# Úradný vestník C 61/2011

| | ISSN 1725-5236
  doi:10.3000/17255236.C_2011.061.slk |
| --- | --- |
| Úradný vestník
  Európskej únie | C 61 |
| | |
| Slovenské vydanie | Informácie a oznámenia | Zväzok 5425. februára 2011 |

ISSN 1725-5236

doi:10.3000/17255236.C_2011.061.slk

Úradný vestník

Európskej únie

C 61

Slovenské vydanie

Informácie a oznámenia

Zväzok 5425. februára 2011

---

| Číslo oznamu | Obsah | Strana |
| --- | --- | --- |
| | IV   Informácie |
| | INFORMÁCIE INŠTITÚCIÍ, ORGÁNOV, ÚRADOV A AGENTÚR EURÓPSKEJ ÚNIE |
| | Európska komisia |
| 2011/C 061/01 | Súhrn rozhodnutí Európskej únie o povolení na uvedenie liekov na trh od 1. novembra 2010 do 31. decembra 2010[Uverejnené v súlade s článkom 13 alebo 38 nariadenia Európskeho parlamentu a Rady (ES) č. 726/2004] | 1 |
| 2011/C 061/02 | Súhrn rozhodnutí Európskej únie o povolení na uvedenie liekov na trh od 1. novembra 2010 do 31. decembra 2010(Rozhodnutia prijaté v súlade s článkom 34 smernice 2001/83/ES
  alebo s článkom 38 smernice 2001/82/ES
  ) | 18 |

Číslo oznamu

Obsah

Strana

IV   Informácie

INFORMÁCIE INŠTITÚCIÍ, ORGÁNOV, ÚRADOV A AGENTÚR EURÓPSKEJ ÚNIE

Európska komisia

2011/C 061/01

Súhrn rozhodnutí Európskej únie o povolení na uvedenie liekov na trh od 1. novembra 2010 do 31. decembra 2010[Uverejnené v súlade s článkom 13 alebo 38 nariadenia Európskeho parlamentu a Rady (ES) č. 726/2004]

[Uverejnené v súlade s článkom 13 alebo 38 nariadenia Európskeho parlamentu a Rady (ES) č. 726/2004]

1

2011/C 061/02

Súhrn rozhodnutí Európskej únie o povolení na uvedenie liekov na trh od 1. novembra 2010 do 31. decembra 2010(Rozhodnutia prijaté v súlade s článkom 34 smernice 2001/83/ES
  alebo s článkom 38 smernice 2001/82/ES
  )

(Rozhodnutia prijaté v súlade s článkom 34 smernice 2001/83/ES

alebo s článkom 38 smernice 2001/82/ES

)

18

| SK | |
| --- | --- |

SK

---

IV Informácie

INFORMÁCIE INŠTITÚCIÍ, ORGÁNOV, ÚRADOV A AGENTÚR EURÓPSKEJ ÚNIE

Európska komisia

| 25.2.2011 | SK | Úradný vestník Európskej únie | C 61/1 |
| --- | --- | --- | --- |

25.2.2011

SK

Úradný vestník Európskej únie

C 61/1

---

Súhrn rozhodnutí Európskej únie o povolení na uvedenie liekov na trh od 1. novembra 2010 do 31. decembra 2010

[Uverejnené v súlade s článkom 13 alebo 38 nariadenia Európskeho parlamentu a Rady (ES) č. 726/2004]
   (1)

2011/C 61/01

—   Udelenie povolenia na uvedenie na trh (článok 13 nariadenia Európskeho parlamentu a Rady (ES) č. 726/2004): Prijaté

| Dátum rozhodnutia | Názov lieku | INN (medzinárodný neregistrovaný názov) | Držiteľ povolenia na uvedenie na trh | Číslo záznamu v registri Spoločenstva | Lieková forma | Kód ATC (anatomicko-terapeuticko-chemický kód) | Dátum oznámenia |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 29.11.2010 | Aflunov | Prepandemická vakcína proti chrípke (H5N1) (inaktivovaný povrchový antigén s adjuvans) | Novartis Vaccines and Diagnostics S.r.l. |
| Via Fiorentina, 1, |
| 53100 Siena, |
| Italia |

Dátum rozhodnutia

Názov lieku

INN (medzinárodný neregistrovaný názov)

Držiteľ povolenia na uvedenie na trh

Číslo záznamu v registri Spoločenstva

Lieková forma

Kód ATC (anatomicko-terapeuticko-chemický kód)

Dátum oznámenia

29.11.2010

Aflunov

Prepandemická vakcína proti chrípke (H5N1) (inaktivovaný povrchový antigén s adjuvans)

Novartis Vaccines and Diagnostics S.r.l.

Via Fiorentina, 1,

53100 Siena,

Italia

EU/1/10/658/001-002

Injekčná suspenzia

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

Filmom obalená tableta

L04AA13

6.12.2010

29.11.2010

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

Prepandemická vakcína proti chrípke (H5N1) (inaktivovaný povrchový antigén s adjuvans)

| 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

Injekčná suspenzia

J07BB02

3.12.2010

3.12.2010

Brilique

tikagrelor

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

AstraZeneca AB

Södertälje S 151 85,

Sverige

EU/1/10/655/001-006

Filmom obalená tableta

B01AC24

7.12.2010

3.12.2010

Possia

tikagrelor

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

AstraZeneca AB

Södertälje S 151 85,

Sverige

EU/1/10/656/001-006

Filmom obalená tableta

B01AC24

7.12.2010

—   Zmena povolenia na uvedenie na trh (článok 13 nariadenia Európskeho parlamentu a Rady (ES) č. 726/2004): Prijaté

| Dátum rozhodnutia | Názov lieku | Držiteľ povolenia na uvedenie na trh | Číslo záznamu v registri Spoločenstva | Dátum oznámenia |
| --- | --- | --- | --- | --- |
| 3.11.2010 | Actraphane | Novo Nordisk A/S |
| Novo Allé, DK-2880 Bagsvaerd, |
| Danmark |

Dátum rozhodnutia

Názov lieku

Držiteľ povolenia na uvedenie na trh

Číslo záznamu v registri Spoločenstva

Dátum oznámenia

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

—   Odňatie povolenia na uvedenie na trh (článok 13 nariadenia Európskeho parlamentu a Rady (ES) č. 726/2004)

| Dátum rozhodnutia | Názov lieku | Držiteľ povolenia na uvedenie na trh | Číslo záznamu v registri Spoločenstva | Dátum oznámenia |
| --- | --- | --- | --- | --- |
| 13.12.2010 | Arepanrix | GlaxoSmithKline Biologicals S.A. |
| rue de l'Institut 89, |
| 1330 Rixensart, |
| Belgique |

Dátum rozhodnutia

Názov lieku

Držiteľ povolenia na uvedenie na trh

Číslo záznamu v registri Spoločenstva

Dátum oznámenia

13.12.2010

Arepanrix

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89,

1330 Rixensart,

Belgique

EU/1/10/624/001

15.12.2010

—   Pozastavenie platnosti povolenia na uvedenie na trh (článok 20 nariadenia Európskeho parlamentu a Rady (ES) č. 726/2004)

| Dátum rozhodnutia | Názov lieku | Držiteľ povolenia na uvedenie na trh | Číslo záznamu v registri Spoločenstva | Dátum oznámenia |
| --- | --- | --- | --- | --- |
| 3.12.2010 | Avaglim | SmithKline Beecham Ltd. |
| 980 Great West Road, |
| Brentford, |
| Middlesex, TW8 9GS |
| United Kingdom |

Dátum rozhodnutia

Názov lieku

Držiteľ povolenia na uvedenie na trh

Číslo záznamu v registri Spoločenstva

Dátum oznámenia

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

—   Udelenie povolenia na uvedenie na trh (článok 38 nariadenia Európskeho parlamentu a Rady (ES) č. 726/2004
   (2)
  ): Prijaté

| Dátum rozhodnutia | Názov lieku | INN (medzinárodný neregistrovaný názov) | Držiteľ povolenia na uvedenie na trh | Číslo záznamu v registri Spoločenstva | Lieková forma | Kód ATC (anatomicko-terapeuticko-chemický kód) | Dátum oznámenia |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 5.11.2010 | BTVPUR AlSap 2-4 | Bluetongue vírus sérotyp 2 - Bluetongue vírus sérotyp 4 | MERIAL |
| 29 avenue Tony Garnier, |
| 69007 LYON, |
| France |

Dátum rozhodnutia

Názov lieku

INN (medzinárodný neregistrovaný názov)

Držiteľ povolenia na uvedenie na trh

Číslo záznamu v registri Spoločenstva

Lieková forma

Kód ATC (anatomicko-terapeuticko-chemický kód)

Dátum oznámenia

5.11.2010

BTVPUR AlSap 2-4

Bluetongue vírus sérotyp 2 - Bluetongue vírus sérotyp 4

MERIAL

29 avenue Tony Garnier,

69007 LYON,

France

EU/2/10/108/001-005

Injekčná suspenzia

QI02AA08

QI04AA02

9.11.2010

19.11.2010

Meloxoral

Meloxikam

| 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

Perorálna suspenzia

QM01AC06

23.11.2010

17.12.2010

BTVPUR AlSap 1

Bluetongue vírus sérotyp 1 antigén

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

MERIAL

29 avenue Tony Garnier,

69007 LYON,

France

EU/2/10/112/001-005

Injekčná suspenzia

QI02AA08

QI04AA02

22.12.2010

17.12.2010

BTVPUR AlSap 1-8

Bluetongue vírus sérotyp 1 antigén - Bluetongue vírus sérotyp 8 antigén

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

MERIAL

29 avenue Tony Garnier,

69007 LYON,

France

EU/2/10/113/001-005

Injekčná suspenzia

QI02AA08

QI04AA02

22.12.2010

—   Zmena povolenia na uvedenie na trh (článok 38 nariadenia Európskeho parlamentu a Rady (ES) č. 726/2004): Prijaté

| Dátum rozhodnutia | Názov lieku | Držiteľ povolenia na uvedenie na trh | Číslo záznamu v registri Spoločenstva | Dátum oznámenia |
| --- | --- | --- | --- | --- |
| 3.11.2010 | Melovem | Dopharma Research B.V. |
| Zalmweg 24, |
| 4941 VX Raamsdonksveer, |
| Nederland |

Dátum rozhodnutia

Názov lieku

Držiteľ povolenia na uvedenie na trh

Číslo záznamu v registri Spoločenstva

Dátum oznámenia

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

Ak sa chcete oboznámiť s verejnou hodnotiacou správou o príslušných liekoch a s ňou súvisiacimi rozhodnutiami, môžete kontaktovať:

| 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)  Ú. v. EÚ L 136, 30.4.2004, s. 1.

