# Uradni list C 128/2011

| | ISSN 1725-5244
  doi:10.3000/17255244.C_2011.128.slv |
| --- | --- |
| Uradni list
  Evropske unije | C 128 |
| | |
| Slovenska izdaja | Informacije in objave | Zvezek 5429. april 2011 |

ISSN 1725-5244

doi:10.3000/17255244.C_2011.128.slv

Uradni list

Evropske unije

C 128

Slovenska izdaja

Informacije in objave

Zvezek 5429. april 2011

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| Obvestilo št. | Vsebina | Stran |
| --- | --- | --- |
| | IV   Informacije |
| | INFORMACIJE INSTITUCIJ, ORGANOV, URADOV IN AGENCIJ EVROPSKE UNIJE |
| | Evropska komisija |
| 2011/C 128/01 | Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. januarja 2011 do 28. februarja 2011(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta
  ) | 1 |
| 2011/C 128/02 | Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. januarja 2011 do 28. februarja 2011(Sklepi, sprejeti na podlagi člena 34 Direktive 2001/83/ES
  ali člena 38 Direktive 2001/82/ES
  ) | 19 |

Obvestilo št.

Vsebina

Stran

IV   Informacije

INFORMACIJE INSTITUCIJ, ORGANOV, URADOV IN AGENCIJ EVROPSKE UNIJE

Evropska komisija

2011/C 128/01

Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. januarja 2011 do 28. februarja 2011(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta
  )

(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta

)

1

2011/C 128/02

Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. januarja 2011 do 28. februarja 2011(Sklepi, sprejeti na podlagi člena 34 Direktive 2001/83/ES
  ali člena 38 Direktive 2001/82/ES
  )

(Sklepi, sprejeti na podlagi člena 34 Direktive 2001/83/ES

ali člena 38 Direktive 2001/82/ES

)

19

| SL | |
| --- | --- |

SL

---

IV Informacije

INFORMACIJE INSTITUCIJ, ORGANOV, URADOV IN AGENCIJ EVROPSKE UNIJE

Evropska komisija

| 29.4.2011 | SL | Uradni list Evropske unije | C 128/1 |
| --- | --- | --- | --- |

29.4.2011

SL

Uradni list Evropske unije

C 128/1

---

Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. januarja 2011 do 28. februarja 2011

(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta
   (1)
  )

2011/C 128/01

—   Izdaja dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena

| Datum sprejetja sklepa | Ime zdravila | INN (mednarodno nelastniško ime) | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Farmacevtska oblika | ATC (anatomsko terapevtska kemijska oznaka) | Datum obvestila |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 6.1.2011 | Potactasol | topotecan | Actavis Group PTC ehf. |
| Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Iceland |

Datum sprejetja sklepa

Ime zdravila

INN (mednarodno nelastniško ime)

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Farmacevtska oblika

ATC (anatomsko terapevtska kemijska oznaka)

Datum obvestila

6.1.2011

Potactasol

topotecan

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Iceland

EU/1/10/660/001-002

Prašek za koncentrat za raztopino za infundiranje

L01XX17

10.1.2011

21.1.2011

Docetaxel Teva Pharma

docetaksel

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

Teva Pharma B.V.

Computerweg 10, DR Utrecht 3542, Nederland

EU/1/10/662/001-002

Koncentrat in topilo za raztopino za infundiranje

L01CD02

26.1.2011

21.1.2011

Iasibon

ibandronska kislina

| Pharmathen S.A. |
| --- |
| 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα |

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

EU/1/10/659/001-010

Filmsko obložene tablete

Koncentrat za raztopino za infundiranje

M05BA06

25.1.2011

27.1.2011

Fluenz

cepivo proti gripi (z živimi oslabljenimi virusi, nosno)

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

MedImmune, LLC

Lagelandseweg 78, 6545 CG Nijmegen, Nederland

EU/1/10/661/001-002

Pršilo za nos, suspenzija

J07BB03

1.2.2011

18.2.2011

Entacapone Teva

entakapon

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

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/10/665/001-004

Filmsko obložene tablete

N04BX02

22.2.2011

28.2.2011

Daliresp

roflumilast

| Nycomed GmbH |
| --- |
| Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland |

Nycomed GmbH

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

EU/1/11/668/001-003

Filmsko obložene tablete

R03DX07

2.3.2011

28.2.2011

Esbriet

Pirfenidon

| InterMune Europe Ltd |
| --- |
| Wellesley House, Duke of Wellington Avenue, Royal Arsenal, London SE18 6SS, United Kingdom |

InterMune Europe Ltd

Wellesley House, Duke of Wellington Avenue, Royal Arsenal, London SE18 6SS, United Kingdom

EU/1/11/667/001-003

Kapsula, trda

L04AX05

2.3.2011

28.2.2011

Lamivudine / Zidovudine Teva

Lamivudin/Zidovudin

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

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/10/663/001-002

Filmsko obložene tablete

J05AR01

2.3.2011

28.2.2011

Libertek

roflumilast

| Nycomed GmbH |
| --- |
| Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland |

Nycomed GmbH

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

EU/1/11/666/001-003

Filmsko obložene tablete

R03DX07

2.3.2011

28.2.2011

Xiapex

kolagenaza clostridium histolyticum

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

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom

EU/1/11/671/001

Prašek in vehikel za raztopino za injiciranje

M09AB02

2.3.2011

—   Sprememba dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena

| Datum sprejetja sklepa | Ime zdravila | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Datum obvestila |
| --- | --- | --- | --- | --- |
| 6.1.2011 | Invirase | Roche Registration Limited |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

6.1.2011

Invirase

Roche Registration Limited

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

EU/1/96/026/001-002

10.1.2011

6.1.2011

Irbesartan HCT 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/1/06/377/001-028

11.1.2011

6.1.2011

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

11.1.2011

6.1.2011

Lucentis

| 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/1/06/374/001

11.1.2011

6.1.2011

Rapamune

| 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/1/01/171/001

EU/1/01/171/007-010

EU/1/01/171/013-014

11.1.2011

6.1.2011

Resolor

| Movetis NV |
| --- |
| Veedijk 58, B-2300 Turnhout, België |

Movetis NV

Veedijk 58, B-2300 Turnhout, België

EU/1/09/581/001-008

11.1.2011

6.1.2011

Tepadina

| ADIENNE S.r.l. |
| --- |
| via Broseta, 64/B, 24128 Bergamo, Italia |

ADIENNE S.r.l.

via Broseta, 64/B, 24128 Bergamo, Italia

EU/1/10/622/001-002

11.1.2011

6.1.2011

Yttriga

| Eckert & Ziegler Nuclitec GmbH |
| --- |
| Gieselweg 1, Braunschweig 38110, Deutschland |

Eckert & Ziegler Nuclitec GmbH

Gieselweg 1, Braunschweig 38110, Deutschland

EU/1/05/322/001

10.1.2011

11.1.2011

IntronA

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

Schering Plough Europe

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

EU/1/99/127/011-039

EU/1/99/127/041-044

18.1.2011

11.1.2011

Pantoloc Control

| Nycomed GmbH |
| --- |
| Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland |

Nycomed GmbH

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

EU/1/09/519/001-004

13.1.2011

11.1.2011

Rapiscan

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

Gilead Sciences International Limited

Cambridge CB21 6GT United Kingdom

EU/1/10/643/001

13.1.2010

13.1.2011

Clopidogrel Winthrop

| Sanofi-Aventis |
| --- |
| 174, avenue de France, F-75013 Paris, France |

Sanofi-Aventis

174, avenue de France, F-75013 Paris, France

EU/1/08/465/001-020

17.1.2011

13.1.2011

Copalia

| 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/1/06/372/037-039

17.1.2010

13.1.2011

INOmax

| INO Therapeutics AB |
| --- |
| SE-181 81 Lidingö, Sverige |

INO Therapeutics AB

SE-181 81 Lidingö, Sverige

EU/1/01/194/001-002

18.1.2011

13.1.2011

Iscover

| 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/1/98/070/001a-001b

EU/1/98/070/002a-002b

EU/1/98/070/003a-003b

EU/1/98/070/004a-004b

EU/1/98/070/005a-005b

EU/1/98/070/006a-006b

EU/1/98/070/007a-007b

EU/1/98/070/008-010

EU/1/98/070/011a-011b

EU/1/98/070/012

17.1.2011

13.1.2011

Nimvastid

| 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/1/09/525/001-050

17.1.2011

13.1.2011

Plavix

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

Sanofi Pharma Bristol-Myers Squibb SNC

174 avenue de France - 75013 Paris, France

EU/1/98/069/001a-001b

EU/1/98/069/002a-002b

EU/1/98/069/003a-003b

EU/1/98/069/004a-004b

EU/1/98/069/005a-005b

EU/1/98/069/006a-006b

EU/1/98/069/007a-007b

EU/1/98/069/008-010

EU/1/98/069/011a-011b

EU/1/98/069/012

17.1.2011

17.1.2011

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

19.1.2011

17.1.2011

Kuvan

| Merck KGaA |
| --- |
| Frankfurter Straße 250, 64293 Darmstadt, Deutschland |

Merck KGaA

Frankfurter Straße 250, 64293 Darmstadt, Deutschland

EU/1/08/481/001-003

19.1.2011

17.1.2011

Nevanac

| 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/1/07/433/001

19.1.2011

21.1.2011

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

25.1.2011

21.1.2011

Adenuric

| Menarini International Operations Luxembourg S.A. |
| --- |
| 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg |

Menarini International Operations Luxembourg S.A.

1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg

EU/1/08/447/001-004

25.1.2011

21.1.2011

Arzerra

| Glaxo Group Ltd |
| --- |
| Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom |

Glaxo Group Ltd

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

EU/1/10/625/001-002

26.1.2011

21.1.2011

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

25.1.2011

21.1.2011

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

25.1.2011

21.1.2011

Humira

| 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/1/03/256/001-010

25.1.2011

21.1.2011

INOmax

| INO Therapeutics AB |
| --- |
| SE-181 81 Lidingö, Sverige |

INO Therapeutics AB

SE-181 81 Lidingö, Sverige

EU/1/01/194/001-002

25.1.2011

21.1.2011

Karvea

| 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/1/97/049/001-039

26.1.2011

21.1.2011

Kuvan

| Merck KGaA |
| --- |
| Frankfurter Straße 250, 64293 Darmstadt, Deutschland |

Merck KGaA

Frankfurter Straße 250, 64293 Darmstadt, Deutschland

EU/1/08/481/001-003

25.1.2011

21.1.2011

Mixtard

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

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/02/231/001-023

EU/1/02/231/036-037

25.1.2011

21.1.2011

Multaq

| Sanofi-Aventis |
| --- |
| 174, avenue de France, F-75013 Paris, France |

Sanofi-Aventis

174, avenue de France, F-75013 Paris, France

EU/1/09/591/001-004

25.1.2011

21.1.2011

Olazax Disperzi

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

Glenmark Pharmaceuticals s.r.o.

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

EU/1/09/592/001-005

25.1.2011

21.1.2011

Pandemrix

| 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/1/08/452/001

26.1.2011

21.1.2011

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

25.1.2011

21.1.2011

Rapamune

| 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/1/01/171/001

EU/1/01/171/007-010

EU/1/01/171/013-014

26.1.2011

21.1.2011

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

25.1.2011

21.1.2011

Revatio

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

Pfizer Limited

Sandwich, Kent, CT13 9NJ, United Kingdom

EU/1/05/318/002

25.1.2011

21.1.2011

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

26.1.2011

21.1.2011

RotaTeq

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

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk, Lyon 69007, France

EU/1/06/348/001-002

26.1.2011

21.1.2011

Sprimeo

| 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/1/07/407/001-020

26.1.2011

21.1.2011

Temomedac

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

medac Gesellschaft für klinische Spezialpräparate mbH

Fehlandtstrasse 3, D-20354 Hamburg - Deutschland

EU/1/09/605/001-012

26.1.2011

21.1.2011

Thymanax

| Servier (Ireland) Industries Limited |
| --- |
| Gorey Road, Arklow, Co. Wicklow, Ireland |

Servier (Ireland) Industries Limited

Gorey Road, Arklow, Co. Wicklow, Ireland

EU/1/08/498/001-008

25.1.2011

21.1.2011

Valdoxan

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

Les Laboratoires Servier

22, rue Garnier, 92200 Neuilly-sur-Seine, France

EU/1/08/499/001-008

26.1.2011

21.1.2011

Yentreve

| 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/1/04/280/001-008

25.1.2011

24.1.2011

Apidra

| Sanofi-Aventis Deutschland GmbH |
| --- |
| D-65926 Frankfurt am Main, Deutschland |

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/04/285/001-036

27.1.2011

24.1.2011

Ceplene

| EpiCept GmbH |
| --- |
| Goethestrasse 4, D-80336 München, Deutschland |

EpiCept GmbH

Goethestrasse 4, D-80336 München, Deutschland

EU/1/08/477/001

27.1.2011

24.1.2011

Dafiro

| 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/1/06/371/001-039

27.1.2011

24.1.2011

Eucreas

| 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/1/07/425/001-018

27.1.2011

24.1.2011

Galvus

| 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/1/07/414/001-010

EU/1/07/414/018

27.1.2011

24.1.2011

Isentress

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

Merck Sharp & Dohme Limited

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

EU/1/07/436/001-002

27.1.2011

24.1.2011

Jalra

| 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/1/08/485/001-011

27.1.2011

24.1.2011

Lantus

| Sanofi-Aventis Deutschland GmbH |
| --- |
| D-65926 Frankfurt am Main, Deutschland |

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/00/134/001-037

27.1.2011

24.1.2011

NutropinAq

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

Ipsen Pharma

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

EU/1/00/164/003-005

27.1.2011

24.1.2011

Olanzapine Glenmark

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

Glenmark Generics (Europe) Limited

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

EU/1/09/587/001-017

27.1.2011

24.1.2011

Olanzapine Glenmark Europe

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

Glenmark Generics (Europe) Limited

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

EU/1/09/588/001-012

27.1.2011

24.1.2011

Optisulin

| Sanofi-Aventis Deutschland GmbH |
| --- |
| D-65926 Frankfurt am Main, Deutschland |

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/00/133/001-032

27.1.2011

24.1.2011

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/1/08/460/009-011

EU/1/08/460/013-014

26.1.2011

24.1.2011

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

27.1.2011

24.1.2011

SonoVue

| Bracco International B.V. |
| --- |
| Strawinskylaan 3051, 1077 ZX Amsterdam, Nederland |

Bracco International B.V.

Strawinskylaan 3051, 1077 ZX Amsterdam, Nederland

EU/1/01/177/002

27.1.2011

24.1.2011

Synflorix

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

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/09/508/001-010

27.1.2011

24.1.2011

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

27.1.2011

24.1.2011

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/1/08/459/009-011

EU/1/08/459/013-014

26.1.2011

24.1.2011

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/1/08/458/009-011

EU/1/08/458/013-014

26.1.2011

24.1.2011

Vistide

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

Gilead Sciences International Limited

Cambridge, CB21 6GT, United Kingdom

EU/1/97/037/001

27.1.2011

24.1.2011

Xarelto

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

Bayer Schering Pharma AG

13342 Berlin, Deutschland

EU/1/08/472/001-010

27.1.2011

24.1.2011

Xiliarx

| 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/1/08/486/001-011

27.1.2011

26.1.2011

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

27.1.2011

27.1.2011

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

1.2.2011

27.1.2011

Alimta

| 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/1/04/290/001-002

1.2.2011

27.1.2011

Cymbalta

| 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/1/04/296/001-009

31.1.2011

27.1.2011

Herceptin

| 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/1/00/145/001

1.2.2011

27.1.2011

Icandra

| 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/1/08/484/001-018

1.2.2011

27.1.2011

Menveo

| 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/1/10/614/001

31.1.2011

27.1.2011

Nonafact

| Sanquin |
| --- |
| Plesmanlaan 125, Amsterdam 1066 CX, Nederland |

Sanquin

Plesmanlaan 125, Amsterdam 1066 CX, Nederland

EU/1/01/186/001-002

1.2.2011

27.1.2011

Orgalutran

| N.V. Organon |
| --- |
| P.O. Box 20, Kloosterstraat 6, 5340 BH Oss, Nederland |

N.V. Organon

P.O. Box 20, Kloosterstraat 6, 5340 BH Oss, Nederland

EU/1/00/130/001-002

31.1.2011

27.1.2011

Ranexa

| Menarini International Operations Luxembourg S.A. |
| --- |
| 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg |

Menarini International Operations Luxembourg S.A.

1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg

EU/1/08/462/001-012

1.2.2011

27.1.2011

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

1.2.2011

27.1.2011

Regranex

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

Janssen-Cilag International NV

Turnhoutseweg, 30 - 2340 Beerse - België

EU/1/99/101/001

31.1.2011

27.1.2011

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

1.2.2011

27.1.2011

Ribavirin Mylan

| Three Rivers Global Pharma Limited |
| --- |
| 20-22 Bedford Row, London WC1R4JS, United Kingdom |

Three Rivers Global Pharma Limited

20-22 Bedford Row, London WC1R4JS, United Kingdom

EU/1/10/634/001-004

23.2.2011

27.1.2011

RotaTeq

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

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk, Lyon 69007, France

EU/1/06/348/001-002

1.2.2011

27.1.2011

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

1.2.2011

27.1.2011

Simponi

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

Centocor B.V.

Einsteinweg 101, 2333 CB Leiden, Nederland

EU/1/09/546/001-004

31.1.2011

27.1.2011

Xeristar

| 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/1/04/297/001-008

1.2.2011

27.1.2011

Zomarist

| 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/1/08/483/001-018

1.2.2011

1.2.2011

Ariclaim

| 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/1/04/283/008-012

3.2.2011

1.2.2011

Emend

| 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/1/03/262/001-008

3.2.2011

1.2.2011

Exforge

| 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/1/06/370/001-039

3.2.2011

1.2.2011

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

3.2.2011

1.2.2011

Imprida

| 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/1/06/373/001-039

3.2.2011

1.2.2011

INCRELEX

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

Ipsen Pharma

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

EU/1/07/402/001

3.2.2011

1.2.2011

Insulin Human Winthrop

| Sanofi-Aventis Deutschland GmbH |
| --- |
| D-65926 Frankfurt am Main, Deutschland |

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/06/368/001-168

3.2.2011

1.2.2011

Insuman

| Sanofi-Aventis Deutschland GmbH |
| --- |
| D-65926 Frankfurt am Main, Deutschland |

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/97/030/028-195

3.2.2011

1.2.2011

Irbesartan Teva

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

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/09/576/001-039

3.2.2011

1.2.2011

Nivestim

| Hospira UK Limited |
| --- |
| Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom |

Hospira UK Limited

Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom

EU/1/10/631/001-009

3.2.2011

1.2.2011

Orfadin

| Swedish Orphan Biovitrum International AB |
| --- |
| SE-112 76 Stockholm, Sweden |

Swedish Orphan Biovitrum International AB

SE-112 76 Stockholm, Sweden

EU/1/04/303/001-003

3.2.2011

1.2.2011

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

3.2.2011

1.2.2011

Votrient

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

Glaxo Group Limited

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

EU/1/10/628/001-004

3.2.2011

2.2.2011

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

4.2.2011

2.2.2011

Prevenar

| Wyeth-Lederle Vaccines S.A. |
| --- |
| Pleainlaan 17 Boulevard de la Plaine, 1050 Brussels - Bruxelles, Belgium |

Wyeth-Lederle Vaccines S.A.

Pleainlaan 17 Boulevard de la Plaine, 1050 Brussels - Bruxelles, Belgium

EU/1/00/167/001-008

4.2.2011

2.2.2011

Prolia

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

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/10/618/001-004

4.2.2011

2.2.2011

Replagal

| Shire Human Genetic Therapies AB |
| --- |
| Svärdvägen 11D, 182 33 Danderyd, Sverige |

Shire Human Genetic Therapies AB

Svärdvägen 11D, 182 33 Danderyd, Sverige

EU/1/01/189/001-006

4.2.2011

2.2.2011

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

4.2.2011

8.2.2011

Biopoin

| CT Arzneimittel GmbH |
| --- |
| Lengeder Straße 42a, D-13407 Berlin, Deutschland |

CT Arzneimittel GmbH

Lengeder Straße 42a, D-13407 Berlin, Deutschland

EU/1/09/565/001-028

10.2.2011

8.2.2011

Temodal

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

Schering Plough Europe

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

EU/1/98/096/001-025

14.2.2011

9.2.2011

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

11.2.2011

9.2.2011

Karvezide

| 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/1/98/085/001-034

11.2.2011

9.2.2011

Olazax

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

Glenmark Pharmaceuticals s.r.o.

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

EU/1/09/597/001-005

11.2.2011

9.2.2011

Peyona

| CHIESI FARMACEUTICI SpA |
| --- |
| Via Palermo 26/A, I-43100 Parma, ITALIA |

CHIESI FARMACEUTICI SpA

Via Palermo 26/A, I-43100 Parma, ITALIA

EU/1/09/528/001-002

11.2.2011

9.2.2011

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

11.2.2011

9.2.2011

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

11.2.2011

11.2.2011

Aprovel

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

Sanofi Pharma Bristol-Myers Squibb SNC

174 avenue de France - 75013 Paris, France

EU/1/97/046/001-039

15.2.2011

11.2.2011

Azarga

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

Alcon Laboratories (UK) Ltd.

