ter Heideweg 62

3705 LZ ZEIST

NETHERLANDS

Zinnat

250 mg

Film-coated Tablets

Oral use

N/A

Netherlands

| Glaxo Smith Kline B.V. |
| --- |
| Huis ter Heideweg 62 |
| 3705 LZ ZEIST |
| NETHERLANDS |

Glaxo Smith Kline B.V.

Huis ter Heideweg 62

3705 LZ ZEIST

NETHERLANDS

Zinnat

500 mg

Film-coated Tablets

Oral use

N/A

Poland

| GlaxoSmithKline Export Ltd |
| --- |
| 980 Great West Road |
| Brentford, Middlesex, TW8 9GS |
| UNITED KINGDOM |

GlaxoSmithKline Export Ltd

980 Great West Road

Brentford, Middlesex, TW8 9GS

UNITED KINGDOM

Zinnat

125 mg/5 ml

Granules for Oral Suspension

Oral use

125 mg/5 ml

Poland

| GlaxoSmithKline Export Ltd |
| --- |
| 980 Great West Road |
| Brentford, Middlesex, TW8 9GS |
| UNITED KINGDOM |

GlaxoSmithKline Export Ltd

980 Great West Road

Brentford, Middlesex, TW8 9GS

UNITED KINGDOM

Zinnat

250 mg

Granules for Oral Suspension

Oral use

N/A

Poland

| GlaxoSmithKline Export Ltd |
| --- |
| 980 Great West Road |
| Brentford, Middlesex, TW8 9GS |
| UNITED KINGDOM |

GlaxoSmithKline Export Ltd

980 Great West Road

Brentford, Middlesex, TW8 9GS

UNITED KINGDOM

Zinnat

250 mg/5 ml

Granules for Oral Suspension

Oral use

250 mg/5 ml

Poland

| GlaxoSmithKline Export Ltd |
| --- |
| 980 Great West Road |
| Brentford, Middlesex, TW8 9GS |
| UNITED KINGDOM |

GlaxoSmithKline Export Ltd

980 Great West Road

Brentford, Middlesex, TW8 9GS

UNITED KINGDOM

Zinnat

125 mg

Film-coated Tablets

Oral use

N/A

Poland

| GlaxoSmithKline Export Ltd |
| --- |
| 980 Great West Road |
| Brentford, Middlesex, TW8 9GS |
| UNITED KINGDOM |

GlaxoSmithKline Export Ltd

980 Great West Road

Brentford, Middlesex, TW8 9GS

UNITED KINGDOM

Zinnat

250 mg

Film-coated Tablets

Oral use

N/A

Poland

| GlaxoSmithKline Export Ltd |
| --- |
| 980 Great West Road |
| Brentford, Middlesex, TW8 9GS |
| UNITED KINGDOM |

GlaxoSmithKline Export Ltd

980 Great West Road

Brentford, Middlesex, TW8 9GS

UNITED KINGDOM

Zinnat

500 mg

Film-coated Tablets

Oral use

N/A

Portugal

| Instituto Luso-Fármaco, Lda. |
| --- |
| Rua Dr António Loureiro Borges no3 |
| Arquiparque – Miraflores |
| 1495-131 Algés |
| PORTUGAL |

Instituto Luso-Fármaco, Lda.

Rua Dr António Loureiro Borges no3

Arquiparque – Miraflores

1495-131 Algés

PORTUGAL

Zipos

125 mg/5 ml

Granules for Oral Suspension

Oral use

125 mg/5 ml

Portugal

| Instituto Luso-Fármaco, Lda. |
| --- |
| Rua Dr António Loureiro Borges no3 |
| Arquiparque – Miraflores |
| 1495-131 Algés |
| PORTUGAL |

Instituto Luso-Fármaco, Lda.

