# Den Europæiske Unions C 293/2012

| | ISSN 1977-0871
  doi:10.3000/19770871.C_2012.293.dan |
| --- | --- |
| Den Europæiske Unions
  Tidende | C 293 |
| | |
| Dansk udgave | Meddelelser og oplysninger | 55. årgang28. september 2012 |

ISSN 1977-0871

doi:10.3000/19770871.C_2012.293.dan

Den Europæiske Unions

Tidende

C 293

Dansk udgave

Meddelelser og oplysninger

55. årgang28. september 2012

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| Informationsnummer | Indhold | Side |
| --- | --- | --- |
| | IV   Oplysninger |
| | OPLYSNINGER FRA DEN EUROPÆISKE UNIONS INSTITUTIONER, ORGANER, KONTORER OG AGENTURER |
| | Europa-Kommissionen |
| 2012/C 293/01 | Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. august 2012 til 31. august 2012(Offentliggjort i henhold til artikel 13 eller artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004) | 1 |
| 2012/C 293/02 | Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. august 2012 til 31. august 2012(Afgørelser truffet i henhold til artikel 34 i direktiv 2001/83/EF eller artikel 38 i direktiv 2001/82/EF) | 9 |

Informationsnummer

Indhold

Side

IV   Oplysninger

OPLYSNINGER FRA DEN EUROPÆISKE UNIONS INSTITUTIONER, ORGANER, KONTORER OG AGENTURER

Europa-Kommissionen

2012/C 293/01

Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. august 2012 til 31. august 2012(Offentliggjort i henhold til artikel 13 eller artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004)

(Offentliggjort i henhold til artikel 13 eller artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004)

1

2012/C 293/02

Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. august 2012 til 31. august 2012(Afgørelser truffet i henhold til artikel 34 i direktiv 2001/83/EF eller artikel 38 i direktiv 2001/82/EF)

(Afgørelser truffet i henhold til artikel 34 i direktiv 2001/83/EF eller artikel 38 i direktiv 2001/82/EF)

9

| DA | |
| --- | --- |

DA

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IV Oplysninger

OPLYSNINGER FRA DEN EUROPÆISKE UNIONS INSTITUTIONER, ORGANER, KONTORER OG AGENTURER

Europa-Kommissionen

| 28.9.2012 | DA | Den Europæiske Unions Tidende | C 293/1 |
| --- | --- | --- | --- |

28.9.2012

DA

Den Europæiske Unions Tidende

C 293/1

---

Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. august 2012 til 31. august 2012

(Offentliggjort i henhold til artikel 13 eller artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004
   (1)
  )

2012/C 293/01

—   Udstedelse af markedsføringstilladelse (artikel 13 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004): Godkendt

| Dato for afgørelser | Lægemidlets navn | INN-navn (International Non-Proprietary Name) | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Lægemiddelform | ATC-kode (Anatomical Therapeutic Chemical Code) | Dato for notifikation |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 03.08.2012 | Zoledronic acid medac | zoledronsyre | medac Gesellschaft für klinische Spezialpräparate mbH |
| Theaterstr. 6, D-22880 Wedel, Deutschland |

Dato for afgørelser

Lægemidlets navn

INN-navn (International Non-Proprietary Name)

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Lægemiddelform

ATC-kode (Anatomical Therapeutic Chemical Code)

Dato for notifikation

03.08.2012

Zoledronic acid medac

zoledronsyre

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstr. 6, D-22880 Wedel, Deutschland

