# Den Europæiske Unions C 61/2011

| | ISSN 1725-2393
  doi:10.3000/17252393.C_2011.061.dan |
| --- | --- |
| Den Europæiske Unions
  Tidende | C 61 |
| | |
| Dansk udgave | Meddelelser og oplysninger | 54. årgang25. februar 2011 |

ISSN 1725-2393

doi:10.3000/17252393.C_2011.061.dan

Den Europæiske Unions

Tidende

C 61

Dansk udgave

Meddelelser og oplysninger

54. årgang25. februar 2011

---

| Informationsnummer | Indhold | Side |
| --- | --- | --- |
| | IV   Oplysninger |
| | OPLYSNINGER FRA DEN EUROPÆISKE UNIONS INSTITUTIONER, ORGANER, KONTORER OG AGENTURER |
| | Europa-Kommissionen |
| 2011/C 061/01 | Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. november 2010 til 31. december 2010(Offentliggjort i henhold til artikel 13 eller artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004
  ) | 1 |
| 2011/C 061/02 | Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. november 2010 til 31. december 2010(Afgørelser truffet i henhold til artikel 34 i direktiv 2001/83/EF
  eller artikel 38 i direktiv 2001/82/EF
  ) | 18 |

Informationsnummer

Indhold

Side

IV   Oplysninger

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

Europa-Kommissionen

2011/C 061/01

Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. november 2010 til 31. december 2010(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

2011/C 061/02

Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. november 2010 til 31. december 2010(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

)

18

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

DA

---

IV Oplysninger

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

Europa-Kommissionen

| 25.2.2011 | DA | Den Europæiske Unions Tidende | C 61/1 |
| --- | --- | --- | --- |

25.2.2011

DA

Den Europæiske Unions Tidende

C 61/1

---

Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. november 2010 til 31. december 2010

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

2011/C 61/01

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

| Dato for beslutningen | 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 29.11.2010 | Aflunov | Præpandemisk influenzavaccine (H5N1) (overfladeantigen, inaktiveret, adjuveret). | Novartis Vaccines and Diagnostics S.r.l. |
| Via Fiorentina, 1, |
| 53100 Siena, |
| Italia |

Dato for beslutningen

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

29.11.2010

Aflunov

Præpandemisk influenzavaccine (H5N1) (overfladeantigen, inaktiveret, adjuveret).

Novartis Vaccines and Diagnostics S.r.l.

Via Fiorentina, 1,

53100 Siena,

Italia

EU/1/10/658/001-002

Suspension til injektion

J07BB02

3.12.2010

29.11.2010

Leflunomide ratiopharm

leflunomid

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

ratiopharm GmbH

Graf-Arco-Straße 3,

D-89079 Ulm,

Deutschland

EU/1/10/654/001-004

Filmovertrukket tablet

L04AA13

6.12.2010

29.11.2010

Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostic

Præpandemisk influenzavaccine (H5N1) (overfladeantigen, inaktiveret, adjuveret).

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

Novartis Vaccines and Diagnostics S.r.l.

Via Fiorentina, 1,

53100 Siena,

Italia

EU/1/10/657/001-002

Suspension til injektion

J07BB02

3.12.2010

3.12.2010

Brilique

ticagrelor

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

AstraZeneca AB

Södertälje S 151 85,

Sverige

EU/1/10/655/001-006

Filmovertrukket tablet

B01AC24

7.12.2010

3.12.2010

Possia

ticagrelor

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

AstraZeneca AB

Södertälje S 151 85,

Sverige

EU/1/10/656/001-006

Filmovertrukket tablet

B01AC24

7.12.2010

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

| Dato for beslutningen | Lægemidlets navn | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 3.11.2010 | Actraphane | Novo Nordisk A/S |
| Novo Allé, DK-2880 Bagsvaerd, |
| Danmark |

Dato for beslutningen

Lægemidlets navn

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Dato for notifikation

3.11.2010

Actraphane

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd,

Danmark

EU/1/02/229/001-037

8.11.2010

3.11.2010

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

9.11.2010

3.11.2010

Bridion

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

N.V. Organon

Kloosterstraat 6, 5349 AB Oss,

Nederland

EU/1/08/466/001-002

9.11.2010

3.11.2010

Combivir

| 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/1/98/058/001-002

9.11.2010

3.11.2010

Doribax

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

Janssen-Cilag International NV

Turnhoutseweg, 30 - 2340 Beerse - België

EU/1/08/467/001-002

9.11.2010

3.11.2010

Effentora

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

Cephalon Europe

5 Rue Charles Martigny,

Maisons-Alfort 94700,

France

EU/1/08/441/001-010

9.11.2010

3.11.2010

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

5.11.2010

3.11.2010

Enyglid

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

KRKA, d. d., Novo mesto

Šmarješka cesta 6,

8501 Novo mesto,

Slovenija

EU/1/09/580/001-021

9.11.2010

3.11.2010

Filgrastim Hexal

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

HEXAL AG

Industriestrasse 25,

D-83607 Holzkirchen,

Deutschland

EU/1/08/496/001-016

9.11.2010

3.11.2010

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

5.11.2010

3.11.2010

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

8.11.2010

3.11.2010

Norvir

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

Abbott Laboratories Ltd

Abbott House, Vanwall Business Park, Vanwall Road,

Maidenhead,

Berkshire SL6 4XE,

United Kingdom

EU/1/96/016/001

EU/1/96/016/003-007

8.11.2010

3.11.2010

Olanzapine Mylan

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

Generics [UK] Limited

Station Close, Potters Bar,

Hertfordshire, EN6 1TL,

United Kingdom

EU/1/08/475/001-034

9.11.2010

3.11.2010

Rasilez

| 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/1/07/405/001-040

9.11.2010

3.11.2010

Rasilez 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/1/08/491/001-080

5.11.2010

3.11.2010

Riprazo

| 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/1/07/409/001-020

9.11.2010

3.11.2010

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

9.11.2010

3.11.2010

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

9.11.2010

3.11.2010

Rotarix

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

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89,

Rixensart,

B-1330 Belgique

EU/1/05/330/001-011

8.11.2010

3.11.2010

Stocrin

| 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/1/99/111/001-005

EU/1/99/111/008-011

9.11.2010

3.11.2010

Sustiva

| 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/1/99/110/001-005

EU/1/99/110/008-010

9.11.2010

3.11.2010

Tesavel

| 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/1/07/435/001-018

8.11.2010

3.11.2010

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

9.11.2010

3.11.2010

Xelevia

| 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/1/07/382/001-018

8.11.2010

3.11.2010

Zarzio

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

Sandoz GmbH

Biochemiestrasse 10,

A-6250 Kundl,

Österreich

EU/1/08/495/001-016

9.11.2010

5.11.2010

Abilify

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

Otsuka Pharmaceutical Europe Ltd

Hunton House, Highbridge Business Park,

Oxford Road, Uxbridge,

Middlesex UB8 1HU,

United Kingdom

EU/1/04/276/001-020

EU/1/04/276/024-036

9.11.2010

5.11.2010

Diacomit

| Biocodex |
| --- |
| 7 avenue Gallieni, |
| 94250 Gentilly, |
| France |

Biocodex

7 avenue Gallieni,

94250 Gentilly,

France

EU/1/06/367/001-012

9.11.2010

5.11.2010

Erbitux

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

Merck KGaA

Frankfurter Straße 250,

64271 Darmstadt,

Deutschland

EU/1/04/281/001-005

9.11.2010

5.11.2010

Irbesartan Winthrop

| SANOFI PHARMA BRISTOL MYERS SQUIBB SNC |
| --- |
| 174 avenue de France, |
| F- 75013 Paris, |
| France |

SANOFI PHARMA BRISTOL MYERS SQUIBB SNC

174 avenue de France,

F- 75013 Paris,

France

EU/1/06/376/001-033

9.11.2010

5.11.2010

Torisel

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

Wyeth Europa Ltd

Huntercombe Lane South, Taplow,

Maidenhead,

Berkshire SL6 0PH,

United Kingdom

EU/1/07/424/001

9.11.2010

5.11.2010

Twinrix Paediatric

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

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89,

Rixensart,

B-1330 Belgique

EU/1/97/029/001-010

9.11.2010

12.11.2010

Kentera

| Nicobrand Limited |
| --- |
| 189 Castleroe Road, |
| Coleraine, |
| Northern Ireland BT51 3 RP |

Nicobrand Limited

189 Castleroe Road,

Coleraine,

Northern Ireland BT51 3 RP

EU/1/03/270/001-003

16.11.2010

12.11.2010

Xolair

| 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/1/05/319/001-010

16.11.2010

19.11.2010

Qutenza

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

Astellas Pharma Europe B.V.

Elisabethhof 19,

2353 EW Leiderdorp,

Nederland

EU/1/09/524/001-002

23.11.2010

26.11.2010

Ambirix

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

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89,

Rixensart,

B-1330 Belgique

EU/1/02/224/001-005

1.12.2010

26.11.2010

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

1.12.2010

26.11.2010

Cancidas

| 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/1/01/196/001

EU/1/01/196/003

1.12.2010

26.11.2010

Circadin

| RAD Neurim Pharmaceuticals EEC Limited |
| --- |
| One Forbury Square, The Forbury, |
| Reading, |
| Berkshire RG1 3EB, |
| United Kingdom |

RAD Neurim Pharmaceuticals EEC Limited

One Forbury Square, The Forbury,

Reading,

Berkshire RG1 3EB,

United Kingdom

EU/1/07/392/001-002

2.12.2010

26.11.2010

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

1.12.2010

26.11.2010

Enbrel

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

Wyeth Europa Limited

Huntercombe Lane South, Taplow,

Maidenhead,

Berkshire, SL6 0PH,

United Kingdom

EU/1/99/126/001-021

1.12.2010

26.11.2010

Iressa

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

AstraZeneca AB

Sodertalje S 151 85,

Sverige

EU/1/09/526/001-002

1.12.2010

26.11.2010

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

1.12.2010

26.11.2010

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

1.12.2010

26.11.2010

Livensa

| Warner Chilcott Deutschland Gmbh |
| --- |
| Dr.-Otto-Röhm-Strasse 2-4, |
| Weiterstadt 64331, |
| Deutschland |

Warner Chilcott Deutschland Gmbh

Dr.-Otto-Röhm-Strasse 2-4,

Weiterstadt 64331,

Deutschland

EU/1/06/351/001-003

1.12.2010

26.11.2010

Nexavar

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

Bayer Schering Pharma AG

13342 Berlin,

Deutschland

EU/1/06/342/001

1.12.2010

26.11.2010

Nplate

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

Amgen Europe B.V.

Minervum 7061,

4817 ZK Breda,

Nederland

EU/1/08/497/001-008

1.12.2010

26.11.2010

Prevenar 13

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

Wyeth Lederle Vaccines S.A.

Rue du Bosquet, 15,

B-1348 Louvain-la-Neuve,

Belgium

EU/1/09/590/001-006

1.12.2010

26.11.2010

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

1.12.2010

26.11.2010

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

1.12.2010

26.11.2010

Tamiflu

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

Roche Registration Limited

6 Falcon Way,

Shire Park,

Welwyn Garden City, AL7 1TW,

United Kingdom

EU/1/02/222/001-004

1.12.2010

26.11.2010

Temozolomide Teva

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

Teva Pharma B.V.

Computerweg 10,

DR Utrecht 3542,

Nederland

EU/1/09/606/001-012

1.12.2010

26.11.2010

Thalidomide Celgene

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

Celgene Europe Limited

Riverside House, Riverside Walk,

Windsor SL4 1NA,

United Kingdom

EU/1/08/443/001

1.12.2010

26.11.2010

Truvada

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

Gilead Sciences International Limited

Cambridge CB21 6GT

United Kingdom

EU/1/04/305/001-002

1.12.2010

26.11.2010

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

1.12.2010

26.11.2010

Xagrid

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

Shire Pharmaceutical Contracts Ltd

Hampshire International Business Park, Chineham,

Basingstoke,

Hampshire RG24 8EP,

United Kingdom

EU/1/04/295/001

1.12.2010

26.11.2010

Xelevia

| 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/1/07/382/001-018

1.12.2010

26.11.2010

Zeffix

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

Glaxo Group Ltd.

Greenford Road,

Greenford,

Middlesex UB6 0NN,

United Kingdom

EU/1/99/114/001-003

1.12.2010

29.11.2010

Adrovance

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

Merck Sharp & Dohme Ltd

Hertford Road,

Hoddesdon,

Hertfordshire EN11 9BU,

United Kingdom

EU/1/06/364/001-009

6.12.2010

29.11.2010

alli

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

Glaxo Group Limited

Berkeley Avenue,

Greenford,

Middlesex UB6 0NN,

United Kingdom

EU/1/07/401/007-015

3.12.2010

29.11.2010

Atriance

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

Glaxo Group Limited

Berkeley Avenue,

Greenford,

Middlesex UB6 0NN,

United Kingdom

EU/1/07/403/001

3.12.2010

29.11.2010

Cimzia

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

UCB Pharma SA.

Allée de la Recherche 60,

1070 Bruxelles,

Belgique/Researchdreef, 60,

Brussel 1070,

België

EU/1/09/544/001-002

2.12.2010

29.11.2010

Corlentor

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

Les Laboratoires Servier

22, rue Garnier,

92200 Neuilly-sur-Seine,

France

EU/1/05/317/001-014

2.12.2010

29.11.2010

Cubicin

| 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/1/05/328/001-004

6.12.2010

29.11.2010

DepoCyte

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

Pacira Limited

3 Glory Park Avenue, Wooburn Green,

High Wycombe,

Buckinghamshire, HP10 0DF,

United Kingdom

EU/1/01/187/001

18.1.2011

29.11.2010

Exalief

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

BIAL - Portela & Ca, SA

A Av. da Siderurgia Nacional

4745-457 S. Mamede do Coronado - Portugal

EU/1/09/520/001-020

2.12.2010

29.11.2010

Fertavid

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

SP Europe

Rue de Stalle, 73,

1180 Bruxelles,

Belgique - Stallestraat,

73 - 1180 Brussel,

België

EU/1/09/510/001-019

6.12.2010

29.11.2010

Fosavance

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

Merck Sharp & Dohme Ltd

Hertford Road,

Hoddesdon,

Hertfordshire EN11 9BU,

United Kingdom

EU/1/05/310/001-009

1.12.2010

29.11.2010

Intelence

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

Janssen-Cilag International NV

Turnhoutseweg, 30 - 2340 Beerse - België

EU/1/08/468/001

2.12.2010

29.11.2010

Intelence

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

Janssen-Cilag International NV

Turnhoutseweg, 30 - 2340 Beerse - België

EU/1/08/468/001

2.12.2010

29.11.2010

Neupro

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

Schwarz Pharma Ltd

Shannon, Industrial Estate,

Co.Clare,

Ireland

EU/1/05/331/001-055

2.12.2010

29.11.2010

NeuroBloc

| 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/1/00/166/001-003

2.12.2010

29.11.2010

PREZISTA

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

Janssen-Cilag International NV

Turnhoutseweg, 30 - 2340 Beerse - België

EU/1/06/380/001-005

2.12.2010

29.11.2010

Procoralan

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

Les Laboratoires Servier

22, rue Garnier,

92200 Neuilly-sur-Seine,

France

EU/1/05/316/001-014

2.12.2010

29.11.2010

Puregon

| Organon N.V. |
| --- |
| Kloosterstraat 6, Postbus 20, |
| 5340 BH Oss, |
| Nederland |

Organon N.V.

Kloosterstraat 6, Postbus 20,

5340 BH Oss,

Nederland

EU/1/96/008/001-041

6.12.2010

29.11.2010

Remicade

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

Centocor B.V.

Einsteinweg 101,

2333 CB Leiden,

Nederland

EU/1/99/116/001-005

6.12.2010

29.11.2010

Sebivo

| 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/1/07/388/001-003

6.12.2010

29.11.2010

Sildenafil Teva

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

Teva Pharma B.V.

Computerweg 10,

3542 DR Utrecht,

Nederland

EU/1/09/584/001-018

2.12.2010

29.11.2010

Sutent

| Pfizer Ltd |
| --- |
| Ramsgate Road, |
| Sandwich, |
| Kent CT 13 0NJ, |
| United Kingdom |

Pfizer Ltd

Ramsgate Road,

Sandwich,

Kent CT 13 0NJ,

United Kingdom

EU/1/06/347/001-008

3.12.2010

29.11.2010

Travatan

| Alcon Laboratories (UK) Ltd. |
| --- |
| Boundary Way, |
| Hemel Hempstead, |
| Herts HP2 7UD, |
| United Kingdom |

Alcon Laboratories (UK) Ltd.

Boundary Way,

Hemel Hempstead,

Herts HP2 7UD,

United Kingdom

EU/1/01/199/001-002

2.12.2010

29.11.2010

Trizivir

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

ViiV Healthcare UK Limited

980 Great West Road,

Brentford,

Middlesex, TW8 9GS,

United Kingdom

EU/1/00/156/002-004

2.12.2010

29.11.2010

Tysabri

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

Elan Pharma International Ltd.

Monksland,

Athlone,

County Westmeath,

Ireland

EU/1/06/346/001

2.12.2010

29.11.2010

Vantavo

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

Merck Sharp & Dohme Ltd.

Hertford Road,

Hoddesdon,

Hertfordshire EN11 9BU,

United Kingdom

EU/1/09/572/001-009

2.12.2010

29.11.2010

Vfend

| Pfizer Ltd |
| --- |
| Ramsgate Road, |
| Sandwich, |
| Kent CT 13 0NJ, |
| United Kingdom |

Pfizer Ltd

Ramsgate Road,

Sandwich,

Kent CT 13 0NJ,

United Kingdom

EU/1/02/212/001-026

6.12.2010

29.11.2010

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

2.12.2010

3.12.2010

Aranesp

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

Amgen Europe B.V.

Minervum 7061,

NL-4817 ZK Breda,

Nederland

EU/1/01/185/001-022

EU/1/01/185/031-099

7.12.2010

3.12.2010

Orencia

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

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park,

Sanderson Road,

Uxbridge UB8 1DH,

United Kingdom

EU/1/07/389/001-003

7.12.2010

3.12.2010

Tesavel

| 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/1/07/435/001-018

7.12.2010

3.12.2010

Zerit

| 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/1/96/009/001-009

7.12.2010

6.12.2010

Ilaris

| 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/1/09/564/001-002

8.12.2010

6.12.2010

Kiovig

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

Baxter AG

Industriestraße 67,

A - 1221 Wien,

Österreich

EU/1/05/329/001-006

9.12.2010

6.12.2010

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

8.12.2010

13.12.2010

Diacomit

| Biocodex |
| --- |
| 7 avenue Gallieni, |
| 94250 Gentilly, |
| France |

Biocodex

7 avenue Gallieni,

94250 Gentilly,

France

EU/1/06/367/001-012

15.12.2010

13.12.2010

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

15.12.2010

13.12.2010

Invega

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

Janssen-Cilag International NV

Turnhoutseweg, 30 - 2340 Beerse - België

EU/1/07/395/001-095

15.12.2010

13.12.2010

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

15.12.2010

13.12.2010

Revlimid

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

Celgene Europe Limited

Riverside House, Riverside Walk, Windsor,

Berkshire SL4 1NA,

United Kingdom

EU/1/07/391/001-004

15.12.2010

13.12.2010

Sifrol

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

Boehringer Ingelheim International GmbH

Binger Strasse 173,

D-55216 Ingelheim am Rhein,

Deutschland

EU/1/97/050/001-006

EU/1/97/050/009-033

15.12.2010

13.12.2010

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

15.12.2010

13.12.2010

Velcade

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

Janssen-Cilag International NV

Turnhoutseweg 30,

B-2340 Beerse,

België

EU/1/04/274/001-002

15.12.2010

17.12.2010

Revlimid

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

Celgene Europe Limited

Riverside House, Riverside Walk,

Windsor,

Berkshire SL4 1NA,

United Kingdom

EU/1/07/391/001-004

22.12.2010

20.12.2010

Aloxi

| Helsinn Birex Pharmaceuticals Ltd |
| --- |
| Damastown, |
| Mulhuddart, Dublin 15, |
| Republic of Ireland |

Helsinn Birex Pharmaceuticals Ltd

Damastown,

Mulhuddart, Dublin 15,

Republic of Ireland

EU/1/04/306/001-003

4.1.2011

20.12.2010

Aranesp

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

Amgen Europe B.V.