(2)  Ú. v. EÚ L 136, 30.4.2004, s. 1.

---

| 25.2.2011 | SK | Úradný vestník Európskej únie | C 61/18 |
| --- | --- | --- | --- |

25.2.2011

SK

Úradný vestník Európskej únie

C 61/18

---

Súhrn rozhodnutí Európskej únie o povolení na uvedenie liekov na trh od 1. novembra 2010 do 31. decembra 2010

(Rozhodnutia prijaté v súlade s článkom 34 smernice 2001/83/ES
   (1)
  alebo s článkom 38 smernice 2001/82/ES
   (2)
  )

2011/C 61/02

—   Udelenie, zachovanie alebo zmena vnútroštátneho povolenia na uvedenie na trh

| Dátum rozhodnutia | Názov(-vy) lieku | Držiteľ(-lia) povolenia na uvedenie na trh | Príslušný členský štát | Dátum oznámenia |
| --- | --- | --- | --- | --- |
| 13.12.2010 | Lipitor and associated names | Pozri prílohu I | Pozri prílohu I | 14.12.2010 |
| 3.12.2010 | Prevora | Pozri prílohu II | Pozri prílohu II | 6.12.2010 |
| 29.11.2010 | Leflunomide ratiopharm | Ratiopharm GmbH, |
| Graf-Arco-Straße |
| 3, D-89079 Ulm, |
| Deutschland |

Dátum rozhodnutia

Názov(-vy) lieku

Držiteľ(-lia) povolenia na uvedenie na trh

Príslušný členský štát

Dátum oznámenia

13.12.2010

Lipitor and associated names

Pozri prílohu I

Pozri prílohu I

14.12.2010

3.12.2010

Prevora

Pozri prílohu II

Pozri prílohu II

6.12.2010

29.11.2010

Leflunomide ratiopharm

Ratiopharm GmbH,

Graf-Arco-Straße

3, D-89079 Ulm,

Deutschland

Tieto rozhodnutia sú určené členským štátom

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

Tieto rozhodnutia sú určené členským štátom

14.12.2010

—   Pozastavenie platnosti vnútroštátneho povolenia na uvedenie na trh

| Dátum rozhodnutia | Názov(-vy) lieku | Držiteľ(-lia) povolenia na uvedenie na trh | Príslušný členský štát | Dátum oznámenia |
| --- | --- | --- | --- | --- |
| 29.11.2010 | Ketoprofen containing topical products | Pozri prílohu III | Pozri prílohu III | 1.12.2010 |

Dátum rozhodnutia

Názov(-vy) lieku

Držiteľ(-lia) povolenia na uvedenie na trh

Príslušný členský štát

Dátum oznámenia

29.11.2010

Ketoprofen containing topical products

Pozri prílohu III

Pozri prílohu III

1.12.2010

---

(1)  Ú. v. EÚ L 311, 28.11.2001, s. 67.

(2)  Ú. v. EÚ L 311, 28.11.2001, s. 1.

---

PRÍLOHA I

ZOZNAM NÁZVOV, LIEKOVÁ FORMA, SILY LIEKOV, SPÔSOB PODÁVANIA, DRŽITELIA POVOLENIA NA UVEDENIE LIEKU NA TRH V ČLENSKÝCH ŠTÁTOCH

| Členský štát EÚ/EHP | Držiteľ rozhodnutia o registrácii | Vymyslený názov | Množstvo aktívnej látky | Farmaceutická forma | Spôsob podávania |
| --- | --- | --- | --- | --- | --- |
| Rakúsko | Pfizer Corporation Austria Ges.m.b.H. |
| Floridsdorfer Hauptstrasse 1 |
| A - 1210 Wien |
| Austria |

Členský štát EÚ/EHP

Držiteľ rozhodnutia o registrácii

Vymyslený názov

Množstvo aktívnej látky

Farmaceutická forma

Spôsob podávania

Rakúsko

Pfizer Corporation Austria Ges.m.b.H.