Pentagon Park, Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom

EU/1/08/482/001-002

15.2.2011

11.2.2011

Brinavess

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

Merck Sharp & Dohme Limited

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

EU/1/10/645/001-002

15.2.2011

11.2.2011

Clopidogrel Krka

| 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/1/09/556/001-011

15.2.2011

11.2.2011

CoAprovel

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

Sanofi Pharma Bristol-Myers Squibb SNC

174 avenue de France - 75013 Paris, France

EU/1/98/086/001-034

15.2.2011

11.2.2011

Crixivan

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

Merck Sharp & Dohme Ltd

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

EU/1/96/024/001-005

EU/1/96/024/008

EU/1/96/024/010

15.2.2011

11.2.2011

Eporatio

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

ratiopharm GmbH

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

EU/1/09/573/001-028

15.2.2011

11.2.2011

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

15.2.2011

11.2.2011

Rilonacept Regeneron

| Regeneron UK Limited |
| --- |
| 40 Bank Street, E14 5DS London, United Kingdom |

Regeneron UK Limited

40 Bank Street, E14 5DS London, United Kingdom

EU/1/09/582/001

15.2.2011

11.2.2011

Zutectra

| Biotest Pharma GmbH |
| --- |
| Landsteinerstr.5, 63303 Dreieich, Deutschland |

Biotest Pharma GmbH

Landsteinerstr.5, 63303 Dreieich, Deutschland

EU/1/09/600/001

15.2.2011

11.2.2011

Zyllt

| 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/1/09/553/001-010

15.2.2011

18.2.2011

Actrapid

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

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/02/230/001-007

EU/1/02/230/016-017

22.2.2011

18.2.2011

Elaprase

| Shire Human Genetic Therapies AB |
| --- |
| Svärdvägen 11D, 182 33 Danderyd, Sverige |

Shire Human Genetic Therapies AB

Svärdvägen 11D, 182 33 Danderyd, Sverige

EU/1/06/365/001-003

22.2.2011

18.2.2011

Keppra

| 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/1/00/146/001-032

22.2.2011

18.2.2011

Mimpara

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

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/04/292/001-012

22.2.2011

18.2.2011

Optaflu

| Novartis Vaccines and Diagnostics GmbH |
| --- |
| Emil-von-Behring-Strasse 76, D-35041 Marburg, Deutschland |

Novartis Vaccines and Diagnostics GmbH

Emil-von-Behring-Strasse 76, D-35041 Marburg, Deutschland

EU/1/07/394/001-009

22.2.2011

18.2.2011

Renagel

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

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/99/123/005-013

22.2.2011

21.2.2011

Arzerra

| Glaxo Group Ltd |
| --- |
| Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom |

Glaxo Group Ltd

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

EU/1/10/625/001-003

25.2.2011

21.2.2011

Baraclude

| 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/1/06/343/001-007

28.2.2011

21.2.2011

Cervarix

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

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/07/419/001-012

25.2.2011

21.2.2011

Cialis

| 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/1/02/237/001-009

23.2.2011

21.2.2011

Clopidogrel Teva

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

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/09/540/001-016

24.2.2011

21.2.2011

Competact

| Takeda Global Research and Development Centre (Europe) Ltd |
| --- |
| 61 Aldwych, London WC2B 4AE, United Kingdom |

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych, London WC2B 4AE, United Kingdom

EU/1/06/354/001-011

23.2.2011

21.2.2011

Conbriza

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

Pfizer Limited

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

EU/1/09/511/001-005

23.2.2011

21.2.2011

Dukoral

| Crucell Sweden AB |
| --- |
| SE-105 21 Stockholm, Sweden |

Crucell Sweden AB

SE-105 21 Stockholm, Sweden

EU/1/03/263/001-003

1.3.2011

21.2.2011

Dynastat

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

Pfizer Ltd

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

EU/1/02/209/001-008

23.2.2011

21.2.2011

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

24.2.2011

21.2.2011

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

25.2.2011

21.2.2011

Firazyr

| Jerini AG |
| --- |
| Invalidenstr. 130, D-10115 Berlin, Deutschland |

Jerini AG

Invalidenstr. 130, D-10115 Berlin, Deutschland

EU/1/08/461/001-002

24.2.2011

21.2.2011

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

28.2.2011

21.2.2011

Humira

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

Abbott Laboratories Ltd

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

EU/1/03/256/001-010

23.2.2011

21.2.2011

Insulatard

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

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/02/233/005-007

25.2.2011

21.2.2011

Intanza

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

Sanofi Pasteur MSD SNC

8, rue Jonas Salk, Lyon 69007, France

EU/1/08/505/001-006

23.2.2011

21.2.2011

Ivemend

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

Merck Sharp & Dohme Limited

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

EU/1/07/437/001-004

24.2.2011

21.2.2011

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

24.2.2011

21.2.2011

Kineret

| Swedish Orphan Biovitrum AB (publ) |
| --- |
| SE-112 76, Stockholm, Sverige |

Swedish Orphan Biovitrum AB (publ)

SE-112 76, Stockholm, Sverige

EU/1/02/203/001-004

25.2.2011

21.2.2011

Levemir

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

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/04/278/001-003

28.2.2011

21.2.2011

Myozyme

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

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/06/333/001-003

28.2.2011

21.2.2011

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

25.2.2011

21.2.2011

Pritor

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

Bayer Schering Pharma AG

13342 Berlin, Deutschland

EU/1/98/089/001-022

25.2.2011

21.2.2011

PritorPlus

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

Bayer Schering Pharma AG

13342 Berlin, Deutschland

EU/1/02/215/001-021

28.2.2011

21.2.2011

Protaphane

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

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/02/234/005-007

25.2.2011

21.2.2011

Protopic

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

Astellas Pharma Europe B.V.

Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland

EU/1/02/201/001-006

28.2.2011

21.2.2011

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

25.2.2011

21.2.2011

Ranexa

| Menarini International Operations Luxembourg S.A. |
| --- |
| 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg |

Menarini International Operations Luxembourg S.A.

1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg

EU/1/08/462/001-012

25.2.2011

21.2.2011

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

25.2.2011

21.2.2011

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

25.2.2011

21.2.2011

Remicade

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

Janssen Biologics B.V.

Einsteinweg 101, 2333 CB Leiden, Nederland

EU/1/99/116/001-005

25.2.2011

21.2.2011

Ribavirin Teva

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

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/09/509/001-004

24.2.2011

21.2.2011

Ribavirin Teva Pharma BV

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

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/09/527/001-016

24.2.2011

21.2.2011

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

28.2.2011

21.2.2011

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

24.2.2011

21.2.2011

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

24.2.2011

21.2.2011

Simponi

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

Janssen Biologics B.V.

Einsteinweg 101, CB Leiden 2333, Nederland

EU/1/09/546/001-004

23.2.2011

21.2.2011

Sprimeo

| 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/1/07/407/001-020

28.3.2011

21.2.2011

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

25.2.2011

21.2.2011

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

23.2.2011

21.2.2011

Tysabri

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

Elan Pharma International Ltd.

Monksland, Athlone, County Westmeath, Ireland

EU/1/06/346/001

23.2.2011

21.2.2011

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

24.2.2011

21.2.2011

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

23.2.2011

21.2.2011

Volibris

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

Glaxo Group Ltd

Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/08/451/001-004

2.3.2011

21.2.2011

Zylagren

| 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/1/09/558/001-010

28.2.2011

21.2.2011

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/1/96/022/016-017

23.2.2011

28.2.2011

Altargo

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

Glaxo Group Limited

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

EU/1/07/390/001-004

4.3.2011

28.2.2011

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/1/01/185/031-111

4.3.2011

28.2.2011

Arixtra

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

Glaxo Group Ltd.

Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/02/206/001-035

2.3.2011

28.2.2011

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

4.3.2011

28.2.2011

Baraclude

| 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/1/06/343/001-007

3.3.2011

28.2.2011

Clopidogrel Qualimed

| Qualimed |
| --- |
| 117, Allée des Parcs, 69 800 Saint Priest, France |

Qualimed

117, Allée des Parcs, 69 800 Saint Priest, France

EU/1/09/557/001-010

4.3.2011

28.2.2011

Clopidogrel TAD

| TAD Pharma GmbH |
| --- |
| Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Deutschland |

TAD Pharma GmbH

Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Deutschland

EU/1/09/555/001-009

4.3.2011

28.2.2011

Fabrazyme

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

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/01/188/001-006

4.3.2011

28.2.2011

Firazyr

| Jerini AG |
| --- |
| Invalidenstr. 130, D-10115 Berlin, Deutschland |

Jerini AG

Invalidenstr. 130, D-10115 Berlin, Deutschland

EU/1/08/461/001-002

4.3.2011

28.2.2011

IDflu

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

Sanofi Pasteur SA

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

EU/1/08/507/001-006

3.3.2011

28.2.2011

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

4.3.2011

28.2.2011

Invanz

| 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/1/02/216/001-002

3.3.2011

28.2.2011

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

4.3.2011

28.2.2011

Kinzalkomb

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

Bayer Schering Pharma AG

D-13342 Berlin, Deutschland

EU/1/02/214/001-015

2.3.2011

28.2.2011

Kinzalmono

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

Bayer Schering Pharma AG

D-13342 Berlin, Deutschland

EU/1/98/091/001-014

2.3.2011

28.2.2011

Micardis

| 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/1/98/090/001-020

2.3.2011

28.2.2011

MicardisPlus

| 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/1/02/213/001-023

3.3.2011

28.2.2011

NovoMix

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

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/00/142/004-005

EU/1/00/142/009-025

3.3.2011

28.2.2011

Omnitrope

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

Sandoz GmbH

Biochemiestrasse 10, Kundl 6250, Österreich

EU/1/06/332/001-009

2.3.2011

28.2.2011

Onglyza

| Bristol Myers Squibb/AstraZeneca EEIG |
| --- |
| Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom |

Bristol Myers Squibb/AstraZeneca EEIG

Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom

EU/1/09/545/011-015

3.3.2011

28.2.2011

Onglyza

| Bristol Myers Squibb/AstraZeneca EEIG |
| --- |
| Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom |

Bristol Myers Squibb/AstraZeneca EEIG

Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom

EU/1/09/545/001-010

3.3.2011

28.2.2011

Osigraft

| Howmedica International S. de R.L. |
| --- |
| Division of Stryker Corporation, Raheen Industrial Estate, Raheen, Limerick, Ireland |

Howmedica International S. de R.L.

Division of Stryker Corporation, Raheen Industrial Estate, Raheen, Limerick, Ireland

EU/1/01/179/001

4.3.2011

28.2.2011

Osseor

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

Les Laboratoires Servier

22, rue Garnier, 92200 Neuilly-sur-Seine, France

EU/1/04/287/001-006

4.3.2011

28.2.2011

PegIntron

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

Schering Plough Europe

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

EU/1/00/131/001-050

3.3.2011

28.2.2011

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

4.3.2011

28.2.2011

ProQuad

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

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk, 69007 Lyon, France

EU/1/05/323/001-013

2.3.2011

28.2.2011

Protelos

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

Les Laboratoires Servier

22, rue Garnier, 92200 Neuilly-sur-Seine, France

EU/1/04/288/001-006

4.3.2011

28.2.2011

Quadramet

| CIS bio international |
| --- |
| Boite Postale 32 - F-91192 Gif-sur-Yvette - France |

CIS bio international

Boite Postale 32 - F-91192 Gif-sur-Yvette - France

EU/1/97/057/001

4.4.2011

28.2.2011

RotaTeq

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

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk, Lyon 69007, France

EU/1/06/348/001-002

3.3.2011

28.2.2011

Siklos

| ADDMEDICA |
| --- |
| 101, rue Saint Lazare, Paris 75009, France |

ADDMEDICA

101, rue Saint Lazare, Paris 75009, France

EU/1/07/397/001-004

3.3.2011

28.2.2011

Tracleer

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

Actelion Registration Ltd

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

EU/1/02/220/001-006

3.3.2011

28.2.2011

Vedrop

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

Orphan Europe SARL

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

EU/1/09/533/001-003

3.3.2011

28.2.2011

Ytracis

| CIS bio international |
| --- |
| Boite Postale 32 - F-91192 Gif-sur-Yvette Cedex- France |

CIS bio international

Boite Postale 32 - F-91192 Gif-sur-Yvette Cedex- France

EU/1/03/250/001

4.3.2011

—   Ukinitev dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta)

| Datum sprejetja sklepa | Ime zdravila | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Datum obvestila |
| --- | --- | --- | --- | --- |
| 6.1.2011 | Thelin | Pfizer Limited |
| Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

6.1.2011

Thelin

Pfizer Limited

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

EU/1/06/353/001-005

11.1.2011

1.2.2011

Clopidogrel 1A Pharma

| Acino Pharma GmbH |
| --- |
| Am Windfeld 35, 83714 Miesbach, Deutschland |

Acino Pharma GmbH

Am Windfeld 35, 83714 Miesbach, Deutschland

EU/1/09/542/001-007

3.2.2011

—   Izdaja dovoljenja za promet (člen 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta
   (2)
  ): Odobrena

| Datum sprejetja sklepa | Ime zdravila | INN (mednarodno nelastniško ime) | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Farmacevtska oblika | ATC (anatomsko terapevtska kemijska oznaka) | Datum obvestila |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 27.1.2011 | Hiprabovis IBR Marker Live | Živ gE<sup>-</sup> tk<sup>-</sup> goveji herpes virus vrste 1 (BoHV-1) z dvojno delecijo genov, sev CEDDEL | Laboratorios Hipra, S.A. |
| Avda. La Selva, 135, 17170- Amer (Girona), España |

Datum sprejetja sklepa

Ime zdravila

INN (mednarodno nelastniško ime)

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Farmacevtska oblika

ATC (anatomsko terapevtska kemijska oznaka)

Datum obvestila

27.1.2011

Hiprabovis IBR Marker Live

Živ gE<sup>-</sup> tk<sup>-</sup> goveji herpes virus vrste 1 (BoHV-1) z dvojno delecijo genov, sev CEDDEL

Laboratorios Hipra, S.A.

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

EU/2/10/114/001-002

Liofilizat za suspenzijo

QI02AD01

1.2.2011

11.2.2011

Comfortis

spinosad

| Eli Lilly and Company Ltd |
| --- |
| Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom |

Eli Lilly and Company Ltd

Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom

EU/2/10/115/001-010

Žvečljive tablete

QP53BX03

15.2.2011

18.2.2011

Activyl

indoksakarb

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

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/10/118/001-014

Kožni nanos, raztopina

QP53AX27

22.2.2011

18.2.2011

Cimalgex

Cimikoksib

| Vétoquinol SA |
| --- |
| Magny-Vernois - 70200 LURE - France |

Vétoquinol SA

Magny-Vernois - 70200 LURE - France

EU/2/10/119/001-012

Tableta

QM01AH93

24.2.2011

18.2.2011

Purevax Rabies

Rekombinantni poxvirus kanarčkov, ki vsebuje antigen virusa stekline (vCP65)

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

MERIAL

29 avenue Tony Garnier, 69007 LYON, France

EU/2/10/117/001-002

Suspenzija za injiciranje

QI06AX

22.2.2011

21.2.2011

Melosus

Meloksikam

| CP-Pharma Handelsgesellschaft mbH |
| --- |
| Ostlandring 13, D-31303 Burgdorf, Deutschland |

CP-Pharma Handelsgesellschaft mbH

Ostlandring 13, D-31303 Burgdorf, Deutschland

EU/2/10/116/001-004

Oralna suspenzija

QM01AC06

24.2.2011

—   Sprememba dovoljenja za promet (člen 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena

| Datum sprejetja sklepa | Ime zdravila | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Datum obvestila |
| --- | --- | --- | --- | --- |
| 6.1.2011 | Econor | Novartis Animal Health Austria GmbH |
| Biochemiestrasse 10, 6250 Kundl, Österreich |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

6.1.2011

Econor

Novartis Animal Health Austria GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/2/98/010/004-006

EU/2/98/010/017-018

EU/2/98/010/021-025

11.1.2011

13.1.2011

Duvaxyn WNV

| 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/2/08/086/001-003

18.1.2011

13.1.2011

Palladia

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

Pfizer Ltd

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

EU/2/09/100/001-003

17.1.2011

17.1.2011

Zolvix

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172, DK-2100 Copenhagen, Denmark |

Novartis Healthcare A/S

Lyngbyvej 172, DK-2100 Copenhagen, Denmark

EU/2/09/101/001-010

19.1.2011

21.1.2011

Dicural

| 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/2/97/003/001-018

25.1.2011

21.1.2011

Zulvac 8 Ovis

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

Pfizer Limited

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

EU/2/09/104/001-002

26.1.2011

24.1.2011

Poulvac FluFend H5N3 RG

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

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom

EU/2/06/060/001-002

27.1.2011

24.1.2011

Rheumocam

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Loughrea, Co. Galway, IRELAND |

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, IRELAND

EU/2/07/078/001-010

26.1.2011

27.1.2011

Ingelvac CircoFLEX

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

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim am Rhein, Deutschland

EU/2/07/079/001-004

1.2.2011

27.1.2011

Meloxidyl

| CEVA SANTE ANIMALE |
| --- |
| 10 avenue de la Ballastière, 33500 Libourne, France |

CEVA SANTE ANIMALE

10 avenue de la Ballastière, 33500 Libourne, France

EU/2/06/070/005-007

1.2.2011

11.2.2011

SevoFlo

| Abbott Laboratories Limited |
| --- |
| Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, UNITED KINGDOM |

Abbott Laboratories Limited

Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, UNITED KINGDOM

EU/2/02/035/007

15.2.2011

—   Umik dovoljenja za promet (člen 45 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta)

| Datum sprejetja sklepa | Ime zdravila | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Datum obvestila |
| --- | --- | --- | --- | --- |
| 24.1.2011 | Acticam | Ecuphar NV |
| Legeweg 157-I, B-8020 Oostkamp, Belgïe |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

24.1.2011

Acticam

Ecuphar NV

Legeweg 157-I, B-8020 Oostkamp, Belgïe

EU/2/08/088/001-003

26.1.2011

Kdor želi dobiti vpogled v javno poročilo o oceni zadevnih zdravil ter o zadevnih sklepih o zdravilih, se lahko obrne na naslov:

| 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)  UL L 136, 30.4.04, str. 1.

(2)  UL L 136, 30.4.04, str. 1.

---

| 29.4.2011 | SL | Uradni list Evropske unije | C 128/19 |
| --- | --- | --- | --- |

29.4.2011

SL

Uradni list Evropske unije

C 128/19

---

Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. januarja 2011 do 28. februarja 2011

(Sklepi, sprejeti na podlagi člena 34 Direktive 2001/83/ES
   (1)
  ali člena 38 Direktive 2001/82/ES
   (2)
  )

2011/C 128/02

—   Izdaja, ohranjanje ali sprememba nacionalnega dovoljenja za promet

| Datum sprejetja sklepa | Ime zdravila | Imetnik dovoljenja za promet | Zadevna država članica | Datum obvestila |
| --- | --- | --- | --- | --- |
| 21.2.2011 | Tazocin | Glej Prilogo I | Glej Prilogo I | 23.2.2011 |
| 13.1.2011 | Fortum and associated names | Glej Prilogo II | Glej Prilogo II | 17.1.2011 |
| 21.1.2011 | Vascace plus and associated names | Glej Prilogo III | Glej Prilogo III | 24.1.2011 |
| 28.2.2011 | fenofibrate, bezafibrate, ciprofibrate, gemfibrozil | Glej Prilogo IV | Glej Prilogo IV | 1.3.2011 |
| 27.1.2011 | Modafinil containing medicinal products | Glej Prilogo V | Glej Prilogo V | 31.1.2011 |
| 6.1.2011 | Lucentis | Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Ti sklepi so naslovljeni na države članice | 10.1.2011 |
| 28.2.2011 | Xiapex | Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom | Ti sklepi so naslovljeni na države članice | 1.3.2011 |
| 21.1.2011 | Revatio | Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom | Ti sklepi so naslovljeni na države članice | 25.1.2011 |
| 28.2.2011 | Daliresp | Nycomed GmbH, Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | Ti sklepi so naslovljeni na države članice | 1.3.2011 |
| 28.2.2011 | Esbriet | InterMune Europe Ltd, Wellesley House, Duke of Wellington Avenue, Royal Arsenal, London SE18 6SS, United Kingdom | Ti sklepi so naslovljeni na države članice | 1.3.2011 |
| 28.2.2011 | Libertek | Nycomed GmbH, Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | Ti sklepi so naslovljeni na države članice | 1.3.2011 |
| 28.1.2011 | Siklos | ADDMEDICA, 101, rue Saint Lazare, Paris 75009, France | Ti sklepi so naslovljeni na države članice | 4.3.2011 |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Zadevna država članica

Datum obvestila

21.2.2011

Tazocin

Glej Prilogo I

Glej Prilogo I

23.2.2011

13.1.2011

Fortum and associated names

Glej Prilogo II

Glej Prilogo II

17.1.2011

21.1.2011

Vascace plus and associated names

Glej Prilogo III

Glej Prilogo III

24.1.2011

28.2.2011

fenofibrate, bezafibrate, ciprofibrate, gemfibrozil

Glej Prilogo IV

Glej Prilogo IV

1.3.2011

27.1.2011

Modafinil containing medicinal products

Glej Prilogo V

Glej Prilogo V

31.1.2011

6.1.2011

Lucentis

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

Ti sklepi so naslovljeni na države članice

10.1.2011

28.2.2011

Xiapex

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

Ti sklepi so naslovljeni na države članice

1.3.2011

21.1.2011

Revatio

Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom

Ti sklepi so naslovljeni na države članice

25.1.2011

28.2.2011

Daliresp

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

Ti sklepi so naslovljeni na države članice

1.3.2011

28.2.2011

Esbriet

InterMune Europe Ltd, Wellesley House, Duke of Wellington Avenue, Royal Arsenal, London SE18 6SS, United Kingdom

Ti sklepi so naslovljeni na države članice

1.3.2011

28.2.2011

Libertek

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

Ti sklepi so naslovljeni na države članice

1.3.2011

28.1.2011

Siklos

ADDMEDICA, 101, rue Saint Lazare, Paris 75009, France

Ti sklepi so naslovljeni na države članice

4.3.2011

—   Zavrnitev izdaje nacionalnega dovoljenja za promet z zdravili

| Datum sprejetja sklepa | Ime zdravila | Imetnik dovoljenja za promet | Zadevna država članica | Datum obvestila |
| --- | --- | --- | --- | --- |
| 21.2.2011 | Galantamine STADA and ass. names | Glej Prilogo VI | Glej Prilogo VI | 24.2.2011 |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Zadevna država članica

Datum obvestila

21.2.2011

Galantamine STADA and ass. names

Glej Prilogo VI

Glej Prilogo VI

24.2.2011

---

(1)  UL L 311, 28.11.01, str. 67.