EU/1/12/779/001-006

Koncentrat till infusionsvaeske, opløsning

M05BA08

07.08.2012

16.08.2012

Zoledronic acid Teva

Zoledronsyre

| 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

Koncentrat till infusionsvaeske, opløsning

M05BA08

20.08.2012

16.08.2012

Zoledronic acid Teva Pharma

Zoledronsyre

| 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

Infussionsvæske, opløsning

M05BA08

20.08.2012

23.08.2012

Cuprymina

Kobber (64Cu)-chlorid

| 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

Radiofarmaceutisk mærkningsopløsning

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

ceftarolin fosamil

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

AstraZeneca AB

S-151 85 Södertälje, Sverige

EU/1/12/785/001

Pulver til koncentrat til infusionsvæske, opløsning

J01DI02

27.08.2012

23.08.2012

Zoledronic acid Mylan

Zoledronsyre

| 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

Koncentrat till infusionsvaeske, opløsning

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

Creme

D06BB10

27.08.2012

30.08.2012

Revestive

teduglutid

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

Nycomed Danmark ApS

Langebjerg 1, DK-4000 Roskilde, Danmark

EU/1/12/787/001

Pulver og solvens til opløsning, injektion

A16AX08

04.09.2012

—   Ændring af markedsføringstilladelse (artikel 13 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004): Godkendt

| Dato for afgørelser | Lægemidlets navn | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 03.08.2012 | Hirobriz Breezhaler | Novartis Europharm Limited |
| Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom |

Dato for afgørelser

Lægemidlets navn

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Dato for notifikation

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

—   Tilbagekaldelse af markedsføringstilladelse (artikel 13 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004)

| Dato for afgørelser | Lægemidlets navn | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 08.08.2012 | MabCampath | Genzyme Europe B.V. |
| Gooimeer 10, NL-1411 DD Naarden, Nederland |

Dato for afgørelser

Lægemidlets navn

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Dato for notifikation

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

—   Ændring af markedsføringstilladelse (artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004): Godkendt

| Dato for afgørelser | Lægemidlets navn | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 16.08.2012 | Inflacam | Chanelle Pharmaceuticals Manufacturing Limited |
| Loughrea, Co. Galway, IRELAND |

Dato for afgørelser

Lægemidlets navn

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Dato for notifikation

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

Alle interesserede kan ved henvendelse på nedenstående adresse få tilsendt den offentlige evalueringsrapport om de pågældende lægemidler og de afgørelser, der er truffet vedrørende disse:

| 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)  EUT L 136 af 30.4.2004, s. 1.

---

| 28.9.2012 | DA | Den Europæiske Unions Tidende | C 293/9 |
| --- | --- | --- | --- |

28.9.2012

DA

Den Europæiske Unions Tidende

C 293/9

---

Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. august 2012 til 31. august 2012

(Afgørelser truffet i henhold til artikel 34 i direktiv 2001/83/EF
   (1)
  eller artikel 38 i direktiv 2001/82/EF
   (2)
  )

2012/C 293/02

—   Udstedelse, videreførsel eller ændring af en national markedsføringstilladelse

| Dato for afgørelser | Lægemidlets navn/navne | Indehaver/indehavere af markedsføringstilladelsen | Medlemsstat | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 23/8/2012 | Zinnat and associated names | Se bilaget | Se bilaget | 27/8/2012 |

Dato for afgørelser

Lægemidlets navn/navne

Indehaver/indehavere af markedsføringstilladelsen

Medlemsstat

Dato for notifikation

23/8/2012

Zinnat and associated names

Se bilaget

Se bilaget

27/8/2012

---

(1)  EFT L 311 af 28.11.2001, s. 67.

(2)  EFT L 311 af 28.11.2001, s. 1.

---

BILAG

FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORMER, STYRKER, INDGIVELSESVEJE, INDEHAVERE AF MARKEDSFØRINGSTILLADELSER I MEDLEMSSTATERNE

| Medlemsstat
  EU/EAA | Indehaver af markedsføringstilladelsefirmanavn, adresse | Særnavn Navn | Styrke | Lægemiddelform | Indgivelsesvej | Indhold
  (Koncentration) |
| --- | --- | --- | --- | --- | --- | --- |
| Østrig | GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6, |
| A-1140 Wien |
| ØSTRIG |

Medlemsstat

EU/EAA

Indehaver af markedsføringstilladelsefirmanavn, adresse

Særnavn Navn

Styrke

Lægemiddelform

Indgivelsesvej

Indhold

(Koncentration)