Minervum 7061,

NL-4817 ZK Breda,

Nederland

EU/1/01/185/001-022

EU/1/01/185/031-099

23.12.2010

20.12.2010

Atripla

| Bristol-Myers Squibb and Gilead Sciences Limited |
| --- |
| IDA Business & Technology Park, |
| Carrigtohill, Co. Cork, |
| Ireland |

Bristol-Myers Squibb and Gilead Sciences Limited

IDA Business & Technology Park,

Carrigtohill, Co. Cork,

Ireland

EU/1/07/430/001-002

23.12.2010

20.12.2010

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

23.12.2010

20.12.2010

Celsentri

| 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/1/07/418/001-010

23.12.2010

20.12.2010

Champix

| Pfizer Ltd |
| --- |
| Ramsgate Road, |
| Sandwich, |
| Kent CT 13 0NJ, |
| United Kingdom |

Pfizer Ltd

Ramsgate Road,

Sandwich,

Kent CT 13 0NJ,

United Kingdom

EU/1/06/360/001-013

23.12.2010

20.12.2010

Conbriza

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

Wyeth Europa Limited

Huntercombe Lane South, Taplow,

Maidenhead,

Berkshire, SL6 0PH,

United Kingdom

EU/1/09/511/001-004

23.12.2010

20.12.2010

DuoCover

| 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/1/10/623/001-015

23.12.2010

20.12.2010

DuoPlavin

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

Sanofi Pharma Bristol-Myers Squibb SNC

174 Avenue de France,

F-75013 Paris,

France

EU/1/10/619/001-015

23.12.2010

20.12.2010

Emselex

| 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/1/04/294/001-028

23.12.2010

20.12.2010

Exjade

| 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/1/06/356/001-009

23.12.2010

20.12.2010

Glivec

| 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/1/01/198/001-013

23.12.2010

20.12.2010

Helixate NexGen

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

Bayer Schering Pharma AG

13342 Berlin,

Deutschland

EU/1/00/144/001-005

23.12.2010

20.12.2010

Javlor

| Pierre Fabre Médicament |
| --- |
| 45, place Abel Gance, |
| F-92100 Boulogne, |
| France |

Pierre Fabre Médicament

45, place Abel Gance,

F-92100 Boulogne,

France

EU/1/09/550/001-012

23.12.2010

20.12.2010

Kogenate Bayer

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

Bayer Schering Pharma AG

13342 Berlin,

Deutschland

EU/1/00/143/004-013

23.12.2010

20.12.2010

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

23.12.2010

20.12.2010

Macugen

| Pfizer Ltd |
| --- |
| Ramsgate Road, |
| Sandwich, |
| Kent CT 13 0NJ, |
| United Kingdom |

Pfizer Ltd

Ramsgate Road,

Sandwich,

Kent CT 13 0NJ,

United Kingdom

EU/1/05/325/002

23.12.2010

20.12.2010

Mirapexin

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

Boehringer Ingelheim International GmbH

Binger Strasse 173-

D - 55216 Ingelheim am Rhein,

Deutschland

EU/1/97/051/001-006

EU/1/97/051/009-033

23.12.2010

20.12.2010

Mycamine

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

Astellas Pharma Europe B.V.

Elisabethhof 19,

2353 EW Leiderdorp,

Nederland

EU/1/08/448/001-002

23.12.2010

20.12.2010

Naglazyme

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

BioMarin Europe Ltd

164 Shaftesbury Avenue,

London WC2H 8HL,

United Kingdom

EU/1/05/324/001-002

22.12.2010

20.12.2010

Optison

| GE Healthcare AS |
| --- |
| Nycoveien 1-2, P.O.Box 4220 Nydalen, |
| N-0401 OSLO, |
| Norway |

GE Healthcare AS

Nycoveien 1-2, P.O.Box 4220 Nydalen,

N-0401 OSLO,

Norway

EU/1/98/065/001-002

22.12.2010

20.12.2010

Pelzont

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

Merck Sharp & Dohme Ltd

Hertford Road,

Hoddesdon,

Hertfordshire EN11 9BU,

United Kingdom

EU/1/08/460/001-014

23.12.2010

20.12.2010

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/1/08/442/001-008

23.12.2010

20.12.2010

RoActemra

| 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/1/08/492/001-006

23.12.2010

20.12.2010

Stelara

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

Janssen-Cilag International NV

Turnhoutseweg, 30 - 2340 Beerse - België

EU/1/08/494/001-004

23.12.2010

20.12.2010

Sutent

| Pfizer Ltd |
| --- |
| Ramsgate Road, |
| Sandwich, |
| Kent CT 13 0NJ, |
| United Kingdom |

Pfizer Ltd

Ramsgate Road,

Sandwich,

Kent CT 13 0NJ,

United Kingdom

EU/1/06/347/001-008

23.12.2010

20.12.2010

Tamiflu

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

Roche Registration Limited

6 Falcon Way,

Shire Park,

Welwyn Garden City, AL7 1TW,

United Kingdom

EU/1/02/222/001-004

23.12.2010

20.12.2010

Tasigna

| 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/1/07/422/001-006

23.12.2010

20.12.2010

Tasigna

| 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/1/07/422/001-006

23.12.2010

20.12.2010

Thalidomide Celgene

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

Celgene Europe Limited

Riverside House, Riverside Walk,

Windsor SL4 1NA,

United Kingdom

EU/1/08/443/001

23.12.2010

20.12.2010

Tredaptive

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

Merck Sharp & Dohme Ltd

Hertford Road,

Hoddesdon,

Hertfordshire EN11 9BU,

United Kingdom

EU/1/08/459/001-014

23.12.2010

20.12.2010

Trevaclyn

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

Merck Sharp & Dohme Ltd

Hertford Road,

Hoddesdon,

Hertfordshire EN11 9BU,

United Kingdom

EU/1/08/458/001-014

23.12.2010

20.12.2010

Ventavis

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178, |
| D - 13342 Berlin, |
| Deutschland |

Bayer Schering Pharma AG

Müllerstrasse 170-178,

D - 13342 Berlin,

Deutschland

EU/1/03/255/001-008

23.12.2010

20.12.2010

Vfend

| Pfizer Ltd |
| --- |
| Ramsgate Road, |
| Sandwich, |
| Kent CT 13 0NJ, |
| United Kingdom |

Pfizer Ltd

Ramsgate Road,

Sandwich,

Kent CT 13 0NJ,

United Kingdom

EU/1/02/212/001-026

23.12.2010

20.12.2010

Victoza

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

Novo Nordisk A/S

Novo Allé,

DK-2880 Bagsvaerd,

Danmark

EU/1/09/529/001-005

27.12.2010

20.12.2010

Zostavax

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

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk,

69007 Lyon,

France

EU/1/06/341/001-013

22.12.2010

20.12.2010

Zyprexa

| 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/1/96/022/002

EU/1/96/022/004

EU/1/96/022/006

EU/1/96/022/009-012

EU/1/96/022/014

EU/1/96/022/016-017

EU/1/96/022/019-040

23.12.2010

20.12.2010

Zyprexa Velotab

| 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/1/99/125/017-020

23.12.2010

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

| Dato for beslutningen | Lægemidlets navn | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 13.12.2010 | Arepanrix | GlaxoSmithKline Biologicals S.A. |
| rue de l'Institut 89, |
| 1330 Rixensart, |
| Belgique |

Dato for beslutningen

Lægemidlets navn

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Dato for notifikation

13.12.2010

Arepanrix

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89,

1330 Rixensart,

Belgique

EU/1/10/624/001

15.12.2010

—   Suspension af markedsføringstilladelse (artikel 20 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004)

| Dato for beslutningen | Lægemidlets navn | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 3.12.2010 | Avaglim | SmithKline Beecham Ltd. |
| 980 Great West Road, |
| Brentford, |
| Middlesex, TW8 9GS |
| United Kingdom |

Dato for beslutningen

Lægemidlets navn

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Dato for notifikation

3.12.2010

Avaglim

SmithKline Beecham Ltd.

980 Great West Road,

Brentford,

Middlesex, TW8 9GS

United Kingdom

EU/1/06/349/001-010

7.12.2010

3.12.2010

Avandamet

| SmithKline Beecham Ltd. |
| --- |
| 980 Great West Road, |
| Brentford, |
| Middlesex, TW8 9GS |
| United Kingdom |

SmithKline Beecham Ltd.

980 Great West Road,

Brentford,

Middlesex, TW8 9GS

United Kingdom

EU/1/03/258/001-022

7.12.2010

3.12.2010

Avandia

| SmithKline Beecham Ltd. |
| --- |
| 980 Great West Road, |
| Brentford, |
| Middlesex, TW8 9GS |
| United Kingdom |

SmithKline Beecham Ltd.

980 Great West Road,

Brentford,

Middlesex, TW8 9GS

United Kingdom

EU/1/00/137/002-018

7.12.2010

—   Udstedelse af markedsføringstilladelse (artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004
   (2)
  ): Godkendt

| Dato for beslutningen | 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 5.11.2010 | BTVPUR AlSap 2-4 | Bluetonguevirus serotype 2 antigen - Bluetonguevirus serotype 4 antigen | MERIAL |
| 29 avenue Tony Garnier, |
| 69007 LYON, |
| France |

Dato for beslutningen

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

5.11.2010

BTVPUR AlSap 2-4

Bluetonguevirus serotype 2 antigen - Bluetonguevirus serotype 4 antigen

MERIAL

29 avenue Tony Garnier,

69007 LYON,

France

EU/2/10/108/001-005

Suspension til injektion

QI02AA08

QI04AA02

9.11.2010

19.11.2010

Meloxoral

Meloxicam

| Le Vet B.V. |
| --- |
| Wilgenweg 7, |
| 3421 TV Oudewater, |
| Nederland |

Le Vet B.V.

Wilgenweg 7,

3421 TV Oudewater,

Nederland

EU/2/10/111/001-004

Oral suspension

QM01AC06

23.11.2010

17.12.2010

BTVPUR AlSap 1

Bluetonguevirus serotype 1 antigen

| MERIAL |
| --- |
| 29 avenue Tony Garnier, |
| 69007 LYON, |
| France |

MERIAL

29 avenue Tony Garnier,

69007 LYON,

France

EU/2/10/112/001-005

Suspension til injektion

QI02AA08

QI04AA02

22.12.2010

17.12.2010

BTVPUR AlSap 1-8

Bluetonguevirus serotype 1 antigen - Bluetonguevirus serotype 8 antigen

| MERIAL |
| --- |
| 29 avenue Tony Garnier, |
| 69007 LYON, |
| France |

MERIAL

29 avenue Tony Garnier,

69007 LYON,

France

EU/2/10/113/001-005

Suspension til injektion

QI02AA08

QI04AA02

22.12.2010

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

| Dato for beslutningen | Lægemidlets navn | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 3.11.2010 | Melovem | Dopharma Research B.V. |
| Zalmweg 24, |
| 4941 VX Raamsdonksveer, |
| Nederland |

Dato for beslutningen

Lægemidlets navn

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Dato for notifikation

3.11.2010

Melovem

Dopharma Research B.V.

Zalmweg 24,

4941 VX Raamsdonksveer,

Nederland

EU/2/09/098/001

8.11.2010

26.11.2010

ProMeris

| Fort Dodge Animal Health Holland |
| --- |
| C.J. van Houtenlaan 36, |
| 1381 CP Weesp, |
| Nederland |

Fort Dodge Animal Health Holland

C.J. van Houtenlaan 36,

1381 CP Weesp,

Nederland

EU/2/06/064/001-004

3.12.2010

26.11.2010

ProMeris Duo

| Fort Dodge Animal Health Holland |
| --- |
| C.J. van Houtenlaan 36, |
| 1381 CP Weesp, |
| Nederland |

Fort Dodge Animal Health Holland

C.J. van Houtenlaan 36,

1381 CP Weesp,

Nederland

EU/2/06/065/001-010

3.12.2010

29.11.2010

Circovac

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

Merial

29 Avenue Tony Garnier,

69007 Lyon,

France

EU/2/07/075/001-004

3.12.2010

3.12.2010

Masivet

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

AB Science S.A.

3 avenue George V,

75008 Paris,

France

EU/2/08/087/001-002

7.12.2010

13.12.2010

Poulvac FluFend H5N3 RG

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

Fort Dodge Animal Health Ltd

Flanders Road, Hedge End,

Southampton SO30 4QH,

United Kingdom

EU/2/06/060/001-002

15.12.2010

20.12.2010

Improvac

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

Pfizer Limited

Ramsgate Road,

Sandwich,

Kent CT13 9NJ,

United Kingdom

EU/2/09/095/001-006

23.12.2010

20.12.2010

Metacam

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

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim am Rhein,

Deutschland

EU/2/97/004/001

EU/2/97/004/003-048

23.12.2010

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.

(2)  EUT L 136 af 30.4.2004, s. 1.

---

| 25.2.2011 | DA | Den Europæiske Unions Tidende | C 61/18 |
| --- | --- | --- | --- |

25.2.2011

DA

Den Europæiske Unions Tidende

C 61/18

---

Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. november 2010 til 31. december 2010

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

2011/C 61/02

—   Udstedelse, videreførsel eller ændring af en national markedsføringstilladelse

| Dato for beslutningen | Lægemidlets navn/navne | Indehaver/indehavere af markedsføringstilladelsen | Medlemsstat | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 13.12.2010 | Lipitor and associated names | Se bilaget I | Se bilaget I | 14.12.2010 |
| 3.12.2010 | Prevora | Se bilaget II | Se bilaget II | 6.12.2010 |
| 29.11.2010 | Leflunomide ratiopharm | Ratiopharm GmbH, |
| Graf-Arco-Straße |
| 3, D-89079 Ulm, |
| Deutschland |

Dato for beslutningen

Lægemidlets navn/navne

Indehaver/indehavere af markedsføringstilladelsen

Medlemsstat

Dato for notifikation

13.12.2010

Lipitor and associated names

Se bilaget I

Se bilaget I

14.12.2010

3.12.2010

Prevora

Se bilaget II

Se bilaget II

6.12.2010

29.11.2010

Leflunomide ratiopharm

Ratiopharm GmbH,

Graf-Arco-Straße

3, D-89079 Ulm,

Deutschland

Disse beslutninger er rettet til medlemsstaterne

1.12.2010

13.12.2010

Revlimid

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

Celgene Europe Limited,

Riverside House,

Riverside Walk, Windsor,

Berkshire SL4 1NA,

United Kingdom

Disse beslutninger er rettet til medlemsstaterne

14.12.2010

—   Suspension af en national markedsføringstilladelse

| Dato for beslutningen | Lægemidlets navn/navne | Indehaver/indehavere af markedsføringstilladelsen | Medlemsstat | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 29.11.2010 | Ketoprofen containing topical products | Se bilaget III | Se bilaget III | 1.12.2010 |

Dato for beslutningen

Lægemidlets navn/navne

Indehaver/indehavere af markedsføringstilladelsen

Medlemsstat

Dato for notifikation

29.11.2010

Ketoprofen containing topical products

Se bilaget III

Se bilaget III

1.12.2010

---

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

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

---

BILAG I

LISTE OVER LÆGEMIDLETS NAVNE, LÆGEMIDDELFORMER, STYRKER, INDGIVELSESVEJ SAMT INDEHAVERE AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE

| Medlemsstat EU/EØS | Indehaver af markedsføringstilladelse | Særnavn | Styrke | Lægemiddelform | Indgivelsesvej |
| --- | --- | --- | --- | --- | --- |
| Østrig | Pfizer Corporation Austria Ges.m.b.H. |
| Floridsdorfer Hauptstraße 1 |
| A - 1210 Wien |
| Austria |

Medlemsstat EU/EØS

Indehaver af markedsføringstilladelse

Særnavn

Styrke

Lægemiddelform

Indgivelsesvej

Østrig

Pfizer Corporation Austria Ges.m.b.H.

Floridsdorfer Hauptstraße 1

A - 1210 Wien

Austria

Sortis 10 mg - Filmtabletten

10 mg

Filmovertrukken tablet

Oral anvendelse

Østrig

| Pfizer Corporation Austria Ges.m.b.H. |
| --- |
| Floridsdorfer Hauptstraße 1 |
| A - 1210 Wien |
| Austria |

Pfizer Corporation Austria Ges.m.b.H.

Floridsdorfer Hauptstraße 1

A - 1210 Wien

Austria

Sortis 20 mg - Filmtabletten

20 mg

Filmovertrukken tablet

Oral anvendelse

Østrig

| Pfizer Corporation Austria Ges.m.b.H. |
| --- |
| Floridsdorfer Hauptstraße 1 |
| A - 1210 Wien |
| Austria |

Pfizer Corporation Austria Ges.m.b.H.

Floridsdorfer Hauptstraße 1

A - 1210 Wien

Austria

Sortis 40 mg - Filmtabletten

40 mg

Filmovertrukken tablet

Oral anvendelse

Østrig

| Pfizer Corporation Austria Ges.m.b.H. |
| --- |
| Floridsdorfer Hauptstraße 1 |
| A - 1210 Wien |
| Austria |

Pfizer Corporation Austria Ges.m.b.H.