(2)  UL L 311, 28.11.01, str. 1.

---

DODATEK I

SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH

| Država članica | Imetnik dovoljenja za promet z zdravilom | Izmišljeno ime | Jakost | Farmacevtska oblika | Pot uporabe | Vsebnost (koncentracija) |
| --- | --- | --- | --- | --- | --- | --- |
| Avstrija | Pfizer Corporation Austria Ges.m.b.H |
| Floridsdorfer |
| Hauptstraße 1, |
| A-1210 Wien |
| Avstrija |

Država članica

Imetnik dovoljenja za promet z zdravilom

Izmišljeno ime

Jakost

Farmacevtska oblika

Pot uporabe

Vsebnost (koncentracija)

Avstrija

Pfizer Corporation Austria Ges.m.b.H

Floridsdorfer

Hauptstraße 1,

A-1210 Wien

Avstrija

Tazonam 4,0 g/0,5 g - Trockenstechampullen

4,0 g/0,5 g

liofilizat za raztopino za injiciranje ali infundiranje

intravenska uporaba

1 viala vsebuje natrijevo sol piperacilina, ki ustreza 4,0 g piperacilina in natrijevo sol tazobaktama, ki ustreza 0,5 g tazobaktama

Belgija

| Pfizer S.A. |
| --- |
| Boulevard de la Plaine 17 |
| 1050 Brussels |
| Belgija |

Pfizer S.A.

Boulevard de la Plaine 17

1050 Brussels

Belgija

Tazocin 2g/250 mg

poudre pour solution injectable

2g/250 mg

prašek za raztopino za injiciranje

intravenska uporaba

2,085 g natrijeve soli piperacilina + 268,30 mg natrijeve soli tazobaktama

Belgija

| Pfizer S.A. |
| --- |
| Boulevard de la Plaine 17 |
| 1050 Brussels |
| Belgija |

Pfizer S.A.

Boulevard de la Plaine 17

1050 Brussels

Belgija

Tazocin 4g/500 mg

poudre pour solution injectable

4 g/500 mg

prašek za raztopino za injiciranje

intravenska uporaba

4,170 g natrijeve soli piperacilina + 536,60 mg natrijeve soli tazobaktama

Bolgarija

| Pfizer Europe MA EEIG |
| --- |
| Ramsgate Road, Sandwich, |
| Kent, |
| CT13 9NJ, |
| Velika Britanija |

Pfizer Europe MA EEIG

Ramsgate Road, Sandwich,

Kent,

CT13 9NJ,

Velika Britanija

TAЗОЦИНТМ 4 g/0,5 g

прах за инжекционен/инфузионен разтвор Пиперацилин/Тазобактам

4g/0,5g

prašek za raztopino za injiciranje ali infundiranje

intravenska uporaba

4,170 g natrijeve soli piperacilina, ki ustreza 4 g piperacilina in 0,5366 g natrijeve soli tazobaktama, ki ustreza 500 mg tazobaktama

Ciper

| Pfizer Hellas A.E. |
| --- |
| 243 Messoghion Avenue 154 51 |
| Neo Psychico |
| Grčija |

Pfizer Hellas A.E.

243 Messoghion Avenue 154 51

Neo Psychico

Grčija

TAZOCIN® EF

2,25 G/VIAL

prašek za raztopino za injiciranje

intravenska uporaba

2,085 g natrijeve soli piperacilina, ki ustreza 2 g piperacilina in 0,2683 g natrijeve soli tazobaktama, ki ustreza 0,250 g tazobaktama

Ciper

| Pfizer Hellas A.E. |
| --- |
| 243 Messoghion Avenue 154 51 |
| Neo Psychico |
| Grčija |

Pfizer Hellas A.E.

243 Messoghion Avenue 154 51

Neo Psychico

Grčija

TAZOCIN® EF

4,5 G/VIAL

prašek za raztopino za injiciranje

intravenska uporaba

4,17 g natrijeve soli piperacilina, ki ustreza 4 g piperacilina in 0,5366 g natrijeve soli tazobaktama, ki ustreza 0,5 g tazobaktama

Češka

| Pfizer spol. s r.o. |
| --- |
| Stroupežnického 3191/17, |
| 150 00 Praha Smíchov, |
| Češka |

Pfizer spol. s r.o.

Stroupežnického 3191/17,

150 00 Praha Smíchov,

Češka

Tazocin 2,25 g

2,25 g

prašek za raztopino za injiciranje

intravenska uporaba

2 g piperacilina / 0,25 g tazobaktama

Češka

| Pfizer spol. s r.o. |
| --- |
| Stroupežnického 3191/17, |
| 150 00 Praha Smíchov |
| Češka |

Pfizer spol. s r.o.

Stroupežnického 3191/17,

150 00 Praha Smíchov

Češka

Tazocin 4,5 g

4,5 g

prašek za raztopino za injiciranje

intravenska uporaba

4 g piperacilina / 0,5 g tazobaktama

Danska

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

Pfizer ApS

Lautrupvang 8

2750 Ballerup,

Danska

Tazocin

2 g/0,25 g

prašek za raztopino za injiciranje ali infundiranje

intravenska uporaba

natrijeva sol piperacilina, ki ustreza 2 g piperacilina, natrijeva sol tazobaktama, ki ustreza 0,25 g tazobaktama

Danska

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

Pfizer ApS

Lautrupvang 8

2750 Ballerup,

Danska

Tazocin

4 g/0,5 g

prašek za raztopino za injiciranje ali infundiranje

intravenska uporaba

natrijeva sol piperacilina, ki ustreza 4 g piperacilina, natrijeva sol tazobaktama, ki ustreza 0,5 g tazobaktama

Estonija

| Pfizer Europe MA EEIG |
| --- |
| Ramsgate Road, Sandwich, Kent, |
| CT13 9NJ, |
| Velika Britanija |

Pfizer Europe MA EEIG

Ramsgate Road, Sandwich, Kent,

CT13 9NJ,

Velika Britanija

TAZOCIN 4,5G

4 000mg +500mg g

prašek za raztopino za injiciranje ali infundiranje

intravenska uporaba

4,170 g natrijeve soli piperacilina, ki ustreza 4 000 mg piperacilina in 0,5366 g natrijeve soli tazobaktama, ki ustreza 500 mg tazobaktama

Finska

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

Pfizer Oy

Tietokuja 4, 00330 Helsinki,

Finska

Tazocin

2 g/0,25 g

prašek za raztopino za injiciranje ali infundiranje

intravenska uporaba

natrijeva sol piperacilina 2,085 g

natrijeva sol tazobaktama 0,2683 g

Finska

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

Pfizer Oy

Tietokuja 4, 00330 Helsinki,

Finska

Tazocin

4 g/0,5 g

prašek za raztopino za injiciranje ali infundiranje

intravenska uporaba

natrijeva sol piperacilina 4,170 g

natrijeva sol tazobaktama 0,5366 g

Francija

| Pfizer, Coeur Défense - Tour A – La Défense 4 |
| --- |
| 92931 PARIS LA DEFENSE Cedex, |
| Francija |

Pfizer, Coeur Défense - Tour A – La Défense 4

92931 PARIS LA DEFENSE Cedex,

Francija

TAZOCILLINE 2 g/250 mg,

poudre pour solution pour perfusion

2g/250mg

prašek za raztopino za infundiranje

infuzija

natrijeva sol piperacilina 2,085 g

natrijeva sol tazobaktama 268,300 mg

Francija

| Pfizer, Coeur Défense - Tour A – La Défense 4 |
| --- |
| 92931 PARIS LA DEFENSE Cedex, |
| Francija |

Pfizer, Coeur Défense - Tour A – La Défense 4

92931 PARIS LA DEFENSE Cedex,

Francija

TAZOCILLINE 4 g/500 mg,

poudre pour solution pour perfusion

4g/500mg

prašek za raztopino za infundiranje

infuzija

natrijeva sol piperacilina 4,170 g

natrijeva sol tazobaktama 536,600 mg

Nemčija

| Pfizer Pharma GmbH |
| --- |
| Linkstr. 10 |
| 10785 Berlin |
| Nemčija |

Pfizer Pharma GmbH

Linkstr. 10

10785 Berlin

Nemčija

Tazobac EF 4g/0,5g

4g/0,5g

liofilizat za injiciranje ali infundiranje

intravenska uporaba (infuzija, injekcija)

4 g piperacilina, ki ustreza 4,17 g natrijeve soli piperacilina

0,5 g tazobaktama, ki ustreza 0,5366 g natrijeve soli tazobaktama

Grčija

| Pfizer Hellas A.E. |
| --- |
| 243 Messoghion Avenue 154 51 |
| Neo Psychico |
| Grčija |

Pfizer Hellas A.E.

243 Messoghion Avenue 154 51

Neo Psychico

Grčija

TAZOCIN® EF

2+0,250 G/VIAL

prašek za raztopino za injiciranje

intravenska uporaba

2,085 g natrijeve soli piperacilina, ki ustreza 2 g piperacilina in 0,2683 g natrijeve soli tazobaktama, ki ustreza 0,250 g tazobaktama

Grčija

| Pfizer Hellas A.E. |
| --- |
| 243 Messoghion Avenue 154 51 |
| Neo Psychico |
| Grčija |

Pfizer Hellas A.E.

243 Messoghion Avenue 154 51

Neo Psychico

Grčija

TAZOCIN® EF

4+0,500 G/VIAL

prašek za raztopino za injiciranje

intravenska uporaba

4,17 g natrijeve soli piperacilina, ki ustreza 4 g piperacilina in 0,5366 g natrijeve soli tazobaktama, ki ustreza 0,5 g tazobaktama

Madžarska

| Wyeth Whitehall Export GmbH |
| --- |
| Storchengasse 1 A-1150 Vienna |
| Avstrija |

Wyeth Whitehall Export GmbH

Storchengasse 1 A-1150 Vienna

Avstrija

Tazocin 4,5 g injekció

4,5 g

prašek za raztopino za injiciranje ali infundiranje

intravenska uporaba

0,5366 g natrijeve soli tazobaktama, ki ustreza 0,500 g tazobaktama in 4,170 g natrijeve soli piperacilina, ki ustreza 4,00 g piperacilina

Irska

| John Wyeth & Brother Limited |
| --- |
| (trading as Wyeth Pharmaceuticals) |
| Huntercombe Lane South |
| Taplow, Maidenhead, |
| Berks, SL6 0PH |
| Velika Britanija |

John Wyeth & Brother Limited

(trading as Wyeth Pharmaceuticals)

Huntercombe Lane South

Taplow, Maidenhead,

Berks, SL6 0PH

Velika Britanija

Tazocin2g/0,25g

Powder for Solution for Injection or Infusion

2g/0,25g

prašek za raztopino za injiciranje ali infundiranje

intravenska uporaba

2 g piperacilina in 0,25 g tazobaktama (oba v obliki natrijeve soli)

Irska

| John Wyeth & Brother Limited |
| --- |
| (trading as Wyeth Pharmaceuticals) |
| Huntercombe Lane South |
| Taplow, Maidenhead, |
| Berks, SL6 0PH |
| Velika Britanija |

John Wyeth & Brother Limited

(trading as Wyeth Pharmaceuticals)

Huntercombe Lane South

Taplow, Maidenhead,

Berks, SL6 0PH

Velika Britanija

Tazocin4g/0,5g

Powder for Solution for Injection or Infusion

4g/0.5g

prašek za raztopino za injiciranje ali infundiranje

intravenska uporaba

4 g piperacilina in 0,5 g tazobaktama (oba v obliki natrijeve soli)

Italija

| Wyeth Lederle S.p.A. |
| --- |
| Via Nettunense, 90 |
| Aprilia (LT), 04011, |
| Italija |

Wyeth Lederle S.p.A.

Via Nettunense, 90

Aprilia (LT), 04011,

Italija

TAZOCIN

2g+0,250g

prašek za raztopino za infundiranje

intravenska uporaba

natrijeva sol piperacilina (ki ustreza 2 g piperacilina) 2 085 mg

natrijeva sol tazobaktama (ki ustreza 250 mg tazobaktama) 268,3 mg

Italija

| Wyeth Lederle S.p.A. |
| --- |
| Via Nettunense, 90 |
| Aprilia (LT), 04011, |
| Italija |

Wyeth Lederle S.p.A.

Via Nettunense, 90

Aprilia (LT), 04011,

Italija

TAZOCIN

4g+0,500 g

prašek za raztopino za infundiranje

intravenska uporaba

natrijeva sol piperacilina (ki ustreza 4 g piperacilina) 4 170 mg

natrijeva sol tazobaktama (ki ustreza 500 mg tazobaktama) 536,6 mg

Latvija

| Pfizer Europe MA EEIG |
| --- |
| Ramsgate Road, Sandwich, Kent, |
| CT13 9NJ, |
| Velika Britanija |

Pfizer Europe MA EEIG

Ramsgate Road, Sandwich, Kent,

CT13 9NJ,

Velika Britanija

TAZOCIN 4,0g/0,5g

pulveris injekciju vai infūziju šķīduma pagatavošanai

4,0g/0,500 mg

prašek za raztopino za injiciranje ali infundiranje

intravenska uporaba

4,170 g natrijeve soli piperacilina, ki ustreza 4 g piperacilina in 0,5366 g natrijeve soli tazobaktama, ki ustreza 500 mg tazobaktama

Litva

| Pfizer Europe MA EEIG |
| --- |
| Ramsgate Road, Sandwich, Kent, |
| CT13 9NJ, |
| Velika Britanija |

Pfizer Europe MA EEIG

Ramsgate Road, Sandwich, Kent,

CT13 9NJ,

Velika Britanija

TAZOCIN

4,0g/0,5g

prašek za raztopino za injiciranje ali infundiranje

intravenska uporaba

4,170 g natrijeve soli piperacilina, ki ustreza 4 g piperacilina in 0,5366 g natrijeve soli tazobaktama, ki ustreza 500 mg tazobaktama

Luksemburg

| Pfizer S.A. |
| --- |
| Boulevard de la Plaine 17 |
| 1050 Brussels |
| Belgija |

Pfizer S.A.

Boulevard de la Plaine 17

1050 Brussels

Belgija

Tazocin 2g/250 mg

poudre pour solution injectable

2g/250 mg

prašek za raztopino za injiciranje ali infundiranje

intravenska uporaba

2,085 g natrijeve soli piperacilina + 268,30 mg natrijeve soli tazobaktama

Luksemburg

| Pfizer S.A. |
| --- |
| Boulevard de la Plaine 17 |
| 1050 Brussels |
| Belgija |

Pfizer S.A.

Boulevard de la Plaine 17

1050 Brussels

Belgija

Tazocin 4g/500 mg

poudre pour solution injectable

4g/500 mg

prašek za raztopino za injiciranje ali infundiranje

intravenska uporaba

4,170 g natrijeve soli piperacilina + 536,60 mg natrijeve soli tazobaktama

Malta

| John Wyeth & Brother Limited |
| --- |
| (trading as Wyeth Pharmaceuticals) |
| Huntercombe Lane South |
| Taplow |
| Maidenhead |
| Berkshire SL6 0PH |
| Velika Britanija |

John Wyeth & Brother Limited

(trading as Wyeth Pharmaceuticals)

Huntercombe Lane South

Taplow

Maidenhead

Berkshire SL6 0PH

Velika Britanija

Tazocin 2g/0,25 g

Powder for Solution for Injection or Infusion

2g/0,25g

prašek za raztopino za injiciranje ali infundiranje

intravenska uporaba

TAZOCIN 2g/0,25g vsebuje 2 zdravilni učinkovini; piperacilin 2 g in tazobaktam 0,25 g, obe v obliki natrijeve soli.

Malta

| John Wyeth & Brother Limited |
| --- |
| (trading as Wyeth Pharmaceuticals) |
| Huntercombe Lane South |
| Taplow |
| Maidenhead |
| Berkshire SL6 0PH |
| Velika Britanija |

John Wyeth & Brother Limited

(trading as Wyeth Pharmaceuticals)

Huntercombe Lane South

Taplow

Maidenhead

Berkshire SL6 0PH

Velika Britanija

TAZOCIN 4g/0,5g

Powder for Solution for Injection or Infusion

4g/0,5g

prašek za raztopino za injiciranje ali infundiranje

intravenska uporaba

TAZOCIN 4g/0,5g vsebuje 2 zdravilni učinkovini; piperacilin 4 g in tazobaktam 0,5 g, obe v obliki natrijeve soli.

Nizozemska

| Pfizer B.V. |
| --- |
| Rivium westlaan 142 2909 LD Capelle a/d Ijssel |
| Nizozemska |

Pfizer B.V.

Rivium westlaan 142 2909 LD Capelle a/d Ijssel

Nizozemska

Tazocin® 2 g/ 250 mg

2g /250 mg

prašek za raztopino za injiciranje

intravenska uporaba

natrijeva sol piperacilina in natrijeva sol tazobaktama, ki ustrezata 2 g piperacilina in 250 mg tazobaktama

Nizozemska

| Pfizer B.V. |
| --- |
| Rivium westlaan 142 2909 LD Capelle a/d Ijssel |
| Nizozemska |

Pfizer B.V.

Rivium westlaan 142 2909 LD Capelle a/d Ijssel

Nizozemska

Tazocin® 4 g/ 500 mg

4 g/500mg

prašek za raztopino za injiciranje

intravenska uporaba

natrijeva sol piperacilina in natrijeva sol tazobaktama, ki ustrezata 4 g piperacilina in 500 mg tazobaktama

Norveška

| Pfizer AS |
| --- |
| Postboks 3 |
| 1324 Lysaker |
| Norveška |

Pfizer AS

Postboks 3

1324 Lysaker

Norveška

Tazocin

2 g/0,25 g

prašek za raztopino za injiciranje ali infundiranje

intravenska uporaba

natrijeva sol piperacilina, ki ustreza 2 g piperacilina, natrijeva sol tazobaktama, ki ustreza 0,25 g tazobaktama

Norveška

| Pfizer AS |
| --- |
| Postboks 3 |
| 1324 Lysaker |
| Norveška |

Pfizer AS

Postboks 3

1324 Lysaker

Norveška

Tazocin

4 g/0,5 g

prašek za raztopino za injiciranje ali infundiranje

intravenska uporaba

natrijeva sol piperacilina, ki ustreza 4 g piperacilina, natrijeva sol tazobaktama, ki ustreza 0,5 g tazobaktama

Poljska

| Pfizer Europe MA EEIG |
| --- |
| Ramsgate Road, Sandwich, Kent, |
| CT13 9NJ, |
| Velika Britanija |

Pfizer Europe MA EEIG

Ramsgate Road, Sandwich, Kent,

CT13 9NJ,

Velika Britanija

Tazocin

2g + 0,25g

prašek za raztopino za injiciranje ali infundiranje

intravenska uporaba

2 g piperacilina (v obliki natrijeve soli piperacilina) in 0,25 g tazobaktama (v obliki natrijeve soli tazobaktama)

Poljska

| Pfizer Europe MA EEIG |
| --- |
| Ramsgate Road, Sandwich, Kent, |
| CT13 9NJ, |
| Velika Britanija |

Pfizer Europe MA EEIG

Ramsgate Road, Sandwich, Kent,

CT13 9NJ,

Velika Britanija

Tazocin

4g + 0,5g

prašek za raztopino za injiciranje ali infundiranje

intravenska uporaba

4 g piperacilina (v obliki natrijeve soli piperacilina) in 0,5 g tazobaktama (v obliki natrijeve soli tazobaktama)

Portugalska

| Instituto Pasteur de Lisboa, S.A. |
| --- |
| Rua Dr. António Loureiro Borges, 2 |
| Arquiparque - Miraflores |
| 1495-131 ALGÉS |
| Portugalska |

Instituto Pasteur de Lisboa, S.A.

Rua Dr. António Loureiro Borges, 2

Arquiparque - Miraflores

1495-131 ALGÉS

Portugalska

Tazobac

2 000mg + 250 mg

prašek za raztopino za injiciranje

intravenska uporaba

2,085 g natrijeve soli piperacilina, ki ustreza 2 g piperacilina in 0,2683 g natrijeve soli tazobaktama, ki ustreza 250 mg tazobaktama

Portugalska

| Instituto Pasteur de Lisboa, S.A. |
| --- |
| Rua Dr. António Loureiro Borges, 2 |
| Arquiparque - Miraflores |
| 1495-131 ALGÉS |
| Portugalska |

Instituto Pasteur de Lisboa, S.A.