Floridsdorfer Hauptstrasse 1

A - 1210 Wien

Austria

Sortis 10 mg - Filmtabletten

10 mg

Filmom obalená tableta

Perorálne použitie

Rakúsko

| 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

Filmom obalená tableta

Perorálne použitie

Rakúsko

| 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

Filmom obalená tableta

Perorálne použitie

Rakúsko

| 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

Filmom obalená tableta

Perorálne použitie

Belgicko

| 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

Filmom obalená tableta

Perorálne použitie

Belgicko

| 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

Filmom obalená tableta

Perorálne použitie

Belgicko

| 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

Filmom obalená tableta

Perorálne použitie

Belgicko

| 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

Filmom obalená tableta

Perorálne použitie

Bulharsko

| 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

Filmom obalená tableta

Perorálne použitie

Bulharsko

| 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

Filmom obalená tableta

Perorálne použitie

Bulharsko

| 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

Filmom obalená tableta

Perorálne použitie

Bulharsko

| 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

Filmom obalená tableta

Perorálne použitie

Cyprus

| 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

Filmom obalená tableta

Perorálne použitie

Cyprus

| 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

Filmom obalená tableta

Perorálne použitie

Cyprus

| 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

Filmom obalená tableta

Perorálne použitie

Česká republika

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

Pfizer. s r.o

Stroupežnického 17

150 00 Prague 5

Czech Republic

Sortis

10 mg

Filmom obalená tableta

Perorálne použitie

Česká republika

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

Pfizer. s r.o

Stroupežnického 17

150 00 Prague 5

Czech Republic

Sortis

20 mg

Filmom obalená tableta

Perorálne použitie

Česká republika

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

Pfizer. s r.o

Stroupežnického 17

150 00 Prague 5

Czech Republic

Sortis

40 mg

Filmom obalená tableta

Perorálne použitie

Česká republika

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

Pfizer. s r.o

Stroupežnického 17

150 00 Prague 5

Czech Republic

Sortis

80 mg

Filmom obalená tableta

Perorálne použitie

Dánsko

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

Pfizer ApS

Lautrupvang 8

2750 Ballerup

Denmark

Zarator

10 mg

Filmom obalená tableta

Perorálne použitie

Dánsko

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

Pfizer ApS

Lautrupvang 8

2750 Ballerup

Denmark

Zarator

20 mg

Filmom obalená tableta

Perorálne použitie

Dánsko

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

Pfizer ApS

Lautrupvang 8

2750 Ballerup

Denmark

Zarator

40 mg

Filmom obalená tableta

Perorálne použitie

Dánsko

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

Pfizer ApS

Lautrupvang 8

2750 Ballerup

Denmark

Zarator

80 mg

Filmom obalená tableta

Perorálne použitie

Estónsko

| 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

Filmom obalená tableta

Perorálne použitie

Estónsko

| 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

Filmom obalená tableta

Perorálne použitie

Estónsko

| 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

Filmom obalená tableta

Perorálne použitie

Estónsko

| 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

Filmom obalená tableta

Perorálne použitie

Fínsko

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

Pfizer Oy

Tietokuja 4

00330 Helsinki

Finland

Lipitor

10 mg

Filmom obalená tableta

Perorálne použitie

Fínsko

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

Pfizer Oy

Tietokuja 4

00330 Helsinki

Finland

Lipitor

20 mg

Filmom obalená tableta

Perorálne použitie

Fínsko

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

Pfizer Oy

Tietokuja 4

00330 Helsinki

Finland

Lipitor

40 mg

Filmom obalená tableta

Perorálne použitie

Fínsko

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

Pfizer Oy

Tietokuja 4

00330 Helsinki

Finland

Lipitor

80 mg

Filmom obalená tableta

Perorálne použitie

Fínsko

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

Pfizer Oy

Tietokuja 4

00330 Helsinki

Finland

Orbeos

10 mg

Filmom obalená tableta

Perorálne použitie

Fínsko

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

Pfizer Oy

Tietokuja 4

00330 Helsinki

Finland

Orbeos

20 mg

Filmom obalená tableta

Perorálne použitie

Fínsko

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

Pfizer Oy

Tietokuja 4

00330 Helsinki

Finland

Orbeos

40 mg

Filmom obalená tableta

Perorálne použitie

Fínsko

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

Pfizer Oy

Tietokuja 4

00330 Helsinki

Finland

Orbeos

80 mg

Filmom obalená tableta

Perorálne použitie

Francúzsko

| 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

Filmom obalená tableta

Perorálne použitie

Francúzsko

| 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

Filmom obalená tableta

Perorálne použitie

Francúzsko

| 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

Filmom obalená tableta

Perorálne použitie

Francúzsko

| 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

Filmom obalená tableta

Perorálne použitie

Nemecko

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

Pfizer Pharma GmbH

Linkstraße 10

10785 Berlin

Germany

Sortis 10 mg

10 mg

Filmom obalená tableta

Perorálne použitie

Nemecko

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

Pfizer Pharma GmbH

Linkstraße 10

10785 Berlin

Germany

Sortis 20 mg

20 mg

Filmom obalená tableta

Perorálne použitie

Nemecko

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

Pfizer Pharma GmbH

Linkstraße 10

10785 Berlin

Germany

Sortis 40 mg

40 mg

Filmom obalená tableta

Perorálne použitie

Nemecko

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

Pfizer Pharma GmbH

Linkstraße 10

10785 Berlin

Germany

Sortis 80 mg

80 mg

Filmom obalená tableta

Perorálne použitie

Nemecko

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

Pfizer Pharma GmbH

Linkstraße 10

10785 Berlin

Germany

Liprimar 10 mg

10 mg

Filmom obalená tableta

Perorálne použitie

Nemecko

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

Pfizer Pharma GmbH

Linkstraße 10

10785 Berlin

Germany

Liprimar 20 mg

20 mg

Filmom obalená tableta

Perorálne použitie

Nemecko

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

Pfizer Pharma GmbH

Linkstraße 10

10785 Berlin

Germany

Liprimar 40 mg

40 mg

Filmom obalená tableta

Perorálne použitie

Nemecko

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

Pfizer Pharma GmbH

Linkstraße 10

10785 Berlin

Germany

Liprimar 80 mg

80 mg

Filmom obalená tableta

Perorálne použitie

Nemecko

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

Pfizer Pharma GmbH

Linkstraße 10

10785 Berlin

Germany

Atorvastatin Pfizer 10 mg

10 mg

Filmom obalená tableta

Perorálne použitie

Nemecko

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

Pfizer Pharma GmbH

Linkstraße 10

10785 Berlin

Germany

Atorvastatin Pfizer 20 mg

20 mg

Filmom obalená tableta

Perorálne použitie

Nemecko

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

Pfizer Pharma GmbH

Linkstraße 10

10785 Berlin

Germany

Atorvastatin Pfizer 40 mg

40 mg

Filmom obalená tableta

Perorálne použitie

Nemecko

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

Pfizer Pharma GmbH

Linkstraße 10

10785 Berlin

Germany

Atorvastatin Pfizer 80 mg

80 mg

Filmom obalená tableta

Perorálne použitie

Grécko

| 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

Filmom obalená tableta

Perorálne použitie

Grécko

| 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

Filmom obalená tableta

Perorálne použitie

Grécko

| 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

Filmom obalená tableta

Perorálne použitie

Grécko

| 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

Filmom obalená tableta

Perorálne použitie

Grécko

| 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

Filmom obalená tableta

Perorálne použitie

Grécko

| 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

Filmom obalená tableta

Perorálne použitie

Grécko

| 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

Filmom obalená tableta

Perorálne použitie

Grécko

| 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

Filmom obalená tableta

Perorálne použitie

Grécko

| 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

Filmom obalená tableta

Perorálne použitie

Grécko

| 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

Filmom obalená tableta

Perorálne použitie

Maďarsko

| 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

Filmom obalená tableta

Perorálne použitie

Maďarsko

| 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

Filmom obalená tableta

Perorálne použitie

Maďarsko

| 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

Filmom obalená tableta

Perorálne použitie

Maďarsko

| 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

Filmom obalená tableta

Perorálne použitie

Maďarsko

| 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

Filmom obalená tableta

Perorálne použitie

Maďarsko

| 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

Filmom obalená tableta

Perorálne použitie

Maďarsko

| 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

Filmom obalená tableta

Perorálne použitie

Maďarsko

| 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

Filmom obalená tableta

Perorálne použitie

Island

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

Pfizer ApS

Lautrupvang 8

2750 Ballerup

Denmark

Zarator

10 mg

Filmom obalená tableta

Perorálne použitie

Island

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

Pfizer ApS

Lautrupvang 8

2750 Ballerup

Denmark

Zarator

20 mg

Filmom obalená tableta

Perorálne použitie

Island

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

Pfizer ApS

Lautrupvang 8

2750 Ballerup

Denmark

Zarator

40 mg

Filmom obalená tableta

Perorálne použitie

Island

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

Pfizer ApS

Lautrupvang 8

2750 Ballerup

Denmark

Zarator

80 mg

Filmom obalená tableta

Perorálne použitie

Írsko

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

Pfizer Ireland Pharmaceuticals,

Pottery Road, Dun Laoghaire, Co Dublin

Ireland

Lipitor

10 mg

Filmom obalená tableta

Perorálne použitie

Írsko

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

Pfizer Ireland Pharmaceuticals,

Pottery Road, Dun Laoghaire, Co Dublin

Ireland

Lipitor

20 mg

Filmom obalená tableta

Perorálne použitie

Írsko

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

Pfizer Ireland Pharmaceuticals,

Pottery Road, Dun Laoghaire, Co Dublin

Ireland

Lipitor

40 mg

Filmom obalená tableta

Perorálne použitie

Írsko

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

Pfizer Ireland Pharmaceuticals,

Pottery Road, Dun Laoghaire, Co Dublin

Ireland

Lipitor

80 mg

Filmom obalená tableta

Perorálne použitie

Taliansko

| 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

Filmom obalená tableta

Perorálne použitie

Taliansko

| 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

Filmom obalená tableta

Perorálne použitie

Taliansko

| 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

Filmom obalená tableta

Perorálne použitie

Taliansko

| 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

Filmom obalená tableta

Perorálne použitie

Taliansko

| 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

Filmom obalená tableta

Perorálne použitie

Taliansko

| 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

Filmom obalená tableta

Perorálne použitie

Taliansko

| 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

Filmom obalená tableta

Perorálne použitie

Taliansko

| 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

Filmom obalená tableta

Perorálne použitie

Taliansko

| 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

Filmom obalená tableta

Perorálne použitie

Taliansko

| 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

Filmom obalená tableta

Perorálne použitie

Taliansko

| 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

Filmom obalená tableta

Perorálne použitie

Taliansko

| 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

Filmom obalená tableta

Perorálne použitie

Taliansko

| Laboratori Guidotti S.p.A. |
| --- |
| Via Livornese 897 - La Vettola |
| 56122 Pisa |
| Italy |

Laboratori Guidotti S.p.A.

Via Livornese 897 - La Vettola

56122 Pisa

Italy

Totalip

10 mg

Filmom obalená tableta

Perorálne použitie

Taliansko

| Laboratori Guidotti S.p.A. |
| --- |
| Via Livornese 897 - La Vettola |
| 56122 Pisa |
| Italy |

Laboratori Guidotti S.p.A.

Via Livornese 897 - La Vettola

56122 Pisa

Italy

Totalip

20 mg

Filmom obalená tableta

Perorálne použitie

Taliansko

| Laboratori Guidotti S.p.A. |
| --- |
| Via Livornese 897 - La Vettola |
| 56122 Pisa |
| Italy |

Laboratori Guidotti S.p.A.

Via Livornese 897 - La Vettola

56122 Pisa

Italy

Totalip

40 mg

Filmom obalená tableta

Perorálne použitie

Taliansko

| Laboratori Guidotti S.p.A. |
| --- |
| Via Livornese 897 - La Vettola |
| 56122 Pisa |
| Italy |

Laboratori Guidotti S.p.A.