Floridsdorfer Hauptstraße 1

A - 1210 Wien

Austria

Sortis 80 mg - Filmtabletten

80 mg

Filmovertrukken tablet

Oral anvendelse

Belgien

| Pfizer SA |
| --- |
| Boulevard de la Plaine 17 |
| B-1050 Brussels, |
| Belgium |

Pfizer SA

Boulevard de la Plaine 17

B-1050 Brussels,

Belgium

Lipitor

10 mg

Filmovertrukken tablet

Oral anvendelse

Belgien

| Pfizer SA |
| --- |
| Boulevard de la Plaine 17 |
| B-1050 Brussels, |
| Belgium |

Pfizer SA

Boulevard de la Plaine 17

B-1050 Brussels,

Belgium

Lipitor

20 mg

Filmovertrukken tablet

Oral anvendelse

Belgien

| Pfizer SA |
| --- |
| Boulevard de la Plaine 17 |
| B-1050 Brussels, |
| Belgium |

Pfizer SA

Boulevard de la Plaine 17

B-1050 Brussels,

Belgium

Lipitor

40 mg

Filmovertrukken tablet

Oral anvendelse

Belgien

| Pfizer SA |
| --- |
| Boulevard de la Plaine 17 |
| B-1050 Brussels, |
| Belgium |

Pfizer SA

Boulevard de la Plaine 17

B-1050 Brussels,

Belgium

Lipitor

80 mg

Filmovertrukken tablet

Oral anvendelse

Bulgarien

| Pfizer Europe MA EEIG, Ramsgate Road, |
| --- |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG, Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Sortis

10 mg

Filmovertrukken tablet

Oral anvendelse

Bulgarien

| Pfizer Europe MA EEIG, Ramsgate Road, |
| --- |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG, Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Sortis

20 mg

Filmovertrukken tablet

Oral anvendelse

Bulgarien

| Pfizer Europe MA EEIG, Ramsgate Road, |
| --- |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG, Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Sortis

40 mg

Filmovertrukken tablet

Oral anvendelse

Bulgarien

| Pfizer Europe MA EEIG, Ramsgate Road, |
| --- |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG, Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Sortis

80 mg

Filmovertrukken tablet

Oral anvendelse

Cypern

| Pfizer Hellas A. E. |
| --- |
| 243, Messoghion Ave., |
| 154 51 Νeo Psychiko, Athens, |
| Greece |

Pfizer Hellas A. E.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens,

Greece

Lipitor

10 mg

Filmovertrukken tablet

Oral anvendelse

Cypern

| Pfizer Hellas A. E. |
| --- |
| 243, Messoghion Ave., |
| 154 51 Νeo Psychiko, Athens, |
| Greece |

Pfizer Hellas A. E.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens,

Greece

Lipitor

20 mg

Filmovertrukken tablet

Oral anvendelse

Cypern

| Pfizer Hellas A. E. |
| --- |
| 243, Messoghion Ave., |
| 154 51 Νeo Psychiko, Athens, |
| Greece |

Pfizer Hellas A. E.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens,

Greece

Lipitor

40 mg

Filmovertrukken tablet

Oral anvendelse

Tjekkiet

| Pfizer, spol. s r.o., |
| --- |
| Stroupežnického 17, |
| 150 00 Prague 5, |
| Czech Republic |

Pfizer, spol. s r.o.,

Stroupežnického 17,

150 00 Prague 5,

Czech Republic

Sortis

10 mg

Filmovertrukken tablet

Oral anvendelse

Tjekkiet

| Pfizer, spol. s r.o., |
| --- |
| Stroupežnického 17, |
| 150 00 Prague 5, |
| Czech Republic |

Pfizer, spol. s r.o.,

Stroupežnického 17,

150 00 Prague 5,

Czech Republic

Sortis

20 mg

Filmovertrukken tablet

Oral anvendelse

Tjekkiet

| Pfizer, spol. s r.o., |
| --- |
| Stroupežnického 17, |
| 150 00 Prague 5, |
| Czech Republic |

Pfizer, spol. s r.o.,

Stroupežnického 17,

150 00 Prague 5,

Czech Republic

Sortis

40 mg

Filmovertrukken tablet

Oral anvendelse

Tjekkiet

| Pfizer, spol. s r.o., |
| --- |
| Stroupežnického 17, |
| 150 00 Prague 5, |
| Czech Republic |

Pfizer, spol. s r.o.,

Stroupežnického 17,

150 00 Prague 5,

Czech Republic

Sortis

80 mg

Filmovertrukken tablet

Oral anvendelse

Danmark

| Pfizer ApS, |
| --- |
| Lautrupvang 8, |
| 2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8,

2750 Ballerup,

Denmark

Zarator

10 mg

Filmovertrukken tablet

Oral anvendelse

Danmark

| Pfizer ApS, |
| --- |
| Lautrupvang 8, |
| 2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8,

2750 Ballerup,

Denmark

Zarator

20 mg

Filmovertrukken tablet

Oral anvendelse

Danmark

| Pfizer ApS, |
| --- |
| Lautrupvang 8, |
| 2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8,

2750 Ballerup,

Denmark

Zarator

40 mg

Filmovertrukken tablet

Oral anvendelse

Danmark

| Pfizer ApS, |
| --- |
| Lautrupvang 8, |
| 2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8,

2750 Ballerup,

Denmark

Zarator

80 mg

Filmovertrukken tablet

Oral anvendelse

Estland

| Pfizer Europe MA EEIG, Ramsgate Road, |
| --- |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG, Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Sortis

10 mg

Filmovertrukken tablet

Oral anvendelse

Estland

| Pfizer Europe MA EEIG, Ramsgate Road, |
| --- |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG, Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Sortis

20 mg

Filmovertrukken tablet

Oral anvendelse

Estland

| Pfizer Europe MA EEIG, Ramsgate Road, |
| --- |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG, Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Sortis

40 mg

Filmovertrukken tablet

Oral anvendelse

Estland

| Pfizer Europe MA EEIG, Ramsgate Road, |
| --- |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG, Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Sortis 80 mg

80 mg

Filmovertrukken tablet

Oral anvendelse

Finland

| Pfizer Oy, |
| --- |
| Tietokuja 4, |
| 00330 Helsinki, |
| Finland |

Pfizer Oy,

Tietokuja 4,

00330 Helsinki,

Finland

Lipitor

10 mg

Filmovertrukken tablet

Oral anvendelse

Finland

| Pfizer Oy, |
| --- |
| Tietokuja 4, |
| 00330 Helsinki, |
| Finland |

Pfizer Oy,

Tietokuja 4,

00330 Helsinki,

Finland

Lipitor

20 mg

Filmovertrukken tablet

Oral anvendelse

Finland

| Pfizer Oy, |
| --- |
| Tietokuja 4, |
| 00330 Helsinki, |
| Finland |

Pfizer Oy,

Tietokuja 4,

00330 Helsinki,

Finland

Lipitor

40 mg

Filmovertrukken tablet

Oral anvendelse

Finland

| Pfizer Oy, |
| --- |
| Tietokuja 4, |
| 00330 Helsinki, |
| Finland |

Pfizer Oy,

Tietokuja 4,

00330 Helsinki,

Finland

Lipitor

80 mg

Filmovertrukken tablet

Oral anvendelse

Finland

| Pfizer Oy, |
| --- |
| Tietokuja 4, |
| 00330 Helsinki, |
| Finland |

Pfizer Oy,

Tietokuja 4,

00330 Helsinki,

Finland

Orbeos

10 mg

Filmovertrukken tablet

Oral anvendelse

Finland

| Pfizer Oy, |
| --- |
| Tietokuja 4, |
| 00330 Helsinki, |
| Finland |

Pfizer Oy,

Tietokuja 4,

00330 Helsinki,

Finland

Orbeos

20 mg

Filmovertrukken tablet

Oral anvendelse

Finland

| Pfizer Oy, |
| --- |
| Tietokuja 4, |
| 00330 Helsinki, |
| Finland |

Pfizer Oy,

Tietokuja 4,

00330 Helsinki,

Finland

Orbeos

40 mg

Filmovertrukken tablet

Oral anvendelse

Finland

| Pfizer Oy, |
| --- |
| Tietokuja 4, |
| 00330 Helsinki, |
| Finland |

Pfizer Oy,

Tietokuja 4,

00330 Helsinki,

Finland

Orbeos

80 mg

Filmovertrukken tablet

Oral anvendelse

Frankrig

| Pfizer Holding France |
| --- |
| 23-25 Avenue du Docteur Lannelongue |
| 75668 Paris Cedex 14 |
| France |

Pfizer Holding France

23-25 Avenue du Docteur Lannelongue

75668 Paris Cedex 14

France

Tahor

10 mg

Filmovertrukken tablet

Oral anvendelse

Frankrig

| Pfizer Holding France |
| --- |
| 23-25 Avenue du Docteur Lannelongue |
| 75668 Paris Cedex 14 |
| France |

Pfizer Holding France

23-25 Avenue du Docteur Lannelongue

75668 Paris Cedex 14

France

Tahor

20 mg

Filmovertrukken tablet

Oral anvendelse

Frankrig

| Pfizer Holding France |
| --- |
| 23-25 Avenue du Docteur Lannelongue |
| 75668 Paris Cedex 14 |
| France |

Pfizer Holding France

23-25 Avenue du Docteur Lannelongue

75668 Paris Cedex 14

France

Tahor

40 mg

Filmovertrukken tablet

Oral anvendelse

Frankrig

| Pfizer Holding France |
| --- |
| 23-25 Avenue du Docteur Lannelongue |
| 75668 Paris Cedex 14 |
| France |

Pfizer Holding France

23-25 Avenue du Docteur Lannelongue

75668 Paris Cedex 14

France

Tahor

80 mg

Filmovertrukken tablet

Oral anvendelse

Tyskland

| Pfizer Pharma GmbH, |
| --- |
| Linkstraße 10 |
| 10785 Berlin, |
| Germany |

Pfizer Pharma GmbH,

Linkstraße 10

10785 Berlin,

Germany

Sortis 10 mg

10 mg

Filmovertrukken tablet

Oral anvendelse

Tyskland

| Pfizer Pharma GmbH, |
| --- |
| Linkstraße 10 |
| 10785 Berlin, |
| Germany |

Pfizer Pharma GmbH,

Linkstraße 10

10785 Berlin,

Germany

Sortis 20 mg

20 mg

Filmovertrukken tablet

Oral anvendelse

Tyskland

| Pfizer Pharma GmbH, |
| --- |
| Linkstraße 10 |
| 10785 Berlin, |
| Germany |

Pfizer Pharma GmbH,

Linkstraße 10

10785 Berlin,

Germany

Sortis 40 mg

40 mg

Filmovertrukken tablet

Oral anvendelse

Tyskland

| Pfizer Pharma GmbH, |
| --- |
| Linkstraße 10 |
| 10785 Berlin, |
| Germany |

Pfizer Pharma GmbH,

Linkstraße 10

10785 Berlin,

Germany

Sortis 80 mg

80 mg

Filmovertrukken tablet

Oral anvendelse

Tyskland

| Pfizer Pharma GmbH, |
| --- |
| Linkstraße 10 |
| 10785 Berlin, |
| Germany |

Pfizer Pharma GmbH,

Linkstraße 10

10785 Berlin,

Germany

Liprimar 10 mg

10 mg

Filmovertrukken tablet

Oral anvendelse

Tyskland

| Pfizer Pharma GmbH, |
| --- |
| Linkstraße 10 |
| 10785 Berlin, |
| Germany |

Pfizer Pharma GmbH,

Linkstraße 10

10785 Berlin,

Germany

Liprimar 20 mg

20 mg

Filmovertrukken tablet

Oral anvendelse

Tyskland

| Pfizer Pharma GmbH, |
| --- |
| Linkstraße 10 |
| 10785 Berlin, |
| Germany |

Pfizer Pharma GmbH,

Linkstraße 10

10785 Berlin,

Germany

Liprimar 40 mg

40 mg

Filmovertrukken tablet

Oral anvendelse

Tyskland

| Pfizer Pharma GmbH, |
| --- |
| Linkstraße 10 |
| 10785 Berlin, |
| Germany |

Pfizer Pharma GmbH,

Linkstraße 10

10785 Berlin,

Germany

Liprimar 80 mg

80 mg

Filmovertrukken tablet

Oral anvendelse

Tyskland

| Pfizer Pharma GmbH, |
| --- |
| Linkstraße 10 |
| 10785 Berlin, |
| Germany |

Pfizer Pharma GmbH,

Linkstraße 10

10785 Berlin,

Germany

Atorvastatin 10 mg PD

10 mg

Filmovertrukken tablet

Oral anvendelse

Tyskland

| Pfizer Pharma GmbH, |
| --- |
| Linkstraße 10 |
| 10785 Berlin, |
| Germany |

Pfizer Pharma GmbH,

Linkstraße 10

10785 Berlin,

Germany

Atorvastatin 20 mg PD

20 mg

Filmovertrukken tablet

Oral anvendelse

Tyskland

| Pfizer Pharma GmbH, |
| --- |
| Linkstraße 10 |
| 10785 Berlin, |
| Germany |

Pfizer Pharma GmbH,

Linkstraße 10

10785 Berlin,

Germany

Atorvastatin 40 mg PD

40 mg

Filmovertrukken tablet

Oral anvendelse

Tyskland

| Pfizer Pharma GmbH, |
| --- |
| Linkstraße 10 |
| 10785 Berlin, |
| Germany |

Pfizer Pharma GmbH,

Linkstraße 10

10785 Berlin,

Germany

Atorvastatin 80 mg PD

80 mg

Filmovertrukken tablet

Oral anvendelse

Grækenland

| Pfizer Hellas A. E. |
| --- |
| 243, Messoghion Ave., |
| 154 51 Νeo Psychiko, Athens, |
| Greece |

Pfizer Hellas A. E.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens,

Greece

Lipitor

10 mg

Filmovertrukken tablet

Oral anvendelse

Grækenland

| Pfizer Hellas A. E. |
| --- |
| 243, Messoghion Ave., |
| 154 51 Νeo Psychiko, Athens, |
| Greece |

Pfizer Hellas A. E.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens,

Greece

Lipitor

20 mg

Filmovertrukken tablet

Oral anvendelse

Grækenland

| Pfizer Hellas A. E. |
| --- |
| 243, Messoghion Ave., |
| 154 51 Νeo Psychiko, Athens, |
| Greece |

Pfizer Hellas A. E.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens,

Greece

Lipitor

40 mg

Filmovertrukken tablet

Oral anvendelse

Grækenland

| Pfizer Hellas A. E. |
| --- |
| 243, Messoghion Ave., |
| 154 51 Νeo Psychiko, Athens, |
| Greece |

Pfizer Hellas A. E.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens,

Greece

Lipitor

80 mg

Filmovertrukken tablet

Oral anvendelse

Grækenland

| WIN MEDICA Ltd |
| --- |
| 41 Papadiamantopoulou Street |
| 115 28 Ilisia Athens, |
| Greece |

WIN MEDICA Ltd

41 Papadiamantopoulou Street

115 28 Ilisia Athens,

Greece

Zarator

10 mg

Filmovertrukken tablet

Oral anvendelse

Grækenland

| WIN MEDICA Ltd |
| --- |
| 41 Papadiamantopoulou Street |
| 115 28 Ilisia |
| Athens, |
| Greece |

WIN MEDICA Ltd

41 Papadiamantopoulou Street

115 28 Ilisia

Athens,

Greece

Zarator

20 mg

Filmovertrukken tablet

Oral anvendelse

Grækenland

| WIN MEDICA Ltd |
| --- |
| 41 Papadiamantopoulou Street |
| 115 28 Ilisia |
| Athens, |
| Greece |

WIN MEDICA Ltd

41 Papadiamantopoulou Street

115 28 Ilisia

Athens,

Greece

Zarator

40 mg

Filmovertrukken tablet

Oral anvendelse

Grækenland

| Pfizer Hellas A. E. |
| --- |
| 243, Messoghion Ave., |
| 154 51 Νeo Psychiko, Athens, |
| Greece |

Pfizer Hellas A. E.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens,

Greece

Edovin

10 mg

Filmovertrukken tablet

Oral anvendelse

Grækenland

| Pfizer Hellas A. E. |
| --- |
| 243, Messoghion Ave., |
| 154 51 Νeo Psychiko, Athens, |
| Greece |

Pfizer Hellas A. E.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens,

Greece

Edovin

20 mg

Filmovertrukken tablet

Oral anvendelse

Grækenland

| Pfizer Hellas A. E. |
| --- |
| 243, Messoghion Ave., |
| 154 51 Νeo Psychiko, Athens, |
| Greece |

Pfizer Hellas A. E.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens,

Greece

Edovin

40 mg

Filmovertrukken tablet

Oral anvendelse

Ungarn

| Pfizer KFT, |
| --- |
| 1123 Budapest, |
| Alkotás u. 53. MOM Park »F« Ép., |
| Hungary |

Pfizer KFT,

1123 Budapest,

Alkotás u. 53. MOM Park »F« Ép.,

Hungary

Sortis

10 mg

Filmovertrukken tablet

Oral anvendelse

Ungarn

| Pfizer KFT, |
| --- |
| 1123 Budapest, |
| Alkotás u. 53. MOM Park »F« Ép., |
| Hungary |

Pfizer KFT,

1123 Budapest,

Alkotás u. 53. MOM Park »F« Ép.,

Hungary

Sortis

20 mg

Filmovertrukken tablet

Oral anvendelse

Ungarn

| Pfizer KFT, |
| --- |
| 1123 Budapest, |
| Alkotás u. 53. MOM Park »F« Ép., |
| Hungary |

Pfizer KFT,

1123 Budapest,

Alkotás u. 53. MOM Park »F« Ép.,

Hungary

Sortis

40 mg

Filmovertrukken tablet

Oral anvendelse

Ungarn

| Pfizer KFT, |
| --- |
| 1123 Budapest, |
| Alkotás u. 53. MOM Park »F« Ép., |
| Hungary |

Pfizer KFT,

1123 Budapest,

Alkotás u. 53. MOM Park »F« Ép.,

Hungary

Sortis

80 mg

Filmovertrukken tablet

Oral anvendelse

Ungarn

| C.P. Pharma Gyógyszerkereskedelmi Kft. |
| --- |
| 2040 Budaörs |
| Vasút u. 11. |
| Hungary |

C.P. Pharma Gyógyszerkereskedelmi Kft.

2040 Budaörs

Vasút u. 11.

Hungary

Obradon

10 mg

Filmovertrukken tablet

Oral anvendelse

Ungarn

| C.P. Pharma Gyógyszerkereskedelmi Kft. |
| --- |
| 2040 Budaörs |
| Vasút u. 11. |
| Hungary |

C.P. Pharma Gyógyszerkereskedelmi Kft.

2040 Budaörs

Vasút u. 11.

Hungary

Obradon

20 mg

Filmovertrukken tablet

Oral anvendelse

Ungarn

| C.P. Pharma Gyógyszerkereskedelmi Kft. |
| --- |
| 2040 Budaörs |
| Vasút u. 11. |
| Hungary |

C.P. Pharma Gyógyszerkereskedelmi Kft.

2040 Budaörs

Vasút u. 11.

Hungary

Obradon

40 mg

Filmovertrukken tablet

Oral anvendelse

Ungarn

| C.P. Pharma Gyógyszerkereskedelmi Kft. |
| --- |
| 2040 Budaörs |
| Vasút u. 11. |
| Hungary |

C.P. Pharma Gyógyszerkereskedelmi Kft.

2040 Budaörs

Vasút u. 11.