Østrig

GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6,

A-1140 Wien

ØSTRIG

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

125 mg/5 ml

Granulat til oral suspension

Oral anvendelse

125 mg/5 ml

Østrig

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

GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6,

A-1140 Wien

ØSTRIG

Zinnat 250 mg - Granulat

250 mg

Granulat

Oral anvendelse

N/A

Østrig

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

GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6,

A-1140 Wien

ØSTRIG

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

250 mg/5 ml

Granulat til oral suspension

Oral anvendelse

250 mg/5 ml

Østrig

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

GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6,

A-1140 Wien

ØSTRIG

Zinnat 250 mg - Filmtabletten

250 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Østrig

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

GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6,

A-1140 Wien

ØSTRIG

Zinnat 500 mg - Filmtabletten

500 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Belgien

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

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

1332 Genval

BELGIEN

Zinnat

250 mg/5 ml

Granulat til oral suspension

Oral anvendelse

250 mg/5 ml

Belgien

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

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

1332 Genval

BELGIEN

Zinnat

250 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Belgien

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

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

1332 Genval

BELGIEN

Zinnat

500 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Bulgarien

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

Zinnat

125 mg/5 ml

Granulat til oral suspension

Oral anvendelse

125 mg/5 ml

Bulgarien

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

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

STORBRITANNIEN

Zinnat

250 mg/5 ml

Granulat til oral suspension

Oral anvendelse

250 mg/5 ml

Bulgarien

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

Zinnat

250 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Bulgarien

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

Zinnat

500 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Cypern

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

Glaxo Group Limited

Berkeley Avenue

Greenford

Middlesex UB6 0NN

STORBRITANNIEN

Zinnat

250 mg/5 ml

Granulat til oral suspension

Oral anvendelse

250 mg/5 ml

Cypern

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

Glaxo Group Limited

Berkeley Avenue

Greenford

Middlesex UB6 0NN

STORBRITANNIEN

Zinnat

250 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Cypern

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

Glaxo Group Limited

Berkeley Avenue

Greenford

Middlesex UB6 0NN

STORBRITANNIEN

Zinnat

500 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Tjekkiet

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

Glaxo Group Ltd.,

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

STORBRITANNIEN

Zinnat 125 mg

125 mg/5 ml

Granulat til oral suspension

Oral anvendelse

125 mg/5 ml

Tjekkiet

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

Glaxo Group Ltd.,

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

STORBRITANNIEN

Zinnat 250 mg

250 mg/5 ml

Granulat til oral suspension

Oral anvendelse

250 mg/5 ml

Tjekkiet

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

Glaxo Group Ltd.,

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

STORBRITANNIEN

Zinnat 125 mg

125 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Tjekkiet

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

Glaxo Group Ltd.,

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

STORBRITANNIEN

Zinnat 250 mg

250 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Tjekkiet

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

Glaxo Group Ltd.,

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

STORBRITANNIEN

Zinnat 500 mg

500 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Danmark

| GlaxoSmithKline Pharma A/S |
| --- |
| Nykær 68, 2605 Brøndby |
| DANMARK |

GlaxoSmithKline Pharma A/S

Nykær 68, 2605 Brøndby

DANMARK

Zinnat

125 mg/5 ml (25 mg/ml)

Granulat til oral suspension

Oral anvendelse

125 mg/5 ml

Danmark

| GlaxoSmithKline Pharma A/S |
| --- |
| Nykær 68, 2605 Brøndby |
| DANMARK |

GlaxoSmithKline Pharma A/S

Nykær 68, 2605 Brøndby

DANMARK

Zinnat

125 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Danmark

| GlaxoSmithKline Pharma A/S |
| --- |
| Nykær 68, 2605 Brøndby |
| DANMARK |

GlaxoSmithKline Pharma A/S

Nykær 68, 2605 Brøndby

DANMARK

Zinnat

250 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Danmark

| GlaxoSmithKline Pharma A/S |
| --- |
| Nykær 68, 2605 Brøndby |
| DANMARK |

GlaxoSmithKline Pharma A/S

Nykær 68, 2605 Brøndby

DANMARK

Zinnat

500 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Estland

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

Glaxo Group Ltd.

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

STORBRITANNIEN

Zinnat

25 mg/1 ml

Granulat til oral suspension

Oral anvendelse

25 mg/1 ml

Estland

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

Glaxo Group Ltd.