Rua Dr. António Loureiro Borges, 2

Arquiparque - Miraflores

1495-131 ALGÉS

Portugalska

Tazobac

4 000mg + 500 mg

prašek za raztopino za injiciranje

intravenska uporaba

4,170 g natrijeve soli piperacilina, ki ustreza 4 g piperacilina in 0,5366 g natrijeve soli tazobaktama, ki ustreza 500 mg tazobaktama

Romunija

| Pfizer Europe MA EEIG |
| --- |
| Ramsgate Road, Sandwich, Kent, |
| CT13 9NJ, |
| Velika Britanija |

Pfizer Europe MA EEIG

Ramsgate Road, Sandwich, Kent,

CT13 9NJ,

Velika Britanija

Tazocin 2,25 g,

liofilizat pentru soluție injectabilă/ perfuzabilă

2,00/0,25g

liofilizirani prašek za raztopino za injiciranje ali infundiranje

intravenska uporaba

2,00 g piperacilina v obliki natrijeve soli piperacilina in 0,25 g tazobaktama v obliki natrijeve soli takobaktama

Romunija

| Pfizer Europe MA EEIG |
| --- |
| Ramsgate Road, Sandwich, Kent, |
| CT13 9NJ, |
| Velika Britanija |

Pfizer Europe MA EEIG

Ramsgate Road, Sandwich, Kent,

CT13 9NJ,

Velika Britanija

Tazocin 4,5 g,

liofilizat pentru soluție injectabilă/ perfuzabilă

4,00/0,5g

liofilizirani prašek za raztopino za injiciranje ali infundiranje

intravenska uporaba

4,00 g piperacilina v obliki natrijeve soli piperacilina in 0,5 g tazobaktama v obliki natrijeve soli takobaktama

Slovaška

| Pfizer Europe MA EEIG |
| --- |
| Ramsgate Road, Sandwich, Kent, |
| CT13 9NJ, |
| Velika Britanija |

Pfizer Europe MA EEIG

Ramsgate Road, Sandwich, Kent,

CT13 9NJ,

Velika Britanija

Tazocin 2,25g

2,25 g

prašek za raztopino za injiciranje ali infundiranje

intravenska uporaba

vsebuje 2,085 g natrijeve soli piperacilina, ki ustreza 2 g piperacilina in 0,2683 g natrijeve soli tazobaktama, ki ustreza 250 mg tazobaktama

Slovaška

| Pfizer Europe MA EEIG |
| --- |
| Ramsgate Road, Sandwich, Kent, |
| CT13 9NJ, |
| Velika Britanija |

Pfizer Europe MA EEIG

Ramsgate Road, Sandwich, Kent,

CT13 9NJ,

Velika Britanija

Tazocin 4,5g

4,5 g

prašek za raztopino za injiciranje ali infundiranje

intravenska uporaba

vsebuje 4,170 g natrijeve soli piperacilina, ki ustreza 4 g piperacilina in 0,5366 g natrijeve soli tazobaktama, ki ustreza 500 mg tazobaktama

Slovenija

| Pfizer Europe MA EEIG |
| --- |
| Ramsgate Road Sandwich Kent |
| CT13 9NJ |
| Velika Britanija |

Pfizer Europe MA EEIG

Ramsgate Road Sandwich Kent

CT13 9NJ

Velika Britanija

TAZOCIN 4 g / 0,5 g

prašek za raztopino za injiciranje ali infundiranje

4,0 g / 0,5 g

prašek za raztopino za injiciranje ali infundiranje

intravenska uporaba

4,170 g natrijeve soli piperacilina, ki ustreza 4 g piperacilina in 0,5366 g natrijeve soli tazobaktama, ki ustreza 500 mg tazobaktama

Španija

| Wyeth Farma S.A. |
| --- |
| Ctra. Burgos, Km 23 - Desvío Algete Km 1 |
| 28700 San Sebastián de los Reyes (Madrid), |
| Španija |

Wyeth Farma S.A.

Ctra. Burgos, Km 23 - Desvío Algete Km 1

28700 San Sebastián de los Reyes (Madrid),

Španija

Tazocel 2/0,25 g

Polvo para solución inyectable

2/0,25 g

prašek za raztopino za injiciranje

intravenska uporaba

piperacilin (v obliki natrijeve soli piperacilina) 2 g in tazobaktam

(v obliki natrijeve soli tazobaktama) 0,25 g

Španija

| Wyeth Farma S.A. |
| --- |
| Ctra. Burgos, Km 23 - Desvío Algete Km 1 |
| 28700 San Sebastián de los Reyes (Madrid), |
| Španija |

Wyeth Farma S.A.

Ctra. Burgos, Km 23 - Desvío Algete Km 1

28700 San Sebastián de los Reyes (Madrid),

Španija

Tazocel 4/0,5 g

Polvo para solución inyectable

4/0,5 g

prašek za raztopino za injiciranje

intravenska uporaba

piperacilin (v obliki natrijeve soli piperacilina) 4 g in tazobaktam

(v obliki natrijeve soli tazobaktama) 0,50 g

Švedska

| Pfizer AB |
| --- |
| Vetenskapsvägen 10 |
| 191 90 Sollentuna, |
| Švedska |

Pfizer AB

Vetenskapsvägen 10

191 90 Sollentuna,

Švedska

Tazocin

2 g/0,25 g

prašek za raztopino za injiciranje ali infundiranje

intravenska uporaba

natrijeva sol piperacilina, ki ustreza 2 g piperacilina in natrijeva sol tazobaktama, ki ustreza 0,25 g tazobaktama

Švedska

| Pfizer AB |
| --- |
| Vetenskapsvägen 10 |
| 191 90 Sollentuna, |
| Švedska |

Pfizer AB

Vetenskapsvägen 10

191 90 Sollentuna,

Švedska

Tazocin

4 g/0,5 g

prašek za raztopino za injiciranje ali infundiranje

intravenska uporaba

natrijeva sol piperacilina, ki ustreza 4 g piperacilina in natrijeva sol tazobaktama, ki ustreza 0,5 g tazobaktama

Velika Britanija

| John Wyeth & Brother Limited |
| --- |
| (trading as Wyeth Pharmaceuticals) |
| Huntercombe Lane South |
| Taplow |
| Maidenhead |
| Berkshire SL6 0PH |
| Velika Britanija |

John Wyeth & Brother Limited

(trading as Wyeth Pharmaceuticals)

Huntercombe Lane South

Taplow

Maidenhead

Berkshire SL6 0PH

Velika Britanija

TAZOCIN 2g/0.25g

Powder for Solution for Injection or Infusion

2,25 g

prašek za raztopino za injiciranje ali infundiranje

intravenska uporaba

2 g piperacilina in 250 mg tazobaktama, oba v obliki natrijeve soli

Velika Britanija

| John Wyeth & Brother Limited |
| --- |
| (trading as Wyeth Pharmaceuticals) |
| Huntercombe Lane South |
| Taplow |
| Maidenhead |
| Berkshire SL6 0PH |
| Velika Britanija |

John Wyeth & Brother Limited

(trading as Wyeth Pharmaceuticals)

Huntercombe Lane South

Taplow

Maidenhead

Berkshire SL6 0PH

Velika Britanija

TAZOCIN 4g/0.5g

Powder for Solution for Injection or Infusion

4,5 g

prašek za raztopino za injiciranje ali infundiranje

intravenska uporaba

4 g piperacilina in 500 mg tazobaktama, oba v obliki natrijeve soli

---

PRILOGA II

SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH

| Država članica EU/EEA | Imetnik dovoljenja za promet z zdravilom | (Izmišljeno) ime | Jakost | Farmacevtska oblika | Pot uporabe zdravila | Vsebnost
  (koncentracije) |
| --- | --- | --- | --- | --- | --- | --- |
| Avstrija | GlaxoSmithKline Pharma GmbH, |
| Albert Schweitzer-Gasse 6, |
| A-1140 Wien |

Država članica EU/EEA

Imetnik dovoljenja za promet z zdravilom

(Izmišljeno) ime

Jakost

Farmacevtska oblika

Pot uporabe zdravila

Vsebnost

(koncentracije)

Avstrija

GlaxoSmithKline Pharma GmbH,

Albert Schweitzer-Gasse 6,

A-1140 Wien

Fortum 0,5 g - Trockenstechampullen

500mg

Prašek za injiciranje

Za intravensko ali intramuskularno uporabo

Fortum 1 g - Trockenstechampullen

1g

Prašek za injiciranje

Za intravensko ali intramuskularno uporabo

Fortum 2 g - Trockenstechampullen

2g

Prašek za injiciranje/infundiranje

Za intravensko uporabo

Belgija

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

GlaxoSmithKline s.a. / n.v.

Rue du Tilleul 13

1332 Genval

Belgium

Glazidim

500mg

Prašek za raztopino za injiciranje

Za intravensko ali intramuskularno uporabo

Glazidim

1g

Prašek za raztopino za injiciranje

Za intravensko uporabo

Glazidim

1g

Prašek za raztopino za injiciranje

Za intravensko ali intramuskularno uporabo

Glazidim

2g

Prašek za raztopino za infundiranje

Za intravensko uporabo

Glazidim

2g

Prašek za raztopino za injiciranje

Za intravensko uporabo

Bulgarija

| Glaxo Group Ltd. |
| --- |
| Glaxo Wellcome House, |
| Berkeley avenue, Greenford, |
| Middlesex UB6 0NN, |
| England |

Glaxo Group Ltd.

Glaxo Wellcome House,

Berkeley avenue, Greenford,

Middlesex UB6 0NN,

England

Fortum

1g

Prašek za raztopino za injiciranje

Za intravensko ali intramuskularno uporabo

Ciper

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

Glaxo Group Limited

Berkeley Avenue

Greenford

Middlex UB6 0NN

United Kingdom

Fortum

1g

Prašek za injiciranje

Za intravensko uporabo

Viale vsebujejo 1g ceftazidima (kot pentahidrata)

Češka

| Glaxo Group Ltd., |
| --- |
| Glaxo Welcome House, |
| Berkeley avenue, Greenford, |
| Middlesex UB6 0NN |
| United Kingdom |

Glaxo Group Ltd.,

Glaxo Welcome House,

Berkeley avenue, Greenford,

Middlesex UB6 0NN

United Kingdom

Fortum 500mg

500mg

Prašek za raztopino za injiciranje

Za intravensko uporabo

Fortum 1g

1g

Prašek za raztopino za injiciranje

Za intravensko uporabo

Fortum 2g

2g

Prašek za raztopino za injiciranje

Za intravensko uporabo

Danska

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

GlaxoSmithKline Pharma A/S

Nykaer 68, 2605 Broendby

Denmark

Fortum

500mg

Prašek za injiciranje

Za intravensko uporabo

Fortum

1g

Prašek za injiciranje

Za intravensko uporabo

Fortum

2g

Prašek za injiciranje

Za intravensko uporabo

Estonija

| Glaxo Wellcome Operations, |
| --- |
| Glaxo Wellcome House, |
| Berkeley Avenue, Greenford, |
| Middlesex, UB6 0NN |
| United Kingdom |

Glaxo Wellcome Operations,

Glaxo Wellcome House,

Berkeley Avenue, Greenford,

Middlesex, UB6 0NN

United Kingdom

Fortum

1g

Prašek za raztopino za injiciranje ali infundiranje

Za intramuskularno ali intravensko uporabo

1g

Finska

| Glaxo Operations UK Ltd, Glaxo Wellcome House, |
| --- |
| Berkeley Avenue, Greenford, |
| Middlesex UB6 0NN |
| England |

Glaxo Operations UK Ltd, Glaxo Wellcome House,

Berkeley Avenue, Greenford,

Middlesex UB6 0NN

England

Glazidim

500mg

Prašek za raztopino za injiciranje

Za intramuskularno ali intravensko uporabo

Viale vsebujejo 500 mg ceftazidima (kot pentahidrata)

| Glaxo Operations UK Ltd, Glaxo Wellcome House, |
| --- |
| Berkeley Avenue, Greenford, |
| Middlesex UB6 0NN |
| United Kingdom |

Glaxo Operations UK Ltd, Glaxo Wellcome House,

Berkeley Avenue, Greenford,

Middlesex UB6 0NN

United Kingdom

Glazidim

1g

Prašek za raztopino za injiciranje

Za intramuskularno ali intravensko uporabo

Viale vsebujejo 1 g ceftazidima (kot pentahidrata)

| GlaxoSmithKline Oy, |
| --- |
| PB 24, 02231 Espoo |

GlaxoSmithKline Oy,

PB 24, 02231 Espoo

Glazidim

1g

Prašek za raztopino za injiciranje ali infundiranje

Za intramuskularno ali intravensko uporabo

Viale vsebujejo 1 g ceftazidima (kot pentahidrata)

| GlaxoSmithKline Oy, |
| --- |
| PB 24, 02231 Espoo |
| Finland |

GlaxoSmithKline Oy,

PB 24, 02231 Espoo

Finland

Glazidim

2g

Prašek za raztopino za injiciranje ali infundiranje

Za intramuskularno ali intravensko uporabo

Viale vsebujejo 2 g ceftazidima (kot pentahidrata)

| GlaxoSmithKline Oy, |
| --- |
| PB 24, 02231 Espoo |
| Finland |

GlaxoSmithKline Oy,

PB 24, 02231 Espoo

Finland

Glazidim

3g

Prašek za raztopino za injiciranje ali infundiranje

Za intramuskularno ali intravensko uporabo

Viale vsebujejo 3 g ceftazidima (kot pentahidrata)

Francija

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

Laboratoire GlaxoSmithKline

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

France

Fortum enfants et nourrisons

250mg

Prašek za raztopino za injiciranje

Za intravensko ali intramuskularno uporabo

295mg

Fortum enfants et nourrisons

500mg

Prašek za raztopino za injiciranje

Za intravensko ali intramuskularno uporabo

591mg

Fortumset

1g

Prašek za raztopino za infundiranje (IV)

Za intravensko uporabo

1 182mg

Fortum

1g

Prašek za raztopino za injiciranje

Za intravensko ali intramuskularno uporabo

1 182mg

Fortumset

2g

Prašek za raztopino za infundiranje (IV)

Za intravensko uporabo

2 364mg

Fortum

2g

Prašek za raztopino za injiciranje (IV)

Za intravensko uporabo

2 364mg

Nemčija

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

GlaxoSmithKline GmbH & Co. KG

Theresienhöhe 11

80339 München

Germany

Fortum

500mg

Prašek za raztopino za injiciranje ali infundiranje

Za intravensko ali intramuskularno uporabo

Fortum

1g

Prašek za raztopino za injiciranje ali infundiranje

Za intravensko ali intramuskularno uporabo

Fortum

2g

Prašek za raztopino za injiciranje ali infundiranje

Za intravensko uporabo

Grčija

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

GlaxoSmithKline a.e.b.e, Leof.

Kifissias 266,

152 32 Halandri, Athens

Greece

Solvetan

1g

Prašek za injiciranje

Za intravensko ali intramuskularno uporabo

Solvetan

2g

Prašek za injiciranje

Za intravensko uporabo

Madžarska

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

GlaxoSmithKline Kft.

1124 Bp, Csörsz u. 43.

Hungary

Fortum

500mg

Prašek za injiciranje

Za intravensko uporabo

Fortum

1g

Prašek za injiciranje

Za intravensko uporabo

Fortum

2g

Prašek za infundiranje

Za intravensko uporabo

Islandija

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

GlaxoSmithKline ehf.

Thverholt 14

105 Reykjavík

Iceland

Fortum

1g

Prašek za raztopino za injiciranje

Za intravensko ali intramuskularno uporabo

Fortum

2g

Prašek za raztopino za injiciranje

Za intravensko uporabo

Irska

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

GlaxoSmithKline (Ireland) Limited

Stonemasons Way,

Rathfarnham,

Dublin 16

Ireland

Fortum

500mg

Prašek za raztopino za injiciranje

Za intravensko ali intramuskularno uporabo

Rekonstituirana raztopina vsebuje 500mg ceftrazima

Fortum

1g

Prašek za raztopino za injiciranje ali infundiranje, viale

Za intravensko ali intramuskularno injiciranje ali infundiranje

Rekonstituirana raztopina vsebuje 1 g ceftrazima

Fortum

1g

Prašek za infundiranje, monoviale

Za infundiranje

Rekonstituirana raztopina vsebuje 1 g ceftrazima

Fortum

2g

Prašek za raztopino za injiciranje ali infundiranje, viale

Za intravensko ali intramuskularno injiciranje ali infundiranje

Rekonstituirana raztopina vsebuje 2 g ceftrazima

Fortum

2g

Prašek za infundiranje, monoviale

Za infundiranje

Rekonstituirana raztopina vsebuje 2 g ceftrazima

Italija

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

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

37135 Verona

Italy

Glazidim

250mg/ml

Prašek in topilo za raztopino za injiciranje

Za intramuskularno uporabo

Glazidim

500mg/1,5ml

Prašek in topilo za raztopino za injiciranje

Za intramuskularno uporabo

Glazidim

1g/3ml

Prašek in topilo za raztopino za injiciranje

Za intramuskularno uporabo

Glazidim

1g/10ml

Prašek in topilo za raztopino za injiciranje

Za intravensko uporabo

Glazidim

2g

Prašek za raztopino za injiciranje

Za intravensko uporabo

Glazidim

1g/100ml

Prašek in topilo za raztopino za injiciranje (Monoviale)

Za intravensko uporabo

Glazidim

2g/100ml

Prašek in topilo za raztopino za injiciranje (Monoviale)

Za intravensko uporabo

Glazidim

1g

Prašek za raztopino za infundiranje (Monoviale)

Za intravensko uporabo

Glazidim

2g

Prašek za raztopino za infundiranje (Monoviale)

Za intravensko uporabo

| Glaxo Allen S.p.A |
| --- |
| Via Fleming, 2 |
| Verona |
| Italy |

Glaxo Allen S.p.A

Via Fleming, 2

Verona

Italy

Panzid

1g/3ml

Prašek in topilo za raztopino za injiciranje

Za intramuskularno uporabo

Latvija

| GlaxoSmithKline Latvia SIA |
| --- |
| Bruninieku 5, Riga, LV-1001, |
| Latvia |

GlaxoSmithKline Latvia SIA

Bruninieku 5, Riga, LV-1001,

Latvia

Fortum 1 g powder for solution for injection or infusion

1g

Prašek za raztopino za injiciranje ali infundiranje

Za intravensko uporabo ali intramuskularno uporabo

1 g ceftazidima (kot ceftazidim pentahidrat)

Litva

| UAB „GlaxoSmithKline Lietuva“, |
| --- |
| A. Goštauto g. 40A, |
| LT-01112 Vilnius, Lithuania |

UAB „GlaxoSmithKline Lietuva“,

A. Goštauto g. 40A,

LT-01112 Vilnius, Lithuania

Fortum

500mg

Prašek in topilo za raztopino za injiciranje

Za intravensko ali intramuskularno uporabo

Fortum

1g

Prašek in topilo za raztopino za injiciranje

Za intravensko ali intramuskularno uporabo

Fortum

2g

Prašek za raztopino za injiciranje ali infundiranje

Za intravensko uporabo

Fortum

3g

Prašek za raztopino za injiciranje ali infundiranje

Za intravensko uporabo

Luksemburg

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

GlaxoSmithKline s.a. / n.v.

Rue du Tilleul 13

1332 Genval

Belgium

Glazidim

500mg

Prašek za raztopino za injiciranje

Za intravensko ali intramuskularno uporabo

Glazidim

1g

Prašek za raztopino za infundiranje

Za intravensko uporabo

Glazidim

1g

Prašek za raztopino za injiciranje

Za intravensko ali intramuskularno uporabo

Glazidim

2g

Prašek za raztopino za infundiranje

Za intravensko uporabo

Glazidim

2g

Prašek za raztopino za injiciranje

Za intravensko uporabo

Malta

| Glaxo Operations UK Limited |
| --- |
| Glaxo Wellcome House |
| Berkeley Avenue |
| Greenford |
| Middlesex UB6 0NN |
| United Kingdom |

Glaxo Operations UK Limited

Glaxo Wellcome House

Berkeley Avenue

Greenford

Middlesex UB6 0NN

United Kingdom

Fortum

1g na vialo

Prašek za raztopino za injiciranje

Za intravensko ali intramuskularno uporabo

Nizozemska

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

Glaxo Smith Kline B.V.

Huis ter Heideweg 62

3705 LZ ZEIST

THE NETHERLANDS

Fortum

500mg

Prašek za raztopino za injiciranje

Za intravensko ali intramuskularno uporabo

Fortum

1g

Prašek za raztopino za injiciranje

Za intravensko ali intramuskularno uporabo

Fortum

2g

Prašek za raztopino za injiciranje

Za intravensko uporabo

Norveška

| GlaxoSmithKline AS |
| --- |
| Forskningsveien 2A |
| Postboks 180 Vinderen |
| 0319 Oslo |
| Norway |

GlaxoSmithKline AS

Forskningsveien 2A

Postboks 180 Vinderen

0319 Oslo

Norway

Fortum

500mg

Prašek za infundiranje/injeciranje

Za intravensko ali intramuskularno uporabo

Fortum

1g

Prašek za infundiranje/injeciranje

Za intravensko ali intramuskularno uporabo

Fortum

2g

Prašek za infundiranje/injeciranje

Za intravensko uporabo

Poljska

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

GlaxoSmithKline Export Ltd

980 Great West Road

Brentford, Middlesex, TW8 9GS

United Kingdom

Fortum

250mg

Prašek za raztopino za injiciranje

Za intravensko ali intramuskularno uporabo

Fortum

500mg

Prašek za raztopino za injiciranje

Za intravensko ali intramuskularno uporabo

Fortum

1g

Prašek za raztopino za injiciranje ali infundiranje

Za intravensko ali intramuskularno uporabo

Fortum

2g

Prašek za raztopino za injiciranje ali infundiranje

Za intravensko uporabo

Portugalska

| Glaxo Wellcome Farmacêutica, Lda. |
| --- |
| Rua Dr. António Loureiro Borges, 3 |
| Aquiparque – Miraflores |
| 1495 – 131 Algés |
| Portugal |

Glaxo Wellcome Farmacêutica, Lda.