Hungary

Obradon

80 mg

Filmovertrukken tablet

Oral anvendelse

Island

| Pfizer ApS, |
| --- |
| Lautrupvang 8, |
| 2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8,

2750 Ballerup,

Denmark

Zarator

10 mg

Filmovertrukken tablet

Oral anvendelse

Island

| Pfizer ApS, |
| --- |
| Lautrupvang 8, |
| 2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8,

2750 Ballerup,

Denmark

Zarator

20 mg

Filmovertrukken tablet

Oral anvendelse

Island

| Pfizer ApS, |
| --- |
| Lautrupvang 8, |
| 2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8,

2750 Ballerup,

Denmark

Zarator

40 mg

Filmovertrukken tablet

Oral anvendelse

Island

| Pfizer ApS, |
| --- |
| Lautrupvang 8, |
| 2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8,

2750 Ballerup,

Denmark

Zarator

80 mg

Filmovertrukken tablet

Oral anvendelse

Irland

| Pfizer Ireland Pharmaceuticals, |
| --- |
| Pottery Road, Dun Laoghaire, Co Dublin |
| Ireland |

Pfizer Ireland Pharmaceuticals,

Pottery Road, Dun Laoghaire, Co Dublin

Ireland

Lipitor

10 mg

Filmovertrukken tablet

Oral anvendelse

Irland

| Pfizer Ireland Pharmaceuticals, |
| --- |
| Pottery Road, Dun Laoghaire, Co Dublin |
| Ireland |

Pfizer Ireland Pharmaceuticals,

Pottery Road, Dun Laoghaire, Co Dublin

Ireland

Lipitor

20 mg

Filmovertrukken tablet

Oral anvendelse

Irland

| Pfizer Ireland Pharmaceuticals, |
| --- |
| Pottery Road, Dun Laoghaire, Co Dublin |
| Ireland |

Pfizer Ireland Pharmaceuticals,

Pottery Road, Dun Laoghaire, Co Dublin

Ireland

Lipitor

40 mg

Filmovertrukken tablet

Oral anvendelse

Irland

| Pfizer Ireland Pharmaceuticals, |
| --- |
| Pottery Road, Dun Laoghaire, Co Dublin |
| Ireland |

Pfizer Ireland Pharmaceuticals,

Pottery Road, Dun Laoghaire, Co Dublin

Ireland

Lipitor

80 mg

Filmovertrukken tablet

Oral anvendelse

Italien

| Pfizer Italia S.r.l. |
| --- |
| Via Isonzo, 71 |
| 04100 Latina – |
| Italy |

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina –

Italy

Xarator

10 mg

Filmovertrukken tablet

Oral anvendelse

Italien

| Pfizer Italia S.r.l. |
| --- |
| Via Isonzo, 71 |
| 04100 Latina – |
| Italy |

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina –

Italy

Xarator

20 mg

Filmovertrukken tablet

Oral anvendelse

Italien

| Pfizer Italia S.r.l. |
| --- |
| Via Isonzo, 71 |
| 04100 Latina – |
| Italy |

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina –

Italy

Xarator

40 mg

Filmovertrukken tablet

Oral anvendelse

Italien

| Pfizer Italia S.r.l. |
| --- |
| Via Isonzo, 71 |
| 04100 Latina – |
| Italy |

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina –

Italy

Xarator

80 mg

Filmovertrukken tablet

Oral anvendelse

Italien

| Bioindustria Farmaceutici S.r.l |
| --- |
| Via Isonzo, 71 |
| 04100 Latina – |
| Italy |

Bioindustria Farmaceutici S.r.l

Via Isonzo, 71

04100 Latina –

Italy

Lipitor

10 mg

Filmovertrukken tablet

Oral anvendelse

Italien

| Bioindustria Farmaceutici S.r.l. |
| --- |
| Via Isonzo, 71 |
| 04100 Latina – |
| Italy |

Bioindustria Farmaceutici S.r.l.

Via Isonzo, 71

04100 Latina –

Italy

Lipitor

20 mg

Filmovertrukken tablet

Oral anvendelse

Italien

| Bioindustria Farmaceutici S.r.l. |
| --- |
| Via Isonzo, 71 |
| 04100 Latina – |
| Italy |

Bioindustria Farmaceutici S.r.l.

Via Isonzo, 71

04100 Latina –

Italy

Lipitor

40 mg

Filmovertrukken tablet

Oral anvendelse

Italien

| Bioindustria Farmaceutici S.r.l. |
| --- |
| Via Isonzo, 71 |
| 04100 Latina – |
| Italy |

Bioindustria Farmaceutici S.r.l.

Via Isonzo, 71

04100 Latina –

Italy

Lipitor

80 mg

Filmovertrukken tablet

Oral anvendelse

Italien

| Pfizer Italia S.r.l. |
| --- |
| Via Isonzo, 71 |
| 04100 Latina – |
| Italy |

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina –

Italy

Torvast

10 mg

Filmovertrukken tablet

Oral anvendelse

Italien

| Pfizer Italia S.r.l. |
| --- |
| Via Isonzo, 71 |
| 04100 Latina – |
| Italy |

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina –

Italy

Torvast

20 mg

Filmovertrukken tablet

Oral anvendelse

Italien

| Pfizer Italia S.r.l. |
| --- |
| Via Isonzo, 71 |
| 04100 Latina – |
| Italy |

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina –

Italy

Torvast

40 mg

Filmovertrukken tablet

Oral anvendelse

Italien

| Pfizer Italia S.r.l. |
| --- |
| Via Isonzo, 71 |
| 04100 Latina – |
| Italy |

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina –

Italy

Torvast

80 mg

Filmovertrukken tablet

Oral anvendelse

Italien

| Laboratori Guidotti S.p.A. |
| --- |
| Via Livornese, 897 - La Vettola |
| 56010 Pisa – |
| Italy |

Laboratori Guidotti S.p.A.

Via Livornese, 897 - La Vettola

56010 Pisa –

Italy

Totalip

10 mg

Filmovertrukken tablet

Oral anvendelse

Italien

| Laboratori Guidotti S.p.A. |
| --- |
| Via Livornese, 897 - La Vettola |
| 56010 Pisa – |
| Italy |

Laboratori Guidotti S.p.A.

Via Livornese, 897 - La Vettola

56010 Pisa –

Italy

Totalip

20 mg

Filmovertrukken tablet

Oral anvendelse

Italien

| Laboratori Guidotti S.p.A. |
| --- |
| Via Livornese, 897 - La Vettola |
| 56010 Pisa – |
| Italy |

Laboratori Guidotti S.p.A.

Via Livornese, 897 - La Vettola

56010 Pisa –

Italy

Totalip

40 mg

Filmovertrukken tablet

Oral anvendelse

Italien

| Laboratori Guidotti S.p.A. |
| --- |
| Via Livornese, 897 - La Vettola |
| 56010 Pisa – |
| Italy |

Laboratori Guidotti S.p.A.

Via Livornese, 897 - La Vettola

56010 Pisa –

Italy

Totalip

80 mg

Filmovertrukken tablet

Oral anvendelse

Letland

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

Pfizer Limited,

Ramsgate Road, Sandwich,

Kent CT13 9NJ,

United Kingdom

Sortis

10 mg

Filmovertrukken tablet

Oral anvendelse

Letland

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

Pfizer Limited,

Ramsgate Road, Sandwich,

Kent CT13 9NJ,

United Kingdom

Sortis

20 mg

Filmovertrukken tablet

Oral anvendelse

Letland

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

Pfizer Limited,

Ramsgate Road, Sandwich,

Kent CT13 9NJ,

United Kingdom

Sortis

40 mg

Filmovertrukken tablet

Oral anvendelse

Letland

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

Pfizer Limited,

Ramsgate Road, Sandwich,

Kent CT13 9NJ,

United Kingdom

Sortis

80 mg

Filmovertrukken tablet

Oral anvendelse

Litauen

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

Pfizer Limited,

Ramsgate Road, Sandwich,

Kent CT13 9NJ,

United Kingdom

Sortis

10 mg

Filmovertrukken tablet

Oral anvendelse

Litauen

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

Pfizer Limited,

Ramsgate Road, Sandwich,

Kent CT13 9NJ,

United Kingdom

Sortis

20 mg

Filmovertrukken tablet

Oral anvendelse

Litauen

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

Pfizer Limited,

Ramsgate Road, Sandwich,

Kent CT13 9NJ,

United Kingdom

Sortis

40 mg

Filmovertrukken tablet

Oral anvendelse

Litauen

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

Pfizer Limited,

Ramsgate Road, Sandwich,

Kent CT13 9NJ,

United Kingdom

Sortis

80 mg

Filmovertrukken tablet

Oral anvendelse

Luxembourg

| Pfizer SA |
| --- |
| Boulevard de la Plaine 17 |
| B-1050 Brussels, |
| Belgium |

Pfizer SA

Boulevard de la Plaine 17

B-1050 Brussels,

Belgium

Lipitor

10 mg

Filmovertrukken tablet

Oral anvendelse

Luxembourg

| Pfizer SA |
| --- |
| Boulevard de la Plaine 17 |
| B-1050 Brussels, |
| Belgium |

Pfizer SA

Boulevard de la Plaine 17

B-1050 Brussels,

Belgium

Lipitor

20 mg

Filmovertrukken tablet

Oral anvendelse

Luxembourg

| Pfizer SA |
| --- |
| Boulevard de la Plaine 17 |
| B-1050 Brussels, |
| Belgium |

Pfizer SA

Boulevard de la Plaine 17

B-1050 Brussels,

Belgium

Lipitor

40 mg

Filmovertrukken tablet

Oral anvendelse

Luxembourg

| Pfizer SA |
| --- |
| Boulevard de la Plaine 17 |
| B-1050 Brussels, |
| Belgium |

Pfizer SA

Boulevard de la Plaine 17

B-1050 Brussels,

Belgium

Lipitor

80 mg

Filmovertrukken tablet

Oral anvendelse

Malta

| Pfizer Hellas S.A. |
| --- |
| 243, Messoghion Ave., |
| 154 51 Νeo Psychiko, Athens, |
| Greece |

Pfizer Hellas S.A.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens,

Greece

Lipitor

10 mg

Filmovertrukken tablet

Oral anvendelse

Malta

| Pfizer Hellas S.A. |
| --- |
| 243, Messoghion Ave., |
| 154 51 Νeo Psychiko, Athens, |
| Greece |

Pfizer Hellas S.A.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens,

Greece

Lipitor

20 mg

Filmovertrukken tablet

Oral anvendelse

Malta

| Pfizer Hellas S.A. |
| --- |
| 243, Messoghion Ave., |
| 154 51 Νeo Psychiko, Athens, |
| Greece |

Pfizer Hellas S.A.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens,

Greece

Lipitor

40 mg

Filmovertrukken tablet

Oral anvendelse

Malta

| Pfizer Hellas S.A. |
| --- |
| 243, Messoghion Ave., |
| 154 51 Νeo Psychiko, Athens, |
| Greece |

Pfizer Hellas S.A.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens,

Greece

Lipitor

80 mg

Filmovertrukken tablet

Oral anvendelse

Holland

| Pfizer bv |
| --- |
| Rivium Westlaan 142 |
| 2909 LD Capelle a/d IJssel |
| The Netherlands |

Pfizer bv

Rivium Westlaan 142

2909 LD Capelle a/d IJssel

The Netherlands

Lipitor

10 mg

Filmovertrukken tablet

Oral anvendelse

Holland

| Pfizer bv |
| --- |
| Rivium Westlaan 142 |
| 2909 LD Capelle a/d IJssel |
| The Netherlands |

Pfizer bv

Rivium Westlaan 142

2909 LD Capelle a/d IJssel

The Netherlands

Lipitor

20 mg

Filmovertrukken tablet

Oral anvendelse

Holland

| Pfizer bv |
| --- |
| Rivium Westlaan 142 |
| 2909 LD Capelle a/d IJssel |
| The Netherlands |

Pfizer bv

Rivium Westlaan 142

2909 LD Capelle a/d IJssel

The Netherlands

Lipitor

40 mg

Filmovertrukken tablet

Oral anvendelse

Holland

| Pfizer bv |
| --- |
| Rivium Westlaan 142 |
| 2909 LD Capelle a/d IJssel |
| The Netherlands |

Pfizer bv

Rivium Westlaan 142

2909 LD Capelle a/d IJssel

The Netherlands

Lipitor

80 mg

Filmovertrukken tablet

Oral anvendelse

Norge

| Pfizer AS |
| --- |
| Pb. 3 |
| 1324 Lysaker |
| Norway |

Pfizer AS

Pb. 3

1324 Lysaker

Norway

Lipitor

10 mg

Filmovertrukken tablet

Oral anvendelse

Norge

| Pfizer AS |
| --- |
| Pb. 3 |
| 1324 Lysaker |
| Norway |

Pfizer AS

Pb. 3

1324 Lysaker

Norway

Lipitor

20 mg

Filmovertrukken tablet

Oral anvendelse

Norge

| Pfizer AS |
| --- |
| Pb. 3 |
| 1324 Lysaker |
| Norway |

Pfizer AS

Pb. 3

1324 Lysaker

Norway

Lipitor

40 mg

Filmovertrukken tablet

Oral anvendelse

Norge

| Pfizer AS |
| --- |
| Pb. 3 |
| 1324 Lysaker |
| Norway |

Pfizer AS

Pb. 3

1324 Lysaker

Norway

Lipitor

80 mg

Filmovertrukken tablet

Oral anvendelse

Polen

| Parke-Davis GmbH, |
| --- |
| Pfizerstrasse 1, |
| 76 139 Karlsruhe, |
| Germany |

Parke-Davis GmbH,

Pfizerstrasse 1,

76 139 Karlsruhe,

Germany

Sortis 10

10 mg

Filmovertrukken tablet

Oral anvendelse

Polen

| Parke-Davis GmbH, |
| --- |
| Pfizerstrasse 1, |
| 76 139 Karlsruhe, |
| Germany |

Parke-Davis GmbH,

Pfizerstrasse 1,

76 139 Karlsruhe,

Germany

Sortis 20

20 mg

Filmovertrukken tablet

Oral anvendelse

Polen

| Parke-Davis GmbH, |
| --- |
| Pfizerstrasse 1, |
| 76 139 Karlsruhe, |
| Germany |

Parke-Davis GmbH,

Pfizerstrasse 1,

76 139 Karlsruhe,

Germany

Sortis 40

40 mg

Filmovertrukken tablet

Oral anvendelse

Polen

| Pfizer Polska Sp.z o.o. |
| --- |
| ul. Rzymowskiego 28 |
| 02-697 Warszawa |
| Poland |

Pfizer Polska Sp.z o.o.

ul. Rzymowskiego 28

02-697 Warszawa

Poland

Sortis 80

80 mg

Filmovertrukken tablet

Oral anvendelse

Portugal

| Laboratorios Pfizer, Lda., |
| --- |
| Lagoas Park, Edifício 10, |
| 2740-271 Porto Salvo, |
| Portugal |

Laboratorios Pfizer, Lda.,

Lagoas Park, Edifício 10,

2740-271 Porto Salvo,

Portugal

Zarator

10 mg

Filmovertrukken tablet

Oral anvendelse

Portugal

| Laboratorios Pfizer, Lda., |
| --- |
| Lagoas Park, Edifício 10, |
| 2740-271 Porto Salvo, |
| Portugal |

Laboratorios Pfizer, Lda.,

Lagoas Park, Edifício 10,

2740-271 Porto Salvo,

Portugal

Zarator

20 mg

Filmovertrukken tablet

Oral anvendelse

Portugal

| Laboratorios Pfizer, Lda., |
| --- |
| Lagoas Park, Edifício 10, |
| 2740-271 Porto Salvo, |
| Portugal |

Laboratorios Pfizer, Lda.,

Lagoas Park, Edifício 10,

2740-271 Porto Salvo,

Portugal

Zarator

40 mg

Filmovertrukken tablet

Oral anvendelse

Portugal

| Laboratorios Pfizer, Lda., |
| --- |
| Lagoas Park, Edifício 10, |
| 2740-271 Porto Salvo, |
| Portugal |

Laboratorios Pfizer, Lda.,

Lagoas Park, Edifício 10,

2740-271 Porto Salvo,

Portugal

Zarator

80 mg

Filmovertrukken tablet

Oral anvendelse

Portugal

| Parke-Davis - Produtos Farmaceuticos, Lda., |
| --- |
| Lagoas Park, Edifício 10, |
| 2740-271 Porto Salvo, |
| Portugal |

Parke-Davis - Produtos Farmaceuticos, Lda.,

Lagoas Park, Edifício 10,

2740-271 Porto Salvo,

Portugal

Atorvastatina Parke-Davis

10 mg

Filmovertrukken tablet

Oral anvendelse

Portugal

| Parke-Davis - Produtos Farmaceuticos, Lda., |
| --- |
| Lagoas Park, Edifício 10, |
| 2740-271 Porto Salvo, |
| Portugal |

Parke-Davis - Produtos Farmaceuticos, Lda.,

Lagoas Park, Edifício 10,

2740-271 Porto Salvo,

Portugal

Atorvastatina Parke-Davis

20 mg

Filmovertrukken tablet

Oral anvendelse

Portugal

| Parke-Davis - Produtos Farmaceuticos, Lda., |
| --- |
| Lagoas Park, Edifício 10, |
| 2740-271 Porto Salvo, |
| Portugal |

Parke-Davis - Produtos Farmaceuticos, Lda.,

Lagoas Park, Edifício 10,

2740-271 Porto Salvo,

Portugal

Atorvastatina Parke-Davis

40 mg

Filmovertrukken tablet

Oral anvendelse

Portugal

| Parke-Davis - Produtos Farmaceuticos, Lda., |
| --- |
| Lagoas Park, Edifício 10, |
| 2740-271 Porto Salvo, |
| Portugal |

Parke-Davis - Produtos Farmaceuticos, Lda.,

Lagoas Park, Edifício 10,

2740-271 Porto Salvo,

Portugal

Atorvastatina Parke-Davis

80 mg

Filmovertrukken tablet

Oral anvendelse

Portugal

| Farmogene - Produtos Farmacêuticos, Lda, |
| --- |
| Lagoas Park, Edifício 10, |
| 2740-271 Porto Salvo, |
| Portugal |

Farmogene - Produtos Farmacêuticos, Lda,

Lagoas Park, Edifício 10,

2740-271 Porto Salvo,

Portugal

Texzor

10 mg

Filmovertrukken tablet

Oral anvendelse

Portugal

| Farmogene - Produtos Farmacêuticos, Lda, |
| --- |
| Lagoas Park, Edifício 10, |
| 2740-271 Porto Salvo, |
| Portugal |

Farmogene - Produtos Farmacêuticos, Lda,

Lagoas Park, Edifício 10,

2740-271 Porto Salvo,

Portugal

Texzor

20 mg

Filmovertrukken tablet

Oral anvendelse

Portugal

| Farmogene - Produtos Farmacêuticos, Lda, |
| --- |
| Lagoas Park, Edifício 10, |
| 2740-271 Porto Salvo, |
| Portugal |

Farmogene - Produtos Farmacêuticos, Lda,

Lagoas Park, Edifício 10,

2740-271 Porto Salvo,

Portugal

Texzor

40 mg

Filmovertrukken tablet

Oral anvendelse

Portugal

| Farmogene - Produtos Farmacêuticos, Lda., |
| --- |
| Lagoas Park, Edifício 10, |
| 2740-271 Porto Salvo, |
| Portugal |