Rua Dr António Loureiro Borges no3

Arquiparque – Miraflores

1495-131 Algés

PORTUGAL

Zipos

250 mg/5 ml

Granules for Oral Suspension

Oral use

250 mg/5 ml

Portugal

| Instituto Luso-Fármaco, Lda. |
| --- |
| Rua Dr António Loureiro Borges no3 |
| Arquiparque – Miraflores |
| 1495-131 Algés |
| PORTUGAL |

Instituto Luso-Fármaco, Lda.

Rua Dr António Loureiro Borges no3

Arquiparque – Miraflores

1495-131 Algés

PORTUGAL

Zipos

250 mg

Film-coated Tablets

Oral use

N/A

Portugal

| Instituto Luso-Fármaco, Lda. |
| --- |
| Rua Dr António Loureiro Borges no3 |
| Arquiparque – Miraflores |
| 1495-131 Algés |
| PORTUGAL |

Instituto Luso-Fármaco, Lda.

Rua Dr António Loureiro Borges no3

Arquiparque – Miraflores

1495-131 Algés

PORTUGAL

Zipos

500 mg

Film-coated Tablets

Oral use

N/A

Portugal

| GlaxoWellcome Farmacêutica Lda |
| --- |
| Rua Dr António Loureiro Borges no3 |
| Arquiparque – Miraflores |
| 1495-131 Algés |
| PORTUGAL |

GlaxoWellcome Farmacêutica Lda

Rua Dr António Loureiro Borges no3

Arquiparque – Miraflores

1495-131 Algés

PORTUGAL

Zoref

125 mg/5 ml

Granules for Oral Suspension

Oral use

125 mg/5 ml

Portugal

| GlaxoWellcome Farmacêutica Lda |
| --- |
| Rua Dr António Loureiro Borges no3 |
| Arquiparque – Miraflores |
| 1495-131 Algés |
| PORTUGAL |

GlaxoWellcome Farmacêutica Lda

Rua Dr António Loureiro Borges no3

Arquiparque – Miraflores

1495-131 Algés

PORTUGAL

Zoref

250 mg/5 ml

Granules for Oral Suspension

Oral use

250 mg/5 ml

Portugal

| GlaxoWellcome Farmacêutica Lda |
| --- |
| Rua Dr António Loureiro Borges no3 |
| Arquiparque – Miraflores |
| 1495-131 Algés |
| PORTUGAL |

GlaxoWellcome Farmacêutica Lda

Rua Dr António Loureiro Borges no3

Arquiparque – Miraflores

1495-131 Algés

PORTUGAL

Zoref

250 mg

Film-coated Tablets

Oral use

N/A

Portugal

| GlaxoWellcome Farmacêutica Lda |
| --- |
| Rua Dr António Loureiro Borges no3 |
| Arquiparque – Miraflores |
| 1495-131 Algés |
| PORTUGAL |

GlaxoWellcome Farmacêutica Lda

Rua Dr António Loureiro Borges no3

Arquiparque – Miraflores

1495-131 Algés

PORTUGAL

Zoref

500 mg

Film-coated Tablets

Oral use

N/A

Romania

| Glaxo Wellcome UK Limited, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN, |
| --- |
| UNITED KINGDOM |

Glaxo Wellcome UK Limited, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN,

UNITED KINGDOM

Zinnat

125 mg/5 ml

Granules for Suspension

Oral use

125 mg/5 ml

Romania

| Glaxo Wellcome UK Limited, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN, |
| --- |
| UNITED KINGDOM |

Glaxo Wellcome UK Limited, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN,

UNITED KINGDOM

Zinnat

125 mg

Film-coated Tablets

Oral use

N/A

Romania

| Glaxo Wellcome UK Limited, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN, |
| --- |
| UNITED KINGDOM |

Glaxo Wellcome UK Limited, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN,

UNITED KINGDOM

Zinnat

250 mg

Film-coated Tablets

Oral use

N/A

Romania

| Glaxo Wellcome UK Limited, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN, |
| --- |
| UNITED KINGDOM |

Glaxo Wellcome UK Limited, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN,