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

STORBRITANNIEN

Zinnat

250 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Estland

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

Glaxo Group Ltd.

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

STORBRITANNIEN

Zinnat

500 mg

Filmovertrukne tabletter

Oral anvendelse

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

Granulat til oral suspension

Oral anvendelse

N/A

Finland

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

Zinnat

125 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Finland

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

Zinnat

250 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Frankrig

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

Laboratoire GlaxoSmithKline

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

FRANKRIG

Zinnat 125 mg/5 ml Enfants et Nourrissons

125 mg/5 ml

Granulat til oral suspension

Oral anvendelse

125 mg/5 ml

Frankrig

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

Laboratoire GlaxoSmithKline

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

FRANKRIG

Zinnat

125 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Frankrig

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

Laboratoire GlaxoSmithKline

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

FRANKRIG

Zinnat

250 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Frankrig

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

Laboratoire GlaxoSmithKline

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

FRANKRIG

Zinnat

500 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Frankrig

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

Laboratoire GlaxoSmithKline

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

FRANKRIG

Zinnat 125 mg Enfants et Nourrissons

125 mg

Granulat i breve til oral suspension

Oral anvendelse

N/A

Tyskland

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

GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11

80339 München

TYSKLAND

Zinnat -Trockensaft

125 mg/5 ml (25 mg/ml)

Granulat til oral suspension

Oral anvendelse

125 mg/5 ml

Tyskland

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

GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11

80339 München

TYSKLAND

Zinnat

125 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Tyskland

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

GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11

80339 München

TYSKLAND

Zinnat

250 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Tyskland

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

GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11

80339 München

TYSKLAND

Zinnat

500 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Tyskland

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

GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11

80339 München

TYSKLAND

Elobact 125 mg Dosier-Brief

125 mg

Granulat til oral suspension

Oral anvendelse

N/A

Tyskland

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

GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11

80339 München

TYSKLAND

Elobact Trockensaft

125 mg/5 ml

Granulat til oral suspension

Oral anvendelse

125 mg/5 ml

Tyskland

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

GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11

80339 München

TYSKLAND

Elobact 250 mg Dosier-Brief

250 mg

Granulat til oral suspension

Oral anvendelse

N/A

Tyskland

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

GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11

80339 München

TYSKLAND

Elobact

125 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Tyskland

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

GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11

80339 München

TYSKLAND

Elobact

250 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Tyskland

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

GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11

80339 München

TYSKLAND

Elobact

500 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Grækenland

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

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

152 32 Halandri, Athens

GRÆKENLAND

Zinadol

250 mg/5 ml

Granulat til oral suspension

Oral anvendelse

250 mg/5 ml

Grækenland

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

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

152 32 Halandri, Athens

GRÆKENLAND

Zinadol

250 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Grækenland

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

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

152 32 Halandri, Athens

GRÆKENLAND

Zinadol

500 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Ungarn

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

GlaxoSmithKline Kft.

1124 Bp, Csörsz u. 43.

UNGARN

Zinnat

125 mg/5 ml

Granulat til oral suspension

Oral anvendelse

125 mg/5 ml

Ungarn

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

GlaxoSmithKline Kft.

1124 Bp, Csörsz u. 43.

UNGARN

Zinnat

125 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Ungarn

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

GlaxoSmithKline Kft.

1124 Bp, Csörsz u. 43.

UNGARN

Zinnat

250 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Ungarn

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

GlaxoSmithKline Kft.

1124 Bp, Csörsz u. 43.

UNGARN

Zinnat

500 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Island

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

GlaxoSmithKline ehf.

Thverholt 14

105 Reykjavík.

ISLAND

Zinnat

250 mg/5 ml

(25 mg/ml)

Granulat til oral suspension

Oral anvendelse

250 mg/5 ml

Island

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

GlaxoSmithKline ehf.