Via Livornese 897 - La Vettola

56122 Pisa

Italy

Totalip

80 mg

Filmom obalená tableta

Perorálne použitie

Lotyšsko

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

Pfizer Limited

Ramsgate Road, Sandwich

Kent CT13 9NJ

United Kingdom

Sortis

10 mg

Filmom obalená tableta

Perorálne použitie

Lotyšsko

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

Pfizer Limited

Ramsgate Road, Sandwich

Kent CT13 9NJ

United Kingdom

Sortis

20 mg

Filmom obalená tableta

Perorálne použitie

Lotyšsko

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

Pfizer Limited

Ramsgate Road, Sandwich

Kent CT13 9NJ

United Kingdom

Sortis

40 mg

Filmom obalená tableta

Perorálne použitie

Lotyšsko

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

Pfizer Limited

Ramsgate Road, Sandwich

Kent CT13 9NJ

United Kingdom

Sortis

80 mg

Filmom obalená tableta

Perorálne použitie

Litva

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

Pfizer Limited

Ramsgate Road, Sandwich

Kent CT13 9NJ

United Kingdom

Sortis

10 mg

Filmom obalená tableta

Perorálne použitie

Litva

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

Pfizer Limited

Ramsgate Road, Sandwich

Kent CT13 9NJ

United Kingdom

Sortis

20 mg

Filmom obalená tableta

Perorálne použitie

Litva

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

Pfizer Limited

Ramsgate Road, Sandwich

Kent CT13 9NJ

United Kingdom

Sortis

40 mg

Filmom obalená tableta

Perorálne použitie

Litva

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

Pfizer Limited

Ramsgate Road, Sandwich

Kent CT13 9NJ

United Kingdom

Sortis

80 mg

Filmom obalená tableta

Perorálne použitie

Luxembursko

| 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

Filmom obalená tableta

Perorálne použitie

Luxembursko

| 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

Filmom obalená tableta

Perorálne použitie

Luxembursko

| 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

Filmom obalená tableta

Perorálne použitie

Luxembursko

| 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

Filmom obalená tableta

Perorálne použitie

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

Filmom obalená tableta

Perorálne použitie

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

Filmom obalená tableta

Perorálne použitie

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

Filmom obalená tableta

Perorálne použitie

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

Filmom obalená tableta

Perorálne použitie

Holandsko

| 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

10 mg

Filmom obalená tableta

Perorálne použitie

Holandsko

| 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

20 mg

Filmom obalená tableta

Perorálne použitie

Holandsko

| 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

40 mg

Filmom obalená tableta

Perorálne použitie

Holandsko

| 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

80 mg

Filmom obalená tableta

Perorálne použitie

Nórsko

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

Pfizer AS

Pb. 3

1324 Lysaker

Norway

Lipitor

10 mg

Filmom obalená tableta

Perorálne použitie

Nórsko

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

Pfizer AS

Pb. 3

1324 Lysaker

Norway

Lipitor

20 mg

Filmom obalená tableta

Perorálne použitie

Nórsko

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

Pfizer AS

Pb. 3

1324 Lysaker

Norway

Lipitor

40 mg

Filmom obalená tableta

Perorálne použitie

Nórsko

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

Pfizer AS

Pb. 3

1324 Lysaker

Norway

Lipitor

80 mg

Filmom obalená tableta

Perorálne použitie

Poľsko

| 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

10 mg

Filmom obalená tableta

Perorálne použitie

Poľsko

| 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

20 mg

Filmom obalená tableta

Perorálne použitie

Poľsko

| 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

40 mg

Filmom obalená tableta

Perorálne použitie

Poľsko

| 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

Filmom obalená tableta

Perorálne použitie

Portugalsko

| 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

Filmom obalená tableta

Perorálne použitie

Portugalsko

| 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

Filmom obalená tableta

Perorálne použitie

Portugalsko

| 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

Filmom obalená tableta

Perorálne použitie

Portugalsko

| 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

Filmom obalená tableta

Perorálne použitie

Portugalsko

| 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

Filmom obalená tableta

Perorálne použitie

Portugalsko

| 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

Filmom obalená tableta

Perorálne použitie

Portugalsko

| 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

Filmom obalená tableta

Perorálne použitie

Portugalsko

| 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

Filmom obalená tableta

Perorálne použitie

Portugalsko

| 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

Filmom obalená tableta

Perorálne použitie

Portugalsko

| 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

Filmom obalená tableta

Perorálne použitie

Portugalsko

| 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

Filmom obalená tableta

Perorálne použitie

Portugalsko

| 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

Filmom obalená tableta

Perorálne použitie

Rumunsko

| 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

Filmom obalená tableta

Perorálne použitie

Rumunsko

| 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

Filmom obalená tableta

Perorálne použitie

Rumunsko

| 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

Filmom obalená tableta

Perorálne použitie

Rumunsko

| 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

Filmom obalená tableta

Perorálne použitie

Slovenská republika

| 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

Filmom obalená tableta

Perorálne použitie

Slovenská republika

| 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

Filmom obalená tableta

Perorálne použitie

Slovenská republika

| 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

Filmom obalená tableta

Perorálne použitie

Slovenská republika

| 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

Filmom obalená tableta

Perorálne použitie

Slovinsko

| 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

Filmom obalená tableta

Perorálne použitie

Slovinsko

| 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

Filmom obalená tableta

Perorálne použitie

Slovinsko

| 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

Filmom obalená tableta

Perorálne použitie

Slovinsko

| 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

Filmom obalená tableta

Perorálne použitie

Španielsko

| 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 comprimidos recubiertos con película

10 mg

Filmom obalená tableta

Perorálne použitie

Španielsko

| 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 comprimidos recubiertos con película

20 mg

Filmom obalená tableta

Perorálne použitie

Španielsko

| 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 comprimidos recubiertos con película

40 mg

Filmom obalená tableta

Perorálne použitie

Španielsko

| 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 comprimidos recubiertos con película

80 mg

Filmom obalená tableta

Perorálne použitie

Španielsko

| 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 comprimidos recubiertos con película

10 mg

Filmom obalená tableta

Perorálne použitie

Španielsko

| 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 comprimidos recubiertos con película

20 mg

Filmom obalená tableta

Perorálne použitie

Španielsko

| 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 comprimidos recubiertos con película

40 mg

Filmom obalená tableta

Perorálne použitie

Španielsko

| 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 comprimidos recubiertos con película

80 mg

Filmom obalená tableta

Perorálne použitie

Španielsko

| 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 comprimidos recubiertos con película

10 mg

Filmom obalená tableta

Perorálne použitie

Španielsko

| 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 comprimidos recubiertos con película

20 mg

Filmom obalená tableta

Perorálne použitie

Španielsko

| 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 comprimidos recubiertos con película

40 mg

Filmom obalená tableta

Perorálne použitie

Španielsko

| 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 comprimidos recubiertos con película

80 mg

Filmom obalená tableta

Perorálne použitie

Španielsko

| 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 comprimidos recubiertos con película

10 mg

Filmom obalená tableta

Perorálne použitie

Španielsko

| 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 comprimidos recubiertos con película

20 mg

Filmom obalená tableta

Perorálne použitie

Španielsko

| 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 comprimidos recubiertos con película

40 mg

Filmom obalená tableta

Perorálne použitie

Španielsko

| 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 comprimidos recubiertos con película

80 mg

Filmom obalená tableta

Perorálne použitie

Španielsko

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

Almirall S.A.

General Mitre, 151

08022 - Barcelona

Spain

Prevencor 10 mg comprimidos recubiertos con película

10 mg

Filmom obalená tableta

Perorálne použitie

Španielsko

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

Almirall S.A.

General Mitre, 151

08022 - Barcelona

Spain

Prevencor 20 mg comprimidos recubiertos con película

20 mg

Filmom obalená tableta

Perorálne použitie

Španielsko

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

Almirall S.A.

General Mitre, 151

08022 - Barcelona

Spain

Prevencor 40 mg comprimidos recubiertos con película

40 mg

Filmom obalená tableta

Perorálne použitie

Španielsko

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

Almirall S.A.

General Mitre, 151

08022 - Barcelona

Spain

Prevencor 80 mg comprimidos recubiertos con película

80 mg

Filmom obalená tableta

Perorálne použitie

Švédsko

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

Pfizer AB

191 90 Sollentuna

Sweden

Lipitor

10 mg

Filmom obalená tableta

Perorálne použitie

Švédsko

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

Pfizer AB

191 90 Sollentuna

Sweden

Lipitor

20 mg

Filmom obalená tableta

Perorálne použitie

Švédsko

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

Pfizer AB

191 90 Sollentuna

Sweden

Lipitor

40 mg

Filmom obalená tableta

Perorálne použitie

Švédsko

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

Pfizer AB

191 90 Sollentuna

Sweden

Lipitor

80 mg

Filmom obalená tableta

Perorálne použitie

Veľká Británia

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

Pfizer Ireland Pharmaceuticals,

Pottery Road Dun Laoghaire, Co Dublin

Ireland

Lipitor

10 mg

Filmom obalená tableta

Perorálne použitie

Veľká Británia

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

Pfizer Ireland Pharmaceuticals,

Pottery Road Dun Laoghaire, Co Dublin

Ireland

Lipitor

20 mg

Filmom obalená tableta

Perorálne použitie

Veľká Británia

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

Pfizer Ireland Pharmaceuticals,

Pottery Road Dun Laoghaire, Co Dublin

Ireland

Lipitor

40 mg

Filmom obalená tableta

Perorálne použitie

Veľká Británia

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

Pfizer Ireland Pharmaceuticals,

Pottery Road

Dun Laoghaire, Co Dublin

Ireland

Lipitor

80 mg

Filmom obalená tableta

Perorálne použitie

---

PRÍLOHA II

ZOZNAM OBSAHUJÚCI NÁZVY LIEKU, LIEKOVÚ FORMU, SILU, CESTU PODANIA, ŽIADATEĽA, DRŽITEĽ ROZHODNUTIA O REGISTRÁCII V ČLENSKÝCH ŠTÁTOCH

| Členský štát EU/EEA | Držiteľ rozhodnutia o registrácii | Žiadateľ | (Vymyslený) názov | Sila | Lieková forma | Cesta podania | Obsah
  (koncentrácia) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Írsko | CHX Technologies Europe Limited |
| Guinness Enterprise Centre |
| Taylor’s Lane |
| Dublin 8, Ireland |

Členský štát EU/EEA

Držiteľ rozhodnutia o registrácii

Žiadateľ

(Vymyslený) názov

Sila

Lieková forma

Cesta podania

Obsah

(koncentrácia)

Írsko

CHX Technologies Europe Limited

Guinness Enterprise Centre

Taylor’s Lane

Dublin 8, Ireland

Prevora 100 mg/ml Dental Solution

100 mg na ml roztoku

Dentálny roztok

Dentálne použitie (supragingiválne, len na tvrdé tkanivo)

100 mg/ml

Veľká Británia

| 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 Dental Solution

100 mg na ml roztoku

Dentálny roztok

Dentálne použitie (supragingiválne, len na tvrdé tkanivo)

100 mg/ml

---

PRÍLOHA III

ZOZNAM NÁZVOV, LIEKOVÝCH FORIEM, SÍL LIEKOV, SPÔSOBOV PODANIA A DRŽITEĽOV POVOLENÍ NA UVEDENIE NA TRH V ČLENSKÝCH ŠTÁTOCH

| Členský štát | Držiteľ rozhodnutia o registrácii | Názov lieku | Sila | Lieková forma | Cesta podania |
| --- | --- | --- | --- | --- | --- |
| AT – Rakúsko | A.Menarini Industrie Farmaceutiche Riunite s.r.l. |
| 1-3 Via Sette Santi |
| 50131 Firenze |
| Italy |