Farmogene - Produtos Farmacêuticos, Lda.,

Lagoas Park, Edifício 10,

2740-271 Porto Salvo,

Portugal

Texzor

80 mg

Filmovertrukken tablet

Oral anvendelse

Rumænien

| Pfizer Europe MA EEIG, |
| --- |
| Ramsgate Road, |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG,

Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Sortis

10 mg

Filmovertrukken tablet

Oral anvendelse

Rumænien

| Pfizer Europe MA EEIG, |
| --- |
| Ramsgate Road, |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG,

Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Sortis

20 mg

Filmovertrukken tablet

Oral anvendelse

Rumænien

| Pfizer Europe MA EEIG, |
| --- |
| Ramsgate Road, |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG,

Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Sortis

40 mg

Filmovertrukken tablet

Oral anvendelse

Rumænien

| Pfizer Europe MA EEIG, |
| --- |
| Ramsgate Road, |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG,

Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Sortis

80 mg

Filmovertrukken tablet

Oral anvendelse

Slovakiet

| Pfizer Europe MA EEIG, |
| --- |
| Ramsgate Road, |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG,

Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Sortis

10 mg

Filmovertrukken tablet

Oral anvendelse

Slovakiet

| Pfizer Europe MA EEIG, |
| --- |
| Ramsgate Road, |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG,

Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Sortis

20 mg

Filmovertrukken tablet

Oral anvendelse

Slovakiet

| Pfizer Europe MA EEIG, |
| --- |
| Ramsgate Road, |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG,

Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Sortis

40 mg

Filmovertrukken tablet

Oral anvendelse

Slovakiet

| Pfizer Europe MA EEIG, |
| --- |
| Ramsgate Road, |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG,

Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Sortis

80 mg

Filmovertrukken tablet

Oral anvendelse

Slovenien

| Pfizer Luxembourg SARL, |
| --- |
| 51, Avenue J. F. Kennedy, |
| L-1855 Luxembourg |

Pfizer Luxembourg SARL,

51, Avenue J. F. Kennedy,

L-1855 Luxembourg

Sortis 10 mg filmsko obložene tablete

10 mg

Filmovertrukken tablet

Oral anvendelse

Slovenien

| Pfizer Luxembourg SARL, |
| --- |
| 51, Avenue J. F. Kennedy, |
| L-1855 Luxembourg |

Pfizer Luxembourg SARL,

51, Avenue J. F. Kennedy,

L-1855 Luxembourg

Sortis 20 mg filmsko obložene tablete

20 mg

Filmovertrukken tablet

Oral anvendelse

Slovenien

| Pfizer Luxembourg SARL, |
| --- |
| 51, Avenue J. F. Kennedy, |
| L-1855 Luxembourg |

Pfizer Luxembourg SARL,

51, Avenue J. F. Kennedy,

L-1855 Luxembourg

Sortis 40 mg filmsko obložene tablete

40 mg

Filmovertrukken tablet

Oral anvendelse

Slovenien

| Pfizer Luxembourg SARL, |
| --- |
| 51, Avenue J. F. Kennedy, |
| L-1855 Luxembourg |

Pfizer Luxembourg SARL,

51, Avenue J. F. Kennedy,

L-1855 Luxembourg

Sortis 80 mg filmsko obložene tablete

80 mg

Filmovertrukken tablet

Oral anvendelse

Spanien

| Parke Davis. S.L. |
| --- |
| Avda. de Europa 20B |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Spain |

Parke Davis. S.L.

Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Zarator

10 mg

Filmovertrukken tablet

Oral anvendelse

Spanien

| Parke Davis. S.L. |
| --- |
| Avda. de Europa 20B |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Spain |

Parke Davis. S.L.

Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Zarator

20 mg

Filmovertrukken tablet

Oral anvendelse

Spanien

| Parke Davis. S.L. |
| --- |
| Avda. de Europa 20B |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Spain |

Parke Davis. S.L.

Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Zarator

40 mg

Filmovertrukken tablet

Oral anvendelse

Spanien

| Parke Davis. S.L. |
| --- |
| Avda. de Europa 20B |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Spain |

Parke Davis. S.L.

Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Zarator

80 mg

Filmovertrukken tablet

Oral anvendelse

Spanien

| Pfizer, S.A. |
| --- |
| Avda. de Europa 20B |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Spain |

Pfizer, S.A.

Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Cardyl

10 mg

Filmovertrukken tablet

Oral anvendelse

Spanien

| Pfizer, S.A. |
| --- |
| Avda. de Europa 20B |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Spain |

Pfizer, S.A.

Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Cardyl

20 mg

Filmovertrukken tablet

Oral anvendelse

Spanien

| Pfizer, S.A. |
| --- |
| Avda. de Europa 20B |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Spain |

Pfizer, S.A.

Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Cardyl

40 mg

Filmovertrukken tablet

Oral anvendelse

Spanien

| Pfizer, S.A. |
| --- |
| Avda. de Europa 20B |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Spain |

Pfizer, S.A.

Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Cardyl

80 mg

Filmovertrukken tablet

Oral anvendelse

Spanien

| Nostrum Farma, S.A., |
| --- |
| Avda. de Europa 20B |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Spain |

Nostrum Farma, S.A.,

Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Atorvastatina Nostrum

10 mg

Filmovertrukken tablet

Oral anvendelse

Spanien

| Nostrum Farma, S.A., |
| --- |
| Avda. de Europa 20B |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Spain |

Nostrum Farma, S.A.,

Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Atorvastatina Nostrum

20 mg

Filmovertrukken tablet

Oral anvendelse

Spanien

| Nostrum Farma, S.A., |
| --- |
| Avda. de Europa 20B |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Spain |

Nostrum Farma, S.A.,

Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Atorvastatina Nostrum

40 mg

Filmovertrukken tablet

Oral anvendelse

Spanien

| Nostrum Farma, S.A., |
| --- |
| Avda. de Europa 20B |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Spain |

Nostrum Farma, S.A.,

Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Atorvastatina Nostrum

80 mg

Filmovertrukken tablet

Oral anvendelse

Spanien

| PHARMACIA GRUPO PFIZER, S.L. |
| --- |
| Avda. de Europa 20B |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Spain |

PHARMACIA GRUPO PFIZER, S.L.

Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Atorvastatina Pharmacia

10 mg

Filmovertrukken tablet

Oral anvendelse

Spanien

| PHARMACIA GRUPO PFIZER, S.L. |
| --- |
| Avda. de Europa 20B |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Spain |

PHARMACIA GRUPO PFIZER, S.L.

Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Atorvastatina Pharmacia

20 mg

Filmovertrukken tablet

Oral anvendelse

Spanien

| PHARMACIA GRUPO PFIZER, S.L. |
| --- |
| Avda. de Europa 20B |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Spain |

PHARMACIA GRUPO PFIZER, S.L.

Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Atorvastatina Pharmacia

40 mg

Filmovertrukken tablet

Oral anvendelse

Spanien

| PHARMACIA GRUPO PFIZER, S.L. |
| --- |
| Avda. de Europa 20B |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Spain |

PHARMACIA GRUPO PFIZER, S.L.

Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Atorvastatina Pharmacia

80 mg

Filmovertrukken tablet

Oral anvendelse

Spanien

| Almirall S.A. |
| --- |
| General Mitre, 151 |
| 08022 - Barcelona |
| Spain |

Almirall S.A.

General Mitre, 151

08022 - Barcelona

Spain

Prevencor

10 mg

Filmovertrukken tablet

Oral anvendelse

Spanien

| Almirall S.A. |
| --- |
| General Mitre, 151 |
| 08022 - Barcelona |
| Spain |

Almirall S.A.

General Mitre, 151

08022 - Barcelona

Spain

Prevencor

20 mg

Filmovertrukken tablet

Oral anvendelse

Spanien

| Almirall S.A. |
| --- |
| General Mitre, 151 |
| 08022 - Barcelona |
| Spain |

Almirall S.A.

General Mitre, 151

08022 - Barcelona

Spain

Prevencor

40 mg

Filmovertrukken tablet

Oral anvendelse

Spanien

| Almirall S.A. |
| --- |
| General Mitre, 151 |
| 08022 - Barcelona |
| Spain |

Almirall S.A.

General Mitre, 151

08022 - Barcelona

Spain

Prevencor

80 mg

Filmovertrukken tablet

Oral anvendelse

Sverige

| Pfizer AB |
| --- |
| 191 90 Sollentuna |
| Sweden |

Pfizer AB

191 90 Sollentuna

Sweden

Lipitor

10 mg

Filmovertrukken tablet

Oral anvendelse

Sverige

| Pfizer AB |
| --- |
| 191 90 Sollentuna |
| Sweden |

Pfizer AB

191 90 Sollentuna

Sweden

Lipitor

20 mg

Filmovertrukken tablet

Oral anvendelse

Sverige

| Pfizer AB |
| --- |
| 191 90 Sollentuna |
| Sweden |

Pfizer AB

191 90 Sollentuna

Sweden

Lipitor

40 mg

Filmovertrukken tablet

Oral anvendelse

Sverige

| Pfizer AB |
| --- |
| 191 90 Sollentuna |
| Sweden |

Pfizer AB

191 90 Sollentuna

Sweden

Lipitor

80 mg

Filmovertrukken tablet

Oral anvendelse

Storbritannien

| Pfizer Ireland Pharmaceuticals, |
| --- |
| Pottery Road, Dun Laoghaire, Co Dublin |
| Ireland |

Pfizer Ireland Pharmaceuticals,

Pottery Road, Dun Laoghaire, Co Dublin

Ireland

Lipitor

10 mg

Filmovertrukken tablet

Oral anvendelse

Storbritannien

| Pfizer Ireland Pharmaceuticals, |
| --- |
| Pottery Road, Dun Laoghaire, Co Dublin |
| Ireland |

Pfizer Ireland Pharmaceuticals,

Pottery Road, Dun Laoghaire, Co Dublin

Ireland

Lipitor

20 mg

Filmovertrukken tablet

Oral anvendelse

Storbritannien

| Pfizer Ireland Pharmaceuticals, |
| --- |
| Pottery Road, Dun Laoghaire, Co Dublin |
| Ireland |

Pfizer Ireland Pharmaceuticals,

Pottery Road, Dun Laoghaire, Co Dublin

Ireland

Lipitor

40 mg

Filmovertrukken tablet

Oral anvendelse

Storbritannien

| Pfizer Ireland Pharmaceuticals, |
| --- |
| Pottery Road, |
| Dun Laoghaire, Co Dublin |
| Ireland |

Pfizer Ireland Pharmaceuticals,

Pottery Road,

Dun Laoghaire, Co Dublin

Ireland

Lipitor

80 mg

Filmovertrukken tablet

Oral anvendelse

---

BILAG II

LISTE MED NAVNE, LÆGEMIDDELFORM, LÆGEMIDLETS STYRKE, ADMINISTRATIONSVEJ, ANSØGER, INDEHAVER AF MARKEDSFØRINGSTILLADELSEN I MEDLEMSLANDENE

| EU- eller EØS-land | Indehaver af markedsføringstilladelsen | Ansøger | (Sær)navn | Styrke | Lægemiddelform | Administrationsvej | Indhold
  (koncentration) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Irland | CHX Technologies Europe Limited |
| Guinness Enterprise Centre |
| Taylor’s Lane |
| Dublin 8, Ireland |

EU- eller EØS-land

Indehaver af markedsføringstilladelsen

Ansøger

(Sær)navn

Styrke

Lægemiddelform

Administrationsvej

Indhold

(koncentration)

Irland

CHX Technologies Europe Limited

Guinness Enterprise Centre

Taylor’s Lane

Dublin 8, Ireland

Prevora 100 mg/ml, dentalopløsning

100 mg pr. ml opløsning

Dentalopløsning

Dental anvendelse (supragingival kun til det hårde væv)

100 mg/ml

Storbritannien

| CHX Technologies Europe Limited |
| --- |
| Guinness Enterprise Centre |
| Taylor’s Lane |
| Dublin 8, Ireland |

CHX Technologies Europe Limited

Guinness Enterprise Centre

Taylor’s Lane

Dublin 8, Ireland

Prevora 100 mg/ml, dentalopløsning

100 mg pr. ml opløsning

Dentalopløsning

Dental anvendelse (supragingival kun til det hårde væv)

100 mg/ml

---

BILAG III

FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORMER, STYRKER, INDGIVELSESVEJE, ANSØGERE, INDEHAVERE AF MARKEDSFØRINGS-TILLADELSER I MEDLEMSSTATERNE (EU/EEA)

| Medlemsstat | Indehaver af markedsføringstilladelse | Produktnavn | Styrke | Lægemiddelform | Indgivelsesvej |
| --- | --- | --- | --- | --- | --- |
| AT – Østrig | A.Menarini Industrie Farmaceutiche Riunite s.r.l. |
| 1-3 Via Sette Santi |
| 50131 Firenze |
| Italien |

Medlemsstat

Indehaver af markedsføringstilladelse

Produktnavn

Styrke

Lægemiddelform

Indgivelsesvej

AT – Østrig

A.Menarini Industrie Farmaceutiche Riunite s.r.l.

1-3 Via Sette Santi

50131 Firenze

Italien

Fastum Gel

25 mg/g

Gel

Kutan anvendelse

AT – Østrig

| Cyathus Exquirere Pharmaforschungs GmbH |
| --- |
| Rudolfsplatz 2/1/8 |
| 1010 Wien |
| Østrig |

Cyathus Exquirere Pharmaforschungs GmbH

Rudolfsplatz 2/1/8

1010 Wien

Østrig

Ketospray 10 % - Spray

100 mg/g

afmålt dosis: 20 mg/0,2 ml

Kutanspray, opløsning

Kutan anvendelse

AT – Østrig

| sanofi-aventis GmbH |
| --- |
| SATURN Tower, Leonard-Bernstein-Straße 10 |
| 1220 Wien |
| Østrig |

sanofi-aventis GmbH

SATURN Tower, Leonard-Bernstein-Straße 10

1220 Wien

Østrig

Profenid 2,5 % - Gel

25 mg/g

Gel

Kutan anvendelse

BE – Belgien

| Aktuapharma N.V |
| --- |
| Ambachtenlaan 13E |
| 3001 Leuven |
| Belgien |

Aktuapharma N.V

Ambachtenlaan 13E

3001 Leuven

Belgien

Fastum gel 2,5 %

25 mg/g

Gel

Kutan anvendelse

BE – Belgien

| Menarini Benelux N.V |
| --- |
| Belgicastraat 4 |
| 1930 Zaventem |
| Belgien |

Menarini Benelux N.V

Belgicastraat 4

1930 Zaventem

Belgien

Fastum 2,5 %

25 mg/g

Gel

Kutan anvendelse

BE – Belgien

| Menarini Benelux N.V |
| --- |
| Belgicastraat 4 |
| 1930 Zaventem |
| Belgien |

Menarini Benelux N.V

Belgicastraat 4

1930 Zaventem

Belgien

Fastum gel 2,5 %

25 mg/g

Gel

Kutan anvendelse

BE – Belgien

| Pharmapartner NV |
| --- |
| Bleyveldstraat 19 |
| 3320 Hoegaarden |
| Belgien |

Pharmapartner NV

Bleyveldstraat 19

3320 Hoegaarden

Belgien

Fastum gel

25 mg/g

Gel

Kutan anvendelse

BG – Bulgarien

| VET PROM JSCO |
| --- |
| 26, »Otez Paissij« street |
| 2400 Radomir |
| Bulgarien |

VET PROM JSCO

26, »Otez Paissij« street

2400 Radomir

Bulgarien

Ketoprofen Vetprom

2,5 %

Gel

Kutan anvendelse

BG – Bulgarien

| A.MENARINI Industrie Farmaceutiche Riunite s.r.l., (Menarini Group), |
| --- |
| Via Sette Santi 3, |
| 50131 Florence, |
| Italien |

A.MENARINI Industrie Farmaceutiche Riunite s.r.l., (Menarini Group),

Via Sette Santi 3,

50131 Florence,

Italien

Fastum

2,5 %

Gel

Kutan anvendelse

BG – Bulgarien

| Cyathus Exquirere Pharmaforschungs GmbH, |
| --- |
| Rudolfsplatz 2/1/8, |
| 1010 Vienna, |
| Østrig |

Cyathus Exquirere Pharmaforschungs GmbH,

Rudolfsplatz 2/1/8,

1010 Vienna,

Østrig

Ketospray

0,1 %

Kutanspray, opløsning

Kutan anvendelse

BG – Bulgarien

| Actavis |
| --- |
| 29, Atanas Dukov str. |
| 1407 Sofia |
| Bulgarien |

Actavis

29, Atanas Dukov str.

1407 Sofia

Bulgarien

Topogel

2,5 %

Gel

Kutan anvendelse

BG – Bulgarien

| Sanofi-aventis Bulgarien EOOD |
| --- |
| 103, Alexander Stamboliiski Bld. |
| Office Building Sofia Tower |
| Sofia 1303 |
| Bulgarien |

Sanofi-aventis Bulgarien EOOD

103, Alexander Stamboliiski Bld.