Rua Dr. António Loureiro Borges, 3

Aquiparque – Miraflores

1495 – 131 Algés

Portugal

Cefortam

500mg/1.5ml

Prašek in topilo za raztopino za injiciranje

Za intravensko ali intramuskularno uporabo

Cefortam

1g/3ml

Prašek in topilo za raztopino za injiciranje

Za intravensko ali intramuskularno uporabo

Cefortam

2g

Prašek za raztopino za injiciranje

Za intravensko uporabo

Romunija

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

Glaxo Wellcome UK Limited, Glaxo Wellcome House,

Berkeley Avenue, Greenford,

Middlesex, UB6 0NN

United Kingdom

Fortum

500mg

Prašek za injiciranje

Za intravensko ali intramuskularno uporabo

Fortum

1g

Prašek za injiciranje

Za intravensko ali intramuskularno uporabo

Fortum

1g

Prašek za injiciranje

Za intravensko ali intramuskularno uporabo

Fortum

1g

Prašek za injiciranje

Za intravensko ali intramuskularno uporabo

Fortum

2g

Prašek za injiciranje ali infundiranje

Za intravensko ali intramuskularno uporabo

Slovaška

| GlaxoSmithKline Slovakia sro., |
| --- |
| Galvaniho7/A, 82104 Bratislava, |
| Slovakia. |

GlaxoSmithKline Slovakia sro.,

Galvaniho7/A, 82104 Bratislava,

Slovakia.

Fortum

500mg

Prašek za injiciranje

Za intravensko uporabo

Fortum

1g

Prašek za infundiranje

Za intravensko uporabo

Fortum

2g

Prašek za infundiranje

Za intravensko uporabo

Slovenija

| GSK d.o.o., Ljubljana |
| --- |
| Knezov štradon 90 |
| SI-1000 Ljubljana |
| Slovenija |

GSK d.o.o., Ljubljana

Knezov štradon 90

SI-1000 Ljubljana

Slovenija

Fortum

1g

Prašek za injiciranje ali infundiranje

Za intravensko uporabo

Fortum monoviala

1g

Prašek za infundiranje

Za intravensko uporabo

Španija

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

GlaxoSmithKline, S.A.

P.T.M.- C/Severo Ochoa, 2

28760 Tres Cantos (Madrid)

Spain

Fortam IM/IV

500mg

Prašek za injiciranje

Za intravensko uporabo /IM

Fortam IV

1g

Prašek za injiciranje

Za intravensko uporabo

Fortam 1g

1g

Prašek za injiciranje

Za intravensko uporabo /IM

Fortam IV

2g

Prašek za infundiranje

Za intravensko uporabo

Švedska

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

GlaxoSmithKline AB

Box 516

169 29 Solna

Sweden

Fortum

250mg

Prašek za raztopino za injiciranje

Za intravensko ali intramuskularno uporabo

250 mg ceftazidima (kot pentahidrat)

Fortum

500mg

Prašek za raztopino za injiciranje

Za intravensko ali intramuskularno uporabo

500 mg ceftazidima (kot pentahidrat )

Fortum

1g

Prašek za raztopino za injiciranje

Za intravensko ali intramuskularno uporabo

1 g ceftazidim (kot pentahidrat)

Fortum

1g

Prašek za raztopino za infundiranje

Za intravensko uporabo

1 g ceftazidim (kot pentahidrat )

Fortum

1g Monoviale

Prašek za raztopino za infundiranje

Za intravensko uporabo

1 g ceftazidim (kot pentahidrat)

Fortum

2g Monoviale

Prašek za raztopino za infundiranje

Za intravensko uporabo

2 g ceftazidima (as pentahydrate)

Fortum

2g

Prašek za raztopino za injiciranje ali infundiranje

Za intravensko uporabo

2 g ceftazidime (kot pentahidrat)

Velika Britanija

| Glaxo Operations UK Ltd, |
| --- |
| Glaxo Wellcome House, |
| Berkeley Avenue, Greenford Road, |
| Middlesex, UB6 0NN |
| United Kingdom |

Glaxo Operations UK Ltd,

Glaxo Wellcome House,

Berkeley Avenue, Greenford Road,

Middlesex, UB6 0NN

United Kingdom

Fortum

250mg

Prašek za injiciranje

Za intravensko ali intramuskularno uporabo

118mg na gram ceftazidima

Fortum

500mg

Prašek za injiciranje

Za intravensko ali intramuskularno uporabo

118mg na gram ceftazidima

Fortum

1g

Prašek za injiciranje

Za intravensko ali intramuskularno uporabo

118mg na gram ceftazidima

Fortum

2g and 3g + 2g Monoviale

Prašek za infundiranje

Za intravensko ali intramuskularno uporabo

118mg na gram ceftazidima

---

PRILOGA III

SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH

| Država članica EU/EGP | Imetnik dovoljenja za promet z zdravilom | Izmišljeno ime | Jakost | Farmacevtska oblika | Pot uporabe zdravila |
| --- | --- | --- | --- | --- | --- |
| Avstrija | Roche Austria GmbH, |
| Engelhorngasse 3, |
| A - 1211 Vienna |
| Austria |

Država članica EU/EGP

Imetnik dovoljenja za promet z zdravilom

Izmišljeno ime

Jakost

Farmacevtska oblika

Pot uporabe zdravila

Avstrija

Roche Austria GmbH,

Engelhorngasse 3,

A - 1211 Vienna

Austria

Inhibace plus «Roche» - Filmtabletten

5 mg/12,5 mg

Filmsko obložene tablete

Peroralna uporaba

Belgija

| N.V. Roche S.A. |
| --- |
| Rue Dante 75 |
| 1070 Bruxelles |
| Belgium |

N.V. Roche S.A.

Rue Dante 75

1070 Bruxelles

Belgium

Co-Inhibace

5 mg/12,5 mg

Filmsko obložene tablete

Peroralna uporaba

Češka

| Roche s.r.o. |
| --- |
| Dukelskych hrdinu 567/52 |
| 170 00 / Praha 7 |
| Czech Republic |

Roche s.r.o.

Dukelskych hrdinu 567/52

170 00 / Praha 7

Czech Republic

Inhibace Plus

5 mg/12,5 mg

Filmsko obložene tablete

Peroralna uporaba

Nemčija

| Roche Pharma AG |
| --- |
| Emil-Barell-Strasse 1 |
| 79639/Grenzach |
| Germany |

Roche Pharma AG

Emil-Barell-Strasse 1

79639/Grenzach

Germany

Dynorm Plus

5 mg/12,5 mg

Filmsko obložene tablete

Peroralna uporaba

Grčija

| Roche (Hellas) SA |
| --- |
| 4, Alamanas & Delfon Str. |
| Maroussi 15125 |
| Attiki |
| Greece |

Roche (Hellas) SA

4, Alamanas & Delfon Str.

Maroussi 15125

Attiki

Greece

Vascace Plus

5 mg/12,5 mg

Filmsko obložene tablete

Peroralna uporaba

Madžarska

| Roche Hungary Ltd |
| --- |
| Edison ut 1 |
| 2040 / Budaörs |
| Hungary |

Roche Hungary Ltd

Edison ut 1

2040 / Budaörs

Hungary

Inhibace Plus

5 mg/12,5 mg

Filmsko obložene tablete

Peroralna uporaba

Italija

| Roche S.p.A |
| --- |
| Via G.B Stucchi 110 |
| 20052/Monza |
| Italy |

Roche S.p.A

Via G.B Stucchi 110

20052/Monza

Italy

Inibace Plus

5 mg/12,5 mg

Filmsko obložene tablete

Peroralna uporaba

Luksemburg

| N.V. Roche S.A. |
| --- |
| Rue Dante 75 |
| 1070 Bruxelles |
| Belgium |

N.V. Roche S.A.

Rue Dante 75

1070 Bruxelles

Belgium

Co-Inhibace

5 mg/12,5 mg

Filmsko obložene tablete

Peroralna uporaba

Poljska

| Roche Polska Sp.z.o.o. |
| --- |
| Ul. Domaniewska 39B |
| 02-672 / Warsaw |
| Poland |

Roche Polska Sp.z.o.o.

Ul. Domaniewska 39B

02-672 / Warsaw

Poland

Inhibace Plus

5 mg/12,5 mg

Filmsko obložene tablete

Peroralna uporaba

Portugalska

| Roche Farmacêutica Química, Lda |
| --- |
| Estrada Nacional 249-1 |
| 2720-413 / Amadora |
| Portugal |

Roche Farmacêutica Química, Lda

Estrada Nacional 249-1

2720-413 / Amadora

Portugal

Inibace Plus

5 mg/12,5 mg

Filmsko obložene tablete

Peroralna uporaba

Španija

| Roche Farma S.A. |
| --- |
| Eucalipto no 33 |
| 28016 / Madrid |
| Spain |

Roche Farma S.A.

Eucalipto no 33

28016 / Madrid

Spain

Inhibace Plus

5 mg/12,5 mg

Filmsko obložene tablete

Peroralna uporaba

---

PRILOGA IV

SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI, POTI UPORABE ZDRAVILA IN IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILI V DRŽAVAH ČLANICAH

Zdravila, ki vsebujejo zdravilno učinkovino fenofibrat in imajo dovoljenje za promet v EU

| Država članica (EU/EEA) | Imetnik dovoljenja za promet | Izmišljeno ime | Jakost | Farmacevtska oblika | Pot uporabe zdravila |
| --- | --- | --- | --- | --- | --- |
| AT - Avstrija | Solvay Pharma GmbH |
| Dresdner Straße 91/C2/Top 12 |
| A- 1200 Wien |
| Avstrija |

Država članica (EU/EEA)

Imetnik dovoljenja za promet

Izmišljeno ime

Jakost

Farmacevtska oblika

Pot uporabe zdravila

AT - Avstrija

Solvay Pharma GmbH

Dresdner Straße 91/C2/Top 12

A- 1200 Wien

Avstrija

Apteor 160 mg - Filmtabletten

160 mg

filmsko obložena tableta

peroralno

AT - Avstrija

| G.L. Pharma GmbH |
| --- |
| Schlossplatz 1 |
| A-8502 Lannach |
| Avstrija |

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Avstrija

Fenolip retard 250 mg - Kapseln

250 mg

trda kapsula s podaljšanim sproščanjem

peroralno

AT - Avstrija

| Solvay Pharma GmbH |
| --- |
| Dresdner Straße 91/C2/Top 12 |
| A- 1200 Wien |
| Avstrija |

Solvay Pharma GmbH

Dresdner Straße 91/C2/Top 12

A- 1200 Wien

Avstrija

Lipanthyl Nanopartikel 145 mg - Filmtabletten

145 mg

filmsko obložena tableta

peroralno

AT - Avstrija

| Solvay Pharma GmbH |
| --- |
| Dresdner Straße 91/C2/Top 12 |
| A- 1200 Wien |
| Avstrija |

Solvay Pharma GmbH

Dresdner Straße 91/C2/Top 12

A- 1200 Wien

Avstrija

Lipanthyl supra 160 mg - Filmtabletten

160 mg

filmsko obložena tableta

peroralno

AT - Avstrija

| Solvay Pharma GmbH |
| --- |
| Dresdner Straße 91/C2/Top 12 |
| A- 1200 Wien |
| Avstrija |

Solvay Pharma GmbH

Dresdner Straße 91/C2/Top 12

A- 1200 Wien

Avstrija

Lipcor 200 mg - Kapseln

200 mg

trda kapsula

peroralno

AT - Avstrija

| Solvay Pharma GmbH |
| --- |
| Dresdner Straße 91/C2/Top 12 |
| A- 1200 Wien |
| Avstrija |

Solvay Pharma GmbH

Dresdner Straße 91/C2/Top 12

A- 1200 Wien

Avstrija

Lipsin 100 mg - Kapseln

100 mg

trda kapsula

peroralno

AT - Avstrija

| Solvay Pharma GmbH |
| --- |
| Dresdner Straße 91/C2/Top 12 |
| A- 1200 Wien |
| Avstrija |

Solvay Pharma GmbH

Dresdner Straße 91/C2/Top 12

A- 1200 Wien

Avstrija

Lipsin retard 250 mg - Kapseln

250 mg

trda kapsula s podaljšanim sproščanjem

peroralno

BE - Belgija

| DOCPHARMA N.V. |
| --- |
| Ambachtenlaan 13H |
| 3001 Leuven |
| Belgija |

DOCPHARMA N.V.

Ambachtenlaan 13H

3001 Leuven

Belgija

DOCFENOFI 200

200 mg

kapsula

peroralno

BE - Belgija

| EUROGENERICS N.V. AFGEKORT „E.G.“ |
| --- |
| Heizel Esplanade b22 |
| 1020 Laeken |
| Belgija |

EUROGENERICS N.V. AFGEKORT „E.G.“

Heizel Esplanade b22

1020 Laeken

Belgija

FENOFIBRAAT EG 200 MG

200 mg

kapsula

peroralno

BE - Belgija

| EUROGENERICS N.V. AFGEKORT „E.G.“ |
| --- |
| Heizel Esplanade b22 |
| 1020 Laeken |
| Belgija |

EUROGENERICS N.V. AFGEKORT „E.G.“

Heizel Esplanade b22

1020 Laeken

Belgija

FENOFIBRAAT EG 100 MG

100 mg

kapsula

peroralno

BE - Belgija

| EUROGENERICS N.V. AFGEKORT „E.G.“ |
| --- |
| Heizel Esplanade b22 |
| 1020 Laeken |
| Belgija |

EUROGENERICS N.V. AFGEKORT „E.G.“

Heizel Esplanade b22

1020 Laeken

Belgija

FENOFIBRAAT EG 200 MG

200 mg

kapsula

peroralno

BE - Belgija

| JUBILANT PHARMACEUTICALS NV |
| --- |
| Axxes Business Park |
| Guldensporenpark 22 - Block C |
| 9820 Merelbeke |
| Belgija |

JUBILANT PHARMACEUTICALS NV

Axxes Business Park

Guldensporenpark 22 - Block C

9820 Merelbeke

Belgija

FENOFIBRAAT JUBILANT 200 MG CAPSULES

200 mg

kapsula

peroralno

BE - Belgija

| APOTEX NV |
| --- |
| Av. du Bourg. |
| Etienne Demunter 5 box 8 |
| 1090 Jette |
| Belgija |

APOTEX NV

Av. du Bourg.

Etienne Demunter 5 box 8

1090 Jette

Belgija

FENOFIBRATE APOTEX 200 MG

200 mg

kapsula

peroralno

BE - Belgija

| MYLAN BVBA/SPRL |
| --- |
| Terhulpsesteenweg 6A |
| 1560 Hoeilaart |
| Belgija |

MYLAN BVBA/SPRL

Terhulpsesteenweg 6A

1560 Hoeilaart

Belgija

FENOFIBRATE MYLAN 200 MG MICRONISED

200 mg

trda kapsula

peroralno

BE - Belgija

| SANDOZ N.V. |
| --- |
| Telecom Gardens |
| Medialaan 40 |
| 1800 Vilvoorde |
| Belgija |

SANDOZ N.V.

Telecom Gardens

Medialaan 40

1800 Vilvoorde

Belgija

FENOFIBRATE SANDOZ 200 MG

200 mg

kapsula

peroralno

BE - Belgija

| LABORATOIRES S.M.B. S.A. |
| --- |
| Rue De La Pastorale 26-28 |
| 1080 Bruxelles |
| Belgija |

LABORATOIRES S.M.B. S.A.

Rue De La Pastorale 26-28

1080 Bruxelles

Belgija

FENOGAL 200 LIDOSE

200 mg

trda kapsula

peroralno

BE - Belgija

| LABORATOIRES S.M.B. S.A. |
| --- |
| Rue De La Pastorale 26-28 |
| 1080 Bruxelles |
| Belgija |

LABORATOIRES S.M.B. S.A.

Rue De La Pastorale 26-28

1080 Bruxelles

Belgija

FENOGAL 267 MG LIDOSE

267 mg

trda kapsula

peroralno

BE - Belgija

| S.M.B. TECHNOLOGY S.A. |
| --- |
| Rue du Parc Industriel 39 |
| 6900 Marche-en-Famenne |
| Belgija |

S.M.B. TECHNOLOGY S.A.

Rue du Parc Industriel 39

6900 Marche-en-Famenne

Belgija

FENOSUP LIDOSE 160 MG

160 mg

trda kapsula

peroralno

BE - Belgija

| SOLVAY PHARMA S.A.-N.V. |
| --- |
| Blue Planet Building |
| Av. Brg. E. Demunterlaan 3 |
| 1090 Bruxelles |
| Belgija |

SOLVAY PHARMA S.A.-N.V.

Blue Planet Building

Av. Brg. E. Demunterlaan 3

1090 Bruxelles

Belgija

LIPANTHYL 200 MICRONISED

200 mg

trda kapsula

peroralno

BE - Belgija

| SOLVAY PHARMA S.A.-N.V. |
| --- |
| Blue Planet Building |
| Av. Brg. E. Demunterlaan 3 |
| 1090 Bruxelles |
| Belgija |

SOLVAY PHARMA S.A.-N.V.

Blue Planet Building

Av. Brg. E. Demunterlaan 3

1090 Bruxelles

Belgija

LIPANTHYL 267 MICRONISED

267 mg

trda kapsula

peroralno

BE - Belgija

| SOLVAY PHARMA S.A.-N.V. |
| --- |
| Blue Planet Building |
| Av. Brg. E. Demunterlaan 3 |
| 1090 Bruxelles |
| Belgija |

SOLVAY PHARMA S.A.-N.V.

Blue Planet Building

Av. Brg. E. Demunterlaan 3

1090 Bruxelles

Belgija

LIPANTHYL 67 MICRONISED

67 mg

trda kapsula

peroralno

BE - Belgija

| SOLVAY PHARMA S.A.-N.V. |
| --- |
| Blue Planet Building |
| Av. Brg. E. Demunterlaan 3 |
| 1090 Bruxelles |
| Belgija |

SOLVAY PHARMA S.A.-N.V.

Blue Planet Building

Av. Brg. E. Demunterlaan 3

1090 Bruxelles

Belgija

LIPANTHYL SUPRA 215MG

215 mg

filmsko obložena tableta

peroralno

BE - Belgija

| SOLVAY PHARMA S.A.-N.V. |
| --- |
| Blue Planet Building |
| Av. Brg. E. Demunterlaan 3 |
| 1090 Bruxelles |
| Belgija |

SOLVAY PHARMA S.A.-N.V.

Blue Planet Building

Av. Brg. E. Demunterlaan 3

1090 Bruxelles

Belgija

LIPANTHYL SUPRA 160 MG

160 mg

filmsko obložena tableta

peroralno

BE - Belgija

| SOLVAY PHARMA S.A.-N.V. |
| --- |
| Blue Planet Building |
| Av. Brg. E. Demunterlaan 3 |
| 1090 Bruxelles |
| Belgija |

SOLVAY PHARMA S.A.-N.V.

Blue Planet Building

Av. Brg. E. Demunterlaan 3

1090 Bruxelles

Belgija

LIPANTHYLNANO 145MG

145 mg

filmsko obložena tableta

peroralno

BE - Belgija

| SOLVAY PHARMA S.A.-N.V. |
| --- |
| Blue Planet Building |
| Av. Brg. E. Demunterlaan 3 |
| 1090 Bruxelles |
| Belgija |

SOLVAY PHARMA S.A.-N.V.

Blue Planet Building

Av. Brg. E. Demunterlaan 3

1090 Bruxelles

Belgija

LIPERIAL 145MG

145 mg

filmsko obložena tableta

peroralno

BG - Bolgarija

| Laboratoires Fournier SA |
| --- |
| 28 Boulevard Clemenceau |
| 21000 Dijon |
| Francija |

Laboratoires Fournier SA

28 Boulevard Clemenceau

21000 Dijon

Francija

Lipanthyl Supra

160 mg

tableta s prirejenim sproščanjem

peroralno

BG - Bolgarija

| Laboratoires Fournier SA |
| --- |
| 28 Boulevard Clemenceau |
| 21000 Dijon |
| Francija |

Laboratoires Fournier SA

28 Boulevard Clemenceau

21000 Dijon

Francija

Lipanthyl 200 M

200 mg

trda kapsula

peroralno

BG - Bolgarija

| Laboratoires Fournier SA |
| --- |
| 28 Boulevard Clemenceau |
| 21000 Dijon |
| Francija |

Laboratoires Fournier SA

28 Boulevard Clemenceau

21000 Dijon

Francija

Lipanthyl 267 M

267 mg

trda kapsula

peroralno

CY - Ciper

| Varnavas Hadjipanayis Ltd |
| --- |
| 7 Androcleous street |
| P.O.Box 21229 |
| 1504 Lefkosia |
| Ciper |

Varnavas Hadjipanayis Ltd

7 Androcleous street

P.O.Box 21229

1504 Lefkosia

Ciper

LIPIDIL MICRONISED HARD CAPSULES 267mg

267 mg

kapsula

peroralno

CY - Ciper

| Varnavas Hadjipanayis Ltd, |
| --- |
| 7 Androcleous street |
| P.O.Box 21229 |
| 1504 Lefkosia |
| Ciper |

Varnavas Hadjipanayis Ltd,

7 Androcleous street

P.O.Box 21229

1504 Lefkosia

Ciper

LIPIDIL MICRONISED HARD CAPSULES 200mg

200 mg

kapsula

peroralno

CZ - Češka

| Laboratoires Fournier S.A. |
| --- |
| 28Bd Clemenceau |
| 21 000 Dijon |
| Francija |

Laboratoires Fournier S.A.