Členský štát

Držiteľ rozhodnutia o registrácii

Názov lieku

Sila

Lieková forma

Cesta podania

AT – Rakúsko

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

1-3 Via Sette Santi

50131 Firenze

Italy

Fastum Gel

25 mg/g

Gél

Dermálne použitie

AT – Rakúsko

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

Cyathus Exquirere Pharmaforschungs GmbH

Rudolfsplatz 2/1/8

1010 Wien

Austria

Ketospray 10 % - Spray

100 mg/g

metered dose: 20 mg/0,2 ml

Dermálna roztoková aerodisperzia

Dermálne použitie

AT – Rakúsko

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

sanofi-aventis GmbH

SATURN Tower, Leonard-Bernstein-Straße 10

1220 Wien

Austria

Profenid 2,5 % - Gel

25 mg/g

Gél

Dermálne použitie

BE – Belgicko

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

Aktuapharma N.V

Ambachtenlaan 13E

3001 Leuven

Belgium

Fastum gel 2,5 %

25 mg/g

Gél

Dermálne použitie

BE – Belgicko

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

Menarini Benelux N.V

Belgicastraat 4

1930 Zaventem

Belgium

Fastum 2,5 %

25 mg/g

Gél

Dermálne použitie

BE – Belgicko

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

Menarini Benelux N.V

Belgicastraat 4

1930 Zaventem

Belgium

Fastum gel 2,5 %

25 mg/g

Gél

Dermálne použitie

BE – Belgicko

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

Pharmapartner NV

Bleyveldstraat 19

3320 Hoegaarden

Belgium

Fastum gel

25 mg/g

Gél

Dermálne použitie

BG – Bulharsko

| VET PROM JSCO |
| --- |
| 26, „Otez Paissij“ street |
| 2400 Radomir |
| Bulgaria |

VET PROM JSCO

26, „Otez Paissij“ street

2400 Radomir

Bulgaria

Ketoprofen Vetprom

2,5 %

Gél

Dermálne použitie

BG – Bulharsko

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

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

Via Sette Santi 3,

50131 Florence,

Italy

Fastum

2,5 %

Gél

Dermálne použitie

BG – Bulharsko

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

Cyathus Exquirere Pharmaforschungs GmbH,

Rudolfsplatz 2/1/8,

1010 Vienna,

Austria

Ketospray

0,1 %

Dermálna roztoková aerodisperzia

Dermálne použitie

BG – Bulharsko

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

Actavis

29, Atanas Dukov str.

1407 Sofia

Bulgaria

Topogel

2,5 %

Gél

Dermálne použitie

BG – Bulharsko

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

Sanofi-aventis Bulgaria EOOD

103, Alexander Stamboliiski Bld.

Office Building Sofia Tower

Sofia 1303

Bulgaria

Profenid

2,5 %

Gél

Dermálne použitie

BG – Bulharsko

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

Sopharma AD,

16 Iliensko Shousse Street

1220 Sofia

Bulgaria

Ketoprofen Sopharma

2,5 %

Gél

Dermálne použitie

CY – Cyprus

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

A. Menarini Industrie Farmaceutiche Riunite SRL,

Via Delle Sette Santi 3

50131 Florence

Italy

FASTUM GEL 2,5 %

2,5 %

Gél

Dermálne použitie

CZ – Česká republika

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

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

Via Sette Santi 3,

50131 Florencie

Italy

FASTUM GEL

25 mg (2,5 %)/gm

Gél

Dermálne použitie

CZ – Česká republika

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

CYATHUS Exquirere Pharmaforschungs GmbH,

Rudolfsplatz 2/8,

1010 Vienna,

Austria

PRONTOFLEX 10 %

100 mg/ml

Dermálna roztoková aerodisperzia

Dermálne použitie

CZ – Česká republika

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

Lek Pharmaceuticals d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

KETONAL 5 % KRÉM

50 mg/g

Krém

Dermálne použitie

CZ – Česká republika

| sanofi-aventis s.r.o., |
| --- |
| Evropská 846/176a, 160 00 |
| Prague 6 |
| Czech Republic |

sanofi-aventis s.r.o.,

Evropská 846/176a, 160 00

Prague 6

Czech Republic

PROFENID GEL

25 mg/g

Gél

Dermálne použitie

CZ – Česká republika

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

Hisamitsu UK Limited

500 Chiswick High Road

London W4 5RG

United Kingdom

KEPLAT

20 mg

Liečivá náplasť

Dermálne použitie

DE – Nemecko

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

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen,

Germany

Advel Schmerzgel 2,5 % Gel

25 mg/g

Gél

Dermálne použitie

DE – Nemecko

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

Kreussler & Co. GmbH Chemische Fabrik

Rheingaustr. 87-93

D-65203 Wiesbaden

Germany

Phardol Schmerz-Gel

25 mg/g

Gél

Dermálne použitie

DE – Nemecko

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

Madaus GmbH

Colonia-Allee 15

D-51067 Köln

Germany

Reparil SchmerzGel

25 mg/g

Gél

Dermálne použitie

DE – Nemecko

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

McNeil GmbH & Co. oHG

Johnson & Johnson Platz 2

D-41470 Neuss,

Germany

Dolormin Schmerzgel mit Ketoprofen 2,5 %

25 mg/g

Gél

Dermálne použitie

DE – Nemecko

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

TEOFARMA S.R.L.

Via F.IIi Cervi 8

I-27010 Valle Salimbene (PV)

Italy

Effekton Gel mit Ketoprofen

25 mg/g

Gél

Dermálne použitie

DK – Dánsko

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

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

Via Sette Santi 3

IT-50131 Firenze

Italy

Fastum Gel

2,5 %

Gél

Dermálne použitie

DK – Dánsko

| Antula Healthcare AB |
| --- |
| Östermalmsgatan 19 |
| SE-114 26 Stockholm |
| Sweden |

Antula Healthcare AB

Östermalmsgatan 19

SE-114 26 Stockholm

Sweden

Zon

2,5 %

Gél

Dermálne použitie

DK – Dánsko

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

Nordic Drugs AB,

P.O. 30035, Geijersgatan 2A

SE-21618 Limhamn

Sweden

Ketospray

100 mg/g

Dermálna roztoková aerodisperzia

Dermálne použitie

DK – Dánsko

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

Sanofi-Aventis

Slotsmarken 13

DK-2970 Hørsholm

Denmark

Orudis

25 mg/g

Gél

Dermálne použitie

EE – Estónsko

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

Sandoz d.d.

Verovskova 57

1000 Ljubljana

Slovenia

KETONAL

25 mg/1 mg

Gél

Dermálne použitie

EE – Estónsko

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

AS Grindeks

Krustpils 53

LV-1057 Riga

Latvia

BEGSAN

25 mg/1 mg

Gél

Dermálne použitie

EE – Estónsko

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

Lorenzo Pharma OÜ

Koidu 20-19

10136 Tallinn

Estonia

PRONTOFLEX

100 mg/1 g

Dermálna roztoková aerodisperzia

Dermálne použitie

EE – Estónsko

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

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

Via Sette Santi 3

Florence

Italy

FASTUM

25 mg/1 g

Gél

Dermálne použitie

EE – Estónsko

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

Sanofi-Aventis Estonia OÜ Pärnu mnt 139E/2

11317 Tallinn

Estonia

PROFENID

25 mg/1 g

Gél

Dermálne použitie

EL – Grécko

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

Uni-Pharma, Kleon Tsetis, Pharmaceutical Laboratories ABEE

14 Km National Highway

Athens-Lamia

Kifissia 14564

Greece

DRASTIREL

2,5 %

Krém

Dermálne použitie

EL – Greece

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

Guidotti Hellas AE

An. Damvergi 7

Athens 10445

Greece

MENARIL

2,5 %

Gél

Dermálne použitie

ES – Španielsko

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

LABORATORIOS MILO, S.A.

Los Angeles, 60. Pol. Ind. Centrovía

La Muela. 50196 Zaragoza

Spain

Arcental crema

10 mg/g

Krém

Dermálne použitie

ES – Španielsko

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

Laboratorios Menarini,

S.A. Alfonso XII, 587

08918 Badalona (Barcelona)

Spain

Fastum gel

25 mg/g

Gél

Dermálne použitie

ES – Španielsko

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

Pierre Fabre Ibérica S.A.

Ramón Trías Fargas, 7-11

08005 Barcelona

Spain

Extraplus gel

25 mg/g

Gél

Dermálne použitie

ES – Španielsko

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

Sanofi Aventis S.A.

Josep Plá, 2

08019 Barcelona

Spain

Orudis gel

25 mg/g

Gél

Dermálne použitie

FI – Fínsko

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

Antula Healthcare AB,

Östermalmsgatan 19

114 26 Stockholm

Sweden

ZON

2,5 %

Gél

Dermálne použitie

FI – Fínsko

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

Orion Oyj,

Orionintie 1

02101 Espoo

Finland

KETORIN

2,5 %

Gél

Dermálne použitie

FI – Fínsko

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

sanofi-aventis Oy,

Huopalahdentie 24

00351 Helsinki

Finland

ORUDIS

2,5 %

Gél

Dermálne použitie

FR – Francúzsko

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

Arrow Generiques

26 Avenue Tony Garnier

69 007 Lyon

France

KETOPROFENE ARROW

2,5 %

Gél, 60 g tuba

Dermálne použitie

FR – Francúzsko

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

Biogaran

15 Boulevard Charles de Gaulle

92 700 Colombes

France

KETOPROFENE BIOGARAN

2,5 %

Gél, 60 g tuba

Dermálne použitie

FR – Francúzsko

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

Biogaran

15 Boulevard Charles de Gaulle

92 700 Colombes

France

KETOPROFENE BGR

2,5 %

Gél, 60 g tuba

Dermálne použitie

FR – Francúzsko

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

Biogaran

15 Boulevard Charles de Gaulle

92 700 Colombes

France

KETOPROFENE BGR

2,5 %

Gél, 120 g tuba

Dermálne použitie

FR – Francúzsko

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

Biogaran

15 Boulevard Charles de Gaulle

92 700 Colombes

France

KETOPROFENE BGR

2,5 %

Gél, 120 g tuba s dávkovačom

Dermálne použitie

FR – Francúzsko

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

Cediat Mediffusion

11 bis rue du Colisée

75 008 PARIS

France

KETOPROFENE MEDIFFUSION

2,5 %

Gél, 60 g tuba

Dermálne použitie

FR – Francúzsko

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

Cediat Mediffusion

11 bis rue du Colisée

75 008 PARIS

France

KETOPROFENE MEDIFFUSION

2,5 %

Gél, 120 g tuba

Dermálne použitie

FR – Francúzsko

| EG LABO |
| --- |
| Laboratoires EuroGenerics |
| „Le Quintet“ Bât.A |
| 12 rue Danjou |
| 92 517 Boulogne |
| Billancourt Cedex |
| France |