Thverholt 14

105 Reykjavík.

ISLAND

Zinnat

250 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Irland

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

GlaxoSmithKline (Ireland) Limited

Stonemasons Way,

Rathfarnham,

Dublin 16

IRLAND

Zinnat

125 mg/5 ml

Granulat til oral suspension

Oral anvendelse

125 mg/5 ml

Irland

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

GlaxoSmithKline (Ireland) Limited

Stonemasons Way,

Rathfarnham,

Dublin 16

IRLAND

Zinnat

250 mg/5 ml

Granulat til oral suspension

Oral anvendelse

250 mg/5 ml

Irland

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

GlaxoSmithKline (Ireland) Limited

Stonemasons Way,

Rathfarnham,

Dublin 16

IRLAND

Zinnat

125 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Irland

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

GlaxoSmithKline (Ireland) Limited

Stonemasons Way,

Rathfarnham,

Dublin 16

IRLAND

Zinnat

500 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Italien

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

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

37135 Verona

ITALIEN

Zinnat

125 mg/5 ml

Granulat til oral suspension

Oral anvendelse

125 mg/5 ml

Italien

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

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

37135 Verona

ITALIEN

Zinnat

250 mg

Granulat til oral suspension

Oral anvendelse

N/A

Italien

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

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

37135 Verona

ITALIEN

Zinnat

250 mg/5 ml

Granulat til oral suspension

Oral anvendelse

250 mg/5 ml

Italien

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

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

37135 Verona

ITALIEN

Zinnat

250 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Italien

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

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

37135 Verona

ITALIEN

Zinnat

500 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Italien

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

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

37135 Verona

ITALIEN

Zoref

125 mg/5 ml

Granulat til oral suspension

Oral anvendelse

125 mg/5 ml

Italien

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

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

37135 Verona

ITALIEN

Zoref

250 mg/5 ml

Granulat til oral suspension

Oral anvendelse

250 mg/5 ml

Italien

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

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

37135 Verona

ITALIEN

Zoref

250 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Italien

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

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

37135 Verona

ITALIEN

Zoref

500 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Italien

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

Malesci Istituto Farmacobiologico S.p.A

Via Lungo l’Ema 7,

50012 Bagno A Ripoli

Firenze

ITALIEN

Oraxim

125 mg/5 ml

Granulat til oral suspension

Oral anvendelse

125 mg/5 ml

Italien

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

Malesci Istituto Farmacobiologico S.p.A

Via Lungo l’Ema 7,

50012 Bagno A Ripoli

Firenze

ITALIEN

Oraxim

250 mg

Granulat til oral suspension

Oral anvendelse

N/A

Italien

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

Malesci Istituto Farmacobiologico S.p.A

Via Lungo l’Ema 7,

50012 Bagno A Ripoli

Firenze

ITALIEN

Oraxim

250 mg/5 ml

Granulat til oral suspension

Oral anvendelse

250 mg/5 ml

Italien

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

Malesci Istituto Farmacobiologico S.p.A

Via Lungo l’Ema 7,

50012 Bagno A Ripoli

Firenze

ITALIEN

Oraxim

250 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Italien

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

Malesci Istituto Farmacobiologico S.p.A

Via Lungo l’Ema 7,

50012 Bagno A Ripoli

Firenze

ITALIEN

Oraxim

500 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Letland

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

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

LETLAND

Zinnat 25 mg/ml granulas iekšķīgi lietojamas suspensijas pagatavošanai

125 mg/5 ml

(25 mg/ml)

Granulat til oral suspension

Oral anvendelse

125 mg/5 ml

Letland

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

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

LETLAND

Zinnat 250 mg apvalkotās tabletes

250 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Letland

| 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

Filmovertrukne tabletter

Oral anvendelse

N/A

Litauen

| UAB »GlaxoSmithKline Lietuva«, |
| --- |
| A. Goštauto g. 40A, |
| LT-01112 Vilnius, LITAUEN |

UAB »GlaxoSmithKline Lietuva«,

A. Goštauto g. 40A,

LT-01112 Vilnius, LITAUEN

Zinnat

125 mg/5 ml

Granulat til oral suspension

Oral anvendelse

125 mg/5 ml

Litauen

| UAB »GlaxoSmithKline Lietuva«, |
| --- |
| A. Goštauto g. 40A, |
| LT-01112 Vilnius, LITAUEN |