28Bd Clemenceau

21 000 Dijon

Francija

LIPANTHYL 267 M

267 mg

trda kapsula

peroralno

CZ - Češka

| Laboratoires Fournier S.A. |
| --- |
| 28Bd Clemenceau |
| 21 000 Dijon |
| Francija |

Laboratoires Fournier S.A.

28Bd Clemenceau

21 000 Dijon

Francija

LIPANTHYL NT 145 MG

145 MG

filmsko obložena tableta

peroralno

CZ - Češka

| Laboratoires Fournier S.A. |
| --- |
| 28Bd Clemenceau |
| 21 000 Dijon |
| Francija |

Laboratoires Fournier S.A.

28Bd Clemenceau

21 000 Dijon

Francija

LIPANTHYL SUPRA 160 MG

160 MG

tableta s prirejenim sproščanjem

peroralno

CZ - Češka

| Laboratoires Fournier S.A. |
| --- |
| 28Bd Clemenceau |
| 21 000 Dijon |
| Francija |

Laboratoires Fournier S.A.

28Bd Clemenceau

21 000 Dijon

Francija

LIPANTHYL 200 M

200 MG

trda kapsula

peroralno

CZ - Češka

| Laboratoires Fournier S.A. |
| --- |
| 28Bd Clemenceau |
| 21 000 Dijon |
| Francija |

Laboratoires Fournier S.A.

28Bd Clemenceau

21 000 Dijon

Francija

LIPANTHYL S 215 MG

215 MG

filmsko obložena tableta

peroralno

CZ - Češka

| HEXAL AG |
| --- |
| Industriestraße 25 |
| 83607 Holzkirchen |
| Nemčija |

HEXAL AG

Industriestraße 25

83607 Holzkirchen

Nemčija

LIPOHEXAL 250 RETARD

250 MG

trda kapsula s prirejenim sproščanjem

peroralno

CZ - Češka

| Ingers Industrial Solutions s.r.o. |
| --- |
| Slunná 16 |
| 617 00 Brno |
| Češka |

Ingers Industrial Solutions s.r.o.

Slunná 16

617 00 Brno

Češka

FENOFIX 267 MG

267 MG

trda kapsula

peroralno

CZ - Češka

| Ingers Industrial Solutions s.r.o. |
| --- |
| Slunná 16 |
| 617 00 Brno |
| Češka |

Ingers Industrial Solutions s.r.o.

Slunná 16

617 00 Brno

Češka

FENOFIX 200 MG

200 MG

trda kapsula

peroralno

CZ - Češka

| Zentiva a.s. |
| --- |
| Nitrianska 100 |
| 920 27 Hlohovec |
| Slovac Republic |

Zentiva a.s.

Nitrianska 100

920 27 Hlohovec

Slovac Republic

FEBIRA 200

200 MG

trda kapsula

peroralno

CZ - Češka

| sanofi-aventis s.r.o. |
| --- |
| Evropská 846/176a |
| 160 00 Praha 6 |
| Češka |

sanofi-aventis s.r.o.

Evropská 846/176a

160 00 Praha 6

Češka

LIPIREX 267 MG

267 MG

trda kapsula

peroralno

CZ - Češka

| sanofi-aventis s.r.o. |
| --- |
| Evropská 846/176a |
| 160 00 Praha 6 |
| Češka |

sanofi-aventis s.r.o.

Evropská 846/176a

160 00 Praha 6

Češka

LIPIREX 200MG

200 MG

trda kapsula

peroralno

CZ - Češka

| PharmaSwiss Česká Republika s.r.o., Jankovcova 1569/2c |
| --- |
| 17000 Praha 7 |
| Češka |

PharmaSwiss Česká Republika s.r.o., Jankovcova 1569/2c

17000 Praha 7

Češka

SUPRELIP

200 MG

trda kapsula

peroralno

CZ - Češka

| APOTEX (ČR), spol. s r.o. |
| --- |
| Palladium, Na Poříčí 1079/3a |
| 110 00 Praha – 1 |
| Češka |

APOTEX (ČR), spol. s r.o.

Palladium, Na Poříčí 1079/3a

110 00 Praha – 1

Češka

APO-FENO

200 MG

trda kapsula

peroralno

DE - Nemčija

| AbZ-Pharma GmbH |
| --- |
| Dr.Georg-Spohn-Str. 7 |
| D-89143 Blaubeuren |
| Nemčija |

AbZ-Pharma GmbH

Dr.Georg-Spohn-Str. 7

D-89143 Blaubeuren

Nemčija

Fenofibrat AbZ 100mg Hartkapseln

100 mg

trda kapsula

peroralno

DE - Nemčija

| AbZ-Pharma GmbH |
| --- |
| Dr.Georg-Spohn-Str. 7 |
| D-89143 Blaubeuren |
| Nemčija |

AbZ-Pharma GmbH

Dr.Georg-Spohn-Str. 7

D-89143 Blaubeuren

Nemčija

Fenofibrat AbZ 250 mg Retardkapseln

250 mg

trda kapsula s podaljšanim sproščanjem

peroralno

DE - Nemčija

| ALIUD PHARMA GmbH |
| --- |
| Gottlieb-Daimler-Str. 19 |
| D-89150 Laichingen |
| Nemčija |

ALIUD PHARMA GmbH

Gottlieb-Daimler-Str. 19

D-89150 Laichingen

Nemčija

Fenofibrat AL 250 retard

250 mg

trda kapsula s podaljšanim sproščanjem

peroralno

DE - Nemčija

| betapharm Arzneimittel GmbH |
| --- |
| Kobelweg 95 |
| D-86156 Augsburg |
| Nemčija |

betapharm Arzneimittel GmbH

Kobelweg 95

D-86156 Augsburg

Nemčija

Fenobeta 250 retard

250 mg

trda kapsula s podaljšanim sproščanjem

peroralno

DE - Nemčija

| CHEPLAPHARM Arzneimittel GmbH |
| --- |
| Bahnhofstr. 1a |
| D-17498 Mesekenhagen |
| Nemčija |

CHEPLAPHARM Arzneimittel GmbH

Bahnhofstr. 1a

D-17498 Mesekenhagen

Nemčija

Normalip pro

200 mg

trda kapsula

peroralno

DE - Nemčija

| CT Arzneimittel GmbH |
| --- |
| Lengeder Str. 42 a |
| D-13407 Berlin |
| Nemčija |

CT Arzneimittel GmbH

Lengeder Str. 42 a

D-13407 Berlin

Nemčija

Fenofibrat-CT 100mg Hartkapseln

100 mg

kapsula

peroralno

DE - Nemčija

| CT Arzneimittel GmbH |
| --- |
| Lengeder Str. 42 a |
| D-13407 Berlin |
| Nemčija |

CT Arzneimittel GmbH

Lengeder Str. 42 a

D-13407 Berlin

Nemčija

Fenofibrat-CT 250mg Retardkapseln

250 mg

trda kapsula s podaljšanim sproščanjem

peroralno

DE - Nemčija

| Heumann Pharma GmbH & Co. Generica KG |
| --- |
| Südwestpark 50 |
| D-90449 Nürnberg |
| Nemčija |

Heumann Pharma GmbH & Co. Generica KG

Südwestpark 50

D-90449 Nürnberg

Nemčija

Fenofibrat 200 Heumann

200 mg

trda kapsula

peroralno

DE - Nemčija

| Heumann Pharma GmbH & Co. Generica KG |
| --- |
| Südwestpark 50 |
| D-90449 Nürnberg |
| Nemčija |

Heumann Pharma GmbH & Co. Generica KG

Südwestpark 50

D-90449 Nürnberg

Nemčija

Fenofibrat 250 retard Heumann

250 mg

trda kapsula s podaljšanim sproščanjem

peroralno

DE - Nemčija

| HEXAL AG |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |
| Nemčija |

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Nemčija

FENOFIBRAT HEXAL 160 mg Hartkapseln

160 mg

trda kapsula

peroralno

DE - Nemčija

| HEXAL AG |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |
| Nemčija |

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Nemčija

Fenofibrat Hexal 200 mg Hartkapseln

200 mg

trda kapsula

peroralno

DE - Nemčija

| Juta Pharma GmbH |
| --- |
| Gutenbergstr. 13 |
| D-24941 Flensburg |
| Nemčija |

Juta Pharma GmbH

Gutenbergstr. 13

D-24941 Flensburg

Nemčija

Fenofanton 250 mg Hartkapseln, retardiert

250 mg

trda kapsula s podaljšanim sproščanjem

peroralno

DE - Nemčija

| Mylan dura GmbH |
| --- |
| Wittichstr. 6 |
| D-64295 Darmstadt |
| Nemčija |

Mylan dura GmbH

Wittichstr. 6

D-64295 Darmstadt

Nemčija

Durafenat

100 mg

trda kapsula

peroralno

DE - Nemčija

| Mylan dura GmbH |
| --- |
| Wittichstr. 6 |
| D-64295 Darmstadt |
| Nemčija |

Mylan dura GmbH

Wittichstr. 6

D-64295 Darmstadt

Nemčija

durafenat MF 200 mg

200 mg

trda kapsula s prirejenim sproščanjem

peroralno

DE - Nemčija

| Mylan dura GmbH |
| --- |
| Wittichstr. 6 |
| D-64295 Darmstadt |
| Nemčija |

Mylan dura GmbH

Wittichstr. 6

D-64295 Darmstadt

Nemčija

durafenat retard

250 mg

trda kapsula s podaljšanim sproščanjem

peroralno

DE - Nemčija

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |
| Nemčija |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Nemčija

Fenofibrat-ratiopharm 250 mg Retardkapseln

250 mg

trda kapsula s podaljšanim sproščanjem

peroralno

DE - Nemčija

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |
| Nemčija |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Nemčija

Fenofibrat-ratiopharm 100 mg Hartkapseln

100 mg

trda kapsula

peroralno

DE - Nemčija

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 11 |
| D-83607 Holzkirchen |
| Nemčija |

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

D-83607 Holzkirchen

Nemčija

Fenofibrat Sandoz 200mg Hartkapseln

200 mg

trda kapsula

peroralno

DE - Nemčija

| Abbott Arzneimittel GmbH |
| --- |
| Hans-Boeckler-Allee 20 |
| D-30173 Hannover |
| Nemčija |

Abbott Arzneimittel GmbH

Hans-Boeckler-Allee 20

D-30173 Hannover

Nemčija

Apteor 160 mg Filmtablette

160 mg

filmsko obložena tableta

peroralno

DE - Nemčija

| Abbott Arzneimittel GmbH |
| --- |
| Hans-Boeckler-Allee 20 |
| D-30173 Hannover |
| Nemčija |

Abbott Arzneimittel GmbH

Hans-Boeckler-Allee 20

D-30173 Hannover

Nemčija

Elipsia 145 mg Filmtabletten

145 mg

filmsko obložena tableta

peroralno

DE - Nemčija

| Abbott Arzneimittel GmbH |
| --- |
| Hans-Boeckler-Allee 20 |
| D-30173 Hannover |
| Nemčija |

Abbott Arzneimittel GmbH

Hans-Boeckler-Allee 20

D-30173 Hannover

Nemčija

Liperial 145 mg Filmtablette

145 mg

filmsko obložena tableta

peroralno

DE - Nemčija

| Abbott Arzneimittel GmbH |
| --- |
| Hans-Boeckler-Allee 20 |
| D-30173 Hannover |
| Nemčija |

Abbott Arzneimittel GmbH

Hans-Boeckler-Allee 20

D-30173 Hannover

Nemčija

Lipidil - Ter 160 mg Filmtablette

160 mg

filmsko obložena tableta

peroralno

DE - Nemčija

| Abbott Arzneimittel GmbH |
| --- |
| Hans-Boeckler-Allee 20 |
| D-30173 Hannover |
| Nemčija |

Abbott Arzneimittel GmbH

Hans-Boeckler-Allee 20

D-30173 Hannover

Nemčija

Lipidil 145 ONE

145 mg

filmsko obložena tableta

peroralno

DE - Nemčija

| Abbott Arzneimittel GmbH |
| --- |
| Hans-Boeckler-Allee 20 |
| D-30173 Hannover |
| Nemčija |

Abbott Arzneimittel GmbH

Hans-Boeckler-Allee 20

D-30173 Hannover

Nemčija

Lipidil 200mg

200 mg

trda kapsula

peroralno

DE - Nemčija

| Abbott Arzneimittel GmbH |
| --- |
| Hans-Boeckler-Allee 20 |
| D-30173 Hannover |
| Nemčija |

Abbott Arzneimittel GmbH

Hans-Boeckler-Allee 20

D-30173 Hannover

Nemčija

Xafenor 145 mg Filmtablette

145 mg

filmsko obložena tableta

peroralno

DE - Nemčija

| Stadapharm GmbH |
| --- |
| Stadastr. 2-18 |
| D-61118 Bad Vilbel |
| Nemčija |

Stadapharm GmbH

Stadastr. 2-18

D-61118 Bad Vilbel

Nemčija

Fenofibrat STADA 250 mg Hartkapseln, retardiert

250 mg

trda kapsula s podaljšanim sproščanjem

peroralno

DE - Nemčija

| Winthrop Arzneimittel GmbH |
| --- |
| Urmitzer Str. 5 |
| D-56218 Mülheim-Kärlich |
| Nemčija |

Winthrop Arzneimittel GmbH

Urmitzer Str. 5

D-56218 Mülheim-Kärlich

Nemčija

CiL 160 mg

160 mg

trda kapsula

peroralno

DE - Nemčija

| Winthrop Arzneimittel GmbH |
| --- |
| Urmitzer Str. 5 |
| D-56218 Mülheim-Kärlich |
| Nemčija |

Winthrop Arzneimittel GmbH

Urmitzer Str. 5

D-56218 Mülheim-Kärlich

Nemčija

CIL 200 mg

200 mg

kapsula

peroralno

EL - Grčija

| SOLVAY PHARMA Μ.Ε.Π.Ε |
| --- |
| Agiou DIMITRIOU 63 |
| Alimos 17456 |
| Grčija |

SOLVAY PHARMA Μ.Ε.Π.Ε

Agiou DIMITRIOU 63

Alimos 17456

Grčija

LIPIDIL

200 MG/CAP

trda kapsula

peroralno

EL - Grčija

| SOLVAY PHARMA Μ.Ε.Π.Ε |
| --- |
| Agiou DIMITRIOU 63 |
| Alimos |
| Grčija 17456 |

SOLVAY PHARMA Μ.Ε.Π.Ε

Agiou DIMITRIOU 63

Alimos

Grčija 17456

LIPIDIL (NT)

145 MG/TAB

filmsko obložena tableta

peroralno

EL - Grčija

| LABORATOIRES SMB S.A., BELGIJA |
| --- |
| 26-28 rue de la Pastorale |
| B-1080, Brussels |
| Belgija |

LABORATOIRES SMB S.A., BELGIJA

26-28 rue de la Pastorale

B-1080, Brussels

Belgija

FENOBRAT

160 MG/CAP

trda kapsula

peroralno

ES - Španija

| SOLVAY PHARMA |
| --- |
| S.A.Avda. Diagonal |
| 507 Barcelona |
| Španija |

SOLVAY PHARMA

S.A.Avda. Diagonal

507 Barcelona

Španija

APTEOR

145 mg

filmsko obložena tableta

peroralno

ES - Španija

| SOLVAY PHARMA, |
| --- |
| S.A.Avda. Diagonal |
| 507 Barcelona |
| Španija |

SOLVAY PHARMA,

S.A.Avda. Diagonal

507 Barcelona

Španija

APTEOR

160 mg

filmsko obložena tableta

peroralno

ES - Španija

| KERN PHARMA |
| --- |
| S.L. Venus, 72. |
| Poligono Industrial Colon II.Terrassa |
| Španija |

KERN PHARMA

S.L. Venus, 72.

Poligono Industrial Colon II.Terrassa

Španija

Fenofibrato KernPharma

160 mg

kapsula

peroralno

ES - Španija

| LABORATORIOS RANBAXY |
| --- |
| S.L.Passeig de Gracia |
| 9 Barcelona |
| Španija |

LABORATORIOS RANBAXY

S.L.Passeig de Gracia

9 Barcelona

Španija

FENOFIBRATO RANBAXY

160 mg

filmsko obložena tableta

peroralno

ES - Španija

| LABORATORIOS RANBAXY S.L.Passeig de Gracia |
| --- |
| 9 Barcelona |

LABORATORIOS RANBAXY S.L.Passeig de Gracia

9 Barcelona

FENOFIBRATO RANBAXY

200 mg

kapsula

peroralno

ES - Španija

| LABORATORIOS RANBAXY S.L.Passeig de Gracia |
| --- |
| 9 Barcelona |
| Španija |

LABORATORIOS RANBAXY S.L.Passeig de Gracia

9 Barcelona

Španija

FENOFIBRATO RANBAXYGEN

200 mg

kapsula

peroralno

ES - Španija

| NOVARTIS FARMACEUTICA, S.A. |
| --- |
| Gran Via de les Corts Catalanes |
| 764 Barcelona |
| Španija |

NOVARTIS FARMACEUTICA, S.A.

Gran Via de les Corts Catalanes

764 Barcelona

Španija

Liparison Retard

250 mg

kapsula

peroralno

ES - Španija

| SOLVAY PHARMA S.A. |
| --- |
| Avda. Diagonal |
| 507 BARCELONA |
| Španija |

SOLVAY PHARMA S.A.

Avda. Diagonal

507 BARCELONA

Španija

PANLIPAL

145 mg

filmsko obložena tableta

peroralno

ES - Španija

| SOLVAY PHARMA S.A. |
| --- |
| Avda. Diagonal |
| 507 BARCELONA |
| Španija |

SOLVAY PHARMA S.A.

Avda. Diagonal

507 BARCELONA

Španija

SECALIP

145 mg

filmsko obložena tableta

peroralno

ES - Španija

| SOLVAY PHARMA S.A. |
| --- |
| Avda. Diagonal |
| 507 BARCELONA |
| Španija |

SOLVAY PHARMA S.A.

Avda. Diagonal

507 BARCELONA

Španija

SECALIP

200 mg

kapsula

peroralno

ES - Španija

| SOLVAY PHARMA S.A. |
| --- |
| Avda. Diagonal |
| 507 BARCELONA |
| Španija |

SOLVAY PHARMA S.A.

Avda. Diagonal

507 BARCELONA

Španija

SECALIP

250 mg

kapsula

peroralno

ES - Španija

| SOLVAY PHARMA S.A. |
| --- |
| Avda. Diagonal |
| 507 BARCELONA |
| Španija |

SOLVAY PHARMA S.A.

Avda. Diagonal

507 BARCELONA

Španija

SECALIP SUPRA

160 mg

filmsko obložena tableta

peroralno

ET - Estonija

| Laboratoires Fournier S.A. |
| --- |
| 28 Boulevard Clemenceau |
| 21000 Dijon |
| Francija |

Laboratoires Fournier S.A.

28 Boulevard Clemenceau

21000 Dijon

Francija

LIPANTHYL

200 mg

kapsula

peroralno

ET - Estonija

| Pharmaswiss Eesti OÜ |
| --- |
| Tammsaare tee 47 |
| 11316 Tallinn |
| ESTONIA |

Pharmaswiss Eesti OÜ

Tammsaare tee 47

11316 Tallinn

ESTONIA

FENOLIP

160 mg

trda kapsula

peroralno

FI - Finska

| Laboratoires SMB S.A. |
| --- |
| Rue de la Pastorale 26-28 |
| 1080 Brussels |
| Belgija |

Laboratoires SMB S.A.

Rue de la Pastorale 26-28

1080 Brussels

Belgija

CIL

160 mg

trda kapsula

peroralno

FI - Finska

| Laboratoires SMB S.A. |
| --- |
| Rue de la Pastorale 26-28 |
| 1080 Brussels |
| Belgija |

Laboratoires SMB S.A.