UNITED KINGDOM

Zinnat

500 mg

Film-coated Tablets

Oral use

N/A

Slovakia

| GlaxoSmithKline Slovakia s.r.o., Galvaniho7/A, 82104 Bratislava |
| --- |
| Slovak Republic |

GlaxoSmithKline Slovakia s.r.o., Galvaniho7/A, 82104 Bratislava

Slovak Republic

Zinnat 125 mg/5 ml

125 mg/5 ml

Granules for Oral Suspension

Oral use

125 mg/5 ml

Slovakia

| GlaxoSmithKline Slovakia s.r.o., Galvaniho7/A, 82104 Bratislava |
| --- |
| Slovak Republic |

GlaxoSmithKline Slovakia s.r.o., Galvaniho7/A, 82104 Bratislava

Slovak Republic

Zinnat 250 mg/5 ml

250 mg/5 ml

Granules for Oral Suspension

Oral use

250 mg/5 ml

Slovakia

| GlaxoSmithKline Slovakia s.r.o., Galvaniho7/A, 82104 Bratislava |
| --- |
| Slovak Republic |

GlaxoSmithKline Slovakia s.r.o., Galvaniho7/A, 82104 Bratislava

Slovak Republic

Zinnat 125 mg

125 mg

Film-coated Tablet

Oral use

N/A

Slovakia

| GlaxoSmithKline Slovakia s.r.o., Galvaniho7/A, 82104 Bratislava |
| --- |
| Slovak Republic |

GlaxoSmithKline Slovakia s.r.o., Galvaniho7/A, 82104 Bratislava

Slovak Republic

Zinnat 250 mg

250 mg

Film-coated Tablets

Oral use

N/A

Slovakia

| GlaxoSmithKline Slovakia s.r.o., Galvaniho7/A, 82104 Bratislava |
| --- |
| Slovak Republic |

GlaxoSmithKline Slovakia s.r.o., Galvaniho7/A, 82104 Bratislava

Slovak Republic

Zinnat 500 mg

500 mg

Film-coated Tablets

Oral use

N/A

Slovenia

| GSK d.o.o., Ljubljana |
| --- |
| Cvetkova ulica 29 |
| SI-1000 Ljubljana |
| SLOVENIA |

GSK d.o.o., Ljubljana

Cvetkova ulica 29

SI-1000 Ljubljana

SLOVENIA

Zinnat 125 mg/5 ml zrnca za peroralno suspenzijo

125 mg/5 ml

Granules for Oral Suspension

Oral use

125 mg/5 ml

Slovenia

| GSK d.o.o., Ljubljana |
| --- |
| Cvetkova ulica 29 |
| SI-1000 Ljubljana |
| SLOVENIA |

GSK d.o.o., Ljubljana

Cvetkova ulica 29

SI-1000 Ljubljana

SLOVENIA

Zinnat 250 mg/5 ml zrnca za peroralno suspenzijo

250 mg/5 ml

Granules for Oral Suspension

Oral use

250 mg/5 ml

Slovenia

| GSK d.o.o., Ljubljana |
| --- |
| Cvetkova ulica 29 |
| SI-1000 Ljubljana |
| SLOVENIA |

GSK d.o.o., Ljubljana

Cvetkova ulica 29

SI-1000 Ljubljana

SLOVENIA

Zinnat 250 mg filmsko obložene tablete

250 mg

Film-coated Tablets

Oral use

N/A

Slovenia

| GSK d.o.o., Ljubljana |
| --- |
| Cvetkova ulica 29 |
| SI-1000 Ljubljana |
| SLOVENIA |

GSK d.o.o., Ljubljana

Cvetkova ulica 29

SI-1000 Ljubljana

SLOVENIA

Zinnat 500 mg filmsko obložene tablete

500 mg

Film-coated Tablets

Oral use

N/A

Spain

| GlaxoSmithKline, S.A. |
| --- |
| Parque Tecnológico de Madrid |
| C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) |
| SPAIN |

GlaxoSmithKline, S.A.