UAB »GlaxoSmithKline Lietuva«,

A. Goštauto g. 40A,

LT-01112 Vilnius, LITAUEN

Zinnat

125 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Litauen

| UAB »GlaxoSmithKline Lietuva«, |
| --- |
| A. Goštauto g. 40A, |
| LT-01112 Vilnius, LITAUEN |

UAB »GlaxoSmithKline Lietuva«,

A. Goštauto g. 40A,

LT-01112 Vilnius, LITAUEN

Zinnat

250 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Litauen

| UAB »GlaxoSmithKline Lietuva«, |
| --- |
| A. Goštauto g. 40A, |
| LT-01112 Vilnius, LITAUEN |

UAB »GlaxoSmithKline Lietuva«,

A. Goštauto g. 40A,

LT-01112 Vilnius, LITAUEN

Zinnat

500 mg

Filmovertrukne tabletter

Oral anvendelse

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

Granulat til oral suspension

Oral anvendelse

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

Granulat til oral suspension

Oral anvendelse

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

Granulat til oral suspension

Oral anvendelse

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

Filmovertrukne tabletter

Oral anvendelse

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

Filmovertrukne tabletter

Oral anvendelse

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

Filmovertrukne tabletter

Oral anvendelse

N/A

Malta

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

Zinnat

125 mg/5 ml

Granulat til oral suspension

Oral anvendelse

125 mg/5 ml

Malta

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

Zinnat

250 mg/5 ml

Granulat til oral suspension

Oral anvendelse

250 mg/5 ml

Malta

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

Glaxo Wellcome UK Limited

Glaxo Wellcome House

Berkeley avenue

Greenford, Middlesex

Storbritannien

UB6 0NN

Zinnat

250 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Malta

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

Zinnat

500 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Holland

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

Glaxo Smith Kline B.V.

Huis ter Heideweg 62

3705 LZ ZEIST

HOLLAND

Zinnat

125 mg/5 ml

Granulat til oral suspension

Oral anvendelse

125 mg/5 ml

Holland

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

Glaxo Smith Kline B.V.

Huis ter Heideweg 62

3705 LZ ZEIST

HOLLAND

Zinnat

125 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Holland

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

Glaxo Smith Kline B.V.

Huis ter Heideweg 62

3705 LZ ZEIST

HOLLAND

Zinnat

250 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Holland

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

Glaxo Smith Kline B.V.