Rue de la Pastorale 26-28

1080 Brussels

Belgija

FENOSUP LIDOSE

160 mg

trda kapsula

peroralno

FI - Finska

| Laboratoires Fournier SA |
| --- |
| 28 boulevard Clémenceau |
| BP 27912 |
| 21079 Dijon Cedex |
| Francija |

Laboratoires Fournier SA

28 boulevard Clémenceau

BP 27912

21079 Dijon Cedex

Francija

LIPANTHYL PENTA

145 mg

filmsko obložena tableta

peroralno

FI - Finska

| Laboratoires Fournier SA |
| --- |
| 28 boulevard Clémenceau |
| BP 27912 |
| 21079 Dijon Cedex |
| Francija |

Laboratoires Fournier SA

28 boulevard Clémenceau

BP 27912

21079 Dijon Cedex

Francija

LIPANTHYL SUPRA

160 mg

filmsko obložena tableta

peroralno

FI - Finska

| Laboratoires Fournier SA |
| --- |
| 28 boulevard Clémenceau |
| BP 27912 |
| 21079 Dijon Cedex |
| Francija |

Laboratoires Fournier SA

28 boulevard Clémenceau

BP 27912

21079 Dijon Cedex

Francija

LIPANTHYL SUPRA

215 mg

filmsko obložena tableta

peroralno

FR - Francija

| Société FERLUX SA |
| --- |
| 24, avenue d'Aubière |
| BP 151 |
| 63804 Cournon d'Auvergne Cedex |
| Francija |

Société FERLUX SA

24, avenue d'Aubière

BP 151

63804 Cournon d'Auvergne Cedex

Francija

CENCARAN 140 mg, gélule

140 mg

kapsula

peroralno

FR - Francija

| Société FERLUX SA |
| --- |
| 24, avenue d'Aubière |
| BP 151 |
| 63804 Cournon d'Auvergne Cedex |
| Francija |

Société FERLUX SA

24, avenue d'Aubière

BP 151

63804 Cournon d'Auvergne Cedex

Francija

CENCARAN 67 mg, gélule

67 mg

kapsula

peroralno

FR - Francija

| Laboratoires LEURQUIN MEDIOLANUM |
| --- |
| 68-88, rue Louis Ampère |
| ZI des Chanoux |
| 93330 Neuilly-sur-Marne |
| Francija |

Laboratoires LEURQUIN MEDIOLANUM

68-88, rue Louis Ampère

ZI des Chanoux

93330 Neuilly-sur-Marne

Francija

FEGENOR 140 mg, gélule

140 mg

kapsula

peroralno

FR - Francija

| Laboratoires LEURQUIN MEDIOLANUM |
| --- |
| 68-88, rue Louis Ampère |
| ZI des Chanoux |
| 93330 Neuilly-sur-Marne |
| Francija |

Laboratoires LEURQUIN MEDIOLANUM

68-88, rue Louis Ampère

ZI des Chanoux

93330 Neuilly-sur-Marne

Francija

FEGENOR 200 mg, gélule

200 mg

kapsula

peroralno

FR - Francija

| Laboratoires LEURQUIN MEDIOLANUM |
| --- |
| 68-88, rue Louis Ampère |
| ZI des Chanoux |
| 93330 Neuilly-sur-Marne |
| Francija |

Laboratoires LEURQUIN MEDIOLANUM

68-88, rue Louis Ampère

ZI des Chanoux

93330 Neuilly-sur-Marne

Francija

FEGENOR 67 mg, gélule

67 mg

kapsula

peroralno

FR - Francija

| GALENIX DEVELOPPEMENT |
| --- |
| Les Palanques |
| 33127 Saint Jean d’Illac |
| Francija |

GALENIX DEVELOPPEMENT

Les Palanques

33127 Saint Jean d’Illac

Francija

FENATHOL 160 mg, comprimé pelliculé

160 mg

filmsko obložena tableta

peroralno

FR - Francija

| Laboratoires LEURQUIN MEDIOLANUM |
| --- |
| 68-88, rue Louis Ampère |
| ZI des Chanoux |
| 93330 Neuilly-sur-Marne |
| Francija |

Laboratoires LEURQUIN MEDIOLANUM

68-88, rue Louis Ampère

ZI des Chanoux

93330 Neuilly-sur-Marne

Francija

FENOCOR 100 mg, gélule

100 mg

kapsula

peroralno

FR - Francija

| ACTAVIS Francija |
| --- |
| La Boursidière Centre d'Affaires |
| 92357 Le Plessis Robinson |
| Francija |

ACTAVIS Francija

La Boursidière Centre d'Affaires

92357 Le Plessis Robinson

Francija

FENOFIBRATE ACTAVIS 160 mg, comprimé

160 mg

kapsula

peroralno

FR - Francija

| BIOGARAN |
| --- |
| 15, boulevard Charles de Gaulle |
| 92700 Colombes |
| Francija |

BIOGARAN

15, boulevard Charles de Gaulle

92700 Colombes

Francija

FENOFIBRATE ALMUS 160 mg, comprimé

160 mg

kapsula

peroralno

FR - Francija

| ARROW GENERIQUES |
| --- |
| 26, avenue Tony Garnier |
| 69007 Lyon |
| Francija |

ARROW GENERIQUES

26, avenue Tony Garnier

69007 Lyon

Francija

FENOFIBRATE ALMUS 200 mg, gélule

200 mg

kapsula

peroralno

FR - Francija

| ARROW GENERIQUES |
| --- |
| 26, avenue Tony Garnier |
| 69007 Lyon |
| Francija |

ARROW GENERIQUES

26, avenue Tony Garnier

69007 Lyon

Francija

FENOFIBRATE ALMUS 67 mg, gélule

67 mg

kapsula

peroralno

FR - Francija

| LABORATOIRES ALTER |
| --- |
| 3, avenue de la Baltique |
| ZI de Courtaboeuf |
| 91140 Villebon Sur Yvette |
| Francija |

LABORATOIRES ALTER

3, avenue de la Baltique

ZI de Courtaboeuf

91140 Villebon Sur Yvette

Francija

FENOFIBRATE ALTER 160 mg, comprimé

160 mg

kapsula

peroralno

FR - Francija

| LABORATOIRES ALTER |
| --- |
| 3, avenue de la Baltique |
| ZI de Courtaboeuf |
| 91140 Villebon Sur Yvette |
| Francija |

LABORATOIRES ALTER

3, avenue de la Baltique

ZI de Courtaboeuf

91140 Villebon Sur Yvette

Francija

FENOFIBRATE ALTER 300 mg, gélule

300 mg

kapsula

peroralno

FR - Francija

| ARROW GENERIQUES |
| --- |
| 26, avenue Tony Garnier |
| 69007 Lyon |
| Francija |

ARROW GENERIQUES

26, avenue Tony Garnier

69007 Lyon

Francija

FENOFIBRATE ARROW 160 mg, comprimé

160 mg

tableta

peroralno

FR - Francija

| ARROW GENERIQUES |
| --- |
| 26, avenue Tony Garnier |
| 69007 Lyon |
| Francija |

ARROW GENERIQUES

26, avenue Tony Garnier

69007 Lyon

Francija

FENOFIBRATE ARROW 200 mg, gélule

200 mg

kapsula

peroralno

FR - Francija

| ARROW GENERIQUES |
| --- |
| 26, avenue Tony Garnier |
| 69007 Lyon |
| Francija |

ARROW GENERIQUES

26, avenue Tony Garnier

69007 Lyon

Francija

FENOFIBRATE ARROW 67 mg, gélule

67 mg

kapsula

peroralno

FR - Francija

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| Francija |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

Francija

FENOFIBRATE BIOGARAN 100 mg, gélule

100 mg

kapsula

peroralno

FR - Francija

| BIOGARAN |
| --- |
| 15, boulevard Charles de Gaulle |
| 92700 Colombes |
| Francija |

BIOGARAN

15, boulevard Charles de Gaulle

92700 Colombes

Francija

FENOFIBRATE BIOGARAN 160 mg, comprimé

160 mg

tableta

peroralno

FR - Francija

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| Francija |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

Francija

FENOFIBRATE BIOGARAN 200 mg, gélule

200 mg

kapsula

peroralno

FR - Francija

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| Francija |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

Francija

FENOFIBRATE BIOGARAN 300 mg, gélule

300 mg

kapsula

peroralno

FR - Francija

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| Francija |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

Francija

FENOFIBRATE BIOGARAN 67 mg, gélule

67 mg

kapsula

peroralno

FR - Francija

| CLL PHARMA |
| --- |
| Nice Premier - Arénas |
| 455, Promenade des Anglais |
| 06299 Nice Cedex 03 |
| Francija |

CLL PHARMA

Nice Premier - Arénas

455, Promenade des Anglais

06299 Nice Cedex 03

Francija

FENOFIBRATE CEHEL PHARMA 140 mg, gélule

140 mg

kapsula

peroralno

FR - Francija

| CRISTERS |
| --- |
| 22 quai Gallieni |
| 92150 Suresnes |
| Francija |

CRISTERS

22 quai Gallieni

92150 Suresnes

Francija

FENOFIBRATE CRISTERS 160 mg, comprimé

160 mg

tableta

peroralno

FR - Francija

| CRISTERS |
| --- |
| 22 quai Gallieni |
| 92150 Suresnes |
| Francija |

CRISTERS

22 quai Gallieni

92150 Suresnes

Francija

FENOFIBRATE CRISTERS 200 mg, gélule

200 mg

kapsula

peroralno

FR - Francija

| CRISTERS |
| --- |
| 22 quai Gallieni |
| 92150 Suresnes |
| Francija |

CRISTERS

22 quai Gallieni

92150 Suresnes

Francija

FENOFIBRATE CRISTERS 67 mg, gélule

67 mg

kapsula

peroralno

FR - Francija

| CLL PHARMA |
| --- |
| Nice Premier - Arénas |
| 455, Promenade des Anglais |
| 06299 Nice Cedex 03 |
| Francija |

CLL PHARMA

Nice Premier - Arénas

455, Promenade des Anglais

06299 Nice Cedex 03

Francija

FENOFIBRATE DCI PHARMA 200 mg, gélule

200 mg

kapsula

peroralno

FR - Francija

| CLL PHARMA |
| --- |
| Nice Premier - Arénas |
| 455, Promenade des Anglais |
| 06299 Nice Cedex 03 |
| Francija |

CLL PHARMA

Nice Premier - Arénas

455, Promenade des Anglais

06299 Nice Cedex 03

Francija

FENOFIBRATE DCI PHARMA 67 mg, gélule

67 mg

kapsula

peroralno

FR - Francija

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| Francija |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

Francija

FENOFIBRATE DEBAT CARDIO 140 mg, gélule

140 mg

kapsula

peroralno

FR - Francija

| EG LABO - Laboratoires EuroGenerics |
| --- |
| «Le Quintet» - bâtiment A |
| 12, rue Danjou |
| 92517 Boulogne Billancourt Cedex |
| Francija |

EG LABO - Laboratoires EuroGenerics

«Le Quintet» - bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex

Francija

FENOFIBRATE EG 145 mg, comprimé

145 mg

tableta

peroralno

FR - Francija

| EG LABO - Laboratoires EuroGenerics |
| --- |
| «Le Quintet» - bâtiment A |
| 12, rue Danjou |
| 92517 Boulogne Billancourt Cedex |
| Francija |

EG LABO - Laboratoires EuroGenerics

«Le Quintet» - bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex

Francija

FENOFIBRATE EG 160 mg, comprimé pelliculé

160 mg

tableta

peroralno

FR - Francija

| EG LABO - Laboratoires EuroGenerics |
| --- |
| «Le Quintet» - bâtiment A |
| 12, rue Danjou |
| 92517 Boulogne Billancourt Cedex |
| Francija |

EG LABO - Laboratoires EuroGenerics

«Le Quintet» - bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex

Francija

FENOFIBRATE EG 200 mg, gélule

200 mg

kapsula

peroralno

FR - Francija

| EG LABO - Laboratoires EuroGenerics |
| --- |
| «Le Quintet» - bâtiment A |
| 12, rue Danjou |
| 92517 Boulogne Billancourt Cedex |
| Francija |

EG LABO - Laboratoires EuroGenerics

«Le Quintet» - bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex

Francija

FENOFIBRATE EG 67 mg, gélule

67 mg

kapsula

peroralno

FR - Francija

| SANOFI AVENTIS Francija |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Francija |

SANOFI AVENTIS Francija

1-13, boulevard Romain Rolland

75014 Paris

Francija

FENOFIBRATE ENIREX 160 mg, comprimé pelliculé

160 mg

filmsko obložena tableta

peroralno

FR - Francija

| TEVA SANTE |
| --- |
| Le Palatin 1 |
| 1 cours du Triangle |
| 92936 Paris la Défense Cedex |
| Francija |

TEVA SANTE

Le Palatin 1

1 cours du Triangle

92936 Paris la Défense Cedex

Francija

FENOFIBRATE TEVA 145 mg, comprimé

145 mg pour 1 comprimé

tableta

peroralno

FR - Francija

| ETHYPHARM |
| --- |
| 194, Bureaux de la Colline |
| Bâtiment D |
| 92213 Saint-Cloud Cedex |
| Francija |

ETHYPHARM

194, Bureaux de la Colline

Bâtiment D

92213 Saint-Cloud Cedex

Francija

FENOFIBRATE ETHYPHARM 200 mg, gélule

200 mg

kapsula

peroralno

FR - Francija

| ETHYPHARM |
| --- |
| 194, Bureaux de la Colline |
| Bâtiment D |
| 92213 Saint-Cloud Cedex |
| Francija |

ETHYPHARM

194, Bureaux de la Colline

Bâtiment D

92213 Saint-Cloud Cedex

Francija

FENOFIBRATE ETHYPHARM 67 mg, gélule

67 mg

kapsula

peroralno

FR - Francija

| GALENIX DEVELOPPEMENT |
| --- |
| Les Palanques |
| 33127 Saint Jean d’Illac |
| Francija |

GALENIX DEVELOPPEMENT

Les Palanques

33127 Saint Jean d’Illac

Francija

FENOFIBRATE EXPANPHARM 200 mg, comprimé

200 mg

tableta

peroralno

FR - Francija

| AJC INVEST |
| --- |
| 6, rue de la Rochefoucauld |
| 16000 Angoulême |
| Francija |

AJC INVEST

6, rue de la Rochefoucauld

16000 Angoulême

Francija

FENOFIBRATE EXPANPHARM 200 mg, gélule

200 mg

kapsula

peroralno

FR - Francija

| GALENIX DEVELOPPEMENT |
| --- |
| Les Palanques |
| 33127 Saint Jean d’Illac |
| Francija |

GALENIX DEVELOPPEMENT

Les Palanques

33127 Saint Jean d’Illac

Francija

FENOFIBRATE EXPANPHARM 67 mg, comprimé

67 mg

tableta

peroralno

FR - Francija

| AJC INVEST |
| --- |
| 6, rue de la Rochefoucauld |
| 16000 Angoulême |
| Francija |

AJC INVEST

6, rue de la Rochefoucauld

16000 Angoulême

Francija

FENOFIBRATE EXPANPHARM 67 mg, gélule

67 mg

kapsula

peroralno

FR - Francija

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| Francija |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

Francija

FENOFIBRATE FOURNIER 100 mg, gélule

100 mg

kapsula

peroralno

FR - Francija

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| Francija |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

Francija

FENOFIBRATE FOURNIER 145 mg, comprimé pelliculé

145 mg

filmsko obložena tableta

peroralno

FR - Francija

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| Francija |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

Francija

FENOFIBRATE FOURNIER 160 mg, comprimé pelliculé

160 mg

filmsko obložena tableta

peroralno

FR - Francija

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| Francija |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

Francija

FENOFIBRATE FOURNIER 200 MICRONISE, gélule

200 mg

kapsula

peroralno

FR - Francija

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| Francija |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

Francija

FENOFIBRATE FOURNIER 300 mg, gélule

300 mg

kapsula

peroralno

FR - Francija

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| Francija |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

Francija

FENOFIBRATE FOURNIER 67 MICRONISE, gélule

67 mg

kapsula

peroralno

FR - Francija

| SANDOZ |
| --- |
| 49, avenue Georges Pompidou |
| 92300 Levallois-Perret |
| Francija |

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

Francija

FENOFIBRATE G GAM 200 mg, gélule

200 mg

kapsula

peroralno

FR - Francija

| SANDOZ |
| --- |
| 49, avenue Georges Pompidou |
| 92300 Levallois-Perret |
| Francija |

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

Francija

FENOFIBRATE G GAM 67 mg, gélule

67 mg

kapsula

peroralno

FR - Francija

| GALENIX DEVELOPPEMENT |
| --- |
| Les Palanques |
| 33127 Saint Jean d’Illac |
| Francija |

GALENIX DEVELOPPEMENT

Les Palanques

33127 Saint Jean d’Illac

Francija

FENOFIBRATE GALENIX 160 mg, comprimé pelliculé

160 mg

filmsko obložena tableta

peroralno

FR - Francija

| TEVA SANTE |
| --- |
| Le Palatin 1 |
| 1 cours du Triangle |
| 92936 Paris la Défense Cedex |
| Francija |

TEVA SANTE

Le Palatin 1

1 cours du Triangle

92936 Paris la Défense Cedex

Francija

FENOFIBRATE IVAX 100 mg, gélule

100 mg

kapsula

peroralno

FR - Francija

| TEVA SANTE |
| --- |
| Le Palatin 1 |
| 1 cours du Triangle |
| 92936 Paris la Défense Cedex |
| Francija |

TEVA SANTE

Le Palatin 1

1 cours du Triangle

92936 Paris la Défense Cedex

Francija

FENOFIBRATE IVAX 200 mg, gélule

200 mg

kapsula

peroralno

FR - Francija

| TEVA SANTE |
| --- |
| Le Palatin 1 |
| 1 cours du Triangle |
| 92936 Paris la Défense Cedex |
| Francija |

TEVA SANTE

Le Palatin 1

1 cours du Triangle

92936 Paris la Défense Cedex

Francija

FENOFIBRATE IVAX 300 mg, gélule

300 mg

kapsula

peroralno

FR - Francija

| TEVA SANTE |
| --- |
| Le Palatin 1 |
| 1 cours du Triangle |
| 92936 Paris la Défense Cedex |
| Francija |

TEVA SANTE

Le Palatin 1

1 cours du Triangle

92936 Paris la Défense Cedex

Francija

FENOFIBRATE IVAX 67 mg, gélule

67 mg

kapsula

peroralno

FR - Francija

| CLL PHARMA |
| --- |
| Nice Premier - Arénas |
| 455, Promenade des Anglais |
| 06299 Nice Cedex 03 |
| Francija |

CLL PHARMA

Nice Premier - Arénas

455, Promenade des Anglais

06299 Nice Cedex 03

Francija

FENOFIBRATE MILGEN 200 mg, gélule

200 mg

kapsula

peroralno

FR - Francija

| CLL PHARMA |
| --- |
| Nice Premier - Arénas |
| 455, Promenade des Anglais |
| 06299 Nice Cedex 03 |
| Francija |

CLL PHARMA

Nice Premier - Arénas

455, Promenade des Anglais

06299 Nice Cedex 03

Francija

FENOFIBRATE MILGEN 67 mg, gélule

67 mg

kapsula

peroralno

FR - Francija

| MYLAN SAS |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| Francija |

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

Francija

FENOFIBRATE MYLAN 100 mg, gélule

100,00 mg

kapsula

peroralno

FR - Francija

| MYLAN SAS |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| Francija |

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

Francija

FENOFIBRATE MYLAN 160 mg, comprimé pelliculé

160 mg

filmsko obložena tableta

peroralno

FR - Francija

| MYLAN SAS |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| Francija |

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

Francija

FENOFIBRATE MYLAN 200 mg, gélule

200 mg

kapsula

peroralno

FR - Francija

| MYLAN SAS |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| Francija |

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

Francija

FENOFIBRATE MYLAN 300 mg, gélule

300,00 mg

kapsula

peroralno

FR - Francija

| MYLAN SAS |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| Francija |

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

Francija

FENOFIBRATE MYLAN 67 mg, gélule

67 mg

kapsula

peroralno

FR - Francija

| QUALIMED |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| Francija |

QUALIMED

117, allée des Parcs

69800 Saint-Priest

Francija

FENOFIBRATE QUALIMED 160 mg, comprimé pelliculé

160 mg

filmsko obložena tableta

peroralno

FR - Francija

| QUALIMED |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| Francija |

QUALIMED

117, allée des Parcs

69800 Saint-Priest

Francija

FENOFIBRATE QUALIMED 200 mg, gélule

200 mg

kapsula

peroralno

FR - Francija

| QUALIMED |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| Francija |

QUALIMED

117, allée des Parcs

69800 Saint-Priest

Francija

FENOFIBRATE QUALIMED 67 mg, gélule

67 mg

kapsula

peroralno

FR - Francija

| RANBAXY PHARMACIE GENERIQUES |
| --- |
| 11-15 Quai Dion Bouton |
| 92800 Puteaux |
| Francija |

RANBAXY PHARMACIE GENERIQUES

11-15 Quai Dion Bouton

92800 Puteaux

Francija

FENOFIBRATE RANBAXY 160 mg, comprimé

160 mg

tableta

peroralno

FR - Francija

| RANBAXY PHARMACIE GENERIQUES |
| --- |
| 11-15 Quai Dion Bouton |
| 92800 Puteaux |
| Francija |

RANBAXY PHARMACIE GENERIQUES

11-15 Quai Dion Bouton

92800 Puteaux

Francija

FENOFIBRATE RANBAXY 200 mg, gélule

200 mg

kapsula

peroralno

FR - Francija

| RANBAXY PHARMACIE GENERIQUES |
| --- |
| 11-15 Quai Dion Bouton |
| 92800 Puteaux |
| Francija |

RANBAXY PHARMACIE GENERIQUES

11-15 Quai Dion Bouton

92800 Puteaux

Francija

FENOFIBRATE RANBAXY 300 mg, gélule

300 mg

kapsula

peroralno

FR - Francija

| Laboratoire RATIOPHARM |
| --- |
| 19, boulevard Paul Vaillant Couturier |
| 94200 Ivry sur Seine |
| Francija |