Parque Tecnológico de Madrid

C/Severo Ochoa, 2 28760 Tres Cantos (Madrid)

SPAIN

ZINNAT 125 mg granulado para suspensión oral en sobres

125 mg

Granules for Oral Suspension

Oral use

N/A

Spain

| GlaxoSmithKline, S.A. |
| --- |
| Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) |
| SPAIN |

GlaxoSmithKline, S.A.

Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid)

SPAIN

ZINNAT 125 mg/5 ml granulado para suspensión oral en frasco

125 mg/5 ml

Granules for Oral Suspension

Oral use

125 mg/5 ml

Spain

| GlaxoSmithKline, S.A. |
| --- |
| Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) |
| SPAIN |

GlaxoSmithKline, S.A.

Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid)

SPAIN

ZINNAT 250 mg granulado para suspensión oral en sobres

250 mg

Granules for Oral Suspension

Oral use

N/A

Spain

| GlaxoSmithKline, S.A. |
| --- |
| Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) |
| SPAIN |

GlaxoSmithKline, S.A.

Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid)

SPAIN

ZINNAT 250 mg/5 ml granulado para suspensión oral en frasco

250 mg/5 ml

Granules for Oral Suspension

Oral use

250 mg/5 ml

Spain

| GlaxoSmithKline, S.A. |
| --- |
| Parque Tecnológico de Madrid |
| C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) |
| SPAIN |

GlaxoSmithKline, S.A.

Parque Tecnológico de Madrid

C/Severo Ochoa, 2 28760 Tres Cantos (Madrid)

SPAIN

ZINNAT 500 mg granulado para suspensión oral en sobres

500 mg

Granules for Oral Suspension

Oral use

N/A

Spain

| GlaxoSmithKline, S.A. |
| --- |
| Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) |
| SPAIN |

GlaxoSmithKline, S.A.

Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid)

SPAIN

ZINNAT 125 mg comprimidos recubiertos con película

125 mg

Film-coated Tablets

Oral use

N/A

Spain

| GlaxoSmithKline, S.A. |
| --- |
| Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) |
| SPAIN |

GlaxoSmithKline, S.A.

Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid)

SPAIN

ZINNAT 250 mg comprimidos recubiertos con película

250 mg

Film-coated Tablets

Oral use

N/A

Spain

| GlaxoSmithKline, S.A. |
| --- |
| Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) |
| SPAIN |

GlaxoSmithKline, S.A.

Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid)

SPAIN

ZINNAT 500 mg comprimidos recubiertos con película

500 mg

Film-coated Tablets

Oral use

N/A

Spain

| GlaxoSmithKline, S.A. |
| --- |
| Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) |
| SPAIN |

GlaxoSmithKline, S.A.

Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid)

SPAIN

SELAN 125 mg sobres

125 mg

Granules for Oral Suspension

Oral use

N/A

Spain

| GlaxoSmithKline, S.A. |
| --- |
| Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) |
| SPAIN |

GlaxoSmithKline, S.A.

Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid)

SPAIN

SELAN 125 mg suspensión extemporánea

125 mg/5 ml

Granules for Oral Suspension

Oral use

125 mg/5 ml

Spain

| GlaxoSmithKline, S.A. |
| --- |
| Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) |
| SPAIN |

GlaxoSmithKline, S.A.

Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid)

SPAIN

SELAN 250 mg suspensión extemporánea

250 mg/5 ml

Granules for Oral Suspension

Oral use

250 mg/5 ml

Spain

| GlaxoSmithKline, S.A. |
| --- |
| Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) |
| SPAIN |

GlaxoSmithKline, S.A.

Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid)

SPAIN

SELAN 500 mg sobres

500 mg

Granules for Oral Suspension

Oral use

N/A

Spain

| GlaxoSmithKline, S.A. |
| --- |
| Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) |
| SPAIN |

GlaxoSmithKline, S.A.

Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid)

SPAIN

SELAN 125 mg comprimidos

125 mg

Film-coated Tablets

Oral use

N/A

Spain

| GlaxoSmithKline, S.A. |
| --- |
| Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) |
| SPAIN |

GlaxoSmithKline, S.A.

Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid)

SPAIN

SELAN 250 mg comprimidos

250 mg

Film-coated Tablets

Oral use

N/A

Spain

| GlaxoSmithKline, S.A. |
| --- |
| Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) |
| SPAIN |

GlaxoSmithKline, S.A.

Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid)

SPAIN

SELAN 500 mg comprimidos

500 mg

Film-coated Tablets

Oral use

N/A

Spain

| Wellcome Farmacéutica, S.A. |
| --- |
| Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) |
| SPAIN |

Wellcome Farmacéutica, S.A.

Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid)

SPAIN

NIVADOR 125 mg/5 ml granulado para suspensión oral en frasco

125 mg

Granules for Oral Suspension

Oral use

N/A

Spain

| Wellcome Farmacéutica, S.A. .- Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) |
| --- |
| SPAIN |

Wellcome Farmacéutica, S.A. .- Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid)

SPAIN

NIVADOR 125 mg/5 ml granulado para suspensión oral en frasco

125 mg/5 ml

Granules for Oral Suspension

Oral use

125 mg/5 ml

Spain

| Wellcome Farmacéutica, S.A. P.T.M.- C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) |
| --- |
| SPAIN |

Wellcome Farmacéutica, S.A. P.T.M.- C/Severo Ochoa, 2 28760 Tres Cantos (Madrid)

SPAIN

NIVADOR 250 mg granulado para suspensión oral en sobres

250 mg

Granules for Oral Suspension

Oral use

N/A

Spain

| Wellcome Farmacéutica, S.A. P.T.M.- C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) |
| --- |
| SPAIN |

Wellcome Farmacéutica, S.A. P.T.M.- C/Severo Ochoa, 2 28760 Tres Cantos (Madrid)

SPAIN

NIVADOR 250 mg/5 ml granulado para suspensión oral en frasco

250 mg/5 ml

Granules for Oral Suspension

Oral use

250 mg/5 ml

Spain

| Wellcome Farmacéutica, S.A. P.T.M.- C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) |
| --- |
| SPAIN |

Wellcome Farmacéutica, S.A. P.T.M.- C/Severo Ochoa, 2 28760 Tres Cantos (Madrid)

SPAIN

NIVADOR 500 mg granulado para suspensión oral en sobres

500 mg

Granules for Oral Suspension

Oral use

N/A

Spain

| Wellcome Farmacéutica, S.A. P.T.M.- C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) |
| --- |
| SPAIN |

Wellcome Farmacéutica, S.A. P.T.M.- C/Severo Ochoa, 2 28760 Tres Cantos (Madrid)

SPAIN

NIVADOR 250 mg comprimidos recubiertos con película

250 mg

Film-coated Tablets

Oral use

N/A

Spain

| Wellcome Farmacéutica, S.A. P.T.M.- C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) |
| --- |
| SPAIN |

Wellcome Farmacéutica, S.A. P.T.M.- C/Severo Ochoa, 2 28760 Tres Cantos (Madrid)

SPAIN

NIVADOR 500 mg comprimidos recubiertos con película

500 mg

Film-coated Tablets

Oral use

N/A

Spain

| Allen Farmacéutica, S.A. |
| --- |
| Parque Tecnológico de Madrid |
| C/Severo Ochoa, 2 |
| 28760 Tres Cantos |
| (Madrid) |
| SPAIN |

Allen Farmacéutica, S.A.

Parque Tecnológico de Madrid

C/Severo Ochoa, 2

28760 Tres Cantos

(Madrid)

SPAIN

Cefuroxima Allen 250 mg comprimidos recubiertos con película EFG

250 mg

Film-coated Tablets

Oral use

N/A

Spain

| Allen Farmacéutica, S.A. |
| --- |
| Parque Tecnológico de Madrid |
| C/Severo Ochoa, 2 |
| 28760 Tres Cantos |
| (Madrid) |
| SPAIN |

Allen Farmacéutica, S.A.