Huis ter Heideweg 62

3705 LZ ZEIST

HOLLAND

Zinnat

500 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Poland

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

GlaxoSmithKline Export Ltd

980 Great West Road

Brentford, Middlesex, TW8 9GS

STORBRITANNIEN

Zinnat

125 mg/5 ml

Granulat til oral suspension

Oral anvendelse

125 mg/5 ml

Polen

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

GlaxoSmithKline Export Ltd

980 Great West Road

Brentford, Middlesex, TW8 9GS

STORBRITANNIEN

Zinnat

250 mg

Granulat til oral suspension

Oral anvendelse

N/A

Polen

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

GlaxoSmithKline Export Ltd

980 Great West Road

Brentford, Middlesex, TW8 9GS

STORBRITANNIEN

Zinnat

250 mg/5 ml

Granulat til oral suspension

Oral anvendelse

250 mg/5 ml

Polen

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

GlaxoSmithKline Export Ltd

980 Great West Road

Brentford, Middlesex, TW8 9GS

STORBRITANNIEN

Zinnat

125 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Polen

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

GlaxoSmithKline Export Ltd

980 Great West Road

Brentford, Middlesex, TW8 9GS

STORBRITANNIEN

Zinnat

250 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Polen

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

GlaxoSmithKline Export Ltd

980 Great West Road

Brentford, Middlesex, TW8 9GS

STORBRITANNIEN

Zinnat

500 mg

Filmovertrukne tabletter

Oral anvendelse

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

Granulat til oral suspension

Oral anvendelse

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

Granulat til oral suspension

Oral anvendelse

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

Filmovertrukne tabletter

Oral anvendelse

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

Filmovertrukne tabletter

Oral anvendelse

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

Granulat til oral suspension

Oral anvendelse

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

Granulat til oral suspension

Oral anvendelse

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

Filmovertrukne tabletter

Oral anvendelse

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

Filmovertrukne tabletter

Oral anvendelse

N/A

Rumænien

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

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

STORBRITANNIEN

Zinnat

125 mg/5 ml

Granulat til suspension

Oral anvendelse

125 mg/5 ml

Rumænien

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

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

STORBRITANNIEN

Zinnat

125 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Rumænien

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

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

STORBRITANNIEN

Zinnat

250 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Rumænien

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

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

STORBRITANNIEN

Zinnat

500 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Slovakiet

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

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

Slovakiet

Zinnat 125 mg/5 ml

125 mg/5 ml

Granulat til oral suspension

Oral anvendelse

125 mg/5 ml

Slovakiet

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

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

Slovakiet

Zinnat 250 mg/5 ml

250 mg/5 ml

Granulat til oral suspension

Oral anvendelse

250 mg/5 ml

Slovakiet

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

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

Slovakiet

Zinnat 125 mg

125 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Slovakiet

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

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

Slovakiet

Zinnat 250 mg

250 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Slovakiet

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

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

Slovakiet

Zinnat 500 mg

500 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Slovenien

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

GSK d.o.o., Ljubljana

Cvetkova ulica 29

SI-1000 Ljubljana

SLOVENIEN

Zinnat 125 mg/5 ml zrnca za peroralno suspenzijo

125 mg/5 ml

Granulat til oral suspension

Oral anvendelse

125 mg/5 ml

Slovenien

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

GSK d.o.o., Ljubljana

Cvetkova ulica 29

SI-1000 Ljubljana

SLOVENIEN

Zinnat 250 mg/5 ml zrnca za peroralno suspenzijo

250 mg/5 ml

Granulat til oral suspension

Oral anvendelse

250 mg/5 ml

Slovenien

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

GSK d.o.o., Ljubljana

Cvetkova ulica 29

SI-1000 Ljubljana

SLOVENIEN

Zinnat 250 mg filmsko obložene tablete

250 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Slovenien

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

GSK d.o.o., Ljubljana

Cvetkova ulica 29

SI-1000 Ljubljana

SLOVENIEN

Zinnat 500 mg filmsko obložene tablete

500 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Spanien

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

GlaxoSmithKline, S.A.

Parque Tecnológico de Madrid

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

SPANIEN

ZINNAT 125 mg granulado para suspensión oral en sobres

125 mg

Granulat til oral suspension

Oral anvendelse

N/A

Spanien

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

GlaxoSmithKline, S.A.

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

SPANIEN

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

125 mg/5 ml

Granulat til oral suspension

Oral anvendelse

125 mg/5 ml

Spanien

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

GlaxoSmithKline, S.A.

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

SPANIEN

ZINNAT 250 mg granulado para suspensión oral en sobres

250 mg

Granulat til oral suspension

Oral anvendelse

N/A

Spanien

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

GlaxoSmithKline, S.A.

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

SPANIEN

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

250 mg/5 ml

Granulat til oral suspension

Oral anvendelse

250 mg/5 ml

Spanien

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

GlaxoSmithKline, S.A.

Parque Tecnológico de Madrid

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

SPANIEN

ZINNAT 500 mg granulado para suspensión oral en sobres

500 mg

Granulat til oral suspension

Oral anvendelse

N/A

Spanien

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

GlaxoSmithKline, S.A.

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

SPANIEN

ZINNAT 125 mg comprimidos recubiertos con película

125 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Spanien

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

GlaxoSmithKline, S.A.

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

SPANIEN

ZINNAT 250 mg comprimidos recubiertos con película

250 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Spanien

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

GlaxoSmithKline, S.A.

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

SPANIEN

ZINNAT 500 mg comprimidos recubiertos con película

500 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Spanien

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

GlaxoSmithKline, S.A.

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

SPANIEN

SELAN 125 mg sobres

125 mg

Granulat til oral suspension

Oral anvendelse

N/A

Spanien

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

GlaxoSmithKline, S.A.