EG LABO

Laboratoires EuroGenerics

„Le Quintet“ Bât.A

12 rue Danjou

92 517 Boulogne

Billancourt Cedex

France

KETOPROFENE EG

2,5 %

Gél, 60 g tuba

Dermálne použitie

FR – Francúzsko

| EG LABO |
| --- |
| Laboratoires EuroGenerics |
| „Le Quintet“ Bât.A |
| 12 rue Danjou |
| 92 517 Boulogne Billancourt Cedex |
| France |

EG LABO

Laboratoires EuroGenerics

„Le Quintet“ Bât.A

12 rue Danjou

92 517 Boulogne Billancourt Cedex

France

KETOPROFENE EG

2,5 %

Gél, 120 g tuba

Dermálne použitie

FR – Francúzsko

| EG LABO |
| --- |
| Laboratoires EuroGenerics |
| „Le Quintet“ Bât.A |
| 12 rue Danjou |
| 92 517 Boulogne Billancourt Cedex |
| France |

EG LABO

Laboratoires EuroGenerics

„Le Quintet“ Bât.A

12 rue Danjou

92 517 Boulogne Billancourt Cedex

France

KETOPROFENE EG

2,5 %

Gél, 120 g tuba (HDPE)

Dermálne použitie

FR – Francúzsko

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

MENARINI France

1/7, rue du Jura

Zone Silic – Rungis

91320 WISSOUS

France

KETUM

2,5 %

Gél, 50 g hliníková tuba

Dermálne použitie

FR – Francúzsko

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

MENARINI France

1/7, rue du Jura

Zone Silic – Rungis

91320 WISSOUS

France

KETUM

2,5 %

Gél, 60 g hliníková tuba

Dermálne použitie

FR – Francúzsko

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

MENARINI France

1/7, rue du Jura

Zone Silic – Rungis

91320 WISSOUS

France

KETUM

2,5 %

Gél, 70 g hliníková tuba

Dermálne použitie

FR – Francúzsko

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

MENARINI France

1/7, rue du Jura

Zone Silic – Rungis

91320 WISSOUS

France

KETUM

2,5 %

Gél, 60 g polyetylén / polypropylén / polyacetátová tuba

Dermálne použitie

FR – Francúzsko

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

MENARINI France

1/7, rue du Jura

Zone Silic – Rungis

91320 WISSOUS

France

KETUM

2,5 %

Gél, 120 g polyetylén / polypropylén / polyacetátová tuba

Dermálne použitie

FR – Francúzsko

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

MENARINI France

1/7, rue du Jura

Zone Silic – Rungis

91320 WISSOUS

France

KETUM

2,5 %

Gél, 70 g polyetylén / polypropylén / polyacetátová tuba

Dermálne použitie

FR – Francúzsko

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

MENARINI France

1/7, rue du Jura

Zone Silic – Rungis

91320 WISSOUS

France

KETOPROFENE MENARINI

2,5 %

Gél, 50 g hliníková tuba

Dermálne použitie

FR – Francúzsko

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

MENARINI France

1/7, rue du Jura

Zone Silic – Rungis

91320 WISSOUS

France

KETOPROFENE MENARINI

2,5 %

gél, 60 g hliníková tuba

Dermálne použitie

FR – Francúzsko

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

MENARINI France

1/7, rue du Jura

Zone Silic – Rungis

91320 WISSOUS

France

KETOPROFENE MENARINI

2,5 %

gél, 70 g hliníková tuba

Dermálne použitie

FR – Francúzsko

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

Mylan SAS

117 allée des Parcs

69 800 Saint Priest

France

KETOPROFENE MYLAN

2,5 %

gél, 60 g tuba

Dermálne použitie

FR – Francúzsko

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

Mylan SAS

117 allée des Parcs

69 800 Saint Priest

France

KETOPROFENE MYLAN

2,5 %

gél, 120 g tuba

Dermálne použitie

FR – Francúzsko

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

Mylan SAS

117 allée des Parcs

69 800 Saint Priest

France

KETOPROFENE MYLAN

2,5 %

gél, 60 g tuba s dávkovačom

Dermálne použitie

FR – Francúzsko

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

Mylan SAS

117 allée des Parcs

69 800 Saint Priest

France

KETOPROFENE MYLAN

2,5 %

gél, 120 g tuba s dávkovačom

Dermálne použitie

FR – Francúzsko

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

Mylan SAS

117 allée des Parcs

69 800 Saint Priest

France

KETOPROFENE MYLAN PHARMA

2,5 %

gél, 60 g tuba

Dermálne použitie

FR – Francúzsko

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

Mylan SAS

117 allée des Parcs

69 800 Saint Priest

France

KETOPROFENE MYLAN PHARMA

2,5 %

gél, 120 g tuba

Dermálne použitie

FR – Francúzsko

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

Mylan SAS

117 allée des Parcs

69 800 Saint Priest

France

KETOPROFENE QUALIHEALTH

2,5 %

gél, 60 g tuba

Dermálne použitie

FR – Francúzsko

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

Mylan SAS

117 allée des Parcs

69 800 Saint Priest

France

KETOPROFENE QUALIHEALTH

2,5 %

gél, 120 g tuba

Dermálne použitie

FR – Francúzsko

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

Qualimed

117 allée des Parcs

69 800 SAINT PRIEST

France

KETOPROFENE QUALIMED

2,5 %

gél, 60 g tuba

Dermálne použitie

FR – Francúzsko

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

Qualimed

117 allée des Parcs

69 800 SAINT PRIEST

France

KETOPROFENE QUALIMED

2,5 %

gél, 120 g tuba

Dermálne použitie

FR – Francúzsko

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

Qualimed

117 allée des Parcs

69 800 SAINT PRIEST

France

KETOPROFENE QUALIMED

2,5 %

gél, 60 g tuba s dávkovačom

Dermálne použitie

FR – Francúzsko

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

Qualimed

117 allée des Parcs

69 800 SAINT PRIEST

France

KETOPROFENE QUALIMED

2,5 %

gél, 120 g tuba s dávkovačom

Dermálne použitie

FR – Francúzsko

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

RPG Ranbaxy

Pharmacie Génériques

4, Place Louis Armand

75012 PARIS

France

KETOPROFENE RPG

2,5 %

gél, 60 g tuba

Dermálne použitie

FR – Francúzsko

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

Ratiopharm

19 boulevard Paul Vaillant Couturier

94 200 IVRY sur Seine

France

KETOPROFENE RATIOPHARM

2,5 %

gél, 60 g tuba

Dermálne použitie

FR – Francúzsko

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

Ratiopharm

19 boulevard Paul Vaillant Couturier

94 200 IVRY sur Seine

France

KETOPROFENE RATIOPHARM

2,5 %

gél, 120 g tuba

Dermálne použitie

FR – Francúzsko

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

Ratiopharm

19 boulevard Paul Vaillant Couturier

94 200 IVRY sur Seine

France

KETOPROFENE RATIO

2,5 %

gél, 60 g tuba

Dermálne použitie

FR – Francúzsko

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

Ratiopharm

19 boulevard Paul Vaillant Couturier

94 200 IVRY sur Seine

France

KETOPROFENE RATIO

2,5 %

gél, 120 g tuba

Dermálne použitie

FR – Francúzsko

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

Ratiopharm

19 boulevard Paul Vaillant Couturier

94 200 IVRY sur Seine

France

KETOPROFENE RATIO

2,5 %

gél, 120 g tuba s dávkovačom

Dermálne použitie

FR – Francúzsko

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

Sandoz

49 Avenue Georges Pomidou

92 300 Levallois Perret

France

KETOPROFENE SANDOZ

2,5 %

gél, 60 g tuba

Dermálne použitie

FR – Francúzsko

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

Sandoz

49 Avenue Georges Pomidou

92 300 Levallois Perret

France

KETOPROFENE SANDOZ

2,5 %

gél, 120 g tuba

Dermálne použitie

FR – Francúzsko

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

Sandoz

49 Avenue Georges Pomidou

92 300 Levallois Perret

France

KETOPROFENE SANDOZ

2,5 %

gel, 120 g tuba s dávkovačom

Dermálne použitie

FR – Francúzsko

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

Sanofi Aventis France

1-13 Boulevard Romain Rolland

75 014 PARIS

France

TOPREC

2,5 %

gél, 60 g tuba

Dermálne použitie

FR – Francúzsko

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

Sanofi Aventis France

1-13 Boulevard Romain Rolland

75 014 PARIS

France

KETOPROFEN E WINTHROP

2,5 %

gél, 60 g tuba

Dermálne použitie

FR – Francúzsko

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

Societe Agipharma

40 rue des Bergers

75 015 Paris

France

KETOPROFENE AGIPHARMA

2,5 %

gél, 60 g tuba

Dermálne použitie

FR – Francúzsko

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

Societe Agipharma

40 rue des Bergers

75 015 Paris

France

KETOPROFENE AGIPHARMA

2,5 %

gél, 120 g tuba

Dermálne použitie

FR – Francúzsko

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

Laboratoire Teva Sante

Le Palatin 1

1 cours du Triangle

92 936 Paris La Défense Cedex

France

KETOPROFENE TEVA

2,5 %

gél, 60 g tube

Dermálne použitie

FR – Francúzsko

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

Laboratoire Teva Sante

Le Palatin 1

1 cours du Triangle

92 936 Paris La Défense Cedex

France

KETOPROFENE TEVA SANTE

2,5 %

gel, 60 g tuba

Dermálne použitie

FR – Francúzsko

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

Laboratoire Teva Sante

Le Palatin 1

1 cours du Triangle

92 936 Paris La Défense Cedex

France

KETOPROFENE TEVA SANTE

2,5 %

gél, 120 g tuba

Dermálne použitie

FR – Francúzsko

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

Laboratoire Teva Sante

Le Palatin 1

1 cours du Triangle

92 936 Paris La Défense Cedex

France

KETOPROFENE TEVA SANTE

2,5 %

gél, 120 g tuba s dávkovačom

Dermálne použitie

FR – Francúzsko

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

Zydus France

25 rue des Peupliers/ZAC Les Hautes Pâtures

Parc d'acticité des Peupliers

92 000 Nanterre

France

KETOPROFENE ZYDUS

2,5 %

gél, 60 g tuba

Dermálne použitie

HU – Maďarsko

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

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

Via Sette Santi 3,

50131 Florence

Italy

FASTUM

25 mg/g

Gél

Dermálne použitie

HU – Maďarsko

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

Goodwill Pharma Kft.