Office Building Sofia Tower

Sofia 1303

Bulgarien

Profenid

2,5 %

Gel

Kutan anvendelse

BG – Bulgarien

| Sopharma AD, |
| --- |
| 16 Iliensko Shousse Street |
| 1220 Sofia |
| Bulgarien |

Sopharma AD,

16 Iliensko Shousse Street

1220 Sofia

Bulgarien

Ketoprofen Sopharma

2,5 %

Gel

Kutan anvendelse

CY – Cypern

| A. Menarini Industrie Farmaceutiche Riunite SRL, |
| --- |
| Via Delle Sette Santi 3 |
| 50131 Florence |
| Italien |

A. Menarini Industrie Farmaceutiche Riunite SRL,

Via Delle Sette Santi 3

50131 Florence

Italien

FASTUM GEL 2,5 %

2,5 %

Gel

Kutan anvendelse

CZ – Den Tjekkiske republik

| A. Menarini Industrie Farmaceutiche Riunite S.r.l. |
| --- |
| Via Sette Santi 3, |
| 50131 Florencie |
| Italien |

A. Menarini Industrie Farmaceutiche Riunite S.r.l.

Via Sette Santi 3,

50131 Florencie

Italien

FASTUM GEL

25 mg (2,5 %)/gm

Gel

Kutan anvendelse

CZ – Den Tjekkiske republik

| CYATHUS Exquirere Pharmaforschungs GmbH, |
| --- |
| Rudolfsplatz 2/8, |
| 1010 Vienna, |
| Østrig |

CYATHUS Exquirere Pharmaforschungs GmbH,

Rudolfsplatz 2/8,

1010 Vienna,

Østrig

PRONTOFLEX 10 %

100 mg/ml

Kutanspray, opløsning

Kutan anvendelse

CZ – Den Tjekkiske republik

| Lek Pharmaceuticals d.d. |
| --- |
| Verovskova 57 |
| SI-1000 Ljubljana |
| Slovenien |

Lek Pharmaceuticals d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenien

KETONAL 5 % KRÉM

50 mg/g

Creme

Kutan anvendelse

CZ – Den Tjekkiske republik

| sanofi-aventis s.r.o., |
| --- |
| Evropská 846/176a, 160 00 |
| Prague 6 |
| Den Tjekkiske republik |

sanofi-aventis s.r.o.,

Evropská 846/176a, 160 00

Prague 6

Den Tjekkiske republik

PROFENID GEL

25 mg/g

Gel

Kutan anvendelse

CZ – Den Tjekkiske republik

| Hiamitsu UK Limited |
| --- |
| 500 Chiswick High Road |
| London W4 5RG |
| Storbrittanien |

Hiamitsu UK Limited

500 Chiswick High Road

London W4 5RG

Storbrittanien

KEPLAT

20 mg

Medicinsk plaster

Kutan anvendelse

DE – Tyskland

| HEXAL AG |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen, |
| Tyskland |

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen,

Tyskland

Advel Schmerzgel 2,5 % Gel

25 mg/g

Gel

Kutan anvendelse

DE – Tyskland

| Kreussler & Co. GmbH Chemische Fabrik |
| --- |
| Rheingaustr. 87-93 |
| D-65203 Wiesbaden |
| Tyskland |

Kreussler & Co. GmbH Chemische Fabrik

Rheingaustr. 87-93

D-65203 Wiesbaden

Tyskland

Phardol Schmerz-Gel

25 mg/g

Gel

Kutan anvendelse

DE – Tyskland

| Madaus GmbH |
| --- |
| Colonia-Allee 15 |
| D-51067 Köln |
| Tyskland |

Madaus GmbH

Colonia-Allee 15

D-51067 Köln

Tyskland

Reparil SchmerzGel

25 mg/g

Gel

Kutan anvendelse

DE – Tyskland

| McNeil GmbH & Co. oHG |
| --- |
| Johnson & Johnson Platz 2 |
| D-41470 Neuss, |
| Tyskland |

McNeil GmbH & Co. oHG

Johnson & Johnson Platz 2

D-41470 Neuss,

Tyskland

Dolormin Schmerzgel mit Ketoprofen 2,5 %

25 mg/g

Gel

Kutan anvendelse

DE – Tyskland

| TEOFARMA S.R.L. |
| --- |
| Via F.IIi Cervi 8 |
| I-27010 Valle Salimbene (PV) |
| Italien |

TEOFARMA S.R.L.

Via F.IIi Cervi 8

I-27010 Valle Salimbene (PV)

Italien

Effekton Gel mit Ketoprofen

25 mg/g

Gel

Kutan anvendelse

DK – Danmark

| A. Menarini Industrie Farmaceutiche Riunite S.r.l. |
| --- |
| Via Sette Santi 3 |
| IT-50131 Firenze |
| Italien |

A. Menarini Industrie Farmaceutiche Riunite S.r.l.

Via Sette Santi 3

IT-50131 Firenze

Italien

Fastum Gel

2,5 %

Gel

Kutan anvendelse

DK – Danmark

| Antula Healthcare AB |
| --- |
| Östermalmsgatan 19 |
| SE-11426 Stockholm |
| Sverige |

Antula Healthcare AB

Östermalmsgatan 19

SE-11426 Stockholm

Sverige

Zon

2,5 %

Gel

Kutan anvendelse

DK – Danmark

| Nordic Drugs AB, |
| --- |
| P.O. 30035, Geijersgatan 2A |
| SE-21618 Limhamn |
| Sverige |

Nordic Drugs AB,

P.O. 30035, Geijersgatan 2A

SE-21618 Limhamn

Sverige

Ketospray

100 mg/g

Kutanspray, opløsning

Kutan anvendelse

DK – Danmark

| Sanofi-Aventis |
| --- |
| Slotsmarken 13 |
| DK-2970 Hørsholm |
| Danmark |

Sanofi-Aventis

Slotsmarken 13

DK-2970 Hørsholm

Danmark

Orudis

25 mg/g

Gel

Kutan anvendelse

EE – Estland

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| 1000 Ljubljana |
| Slovenien |

Sandoz d.d.

Verovskova 57

1000 Ljubljana

Slovenien

KETONAL

25 mg/1mg

Gel

Kutan anvendelse

EE – Estland

| AS Grindeks |
| --- |
| Krustpils 53 |
| LV-1057 Riga |
| Letland |

AS Grindeks

Krustpils 53

LV-1057 Riga

Letland

BEGSAN

25 mg/1mg

Gel

Kutan anvendelse

EE – Estland

| Lorenzo Pharma OÜ |
| --- |
| Koidu 20-19 |
| 10136 Tallinn |
| Estland |

Lorenzo Pharma OÜ

Koidu 20-19

10136 Tallinn

Estland

PRONTOFLEX

100mg/1g

Kutanspray, opløsning

Kutan anvendelse

EE – Estland

| A. Menarini Industrie Farmaceutiche Riunite s.r.l. |
| --- |
| Via Sette Santi 3 |
| Florence |
| Italien |

A. Menarini Industrie Farmaceutiche Riunite s.r.l.

Via Sette Santi 3

Florence

Italien

FASTUM

25mg/1g

Gel

Kutan anvendelse

EE – Estland

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

Sanofi-Aventis Estland OÜ Pärnu mnt 139E/2

11317 Tallinn

Estland

PROFENID

25mg/1g

Gel

Kutan anvendelse

EL – Grækenland

| Uni-Pharma, Kleon Tsetis, Pharmaceutical Laboratories ABEE |
| --- |
| 14 Km National Highway |
| Athens-Lamia |
| Kifissia 14564 |
| Grækenland |

Uni-Pharma, Kleon Tsetis, Pharmaceutical Laboratories ABEE

14 Km National Highway

Athens-Lamia

Kifissia 14564

Grækenland

DRASTIREL

2,5 %

Creme

Kutan anvendelse

EL – Grækenland

| Guidotti Hellas AE |
| --- |
| An. Damvergi 7 |
| Athens 10445 |
| Grækenland |

Guidotti Hellas AE

An. Damvergi 7

Athens 10445

Grækenland

MENARIL

2,5 %

Gel

Kutan anvendelse

ES – Spanien

| LABORATORIOS MILO, S.A. |
| --- |
| Los Angeles, 60. Pol. Ind. Centrovía |
| La Muela. 50196 Zaragoza |
| Spanien |

LABORATORIOS MILO, S.A.

Los Angeles, 60. Pol. Ind. Centrovía

La Muela. 50196 Zaragoza

Spanien

Arcental crema

10 mg/g

Creme

Kutan anvendelse

ES – Spanien

| Laboratorios Menarini, |
| --- |
| S.A. Alfonso XII, 587 |
| 08918 Badalona (Barcelona) |
| Spanien |

Laboratorios Menarini,

S.A. Alfonso XII, 587

08918 Badalona (Barcelona)

Spanien

Fastum gel

25 mg/g

Gel

Kutan anvendelse

ES – Spanien

| Pierre Fabre Ibérica S.A. |
| --- |
| Ramón Trías Fargas, 7-11 |
| 08005 Barcelona |
| Spanien |

Pierre Fabre Ibérica S.A.

Ramón Trías Fargas, 7-11

08005 Barcelona

Spanien

Extraplus gel

25 mg/g

Gel

Kutan anvendelse

ES – Spanien

| Sanofi Aventis S.A. |
| --- |
| Josep Plá, 2 |
| 08019 Barcelona |
| Spanien |

Sanofi Aventis S.A.

Josep Plá, 2

08019 Barcelona

Spanien

Orudis gel

25 mg/g

Gel

Kutan anvendelse

FI – Finland

| Antula Healthcare AB, |
| --- |
| Östermalmsgatan 19 |
| 114 26 Stockholm |
| Sverige |

Antula Healthcare AB,

Östermalmsgatan 19

114 26 Stockholm

Sverige

ZON

2,5 %

Gel

Kutan anvendelse

FI – Finland

| Orion Oyj, |
| --- |
| Orionintie 1 |
| 02101 Espoo |
| Finland |

Orion Oyj,

Orionintie 1

02101 Espoo

Finland

KETORIN

2,5 %

Gel

Kutan anvendelse

FI – Finland

| sanofi-aventis Oy, |
| --- |
| Huopalahdentie 24 |
| 00351 Helsinki |
| Finland |

sanofi-aventis Oy,

Huopalahdentie 24

00351 Helsinki

Finland

ORUDIS

2,5 %

Gel

Kutan anvendelse

FR – Frankrig

| Arrow Generiques |
| --- |
| 26 Avenue Tony Garnier |
| 69 007 Lyon |
| Frankrig |

Arrow Generiques

26 Avenue Tony Garnier

69 007 Lyon

Frankrig

KETOPROFENE ARROW

2,5 %

Gel, 60 g tube

Kutan anvendelse

FR – Frankrig

| Biogaran |
| --- |
| 15 Boulevard Charles de Gaulle |
| 92 700 Colombes |
| Frankrig |

Biogaran

15 Boulevard Charles de Gaulle

92 700 Colombes

Frankrig

KETOPROFENE BIOGARAN

2,5 %

Gel, 60 g tube

Kutan anvendelse

FR – Frankrig

| Biogaran |
| --- |
| 15 Boulevard Charles de Gaulle |
| 92 700 Colombes |
| Frankrig |

Biogaran

15 Boulevard Charles de Gaulle

92 700 Colombes

Frankrig

KETOPROFENE BGR

2,5 %

Gel, 60 g tube

Kutan anvendelse

FR – Frankrig

| Biogaran |
| --- |
| 15 Boulevard Charles de Gaulle |
| 92 700 Colombes |
| Frankrig |

Biogaran

15 Boulevard Charles de Gaulle

92 700 Colombes

Frankrig

KETOPROFENE BGR

2,5 %

Gel, 120 g tube

Kutan anvendelse

FR – Frankrig

| Biogaran |
| --- |
| 15 Boulevard Charles de Gaulle |
| 92 700 Colombes |
| Frankrig |

Biogaran

15 Boulevard Charles de Gaulle

92 700 Colombes

Frankrig

KETOPROFENE BGR

2,5 %

Gel, 120 g doseringstube

Kutan anvendelse

FR – Frankrig

| Cediat Mediffusion |
| --- |
| 11 bis rue du Colisée |
| 75 008 PARIS |
| Frankrig |

Cediat Mediffusion

11 bis rue du Colisée

75 008 PARIS

Frankrig

KETOPROFENE MEDIFFUSION

2,5 %

Gel, 60 g tube

Kutan anvendelse

FR – Frankrig

| Cediat Mediffusion |
| --- |
| 11 bis rue du Colisée |
| 75 008 PARIS |
| Frankrig |

Cediat Mediffusion

11 bis rue du Colisée

75 008 PARIS

Frankrig

KETOPROFENE MEDIFFUSION

2,5 %

Gel, 120 g tube

Kutan anvendelse

FR – Frankrig

| EG LABO |
| --- |
| Laboratoires EuroGenerics |
| »Le Quintet« Bât.A |
| 12 rue Danjou |
| 92 517 Boulogne |
| Billancourt Cedex |
| Frankrig |

EG LABO

Laboratoires EuroGenerics

»Le Quintet« Bât.A

12 rue Danjou

92 517 Boulogne

Billancourt Cedex

Frankrig

KETOPROFENE EG

2,5 %

Gel, 60 g tube

Kutan anvendelse

FR – Frankrig

| EG LABO |
| --- |
| Laboratoires EuroGenerics |
| »Le Quintet« Bât.A |
| 12 rue Danjou |
| 92 517 Boulogne Billancourt Cedex |
| Frankrig |

EG LABO

Laboratoires EuroGenerics

»Le Quintet« Bât.A

12 rue Danjou

92 517 Boulogne Billancourt Cedex

Frankrig

KETOPROFENE EG

2,5 %

Gel, 120 g tube

Kutan anvendelse

FR – Frankrig

| EG LABO |
| --- |
| Laboratoires EuroGenerics |
| »Le Quintet« Bât.A |
| 12 rue Danjou |
| 92 517 Boulogne Billancourt Cedex |
| Frankrig |

EG LABO

Laboratoires EuroGenerics

»Le Quintet« Bât.A

12 rue Danjou

92 517 Boulogne Billancourt Cedex

Frankrig

KETOPROFENE EG

2,5 %

Gel, 120 g tube (HDPE)

Kutan anvendelse

FR – Frankrig

| MENARINI Frankrig |
| --- |
| 1/7, rue du Jura |
| Zone Silic – Rungis |
| 91320 WISSOUS |
| Frankrig |

MENARINI Frankrig

1/7, rue du Jura

Zone Silic – Rungis

91320 WISSOUS

Frankrig

KETUM

2,5 %

Gel, 50 g aluminium tube

Kutan anvendelse

FR – Frankrig

| MENARINI Frankrig |
| --- |
| 1/7, rue du Jura |
| Zone Silic – Rungis |
| 91320 WISSOUS |
| Frankrig |

MENARINI Frankrig

1/7, rue du Jura

Zone Silic – Rungis

91320 WISSOUS

Frankrig

KETUM

2,5 %

Gel, 60 g aluminium tube

Kutan anvendelse

FR – Frankrig

| MENARINI Frankrig |
| --- |
| 1/7, rue du Jura |
| Zone Silic – Rungis |
| 91320 WISSOUS |
| Frankrig |

MENARINI Frankrig

1/7, rue du Jura

Zone Silic – Rungis

91320 WISSOUS

Frankrig

KETUM

2,5 %

Gel, 70 g aluminium tube

Kutan anvendelse

FR – Frankrig

| MENARINI Frankrig |
| --- |
| 1/7, rue du Jura |
| Zone Silic – Rungis |
| 91320 WISSOUS |
| Frankrig |

MENARINI Frankrig

1/7, rue du Jura

Zone Silic – Rungis

91320 WISSOUS

Frankrig

KETUM

2,5 %

Gel, 60 g polyethylen-polypropylen-polyacetal tube

Kutan anvendelse

FR – Frankrig

| MENARINI Frankrig |
| --- |
| 1/7, rue du Jura |
| Zone Silic – Rungis |
| 91320 WISSOUS |
| Frankrig |

MENARINI Frankrig

1/7, rue du Jura

Zone Silic – Rungis

91320 WISSOUS

Frankrig

KETUM

2,5 %

Gel, 120 g polyethylen-polypropylen-polyacetal tube

Kutan anvendelse

FR – Frankrig

| MENARINI Frankrig |
| --- |
| 1/7, rue du Jura |
| Zone Silic – Rungis |
| 91320 WISSOUS |
| Frankrig |

MENARINI Frankrig

1/7, rue du Jura

Zone Silic – Rungis

91320 WISSOUS

Frankrig

KETUM

2,5 %

Gel, 70 g polyethylen-polypropylen-polyacetal tube

Kutan anvendelse

FR – Frankrig

| MENARINI Frankrig |
| --- |
| 1/7, rue du Jura |
| Zone Silic – Rungis |
| 91320 WISSOUS |
| Frankrig |

MENARINI Frankrig

1/7, rue du Jura

Zone Silic – Rungis

91320 WISSOUS

Frankrig

KETOPROFENE MENARINI

2,5 %

Gel, 50 g aluminium tube

Kutan anvendelse

FR – Frankrig

| MENARINI Frankrig |
| --- |
| 1/7, rue du Jura |
| Zone Silic – Rungis |
| 91320 WISSOUS |
| Frankrig |

MENARINI Frankrig

1/7, rue du Jura

Zone Silic – Rungis

91320 WISSOUS

Frankrig

KETOPROFENE MENARINI

2,5 %

gel, 60 g aluminium tube

Kutan anvendelse

FR – Frankrig

| MENARINI Frankrig |
| --- |
| 1/7, rue du Jura |
| Zone Silic – Rungis |
| 91320 WISSOUS |
| Frankrig |

MENARINI Frankrig

1/7, rue du Jura

Zone Silic – Rungis

91320 WISSOUS

Frankrig

KETOPROFENE MENARINI

2,5 %

gel, 70 g aluminium tube

Kutan anvendelse

FR – Frankrig

| Mylan SAS |
| --- |
| 117 allée des Parcs |
| 69 800 Saint Priest |
| Frankrig |

Mylan SAS

117 allée des Parcs

69 800 Saint Priest

Frankrig

KETOPROFENE MYLAN

2,5 %

gel, 60 g tube

Kutan anvendelse

FR – Frankrig

| Mylan SAS |
| --- |
| 117 allée des Parcs |
| 69 800 Saint Priest |
| Frankrig |

Mylan SAS

117 allée des Parcs

69 800 Saint Priest

Frankrig

KETOPROFENE MYLAN

2,5 %

gel, 120 g tube

Kutan anvendelse

FR – Frankrig

| Mylan SAS |
| --- |
| 117 allée des Parcs |
| 69 800 Saint Priest |
| Frankrig |

Mylan SAS

117 allée des Parcs

69 800 Saint Priest

Frankrig

KETOPROFENE MYLAN

2,5 %

gel, 60 g doseringstube

Kutan anvendelse

FR – Frankrig

| Mylan SAS |
| --- |
| 117 allée des Parcs |
| 69 800 Saint Priest |
| Frankrig |

Mylan SAS

117 allée des Parcs

69 800 Saint Priest

Frankrig

KETOPROFENE MYLAN

2,5 %

gel, 120 g doseringstube

Kutan anvendelse

FR – Frankrig

| Mylan SAS |
| --- |
| 117 allée des Parcs |
| 69 800 Saint Priest |
| Frankrig |

Mylan SAS

117 allée des Parcs

69 800 Saint Priest

Frankrig

KETOPROFENE MYLAN PHARMA

2,5 %

gel, 60 g tube

Kutan anvendelse

FR – Frankrig

| Mylan SAS |
| --- |
| 117 allée des Parcs |
| 69 800 Saint Priest |
| Frankrig |

Mylan SAS

117 allée des Parcs

69 800 Saint Priest

Frankrig

KETOPROFENE MYLAN PHARMA

2,5 %

gel, 120 g tube

Kutan anvendelse

FR – Frankrig

| Mylan SAS |
| --- |
| 117 allée des Parcs |
| 69 800 Saint Priest |
| Frankrig |

Mylan SAS

117 allée des Parcs

69 800 Saint Priest

Frankrig

KETOPROFENE QUALIHEALTH

2,5 %

gel, 60 g tube

Kutan anvendelse

FR – Frankrig

| Mylan SAS |
| --- |
| 117 allée des Parcs |
| 69 800 Saint Priest |
| Frankrig |

Mylan SAS

117 allée des Parcs

69 800 Saint Priest

Frankrig

KETOPROFENE QUALIHEALTH

2,5 %

gel, 120 g tube

Kutan anvendelse

FR – Frankrig

| Qualimed |
| --- |
| 117 allée des Parcs |
| 69 800 SAINT PRIEST |
| Frankrig |

Qualimed

117 allée des Parcs

69 800 SAINT PRIEST

Frankrig

KETOPROFENE QUALIMED

2,5 %

gel, 60 g tube

Kutan anvendelse

FR – Frankrig

| Qualimed |
| --- |
| 117 allée des Parcs |
| 69 800 SAINT PRIEST |
| Frankrig |