Parque Tecnológico de Madrid

C/Severo Ochoa, 2

28760 Tres Cantos

(Madrid)

SPAIN

Cefuroxima Allen 500 mg comprimidos recubiertos con película EFG

500 mg

Film-coated Tablets

Oral use

N/A

Spain

| Allen Farmacéutica, S.A. |
| --- |
| Parque Tecnológico de Madrid |
| C/Severo Ochoa, 2 |
| 28760 Tres Cantos |
| (Madrid) |
| SPAIN |

Allen Farmacéutica, S.A.

Parque Tecnológico de Madrid

C/Severo Ochoa, 2

28760 Tres Cantos

(Madrid)

SPAIN

Cefuroxima Solasma 250 mg comprimidos recubiertos con película EFG

250 mg

Film-coated Tablets

Oral use

N/A

Spain

| Allen Farmacéutica, S.A. |
| --- |
| Parque Tecnológico de Madrid |
| C/Severo Ochoa, 2 |
| 28760 Tres Cantos |
| (Madrid) |
| SPAIN |

Allen Farmacéutica, S.A.

Parque Tecnológico de Madrid

C/Severo Ochoa, 2

28760 Tres Cantos

(Madrid)

SPAIN

Cefuroxima Solasma 500 mg comprimidos recubiertos con película EFG

500 mg

Film-coated Tablets

Oral use

N/A

Sweden

| GlaxoSmithKline AB |
| --- |
| Box 516 |
| 169 29 Solna |
| SWEDEN |

GlaxoSmithKline AB

Box 516

169 29 Solna

SWEDEN

Zinnat

25 mg/ml

Granules for Oral Suspension

Oral use

N/A

Sweden

| GlaxoSmithKline AB |
| --- |
| Box 516 |
| 169 29 Solna |
| SWEDEN |

GlaxoSmithKline AB

Box 516

169 29 Solna

SWEDEN

Zinnat

250 mg

Film-coated Tablets

Oral use

N/A

United Kingdom

| Glaxo Wellcome UK Ltd, |
| --- |
| Stockley Park West, Uxbridge, Middlesex, UB11 1BT |

Glaxo Wellcome UK Ltd,

Stockley Park West, Uxbridge, Middlesex, UB11 1BT

Zinnat

125 mg/5 ml

Granules for Oral Suspension

Oral use

125 mg/5 ml

United Kingdom

| Glaxo Wellcome UK Ltd, |
| --- |
| Stockley Park West, Uxbridge, Middlesex, UB11 1BT |

Glaxo Wellcome UK Ltd,

Stockley Park West, Uxbridge, Middlesex, UB11 1BT

Zinnat

250 mg/5 ml

Granules for Oral Suspension

Oral use

250 mg/5 ml

United Kingdom

| Glaxo Wellcome UK Ltd, |
| --- |
| Stockley Park West, Uxbridge, Middlesex, UB11 1BT |

Glaxo Wellcome UK Ltd,

Stockley Park West, Uxbridge, Middlesex, UB11 1BT

Zinnat

125 mg

Film-coated Tablets

Oral use

N/A

United Kingdom

| Glaxo Wellcome UK Ltd, |
| --- |
| Stockley Park West, Uxbridge, Middlesex, UB11 1BT |

Glaxo Wellcome UK Ltd,

Stockley Park West, Uxbridge, Middlesex, UB11 1BT

Zinnat

250 mg

Film-coated Tablets

Oral use

N/A

United Kingdom

| Glaxo Wellcome UK Ltd, |
| --- |
| Stockley Park West, Uxbridge, Middlesex, UB11 1BT |

Glaxo Wellcome UK Ltd,

Stockley Park West, Uxbridge, Middlesex, UB11 1BT

Zinnat

500 mg

Film-coated Tablets

Oral use

N/A

---