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

SPANIEN

SELAN 125 mg suspensión extemporánea

125 mg/5 ml

Granulat til oral suspension

Oral anvendelse

125 mg/5 ml

Spanien

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

GlaxoSmithKline, S.A.

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

SPANIEN

SELAN 250 mg suspensión extemporánea

250 mg/5 ml

Granulat til oral suspension

Oral anvendelse

250 mg/5 ml

Spanien

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

GlaxoSmithKline, S.A.

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

SPANIEN

SELAN 500 mg sobres

500 mg

Granulat til oral suspension

Oral anvendelse

N/A

Spanien

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

GlaxoSmithKline, S.A.

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

SPANIEN

SELAN 125 mg comprimidos

125 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Spanien

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

GlaxoSmithKline, S.A.

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

SPANIEN

SELAN 250 mg comprimidos

250 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Spanien

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

GlaxoSmithKline, S.A.

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

SPANIEN

SELAN 500 mg comprimidos

500 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Spanien

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

Wellcome Farmacéutica, S.A.

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

SPANIEN

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

125 mg

Granulat til oral suspension

Oral anvendelse

N/A

Spanien

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

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

SPANIEN

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

125 mg/5 ml

Granulat til oral suspension

Oral anvendelse

125 mg/5 ml

Spanien

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

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

SPANIEN

NIVADOR 250 mg granulado para suspensión oral en sobres

250 mg

Granulat til oral suspension

Oral anvendelse

N/A

Spanien

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

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

SPANIEN

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

250 mg/5 ml

Granulat til oral suspension

Oral anvendelse

250 mg/5 ml

Spanien

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

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

SPANIEN

NIVADOR 500 mg granulado para suspensión oral en sobres

500 mg

Granulat til oral suspension

Oral anvendelse

N/A

Spanien

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

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

SPANIEN

NIVADOR 250 mg comprimidos recubiertos con película

250 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Spanien

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

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

SPANIEN

NIVADOR 500 mg comprimidos recubiertos con película

500 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Spanien

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

Allen Farmacéutica, S.A.

Parque Tecnológico de Madrid

C/Severo Ochoa, 2

28760 Tres Cantos

(Madrid)

SPANIEN

Cefuroxima Allen 250 mg comprimidos recubiertos con película EFG

250 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Spanien

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

Allen Farmacéutica, S.A.

Parque Tecnológico de Madrid

C/Severo Ochoa, 2

28760 Tres Cantos

(Madrid)

SPANIEN

Cefuroxima Allen 500 mg comprimidos recubiertos con película EFG

500 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Spanien

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

Allen Farmacéutica, S.A.

Parque Tecnológico de Madrid

C/Severo Ochoa, 2

28760 Tres Cantos

(Madrid)

SPANIEN

Cefuroxima Solasma 250 mg comprimidos recubiertos con película EFG

250 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Spanien

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

Allen Farmacéutica, S.A.

Parque Tecnológico de Madrid

C/Severo Ochoa, 2

28760 Tres Cantos

(Madrid)

SPANIEN

Cefuroxima Solasma 500 mg comprimidos recubiertos con película EFG

500 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Sverige

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

GlaxoSmithKline AB

Box 516

169 29 Solna

SVERIGE

Zinnat

25 mg/ml

Granulat til oral suspension

Oral anvendelse

N/A

Sverige

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

GlaxoSmithKline AB

Box 516

169 29 Solna

SVERIGE

Zinnat

250 mg

Filmovertrukne tabletter

Oral anvendelse

N/A

Storbritannien

| 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

Granulat til oral suspension

Oral anvendelse

125 mg/5 ml

Storbritannien

| 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

Granulat til oral suspension

Oral anvendelse

250 mg/5 ml

Storbritannien

| 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

Filmovertrukne tabletter

Oral anvendelse

N/A

Storbritannien

| 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

Filmovertrukne tabletter

Oral anvendelse

N/A

Storbritannien

| 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

Filmovertrukne tabletter

Oral anvendelse

N/A

---