Qualimed

117 allée des Parcs

69 800 SAINT PRIEST

Frankrig

KETOPROFENE QUALIMED

2,5 %

gel, 120 g tube

Kutan anvendelse

FR – Frankrig

| Qualimed |
| --- |
| 117 allée des Parcs |
| 69 800 SAINT PRIEST |
| Frankrig |

Qualimed

117 allée des Parcs

69 800 SAINT PRIEST

Frankrig

KETOPROFENE QUALIMED

2,5 %

gel, 60 g doseringstube

Kutan anvendelse

FR – Frankrig

| Qualimed |
| --- |
| 117 allée des Parcs |
| 69 800 SAINT PRIEST |
| Frankrig |

Qualimed

117 allée des Parcs

69 800 SAINT PRIEST

Frankrig

KETOPROFENE QUALIMED

2,5 %

gel, 120 g doseringstube

Kutan anvendelse

FR – Frankrig

| RPG Ranbaxy |
| --- |
| Pharmacie Génériques |
| 4, Place Louis Armand |
| 75012 PARIS |
| Frankrig |

RPG Ranbaxy

Pharmacie Génériques

4, Place Louis Armand

75012 PARIS

Frankrig

KETOPROFENE RPG

2,5 %

gel, 60 g tube

Kutan anvendelse

FR – Frankrig

| Ratiopharm |
| --- |
| 19 boulevard Paul Vaillant Couturier |
| 94 200 IVRY sur Seine |
| Frankrig |

Ratiopharm

19 boulevard Paul Vaillant Couturier

94 200 IVRY sur Seine

Frankrig

KETOPROFENE RATIOPHARM

2,5 %

gel, 60 g tube

Kutan anvendelse

FR – Frankrig

| Ratiopharm |
| --- |
| 19 boulevard Paul Vaillant Couturier |
| 94 200 IVRY sur Seine |
| Frankrig |

Ratiopharm

19 boulevard Paul Vaillant Couturier

94 200 IVRY sur Seine

Frankrig

KETOPROFENE RATIOPHARM

2,5 %

gel, 120 g tube

Kutan anvendelse

FR – Frankrig

| Ratiopharm |
| --- |
| 19 boulevard Paul Vaillant Couturier |
| 94 200 IVRY sur Seine |
| Frankrig |

Ratiopharm

19 boulevard Paul Vaillant Couturier

94 200 IVRY sur Seine

Frankrig

KETOPROFENE RATIO

2,5 %

gel, 60 g tube

Kutan anvendelse

FR – Frankrig

| Ratiopharm |
| --- |
| 19 boulevard Paul Vaillant Couturier |
| 94 200 IVRY sur Seine |
| Frankrig |

Ratiopharm

19 boulevard Paul Vaillant Couturier

94 200 IVRY sur Seine

Frankrig

KETOPROFENE RATIO

2,5 %

gel, 120 g tube

Kutan anvendelse

FR – Frankrig

| Ratiopharm |
| --- |
| 19 boulevard Paul Vaillant Couturier |
| 94 200 IVRY sur Seine |
| Frankrig |

Ratiopharm

19 boulevard Paul Vaillant Couturier

94 200 IVRY sur Seine

Frankrig

KETOPROFENE RATIO

2,5 %

gel, 120 g doseringstube

Kutan anvendelse

FR – Frankrig

| Sandoz |
| --- |
| 49 Avenue Georges Pomidou |
| 92 300 Levallois Perret |
| Frankrig |

Sandoz

49 Avenue Georges Pomidou

92 300 Levallois Perret

Frankrig

KETOPROFENE SANDOZ

2,5 %

gel, 60 g tube

Kutan anvendelse

FR – Frankrig

| Sandoz |
| --- |
| 49 Avenue Georges Pomidou |
| 92 300 Levallois Perret |
| Frankrig |

Sandoz

49 Avenue Georges Pomidou

92 300 Levallois Perret

Frankrig

KETOPROFENE SANDOZ

2,5 %

gel, 120 g tube

Kutan anvendelse

FR – Frankrig

| Sandoz |
| --- |
| 49 Avenue Georges Pomidou |
| 92 300 Levallois Perret |
| Frankrig |

Sandoz

49 Avenue Georges Pomidou

92 300 Levallois Perret

Frankrig

KETOPROFENE SANDOZ

2,5 %

gel, 120 g doseringstube

Kutan anvendelse

FR – Frankrig

| Sanofi Aventis Frankrig |
| --- |
| 1-13 Boulevard Romain Rolland |
| 75 014 PARIS |
| Frankrig |

Sanofi Aventis Frankrig

1-13 Boulevard Romain Rolland

75 014 PARIS

Frankrig

TOPREC

2,5 %

gel, 60 g tube

Kutan anvendelse

FR – Frankrig

| Sanofi Aventis Frankrig |
| --- |
| 1-13 Boulevard Romain Rolland |
| 75 014 PARIS |
| Frankrig |

Sanofi Aventis Frankrig

1-13 Boulevard Romain Rolland

75 014 PARIS

Frankrig

KETOPROFEN E WINTHROP

2,5 %

gel, 60 g tube

Kutan anvendelse

FR – Frankrig

| Societe Agipharma |
| --- |
| 40 rue des Bergers |
| 75 015 Paris |
| Frankrig |

Societe Agipharma

40 rue des Bergers

75 015 Paris

Frankrig

KETOPROFENE AGIPHARMA

2,5 %

gel, 60 g tube

Kutan anvendelse

FR – Frankrig

| Societe Agipharma |
| --- |
| 40 rue des Bergers |
| 75 015 Paris |
| Frankrig |

Societe Agipharma

40 rue des Bergers

75 015 Paris

Frankrig

KETOPROFENE AGIPHARMA

2,5 %

gel, 120 g tube

Kutan anvendelse

FR – Frankrig

| Laboratoire Teva Sante |
| --- |
| Le Palatin 1 |
| 1 cours du Triangle |
| 92 936 Paris La Défense Cedex |
| Frankrig |

Laboratoire Teva Sante

Le Palatin 1

1 cours du Triangle

92 936 Paris La Défense Cedex

Frankrig

KETOPROFENE TEVA

2,5 %

gel, 60 g tube

Kutan anvendelse

FR – Frankrig

| Laboratoire Teva Sante |
| --- |
| Le Palatin 1 |
| 1 cours du Triangle |
| 92 936 Paris La Défense Cedex |
| Frankrig |

Laboratoire Teva Sante

Le Palatin 1

1 cours du Triangle

92 936 Paris La Défense Cedex

Frankrig

KETOPROFENE TEVA SANTE

2,5 %

gel, 60 g tube

Kutan anvendelse

FR – Frankrig

| Laboratoire Teva Sante |
| --- |
| Le Palatin 1 |
| 1 cours du Triangle |
| 92 936 Paris La Défense Cedex |
| Frankrig |

Laboratoire Teva Sante

Le Palatin 1

1 cours du Triangle

92 936 Paris La Défense Cedex

Frankrig

KETOPROFENE TEVA SANTE

2,5 %

gel, 120 g tube

Kutan anvendelse

FR – Frankrig

| Laboratoire Teva Sante |
| --- |
| Le Palatin 1 |
| 1 cours du Triangle |
| 92 936 Paris La Défense Cedex |
| Frankrig |

Laboratoire Teva Sante

Le Palatin 1

1 cours du Triangle

92 936 Paris La Défense Cedex

Frankrig

KETOPROFENE TEVA SANTE

2,5 %

gel, 120 g doseringstube

Kutan anvendelse

FR – Frankrig

| Zydus Frankrig |
| --- |
| 25 rue des Peupliers/ZAC Les Hautes Pâtures |
| Parc d'acticité des Peupliers |
| 92 000 Nanterre |
| Frankrig |

Zydus Frankrig

25 rue des Peupliers/ZAC Les Hautes Pâtures

Parc d'acticité des Peupliers

92 000 Nanterre

Frankrig

KETOPROFENE ZYDUS

2,5 %

gel, 60 g tube

Kutan anvendelse

HU – Ungarn

| A. Menarini Industrie Farnaceutiche Riunite s.r.l. |
| --- |
| Via Sette Santi 3, |
| 50131 Florence |
| Italien |

A. Menarini Industrie Farnaceutiche Riunite s.r.l.

Via Sette Santi 3,

50131 Florence

Italien

FASTUM

25 mg/g

Gel

Kutan anvendelse

HU – Ungarn

| Goodwill Pharma Kft. |
| --- |
| Cserzy Mihály u. 32 |
| 6724 Szeged |
| Ungarn |

Goodwill Pharma Kft.

Cserzy Mihály u. 32

6724 Szeged

Ungarn

KETOSPRAY

100 mg/g

Kutanspray, opløsning

Kutan anvendelse

HU – Ungarn

| Hisamitsu UK Ltd. |
| --- |
| 500 Chiswick High Road |
| London W4 5RG |
| Storbritannien |

Hisamitsu UK Ltd.

500 Chiswick High Road

London W4 5RG

Storbritannien

KEPLAT

20 mg

Medicinsk plaster

Transdermal anvendelse

HU – Ungarn

| sanofi-aventis zrt. |
| --- |
| Tó u. 1-5 |
| 1045 Budapest |
| Ungarn |

sanofi-aventis zrt.

Tó u. 1-5

1045 Budapest

Ungarn

ALGOFLEX GEL

25 mg/g

Gel

Kutan anvendelse

IE – Irland

| A. Menarini Srl |
| --- |
| 1-3 Via Sette Santi |
| P.O.Box 412 |
| Florence |
| Italien |

A. Menarini Srl

1-3 Via Sette Santi

P.O.Box 412

Florence

Italien

Fastum 2,5 % w/w Gel

2,5 % w/w

Gel

Kutan anvendelse

IE – Irland

| Sanofi-Aventis Irland Ltd. |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| Irland |

Sanofi-Aventis Irland Ltd.

Citywest Business Campus

Dublin 24

Irland

Orugesic 2,5 % w/w Gel

2,5 % w/w

Gel

Kutan anvendelse

IE – Irland

| Sanofi-Aventis Irland Ltd. |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| Irland |

Sanofi-Aventis Irland Ltd.

Citywest Business Campus

Dublin 24

Irland

Oruvail 2,5 % w/w Gel

2,5 % w/w

Gel

Kutan anvendelse

IS – Island

| Sanofi-aventis Norge AS, |
| --- |
| Strandveien 15, Box 133 |
| 1325 Lysaker |
| Norge |

Sanofi-aventis Norge AS,

Strandveien 15, Box 133

1325 Lysaker

Norge

Orudis

25 mg/g

Gel

Kutan anvendelse

IT – Italien

| A.Menarini |
| --- |
| Ind.Farm.Riun.Srl |
| Via Sette Santi, 3 |
| 50131 – Firenze |
| Italien |

A.Menarini

Ind.Farm.Riun.Srl

Via Sette Santi, 3

50131 – Firenze

Italien

Fastum

2,5 %

Gel

Kutan anvendelse

IT – Italien

| A.Menarini |
| --- |
| Ind.Farm.Riun.Srl |
| Via Sette Santi, 3 |
| 50131 – Firenze |
| Italien |

A.Menarini

Ind.Farm.Riun.Srl

Via Sette Santi, 3

50131 – Firenze

Italien

Fastum

2,5 %

Kutanspray, opløsning

Kutan anvendelse

IT – Italien

| Almus Srl |
| --- |
| Via Cesarea, 11/10 |
| 16121 Genova |
| Italien |

Almus Srl

Via Cesarea, 11/10

16121 Genova

Italien

Ketoprofene Almus

5 %

Gel

Kutan anvendelse

IT – Italien

| Bayer S.p.A. |
| --- |
| Viale Certosa, 130 |
| 20156 Milano |
| Italien |

Bayer S.p.A.

Viale Certosa, 130

20156 Milano

Italien

Lasonil

2,5 %

Gel

Kutan anvendelse

IT – Italien

| Bayer S.p.A. |
| --- |
| Viale Certosa, 130 |
| 20156 Milano |
| Italien |

Bayer S.p.A.

Viale Certosa, 130

20156 Milano

Italien

Lasoartro

5 %

Creme

Kutan anvendelse

IT – Italien

| Crinos S.p.A. |
| --- |
| Via Pavia, 6 |
| 20136 Milano |
| Italien |

Crinos S.p.A.

Via Pavia, 6

20136 Milano

Italien

Hiruflog

5 %

Gel

Kutan anvendelse

IT – Italien

| Dompè Farmaceutici S.p.A. |
| --- |
| Via San Martino, 12-12/A |
| 20122 Milano |
| Italien |

Dompè Farmaceutici S.p.A.

Via San Martino, 12-12/A

20122 Milano

Italien

Artrosilene

5 %

Gel

Kutan anvendelse

IT – Italien

| Dompè Farmaceutici S.p.A. |
| --- |
| Via San Martino, 12-12/A |
| 20122 Milano |
| Italien |

Dompè Farmaceutici S.p.A.

Via San Martino, 12-12/A

20122 Milano

Italien

Artrosilene

15 %

Kutanskum

Kutan anvendelse

IT – Italien

| Dompè S.p.A. |
| --- |
| Via Campo di Pile |
| 67100 L'Aquila |
| Italien |

Dompè S.p.A.

Via Campo di Pile

67100 L'Aquila

Italien

Oki

15 %

Gel

Kutan anvendelse

IT – Italien

| Eg S.p.A. |
| --- |
| Via Domenico Scarlatti, 31 |
| 20124 Milano |
| Italien |

Eg S.p.A.

Via Domenico Scarlatti, 31

20124 Milano

Italien

Ketoprofene Eurogenerici

5 %

Gel

Kutan anvendelse

IT – Italien

| Hisamitsu UK Limited |
| --- |
| 500 Chiswick Higth Road |
| London |
| Storbritannien |

Hisamitsu UK Limited

500 Chiswick Higth Road

London

Storbritannien

Keplat

20 mg

Medicinsk plaster

Kutan anvendelse

IT – Italien

| I.B.I.Giovanni Lorenzini SpA |
| --- |
| Via Fossignano, 2 |
| 04011 Aprilia (LT) |
| Italien |

I.B.I.Giovanni Lorenzini SpA

Via Fossignano, 2

04011 Aprilia (LT)

Italien

Ibifen

5 %

Gel

Kutan anvendelse

IT – Italien

| I.B.I.Giovanni Lorenzini SpA |
| --- |
| Via Fossignano, 2 |
| 04011 Aprilia (LT) |
| Italien |

I.B.I.Giovanni Lorenzini SpA

Via Fossignano, 2

04011 Aprilia (LT)

Italien

Ibifen

5 %

Kutan opløsning

Kutan anvendelse

IT – Italien

| Italfarmaco S.p.A. |
| --- |
| Viale Fulvio Testi, 330 |
| 20126 Milano |
| Italien |

Italfarmaco S.p.A.

Viale Fulvio Testi, 330

20126 Milano

Italien

Flexen

2,5 %

Gel

Kutan anvendelse

IT – Italien

| Italfarmaco S.p.A. |
| --- |
| Viale Fulvio Testi, 330 |
| 20126 Milano |
| Italien |

Italfarmaco S.p.A.

Viale Fulvio Testi, 330

20126 Milano

Italien

Flexen

5 %

Gel

Kutan anvendelse

IT – Italien

| Ratiopharm Italia Srl |
| --- |
| Centro Direzionale Milanofiori |
| 20131 Assago (MI) |
| Italien |

Ratiopharm Italia Srl

Centro Direzionale Milanofiori

20131 Assago (MI)

Italien

Ketoprofene Ratiopharm Italia

2,5 %

Gel

Kutan anvendelse

IT – Italien

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

Sandoz S.p.A.

Largo Boccioni, 1

21040 Origgio (VA),

Italien

Ketoprofene Sandoz

5 %

Creme

Kutan anvendelse

IT – Italien

| Sanofi-Aventis S.p.A. |
| --- |
| Viale Bodio, 37/B |
| 20158 Milano |
| Italien |

Sanofi-Aventis S.p.A.

Viale Bodio, 37/B

20158 Milano

Italien

Liotondol

2,5 %

Gel

Kutan anvendelse

IT – Italien

| Sanofi-Aventis S.p.A. |
| --- |
| Viale Bodio, 37/B |
| 20158 Milano |
| Italien |

Sanofi-Aventis S.p.A.

Viale Bodio, 37/B

20158 Milano

Italien

Orudis

2,5 %

Gel

Kutan anvendelse

IT – Italien

| Sanofi-Aventis S.p.A. |
| --- |
| Viale Bodio, 37/B |
| 20158 Milano |
| Italien |

Sanofi-Aventis S.p.A.

Viale Bodio, 37/B

20158 Milano

Italien

Orudis

5 %

Gel

Kutan anvendelse

IT – Italien

| Sanofi-Aventis S.p.A. |
| --- |
| Viale Bodio, 37/B |
| 20158 Milano |
| Italien |

Sanofi-Aventis S.p.A.

Viale Bodio, 37/B

20158 Milano

Italien

Orudis

1 %

Creme

Kutan anvendelse

IT – Italien

| Sanofi-Aventis S.p.A. |
| --- |
| Viale Bodio, 37/B |
| 20158 Milano |
| Italien |

Sanofi-Aventis S.p.A.

Viale Bodio, 37/B

20158 Milano

Italien

Orudis

2,5 %

Creme

Kutan anvendelse

IT – Italien

| Teikoku Pharma UK Ltd |
| --- |
| 7 Floor, Central House |
| Ballard Lane, Finchley |
| London |
| Storbritannien |

Teikoku Pharma UK Ltd

7 Floor, Central House

Ballard Lane, Finchley

London

Storbritannien

Ketofarm

5 %

Gel

Kutan anvendelse

IT – Italien

| Teva Italia Srl |
| --- |
| Via Messina, 38 |
| 20154 Milano |
| Italien |

Teva Italia Srl

Via Messina, 38

20154 Milano

Italien

Ketoprofene Teva

5 %

Gel

Kutan anvendelse

LT – Litauen

| A. Menarini Industrie Farmaceutiche Riunite s.r.l. 3 |
| --- |
| Via Sette Santi Florence |
| Italien |

A. Menarini Industrie Farmaceutiche Riunite s.r.l. 3

Via Sette Santi Florence

Italien

Fastum

25 mg/g

Gel

Kutan anvendelse

LT – Litauen

| GlaxoSmithKline Lietuva UAB |
| --- |
| A. Goštauto 40A |
| LT-01112 Vilnius |
| Litauen |

GlaxoSmithKline Lietuva UAB

A. Goštauto 40A

LT-01112 Vilnius

Litauen

Spinax

25 mg/g

Gel

Kutan anvendelse

LT – Litauen

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| 1000 Ljubljana |
| Slovenien |

Sandoz d.d.