Cserzy Mihály u. 32

6724 Szeged

Hungary

KETOSPRAY

100 mg/g

Dermálna roztoková aerodisperzia

Dermálne použitie

HU – Maďarsko

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

Hisamitsu UK Ltd.

500 Chiswick High Road

London W4 5RG

United Kingdom

KEPLAT

20 mg

Liečivá náplasť

Transdermálne použitie

HU – Maďarsko

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

sanofi-aventis zrt.

Tó u. 1-5

1045 Budapest

Hungary

ALGOFLEX GEL

25 mg/g

Gél

Dermálne použitie

IE – Írsko

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

A. Menarini Srl

1-3 Via Sette Santi

P.O.Box 412

Florence

Italy

Fastum 2,5 % w/w Gel

2,5 % w/w

Gél

Dermálne použitie

IE – Írsko

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

Sanofi-Aventis Ireland Ltd.

Citywest Business Campus

Dublin 24

Ireland

Orugesic 2,5 % w/w Gel

2,5 % w/w

Gél

Dermálne použitie

IE – Írsko

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

Sanofi-Aventis Ireland Ltd.

Citywest Business Campus

Dublin 24

Ireland

Oruvail 2,5 % w/w Gel

2,5 % w/w

Gél

Dermálne použitie

IS – Island

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

Sanofi-aventis Norge AS,

Strandveien 15, Box 133

1325 Lysaker

Norway

Orudis

25 mg/g

Gél

Dermálne použitie

IT – Taliansko

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

A.Menarini

Ind.Farm.Riun.Srl

Via Sette Santi, 3

50131 – Firenze

Italy

Fastum

2,5 %

Gél

Dermálne použitie

IT – Taliansko

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

A.Menarini

Ind.Farm.Riun.Srl

Via Sette Santi, 3

50131 – Firenze

Italy

Fastum

2,5 %

Dermálna roztoková aerodisperzia

Dermálne použitie

IT – Taliansko

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

Almus Srl

Via Cesarea, 11/10

16121 Genova

Italy

Ketoprofene Almus

5 %

Gél

Dermálne použitie

IT – Taliansko

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

Bayer S.p.A.

Viale Certosa, 130

20156 Milano

Italy

Lasonil

2,5 %

Gél

Dermálne použitie

IT – Taliansko

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

Bayer S.p.A.

Viale Certosa, 130

20156 Milano

Italy

Lasoartro

5 %

Krém

Dermálne použitie

IT – Taliansko

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

Crinos S.p.A.

Via Pavia, 6

20136 Milano

Italy

Hiruflog

5 %

Gél

Dermálne použitie

IT – Taliansko

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

Dompè Farmaceutici S.p.A.

Via San Martino, 12-12/A

20122 Milano

Italy

Artrosilene

5 %

Gél

Dermálne použitie

IT – Taliansko

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

Dompè Farmaceutici S.p.A.

Via San Martino, 12-12/A

20122 Milano

Italy

Artrosilene

15 %

Dermálna pena

Dermálne použitie

IT – Taliansko

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

Dompè S.p.A.

Via Campo di Pile

67100 L'Aquila

Italy

Oki

15 %

Gél

Dermálne použitie

IT – Taliansko

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

Eg S.p.A.

Via Domenico Scarlatti, 31

20124 Milano

Italy

Ketoprofene Eurogenerici

5 %

Gél

Dermálne použitie

IT – Taliansko

| Hisamitsu UK Limited |
| --- |
| 500 Chiswick Higth Road |
| London |
| United Kingdom |

Hisamitsu UK Limited

500 Chiswick Higth Road

London

United Kingdom

Keplat

20 mg

Liečivá náplasť

Dermálne použitie

IT – Taliansko

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

I.B.I.Giovanni Lorenzini SpA

Via Fossignano, 2

04011 Aprilia (LT)

Italy

Ibifen

5 %

Gél

Dermálne použitie

IT – Taliansko

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

I.B.I.Giovanni Lorenzini SpA

Via Fossignano, 2

04011 Aprilia (LT)

Italy

Ibifen

5 %

Dermálny roztok

Dermálne použitie

IT – Taliansko

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

Italfarmaco S.p.A.

Viale Fulvio Testi, 330

20126 Milano

Italy

Flexen

2,5 %

Gél

Dermálne použitie

IT – Taliansko

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

Italfarmaco S.p.A.

Viale Fulvio Testi, 330

20126 Milano

Italy

Flexen

5 %

Gél

Dermálne použitie

IT – Taliansko

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

Ratiopharm Italia Srl

Centro Direzionale Milanofiori

20131 Assago (MI)

Italy

Ketoprofene Ratiopharm Italia

2,5 %

Gél

Dermálne použitie

IT – Taliansko

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

Sandoz S.p.A.

Largo Boccioni, 1

21040 Origgio (VA),

Italy

Ketoprofene Sandoz

5 %

Krém

Dermálne použitie

IT – Taliansko

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

Sanofi-Aventis S.p.A.

Viale Bodio, 37/B

20158 Milano

Italy

Liotondol

2,5 %

Gél

Dermálne použitie

IT – Taliansko

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

Sanofi-Aventis S.p.A.

Viale Bodio, 37/B

20158 Milano

Italy

Orudis

2,5 %

Gél

Dermálne použitie

IT – Taliansko

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

Sanofi-Aventis S.p.A.

Viale Bodio, 37/B

20158 Milano

Italy

Orudis

5 %

Gél

Dermálne použitie

IT – Taliansko

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

Sanofi-Aventis S.p.A.

Viale Bodio, 37/B

20158 Milano

Italy

Orudis

1 %

Krém

Dermálne použitie

IT – Taliansko

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

Sanofi-Aventis S.p.A.

Viale Bodio, 37/B

20158 Milano

Italy

Orudis

2,5 %

Krém

Dermálne použitie

IT – Taliansko

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

Teikoku Pharma UK Ltd

7 Floor, Central House

Ballard Lane, Finchley

London

United Kingdom

Ketofarm

5 %

Gél

Dermálne použitie

IT – Taliansko

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

Teva Italia Srl

Via Messina, 38

20154 Milano

Italy

Ketoprofene Teva

5 %

Gél

Dermálne použitie

LT – Litva

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

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

Via Sette Santi Florence

Italy

Fastum

25 mg/g

Gél

Dermálne použitie

LT – Litva

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

GlaxoSmithKline Lietuva UAB

A. Goštauto 40A

LT-01112 Vilnius

Lithuania

Spinax

25 mg/g

Gél

Dermálne použitie

LT – Litva

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

Sandoz d.d.

Verovskova 57

1000 Ljubljana

Slovenia

Ketonal

25 mg/g

Gél

Dermálne použitie

LT – Litva

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

Sandoz d.d.,

Verovskova 57

1000 Ljubljana

Slovenia

Ketonal

50 mg/g

Krém

Dermálne použitie

LT – Litva

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

UAB MRA

Totorių 20-9

LT-01121 Vilnius

Lithuania

Ketospray

100 mg/g

Dermálna roztoková aerodisperzia

Dermálne použitie

LU – Luxembursko

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

MENARINI BENELUX SA

Belgicastraat 4

B- 1930 Zaventem

Belgium

FASTUM

0,025

Gél

Dermálne použitie

LV – Lotyšsko

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

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

Via Sette Santi 3

Florence, I - 50131

Italy

Fastum 2,5 % gel

25 mg/g

Gél

Dermálne použitie

LV – Lotyšsko

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

GlaxoSmithKline Latvia SIA

Bruņinieku iela 5

Rīga, LV-1001

Latvia

Spinax 25 mg/g gel

25 mg/g

Gél

Dermálne použitie

LV – Lotyšsko

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

Sandoz d.d.

Verovškova 57

Ljubljana Sl – 1000

Slovenia

Ketonal 2,5 % gel

25 mg/g

Gél

Dermálne použitie

LV – Lotyšsko

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

Sanofi-aventis Latvia SIA,

Kr.Valdemāra 33-8

Rīga, LV-1010

Latvia

Profenid 25 mg/g gel

25 mg/g

Gél

Dermálne použitie

MT – Malta

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

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

Via Sette Santi, 3

50131, Florence

Italy

Fastum gel 2,5 % w/w

0,025

Gél

Dermálne použitie

MT – Malta

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

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

Via Sette Santi, 3

50131, Florence

Italy

Fastum gel 2,5 % w/w Dispenser

0,025

Gél

Dermálne použitie

MT – Malta

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

Dompé Farmaceutici SPA

Via San Martino 12

20122, Milan

Italy

Artrosilene 15 % cutaneous foam

15 g/100ml

Dermálna pena

Dermálne použitie

MT – Malta

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

Dompé Farmaceutici SPA

Via San Martino 12

20122, Milan

Italy

Artrosilene 5 % gel

5 g/100g

Gél

Dermálne použitie

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

Gél

Dermálne použitie

NO – Nórsko

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

Antula Healthcare AB

Östermalmsgatan 19,

114 26 Stockholm

Sverige

Zon

2,5 %

Gél

Dermálne použitie

NO – Nórsko

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

Sanofi-Aventis

Strandveien 15

1366 Lysaker

Norway

Orudis

2,5 %

Gél

Dermálne použitie

PL – Poľsko

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

A.Menarini Pharmaceutical Industries Group Ltd.

3 Via Sette Santi

I-50 131 Florence

Italy

Fastum

25 mg/g

Gél

Dermálne použitie

PL – Poľsko

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

GlaxoSmithKline Pharmaceuticals S.A

Grunwaldzka st. 189

60-322 Poznań

Poland

Ketoprom

25 mg/g

Gél

Dermálne použitie

PL – Poľsko

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

Hisamitsu UK Limited

500 Chiswick High Road

London W4 5RG UK

United Kingdom

Keplat

20 mg

Liečivá náplasť

Transdermálne použitie

PL – Poľsko

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

Medagro International Sp.z o.o.

83 Podleśna St.,

05-552 Łazy k.

Warszawy

Poland

Ketospray Forte

100 mg/g

Dermálna roztoková aerodisperzia

Dermálne použitie

PL – Poľsko

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

Medana Pharma S.A.

10 Władysława Łokietka st.

98-200 Sieradz

Poland

Ultrafastin

25 mg/g

Gél

Dermálne použitie

PL – Poľsko

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

Sandoz GmbH

Biochemiestrasse 10

A-6250 Kundl

Austria

Ketonal Lek

25 mg/g

Gél

Dermálne použitie

PL – Poľsko

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

Sanofi-Aventis France

boulevard Romain Rolland 1-13

F-75014 Paris

France

Profenid Gel

25 mg/g

Gél

Dermálne použitie

PL – Poľsko

| Zakłady Farmaceutyczne „UNIA“ Spółdzielnia Pracy |
| --- |
| ul. Chłodna 56/60 |
| 00-872 Warsaw |
| Poland |

Zakłady Farmaceutyczne „UNIA“ Spółdzielnia Pracy

ul. Chłodna 56/60

00-872 Warsaw

Poland

Ketopronil

25 mg/g

Gél

Dermálne použitie

PT – Portugalsko

| 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

Gél

Dermálne použitie

PT – Portugalsko

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

Hisamitsu UK Ltd.

500 Chiswick High Road

W4 5RG UK London

United Kingdom

Keplat

20 mg

Liečivá náplasť

Transdermálne použitie

PT – Portugalsko

| 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

Gél

Dermálne použitie

RO – Rumunsko

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

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

Via Sette Santi 3

Firenze

Italy

FASTUM GEL, gel, 2,5 %

25 mg/g

Gél

Dermálne použitie

RO – Rumunsko

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

CSC Pharmaceuticals Handels GmbH

Heiligenstadter Strasse 395 b

1190-Viena

Austria

KETOSPRAY 50 mg/ml, spray cutanat soluție

50 mg/ml

Dermálna roztoková aerodisperzia

Dermálne použitie

RO – Rumunsko

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

Cyathus Exquirere PharmaforschungsGmbH

Rudolfsplatz 2/1/8

A-1010 Viena

Austria

KETOSpray 10 %, spray cutanat, soluție

100 mg/ml

Dermálna roztoková aerodisperzia

Dermálne použitie

RO – Rumunsko

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

Laboratoires Aventis

46, quai de la Rapee

75012 Paris Cedex 12

France

PROFENID GEL, 2,5 %

25 mg/g

Gél

Dermálne použitie

RO – Rumunsko

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

LEK Pharmaceuticals D.D.,

Verovskova 57

1526 Ljublijana

Slovenia

KETONAL 2,5 % gel

25 mg/g

Gél

Dermálne použitie

RO – Rumunsko

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

Ozone Laboratories SRL,

Calea Rahovei nr. 266-268

Corp 60, Etaj 1, Sector 5

București

Romania

KETOPROFEN 25 mg/g GEL

25 mg/g

Gél

Dermálne použitie

RO – Rumunsko

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

S.C. Antibiotice S.A.

Str. Valea Lupului Nr. 1

Iași, jud. Iași

România

RUBIFEN 2,5 %,gel

25 mg/g

Gél

Dermálne použitie

RO – Rumunsko

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

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

Str. Moara de Foc nr. 35,

Iași 700520

România

KETOPROFEN MK, gel, 2,5 %

25 mg/g

Gél

Dermálne použitie

RO – Rumunsko

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

S.C. HYPERION S.A.

B-dul Independenței nr. 18

Bloc Y1, Etj. 8, Ap.4

Cod 700099, Iași

România

KETOPROFEN HYPERION 25 mg/g gel

25 mg/g

Gél

Dermálne použitie

RO – Rumunsko

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

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

Str. Știrbei Vodă nr. 53-55, sector 1

București,

România

KETOPROFEN SLAVIA 25 mg/g gel

25 mg/g

Gél

Dermálne použitie

RO – Rumunsko

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

S.C. Terapia S.A.,

Str. Fabricii, nr. 124

Cluj Napoca

România

KETOPROFEN, 25 mg/g, gel

25 mg/g

Gél

Dermálne použitie

SE – Švédsko

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

ACO Hud AB

Box 622

194 26 Upplands Väsby

Sweden

Ketoflex

2,5 %

Gél

Dermálne použitie

SE – Švédsko

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

Antula Healthcare AB, , Östermalmsgatan 19

114 26 Stockholm

Sweden

Zon

2,5 %

Gél

Dermálne použitie

SE – Švédsko

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

Meda AB,

Box 906

170 09 Solna

Sweden

Siduro

2,5 %

Gél

Dermálne použitie

SE – Švédsko

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

sanofi-aventis AB

Box 14142

167 14 Bromma

Sweden

Orudis

2,5 %

Gél

Dermálne použitie

SI – Slovinsko

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

Galex, d.d.

Tišinska ulica 29g

SI-9000 Murska Sobota,

Slovenia

Prontoflex 100 mg/g dermalno pršilo, raztopina

100 mg/g

Dermálna roztoková aerodisperzia

Dermálne použitie

SI – Slovinsko

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

Lek farmacevtska družba, d.d., Verovškova 57

SI-1000 Ljubljana

Slovenia

Ketonal 25 mg/g gel

25 mg/g

Gél

Dermálne použitie

SI – Slovinsko

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

Lek farmacevtska družba, d.d., Verovškova 57

SI-1000 Ljubljana

Slovenia

Ketonal 50 mg/g krema

50 mg/g

Krém

Dermálne použitie

SI – Slovinsko

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

Menarini Industrie Farmaceutiche Riunite s.r.l.,

Via Sette Santi 3

Firenze I-50131

Italy

Fastum 25 mg/g gel

25 mg/g

Gél

Dermálne použitie

SK – Slovensko

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

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

Via Sette Santi 3

50131 Florence

Italy

FASTUM GEL

2,5 %

Gél

Dermálne použitie

SK – Slovensko

| Herbacos-Bofarma, s.r.o. |
| --- |
| Štrossova 239 |
| 530 03 Pardubice |
| Czech Republic |

Herbacos-Bofarma, s.r.o.

Štrossova 239

530 03 Pardubice

Czech Republic

KETOPROFEN BCH

2,5 %

Gél

Dermálne použitie

SK – Slovensko

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

NTC Pharma, s.r.o.

Strečnianska 13

851 05 Bratislava

Slovakia

KETOSPRAY 10 %

100 mg / 1 ml

Dermálna roztoková aerodisperzia

Dermálne použitie

SK – Slovensko

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

Sandoz Pharmaceuticals d.d. Verovškova 57

1000 Ljubljana

Slovenia

Ketonal 2,5 % gél

2,5 %

Gél

Dermálne použitie

UK – Veľká Británia

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

A Menarini Industrie Farmaceutiche Riunite SRL

Via Sette Sante 3

50131 Florence

Italy

POWERGEL 2,5 % GEL

2,5 % W/W

Gél

Dermálne použitie

UK – Veľká Británia

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

A Menarini Industrie Farmaceutiche Riunite SRL

Via Sette Sante 3

50131 Florence

Italy

FASTUM GEL

2,5 % W/W

Gél

Dermálne použitie

UK – Veľká Británia

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

May & Baker Limited

50 King's Hill Avenue

King's Hill, West Malling

Kent ME19 4AH

United Kingdom

ORUVAIL GEL 2,5 %

2,5 % W/W

Gél

Dermálne použitie

UK – Veľká Británia

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

Pinewood Laboratories Limited Ballymacarbry

Clonmel, CO Tipperary

Ireland

KETOPROFEN 2,5 % W/W GEL

2,5 % W/W

Gél

Dermálne použitie

UK – Veľká Británia

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

Pliva Pharma Limited

Vision House, Bedford Road Petersfield

Hampshire GU32 3QB

United Kingdom

KETOPROFEN 2,5 % W/W GEL

2,5 % W/W

Gél

Dermálne použitie

UK Veľká Británia

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

Tillomed Laboratories Limited

3 Howard Road

Eaton Socon, ST. Neots, Cambridgeshire PE19 8ET

United Kingdom

TILOKET GEL 2,5 %

2,5 % W/W

Gél

Dermálne použitie

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