Verovskova 57

1000 Ljubljana

Slovenien

Ketonal

25 mg/g

Gel

Kutan anvendelse

LT – Litauen

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

Sandoz d.d.,

Verovskova 57

1000 Ljubljana

Slovenien

Ketonal

50 mg/g

Creme

Kutan anvendelse

LT – Litauen

| UAB MRA |
| --- |
| Totorių 20-9 |
| LT-01121 Vilnius |
| Litauen |

UAB MRA

Totorių 20-9

LT-01121 Vilnius

Litauen

Ketospray

100 mg/g

Kutanspray, opløsning

Kutan anvendelse

LU – Luxembourg

| MENARINI BENELUX SA |
| --- |
| Belgicastraat 4 |
| B- 1930 Zaventem |
| Belgien |

MENARINI BENELUX SA

Belgicastraat 4

B- 1930 Zaventem

Belgien

FASTUM

0,025

Gel

Kutan anvendelse

LV – Letland

| A. Menarini Industrie Farmaceutiche Riunite s.r.l. (Menarini Group), |
| --- |
| Via Sette Santi 3 |
| Florence, I - 50131 |
| Italien |

A. Menarini Industrie Farmaceutiche Riunite s.r.l. (Menarini Group),

Via Sette Santi 3

Florence, I - 50131

Italien

Fastum 2,5 % gel

25 mg/g

Gel

Kutan anvendelse

LV – Letland

| GlaxoSmithKline Letland SIA |
| --- |
| Bruņinieku iela 5 |
| Rīga, LV-1001 |
| Letland |

GlaxoSmithKline Letland SIA

Bruņinieku iela 5

Rīga, LV-1001

Letland

Spinax 25 mg/g gel

25 mg/g

Gel

Kutan anvendelse

LV – Letland

| Sandoz d.d. |
| --- |
| Verovškova 57 |
| Ljubljana Sl – 1000 |
| Slovenien |

Sandoz d.d.

Verovškova 57

Ljubljana Sl – 1000

Slovenien

Ketonal 2,5 % gel

25 mg/g

Gel

Kutan anvendelse

LV – Letland

| Sanofi-aventis Letland SIA, |
| --- |
| Kr.Valdemāra 33-8 |
| Rīga, LV-1010 |
| Letland |

Sanofi-aventis Letland SIA,

Kr.Valdemāra 33-8

Rīga, LV-1010

Letland

Profenid 25 mg/g gel

25 mg/g

Gel

Kutan anvendelse

MT – Malta

| A. Menarini industrie farmaceutici riunite S.R.L. |
| --- |
| Via Sette Santi, 3 |
| 50131, Florence |
| Italien |

A. Menarini industrie farmaceutici riunite S.R.L.

Via Sette Santi, 3

50131, Florence

Italien

Fastum gel 2,5 % w/w

0,025

Gel

Kutan anvendelse

MT – Malta

| A. Menarini industrie farmaceutici riunite S.R.L. |
| --- |
| Via Sette Santi, 3 |
| 50131, Florence |
| Italien |

A. Menarini industrie farmaceutici riunite S.R.L.

Via Sette Santi, 3

50131, Florence

Italien

Fastum gel 2,5 % w/w Dispenser

0,025

Gel

Kutan anvendelse

MT – Malta

| Dompé Farmaceutici SPA |
| --- |
| Via San Martino 12 |
| 20122, Milan |
| Italien |

Dompé Farmaceutici SPA

Via San Martino 12

20122, Milan

Italien

Artrosilene 15 % Kutanskum

15 g/100ml

Kutanskum

Kutan anvendelse

MT – Malta

| Dompé Farmaceutici SPA |
| --- |
| Via San Martino 12 |
| 20122, Milan |
| Italien |

Dompé Farmaceutici SPA

Via San Martino 12

20122, Milan

Italien

Artrosilene 5 % gel

5 g/100g

Gel

Kutan anvendelse

MT – Malta

| Sanofi Aventis Malta ltd. |
| --- |
| Triq Kanonku K. Pirotta |
| Bkara BKR1114 |
| Malta |

Sanofi Aventis Malta ltd.

Triq Kanonku K. Pirotta

Bkara BKR1114

Malta

Profenid gel 2,5 % w/w

0,025

Gel

Kutan anvendelse

NO – Norge

| Antula Healthcare AB |
| --- |
| Östermalmsgatan 19, |
| 114 26 Stockholm |
| Sverige |

Antula Healthcare AB

Östermalmsgatan 19,

114 26 Stockholm

Sverige

Zon

2,5 %

Gel

Kutan anvendelse

NO – Norge

| Sanofi-Aventis |
| --- |
| Strandveien 15 |
| 1366 Lysaker |
| Norge |

Sanofi-Aventis

Strandveien 15

1366 Lysaker

Norge

Orudis

2,5 %

Gel

Kutan anvendelse

PL – Polen

| A.Menarini Pharmaceutical Industries Group Ltd. |
| --- |
| 3 Via Sette Santi |
| I-50 131 Florence |
| Italien |

A.Menarini Pharmaceutical Industries Group Ltd.

3 Via Sette Santi

I-50 131 Florence

Italien

Fastum

25 mg/g

Gel

Kutan anvendelse

PL – Polen

| GlaxoSmithKline Pharmaceuticals S.A |
| --- |
| Grunwaldzka st. 189 |
| 60-322 Poznań |
| Polen |

GlaxoSmithKline Pharmaceuticals S.A

Grunwaldzka st. 189

60-322 Poznań

Polen

Ketoprom

25 mg/g

Gel

Kutan anvendelse

PL – Polen

| Hisamitsu UK Limited |
| --- |
| 500 Chiswick High Road |
| London W4 5RG UK |
| Storbritannien |

Hisamitsu UK Limited

500 Chiswick High Road

London W4 5RG UK

Storbritannien

Keplat

20 mg

Medicinsk plaster

Transdermal anvendelse

PL – Polen

| Medagro International Sp.z o.o. |
| --- |
| 83 Podleśna St., |
| 05-552 Łazy k. |
| Warszawy |
| Polen |

Medagro International Sp.z o.o.

83 Podleśna St.,

05-552 Łazy k.

Warszawy

Polen

Ketospray Forte

100 mg/g

Kutanspray, opløsning

Kutan anvendelse

PL – Polen

| Medana Pharma S.A. |
| --- |
| 10 Władysława Łokietka st. |
| 98-200 Sieradz |
| Polen |

Medana Pharma S.A.

10 Władysława Łokietka st.

98-200 Sieradz

Polen

Ultrafastin

25 mg/g

Gel

Kutan anvendelse

PL – Polen

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10 |
| A-6250 Kundl |
| Østrig |

Sandoz GmbH

Biochemiestrasse 10

A-6250 Kundl

Østrig

Ketonal Lek

25 mg/g

Gel

Kutan anvendelse

PL – Polen

| Sanofi-Aventis Frankrig |
| --- |
| boulevard Romain Rolland 1-13 |
| F-75014 Paris |
| Frankrig |

Sanofi-Aventis Frankrig

boulevard Romain Rolland 1-13

F-75014 Paris

Frankrig

Profenid Gel

25 mg/g

Gel

Kutan anvendelse

PL – Polen

| Zakłady Farmaceutyczne »UNIA« Spółdzielnia Pracy |
| --- |
| ul. Chłodna 56/60 |
| 00-872 Warsaw |
| Polen |

Zakłady Farmaceutyczne »UNIA« Spółdzielnia Pracy

ul. Chłodna 56/60

00-872 Warsaw

Polen

Ketopronil

25 mg/g

Gel

Kutan anvendelse

PT – Portugal

| A. Menarini Portugal - Farmacêutica, S.A. |
| --- |
| Quinta da Fonte - Rua dos Malhões, 1 - Edifício D. Manuel I, Piso 2A |
| 2770-071 Paço D'Arcos |
| Portugal |

A. Menarini Portugal - Farmacêutica, S.A.

Quinta da Fonte - Rua dos Malhões, 1 - Edifício D. Manuel I, Piso 2A

2770-071 Paço D'Arcos

Portugal

Fastum

25 mg/g

Gel

Kutan anvendelse

PT – Portugal

| Hisamitsu UK Ltd. |
| --- |
| 500 Chiswick High Road |
| W4 5RG UK London |
| Storbritannien |

Hisamitsu UK Ltd.

500 Chiswick High Road

W4 5RG UK London

Storbritannien

Keplat

20 mg

Medicinsk plaster

Transdermal anvendelse

PT – Portugal

| Laboratórios Vitória, S.A. |
| --- |
| Rua Elias Garcia |
| 28 - Venda Nova |
| 2700-327 Amadora |
| Portugal |

Laboratórios Vitória, S.A.

Rua Elias Garcia

28 - Venda Nova

2700-327 Amadora

Portugal

Profenid

25 mg/g

Gel

Kutan anvendelse

RO – Rumænien

| A. Menarini Industrie Farmaceutiche Riunite S.R.L. |
| --- |
| Via Sette Santi 3 |
| Firenze |
| Italien |

A. Menarini Industrie Farmaceutiche Riunite S.R.L.

Via Sette Santi 3

Firenze

Italien

FASTUM GEL, gel, 2,5 %

25 mg/g

Gel

Kutan anvendelse

RO – Rumænien

| CSC Pharmaceuticals Handels GmbH |
| --- |
| Heiligenstadter Strasse 395 b |
| 1190-Viena |
| Østrig |

CSC Pharmaceuticals Handels GmbH

Heiligenstadter Strasse 395 b

1190-Viena

Østrig

KETOSPRAY 50 mg/ml, spray cutanat soluție

50 mg/ml

Kutanspray, opløsning

Kutan anvendelse

RO – Rumænien

| Cyathus Exquirere PharmaforschungsGmbH |
| --- |
| Rudolfsplatz 2/1/8 |
| A-1010 Viena |
| Østrig |

Cyathus Exquirere PharmaforschungsGmbH

Rudolfsplatz 2/1/8

A-1010 Viena

Østrig

KETOSpray 10 %, spray cutanat, soluție

100 mg/ml

Kutanspray, opløsning

Kutan anvendelse

RO – Rumænien

| Laboratoires Aventis |
| --- |
| 46, quai de la Rapee |
| 75012 Paris Cedex 12 |
| Frankrig |

Laboratoires Aventis

46, quai de la Rapee

75012 Paris Cedex 12

Frankrig

PROFENID GEL, 2,5 %

25 mg/g

Gel

Kutan anvendelse

RO – Rumænien

| LEK Pharmaceuticals D.D., |
| --- |
| Verovskova 57 |
| 1526 Ljublijana |
| Slovenien |

LEK Pharmaceuticals D.D.,

Verovskova 57

1526 Ljublijana

Slovenien

KETONAL 2,5 % gel

25 mg/g

Gel

Kutan anvendelse

RO – Rumænien

| Ozone Laboratories SRL, |
| --- |
| Calea Rahovei nr. 266-268 |
| Corp 60, Etaj 1, Sector 5 |
| București |
| Rumænien |

Ozone Laboratories SRL,

Calea Rahovei nr. 266-268

Corp 60, Etaj 1, Sector 5

București

Rumænien

KETOPROFEN 25 mg/g GEL

25 mg/g

Gel

Kutan anvendelse

RO – Rumænien

| S.C. Antibiotice S.A. |
| --- |
| Str. Valea Lupului Nr. 1 |
| Iași, jud. Iași |
| Rumænien |

S.C. Antibiotice S.A.

Str. Valea Lupului Nr. 1

Iași, jud. Iași

Rumænien

RUBIFEN 2,5 %,gel

25 mg/g

Gel

Kutan anvendelse

RO – Rumænien

| S.C. Fiterman Pharma S.R.L. |
| --- |
| Str. Moara de Foc nr. 35, |
| Iași 700520 |
| Rumænien |

S.C. Fiterman Pharma S.R.L.

Str. Moara de Foc nr. 35,

Iași 700520

Rumænien

KETOPROFEN MK, gel, 2,5 %

25 mg/g

Gel

Kutan anvendelse

RO – Rumænien

| S.C. HYPERION S.A. |
| --- |
| B-dul Independenței nr. 18 |
| Bloc Y1, Etj. 8, Ap.4 |
| Cod 700099, Iași |
| Rumænien |

S.C. HYPERION S.A.

B-dul Independenței nr. 18

Bloc Y1, Etj. 8, Ap.4

Cod 700099, Iași

Rumænien

KETOPROFEN HYPERION 25 mg/g gel

25 mg/g

Gel

Kutan anvendelse

RO – Rumænien

| S.C. Slavia Pharm S.R.L., |
| --- |
| Str. Știrbei Vodă nr. 53-55, sector 1 |
| București, |
| Rumænien |

S.C. Slavia Pharm S.R.L.,

Str. Știrbei Vodă nr. 53-55, sector 1

București,

Rumænien

KETOPROFEN SLAVIA 25 mg/g gel

25 mg/g

Gel

Kutan anvendelse

RO – Rumænien

| S.C. Terapia S.A., |
| --- |
| Str. Fabricii, nr. 124 |
| Cluj Napoca |
| Rumænien |

S.C. Terapia S.A.,

Str. Fabricii, nr. 124

Cluj Napoca

Rumænien

KETOPROFEN, 25 mg/g, gel

25 mg/g

Gel

Kutan anvendelse

SE – Sverige

| ACO Hud AB |
| --- |
| Box 622 |
| 194 26 Upplands Väsby |
| Sverige |

ACO Hud AB

Box 622

194 26 Upplands Väsby

Sverige

Ketoflex

2,5 %

Gel

Kutan anvendelse

SE – Sverige

| Antula Healthcare AB, , Östermalmsgatan 19 |
| --- |
| 114 26 Stockholm |
| Sverige |

Antula Healthcare AB, , Östermalmsgatan 19

114 26 Stockholm

Sverige

Zon

2,5 %

Gel

Kutan anvendelse

SE – Sverige

| Meda AB, |
| --- |
| Box 906 |
| 170 09 Solna |
| Sverige |

Meda AB,

Box 906

170 09 Solna

Sverige

Siduro

2,5 %

Gel

Kutan anvendelse

SE – Sverige

| sanofi-aventis AB |
| --- |
| Box 14142 |
| 167 14 Bromma |
| Sverige |

sanofi-aventis AB

Box 14142

167 14 Bromma

Sverige

Orudis

2,5 %

Gel

Kutan anvendelse

SI – Slovenien

| Galex, d.d. |
| --- |
| Tišinska ulica 29g |
| SI-9000 Murska Sobota, |
| Slovenien |

Galex, d.d.

Tišinska ulica 29g

SI-9000 Murska Sobota,

Slovenien

Prontoflex 100 mg/g dermalno pršilo, raztopina

100 mg/g

Kutanspray, opløsning

Kutan anvendelse

SI – Slovenien

| Lek farmacevtska družba, d.d., Verovškova 57 |
| --- |
| SI-1000 Ljubljana |
| Slovenien |

Lek farmacevtska družba, d.d., Verovškova 57

SI-1000 Ljubljana

Slovenien

Ketonal 25 mg/g gel

25 mg/g

Gel

Kutan anvendelse

SI – Slovenien

| Lek farmacevtska družba, d.d., Verovškova 57 |
| --- |
| SI-1000 Ljubljana |
| Slovenien |

Lek farmacevtska družba, d.d., Verovškova 57

SI-1000 Ljubljana

Slovenien

Ketonal 50 mg/g krema

50 mg/g

Creme

Kutan anvendelse

SI – Slovenien

| Menarini Industrie Farmaceutiche Riunite s.r.l., |
| --- |
| Via Sette Santi 3 |
| Firenze I-50131 |
| Italien |

Menarini Industrie Farmaceutiche Riunite s.r.l.,

Via Sette Santi 3

Firenze I-50131

Italien

Fastum 25 mg/g gel

25 mg/g

Gel

Kutan anvendelse

SK – Slovakiet

| A. Menarini Industrie Farmaceutiche Riunite s.r.l. |
| --- |
| Via Sette Santi 3 |
| 50131 Florence |
| Italien |

A. Menarini Industrie Farmaceutiche Riunite s.r.l.

Via Sette Santi 3

50131 Florence

Italien

FASTUM GEL

2,5 %

Gel

Kutan anvendelse

SK – Slovakiet

| Herbacos-Bofarma, s.r.o. |
| --- |
| Štrossova 239 |
| 530 03 Pardubice |
| Den Tjekkiske republik |

Herbacos-Bofarma, s.r.o.

Štrossova 239

530 03 Pardubice

Den Tjekkiske republik

KETOPROFEN BCH

2,5 %

Gel

Kutan anvendelse

SK – Slovakiet

| NTC Pharma, s.r.o. |
| --- |
| Strečnianska 13 |
| 851 05 Bratislava |
| Slovakiet |

NTC Pharma, s.r.o.

Strečnianska 13

851 05 Bratislava

Slovakiet

KETOSPRAY 10 %

100 mg / 1 ml

Kutanspray, opløsning

Kutan anvendelse

SK – Slovakiet

| Sandoz Pharmaceuticals d.d. Verovškova 57 |
| --- |
| 1000 Ljubljana |
| Slovenien |

Sandoz Pharmaceuticals d.d. Verovškova 57

1000 Ljubljana

Slovenien

Ketonal 2,5 % gél

2,5 %

Gel

Kutan anvendelse

UK – Storbritannien

| A Menarini Industrie Farmaceutiche Riunite SRL |
| --- |
| Via Sette Sante 3 |
| 50131 Florence |
| Italien |

A Menarini Industrie Farmaceutiche Riunite SRL

Via Sette Sante 3

50131 Florence

Italien

POWERGEL 2,5 % GEL

2,5 % W/W

Gel

Kutan anvendelse

UK – Storbritannien

| A Menarini Industrie Farmaceutiche Riunite SRL |
| --- |
| Via Sette Sante 3 |
| 50131 Florence |
| Italien |

A Menarini Industrie Farmaceutiche Riunite SRL

Via Sette Sante 3

50131 Florence

Italien

FASTUM GEL

2,5 % W/W

Gel

Kutan anvendelse

UK – Storbritannien

| May & Baker Limited |
| --- |
| 50 King's Hill Avenue |
| King's Hill, West Malling |
| Kent ME19 4AH |
| Storbritannien |

May & Baker Limited

50 King's Hill Avenue

King's Hill, West Malling

Kent ME19 4AH

Storbritannien

ORUVAIL GEL 2,5 %

2,5 % W/W

Gel

Kutan anvendelse

UK – Storbritannien

| Pinewood Laboratories Limited Ballymacarbry |
| --- |
| Clonmel, CO Tipperary |
| Irland |

Pinewood Laboratories Limited Ballymacarbry

Clonmel, CO Tipperary

Irland

KETOPROFEN 2,5 % W/W GEL

2,5 % W/W

Gel

Kutan anvendelse

UK – Storbritannien

| Pliva Pharma Limited |
| --- |
| Vision House, Bedford Road Petersfield |
| Hampshire GU32 3QB |
| Storbritannien |

Pliva Pharma Limited

Vision House, Bedford Road Petersfield

Hampshire GU32 3QB

Storbritannien

KETOPROFEN 2,5 % W/W GEL

2,5 % W/W

Gel

Kutan anvendelse

UK – Storbritannien

| Tillomed Laboratories Limited |
| --- |
| 3 Howard Road |
| Eaton Socon, ST. Neots, Cambridgeshire PE19 8ET |
| Storbritannien |

Tillomed Laboratories Limited

3 Howard Road

Eaton Socon, ST. Neots, Cambridgeshire PE19 8ET

Storbritannien

TILOKET GEL 2,5 %

2,5 % W/W

Gel

Kutan anvendelse

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