Laboratoire RATIOPHARM

19, boulevard Paul Vaillant Couturier

94200 Ivry sur Seine

Francija

FENOFIBRATE RATIOPHARM 160 mg, comprimé

160 mg

tableta

peroralno

FR - Francija

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| Francija |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

Francija

FENOFIBRATE RATIOPHARM 200 mg, gélule

200 mg

kapsula

peroralno

FR - Francija

| Laboratoire RATIOPHARM |
| --- |
| 19, boulevard Paul Vaillant Couturier |
| 94200 Ivry sur Seine |
| Francija |

Laboratoire RATIOPHARM

19, boulevard Paul Vaillant Couturier

94200 Ivry sur Seine

Francija

FENOFIBRATE RATIOPHARM 300 mg, gélule

300 mg

kapsula

peroralno

FR - Francija

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| Francija |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

Francija

FENOFIBRATE RATIOPHARM 67 mg, gélule

67 mg

kapsula

peroralno

FR - Francija

| RANBAXY PHARMACIE GENERIQUES |
| --- |
| 11-15 Quai Dion Bouton |
| 92800 Puteaux |
| Francija |

RANBAXY PHARMACIE GENERIQUES

11-15 Quai Dion Bouton

92800 Puteaux

Francija

FENOFIBRATE RPG 100 mg, gélule

100,00 mg

kapsula

peroralno

FR - Francija

| RANBAXY PHARMACIE GENERIQUES |
| --- |
| 11-15 Quai Dion Bouton |
| 92800 Puteaux |
| Francija |

RANBAXY PHARMACIE GENERIQUES

11-15 Quai Dion Bouton

92800 Puteaux

Francija

FENOFIBRATE RPG 160 mg, comprimé pelliculé

160 mg

filmsko obložena tableta

peroralno

FR - Francija

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| Francija |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

Francija

FENOFIBRATE RPG 200 mg, gélule

200 mg

kapsula

peroralno

FR - Francija

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| Francija |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

Francija

FENOFIBRATE RPG 67 mg, gélule

67 mg

kapsula

peroralno

FR - Francija

| SANDOZ |
| --- |
| 49, avenue Georges Pompidou |
| 92300 Levallois-Perret |
| Francija |

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

Francija

FENOFIBRATE SANDOZ 100 mg, gélule

100 mg

kapsula

peroralno

FR - Francija

| SANDOZ |
| --- |
| 49, avenue Georges Pompidou |
| 92300 Levallois-Perret |
| Francija |

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

Francija

FENOFIBRATE SANDOZ 160 mg, comprimé

160 mg

tableta

peroralno

FR - Francija

| SANDOZ |
| --- |
| 49, avenue Georges Pompidou |
| 92300 Levallois-Perret |
| Francija |

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

Francija

FENOFIBRATE SANDOZ 200 mg, gélule

200 mg

kapsula

peroralno

FR - Francija

| SANDOZ |
| --- |
| 49, avenue Georges Pompidou |
| 92300 Levallois-Perret |
| Francija |

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

Francija

FENOFIBRATE SANDOZ 300 mg, gélule

300 mg

kapsula

peroralno

FR - Francija

| SANDOZ |
| --- |
| 49, avenue Georges Pompidou |
| 92300 Levallois-Perret |
| Francija |

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

Francija

FENOFIBRATE SANDOZ 67 mg, gélule

67 mg

kapsula

peroralno

FR - Francija

| TEVA SANTE |
| --- |
| Le Palatin 1 |
| 1 cours du Triangle |
| 92936 Paris la Défense Cedex |
| Francija |

TEVA SANTE

Le Palatin 1

1 cours du Triangle

92936 Paris la Défense Cedex

Francija

FENOFIBRATE TEVA 100 mg, gélule

100,00 mg

kapsula

peroralno

FR - Francija

| TEVA SANTE |
| --- |
| Le Palatin 1 |
| 1 cours du Triangle |
| 92936 Paris la Défense Cedex |
| Francija |

TEVA SANTE

Le Palatin 1

1 cours du Triangle

92936 Paris la Défense Cedex

Francija

FENOFIBRATE TEVA 160 mg, comprimé

160 mg

tableta

peroralno

FR - Francija

| TEVA SANTE |
| --- |
| Le Palatin 1 |
| 1 cours du Triangle |
| 92936 Paris la Défense Cedex |
| Francija |

TEVA SANTE

Le Palatin 1

1 cours du Triangle

92936 Paris la Défense Cedex

Francija

FENOFIBRATE TEVA 200 mg, gélule

200 mg

kapsula

peroralno

FR - Francija

| TEVA SANTE |
| --- |
| Le Palatin 1 |
| 1 cours du Triangle |
| 92936 Paris la Défense Cedex |
| Francija |

TEVA SANTE

Le Palatin 1

1 cours du Triangle

92936 Paris la Défense Cedex

Francija

FENOFIBRATE TEVA 300 mg, gélule

300,00 mg

kapsula

peroralno

FR - Francija

| TEVA SANTE |
| --- |
| Le Palatin 1 |
| 1 cours du Triangle |
| 92936 Paris la Défense Cedex |
| Francija |

TEVA SANTE

Le Palatin 1

1 cours du Triangle

92936 Paris la Défense Cedex

Francija

FENOFIBRATE TEVA 67 mg, gélule

67 mg

kapsula

peroralno

FR - Francija

| SANOFI AVENTIS Francija |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Francija |

SANOFI AVENTIS Francija

1-13, boulevard Romain Rolland

75014 Paris

Francija

FENOFIBRATE WINTHROP 160 mg, comprimé pelliculé

160 mg

filmsko obložena tableta

peroralno

FR - Francija

| SANOFI AVENTIS Francija |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Francija |

SANOFI AVENTIS Francija

1-13, boulevard Romain Rolland

75014 Paris

Francija

FENOFIBRATE WINTHROP 200 mg, gélule

200 mg

kapsula

peroralno

FR - Francija

| SANOFI AVENTIS Francija |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Francija |

SANOFI AVENTIS Francija

1-13, boulevard Romain Rolland

75014 Paris

Francija

FENOFIBRATE WINTHROP 67 mg, gélule

67 mg

kapsula

peroralno

FR - Francija

| WYVERN MEDICAL LTD |
| --- |
| Sterling House - 3A New Street |
| Ledbury |
| HR8 2DX Herefordshire |
| Velika Britanija |

WYVERN MEDICAL LTD

Sterling House - 3A New Street

Ledbury

HR8 2DX Herefordshire

Velika Britanija

FENOFIBRATE WYVERN 200 mg, gélule

200 mg

kapsula

peroralno

FR - Francija

| WYVERN MEWYVERN MEDICAL LTD |
| --- |
| Sterling House - 3A New Street |
| Ledbury |
| HR8 2DX Herefordshire |
| Velika Britanija |

WYVERN MEWYVERN MEDICAL LTD

Sterling House - 3A New Street

Ledbury

HR8 2DX Herefordshire

Velika Britanija

FENOFIBRATE WYVERN 67 mg, gélule

67 mg

kapsula

peroralno

FR - Francija

| WYVERN MEDICAL LTD |
| --- |
| Sterling House - 3A New Street |
| Ledbury |
| HR8 2DX Herefordshire |
| Velika Britanija |

WYVERN MEDICAL LTD

Sterling House - 3A New Street

Ledbury

HR8 2DX Herefordshire

Velika Britanija

FENOFIBRATE WYVERN MEDICAL 160 mg, comprimé pelliculé

160,0 mg

filmsko obložena tableta

peroralno

FR - Francija

| WYVERN MEDICAL LTD |
| --- |
| Sterling House - 3A New Street |
| Ledbury |
| HR8 2DX Herefordshire |
| Velika Britanija |

WYVERN MEDICAL LTD

Sterling House - 3A New Street

Ledbury

HR8 2DX Herefordshire

Velika Britanija

FENOFIBRATE WYVERN MEDICAL 200 mg, gélule

200 mg

kapsula

peroralno

FR - Francija

| WYVERN MEDICAL LTD |
| --- |
| Sterling House - 3A New Street |
| Ledbury |
| HR8 2DX Herefordshire |
| Velika Britanija |

WYVERN MEDICAL LTD

Sterling House - 3A New Street

Ledbury

HR8 2DX Herefordshire

Velika Britanija

FENOFIBRATE WYVERN MEDICAL 67 mg, gélule

67 mg

kapsula

peroralno

FR - Francija

| ZYDUS Francija |
| --- |
| 25, rue des Peupliers |
| ZAC Les Hautes Pâtures - Parc d’Activités des Peupliers |
| 92000 Nanterre |
| Francija |

ZYDUS Francija

25, rue des Peupliers

ZAC Les Hautes Pâtures - Parc d’Activités des Peupliers

92000 Nanterre

Francija

FENOFIBRATE ZYDUS 160 mg, comprimé

160 mg

tableta

peroralno

FR - Francija

| ZYDUS Francija |
| --- |
| 25, rue des Peupliers |
| ZAC Les Hautes Pâtures - Parc d’Activités des Peupliers |
| 92000 Nanterre |
| Francija |

ZYDUS Francija

25, rue des Peupliers

ZAC Les Hautes Pâtures - Parc d’Activités des Peupliers

92000 Nanterre

Francija

FENOFIBRATE ZYDUS 200 mg, gélule

200 mg

kapsula

peroralno

FR - Francija

| ZYDUS Francija |
| --- |
| 25, rue des Peupliers |
| ZAC Les Hautes Pâtures - Parc d’Activités des Peupliers |
| 92000 Nanterre |
| Francija |

ZYDUS Francija

25, rue des Peupliers

ZAC Les Hautes Pâtures - Parc d’Activités des Peupliers

92000 Nanterre

Francija

FENOFIBRATE ZYDUS 300 mg, gélule

300 mg

kapsula

peroralno

FR - Francija

| ZYDUS Francija |
| --- |
| 25, rue des Peupliers |
| ZAC Les Hautes Pâtures - Parc d’Activités des Peupliers |
| 92000 Nanterre |
| Francija |

ZYDUS Francija

25, rue des Peupliers

ZAC Les Hautes Pâtures - Parc d’Activités des Peupliers

92000 Nanterre

Francija

FENOFIBRATE ZYDUS 67 mg, gélule

67 mg

kapsula

peroralno

FR - Francija

| SANOFI AVENTIS Francija |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Francija |

SANOFI AVENTIS Francija

1-13, boulevard Romain Rolland

75014 Paris

Francija

FENOFIBRATE WINTHROP 145 mg, comprimé

145 mg

tableta

peroralno

FR - Francija

| QUALIMED |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| Francija |

QUALIMED

117, allée des Parcs

69800 Saint-Priest

Francija

FENOFIBRATE QUALIMED 145 mg, comprimé

145 mg

tableta

peroralno

FR - Francija

| LABORATOIRE RATIOPHARM |
| --- |
| 19, boulevard Paul Vaillant Couturier |
| 94200 Ivry sur Seine |
| Francija |

LABORATOIRE RATIOPHARM

19, boulevard Paul Vaillant Couturier

94200 Ivry sur Seine

Francija

FENOFIBRATE RATIOPHARM 145 mg, comprimé

145 mg

tableta

peroralno

FR - Francija

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| Francija |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

Francija

FENOX 100 mg, gélule

100 mg

kapsula

peroralno

FR - Francija

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| Francija |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

Francija

FENOX 300 mg, gélule

300 mg

kapsula

peroralno

FR - Francija

| SANDOZ |
| --- |
| 49, avenue Georges Pompidou |
| 92300 Levallois-Perret |
| Francija |

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

Francija

FENOFIBRATE SANDOZ 145 mg, comprimé

145 mg

tableta

peroralno

FR - Francija

| GALENIX DEVELOPPEMENT |
| --- |
| Les Palanques |
| 33127 Saint Jean d’Illac |
| Francija |

GALENIX DEVELOPPEMENT

Les Palanques

33127 Saint Jean d’Illac

Francija

GENOTHYL 160 mg, comprimé pelliculé

160 mg

filmsko obložena tableta

peroralno

FR - Francija

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| Francija |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

Francija

LIPANTHYL 140 MICRONISE, gélule

140 mg

kapsula

peroralno

FR - Francija

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| Francija |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

Francija

LIPANTHYL 145 mg, comprimé pelliculé

145 mg

filmsko obložena tableta

peroralno

FR - Francija

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| Francija |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

Francija

LIPANTHYL 160 mg, comprimé pelliculé

160 mg

filmsko obložena tableta

peroralno

FR - Francija

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| Francija |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

Francija

LIPANTHYL 200 micronisé, gélule

200 mg

kapsula

peroralno

FR - Francija

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| Francija |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

Francija

LIPANTHYL 67 Micronisé, gélule

67 mg

kapsula

peroralno

FR - Francija

| BIOGARAN |
| --- |
| 15, boulevard Charles de Gaulle |
| 92700 Colombes |
| Francija |

BIOGARAN

15, boulevard Charles de Gaulle

92700 Colombes

Francija

FENOFIBRATE BIOGARAN 145 mg, comprimé

145 mg

tableta

peroralno

FR - Francija

| ETHYPHARM |
| --- |
| 194, Bureaux de la Colline |
| Bâtiment D |
| 92213 Saint-Cloud Cedex |
| Francija |

ETHYPHARM

194, Bureaux de la Colline

Bâtiment D

92213 Saint-Cloud Cedex

Francija

LIPILFEN 160 mg, comprimé

160 mg

tableta

peroralno

FR - Francija

| MYLAN SAS |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| Francija |

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

Francija

FENOFIBRATE MYLAN 145 mg, comprimé

145 mg

tableta

peroralno

FR - Francija

| SANOFI AVENTIS Francija |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Francija |

SANOFI AVENTIS Francija

1-13, boulevard Romain Rolland

75014 Paris

Francija

FENOFIBRATE WINTHROP 160 mg, comprimé

160 mg

tableta

peroralno

FR - Francija

| ETHYPHARM |
| --- |
| 194, Bureaux de la Colline |
| Bâtiment D |
| 92213 Saint-Cloud Cedex |
| Francija |

ETHYPHARM

194, Bureaux de la Colline

Bâtiment D

92213 Saint-Cloud Cedex

Francija

LIPIPHARM 145 mg, comprimé

145 mg

tableta

peroralno

FR - Francija

| SANOFI AVENTIS Francija |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Francija |

SANOFI AVENTIS Francija

1-13, boulevard Romain Rolland

75014 Paris

Francija

LIPIREX 200 mg, gélule

200 mg

kapsula

peroralno

FR - Francija

| SANOFI AVENTIS Francija |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Francija |

SANOFI AVENTIS Francija

1-13, boulevard Romain Rolland

75014 Paris

Francija

LIPIREX 67 mg, gélule

67 mg

kapsula

peroralno

FR - Francija

| BOUCHARA RECORDATI |
| --- |
| 68, rue Marjolin |
| BP 67 |
| 92302 Levallois-Perret Cedex |
| Francija |

BOUCHARA RECORDATI

68, rue Marjolin

BP 67

92302 Levallois-Perret Cedex

Francija

LIVESAN 200 mg, gélule

200 mg

kapsula

peroralno

FR - Francija

| BOUCHARA RECORDATI |
| --- |
| 68, rue Marjolin |
| BP 67 |
| 92302 Levallois-Perret Cedex |
| Francija |

BOUCHARA RECORDATI

68, rue Marjolin

BP 67

92302 Levallois-Perret Cedex

Francija

LIVESAN 67 mg, gélule

67 mg

kapsula

peroralno

FR - Francija

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| Francija |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

Francija

PANLIPAL 145 mg, comprimé pelliculé

145 mg

filmsko obložena tableta

peroralno

FR - Francija

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| Francija |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

Francija

SECALIP 100 mg, gélule

100 mg

kapsula

peroralno

FR - Francija

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| Francija |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

Francija

SECALIP 200 mg, gélule

200 mg

kapsula

peroralno

FR - Francija

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| Francija |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

Francija

SECALIP 300 mg, gélule

300 mg

kapsula

peroralno

FR - Francija

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| Francija |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

Francija

SECALIP 67 mg, gélule

67 mg

kapsula

peroralno

FR - Francija

| SUBSTIPHARM |
| --- |
| 8, rue Bellini |
| 75116 Paris |
| Francija |

SUBSTIPHARM

8, rue Bellini

75116 Paris

Francija

SUBSTICHOL 160 mg, comprimé pelliculé

160 mg

filmsko obložena tableta

peroralno

FR - Francija

| WYVERN MEDICAL LTD |
| --- |
| Sterling House - 3A New Street |
| Ledbury |
| HR8 2DX Herefordshire |
| Velika Britanija |

WYVERN MEDICAL LTD

Sterling House - 3A New Street

Ledbury

HR8 2DX Herefordshire

Velika Britanija

WYVEBRATE 160 mg, comprimé pelliculé

160,0 mg

filmsko obložena tableta

peroralno

HU - Madžarska

| PharmaSwiss Magyarország Kft. |
| --- |
| Zichy G. u. 5 fszt/1 |
| 1146 Budapest |
| Madžarska |

PharmaSwiss Magyarország Kft.

Zichy G. u. 5 fszt/1

1146 Budapest

Madžarska

Fenobrat

250 mg

trda kapsula s podaljšanim sproščanjem

peroralno

HU - Madžarska

| PharmaSwiss Magyarország Kft. |
| --- |
| Zichy G. u. 5 fszt/1 |
| 1146 Budapest |
| Madžarska |

PharmaSwiss Magyarország Kft.

Zichy G. u. 5 fszt/1

1146 Budapest

Madžarska

Fenoswiss

160 mg

trda kapsula

peroralno

HU - Madžarska

| Laboratoires Fournier SA |
| --- |
| 8 Bd Clemenceau |
| F-21000 Dijon |
| Francija |

Laboratoires Fournier SA

8 Bd Clemenceau

F-21000 Dijon

Francija

Lipidil Supra

160 mg

filmsko obložena tableta

peroralno

HU - Madžarska

| Laboratoires Fournier SA |
| --- |
| 8 Bd Clemenceau |
| F-21000 Dijon |
| Francija |

Laboratoires Fournier SA

8 Bd Clemenceau

F-21000 Dijon

Francija

Lipidil Supra

215 mg

filmsko obložena tableta

peroralno

HU - Madžarska

| Laboratoires Fournier SA |
| --- |
| 8 Bd Clemenceau |
| F-21000 Dijon |
| Francija |

Laboratoires Fournier SA

8 Bd Clemenceau

F-21000 Dijon

Francija

Lipanthyl NT

145 mg

filmsko obložena tableta

peroralno

HU - Madžarska

| Laboratoires Fournier SA |
| --- |
| 8 Bd Clemenceau |
| F-21000 Dijon |
| Francija |

Laboratoires Fournier SA

8 Bd Clemenceau

F-21000 Dijon

Francija

Lipidil

267 mg

trda kapsula

peroralno

IE - Irska

| Solvay Healthcare Limited |
| --- |
| Mansbridge Road |
| West End |
| Southampton |
| SO18 3JD |
| Velika Britanija |

Solvay Healthcare Limited

Mansbridge Road

West End

Southampton

SO18 3JD

Velika Britanija

Lipantil Micro 67 mg capsules, hard

67 mg

trda kapsula

peroralno

IE - Irska

| Solvay Healthcare Limited |
| --- |
| Mansbridge Road |
| West End |
| Southampton |
| SO18 3JD |
| Velika Britanija |

Solvay Healthcare Limited

Mansbridge Road

West End

Southampton

SO18 3JD

Velika Britanija

Lipantil Micro 200 mg capsules, hard

200 mg

trda kapsula

peroralno

IE - Irska

| Solvay Healthcare Limited |
| --- |
| Mansbridge Road |
| West End |
| Southampton |
| SO18 3JD |
| Velika Britanija |

Solvay Healthcare Limited

Mansbridge Road

West End

Southampton

SO18 3JD

Velika Britanija

Lipantil Micro 267 mg capsules, hard

267 mg

trda kapsula

peroralno

IE - Irska

| Solvay Healthcare Limited |
| --- |
| Mansbridge Road |
| West End |
| Southampton |
| SO18 3JD |
| Velika Britanija |

Solvay Healthcare Limited

Mansbridge Road

West End

Southampton

SO18 3JD

Velika Britanija

Lipantil Supra 145mg film-coated tablets

145 mg

filmsko obložena tableta

peroralno

IE - Irska

| Solvay Healthcare Limited |
| --- |
| Mansbridge Road |
| West End |
| Southampton |
| SO18 3JD |
| Velika Britanija |

Solvay Healthcare Limited

Mansbridge Road

West End

Southampton

SO18 3JD

Velika Britanija

Lipantil Supra 160mg film-coated tablets

160 mg

filmsko obložena tableta

peroralno

IE - Irska

| Solvay Healthcare Limited |
| --- |
| Mansbridge Road |
| West End |
| Southampton |
| SO18 3JD |
| Velika Britanija |

Solvay Healthcare Limited

Mansbridge Road

West End

Southampton

SO18 3JD

Velika Britanija

Lipantil Supra 215 mg film-coated tablets

215 mg

filmsko obložena tableta

peroralno

IT - Italija

| Farmaceutici Caber Spa Viale Città D'Europa, 681 00100 ROMA |
| --- |
| Italija |

Farmaceutici Caber Spa Viale Città D'Europa, 681 00100 ROMA

Italija

Lipsin

200 mg

kapsula

peroralno

IT - Italija

| Solvay Pharma Spa |
| --- |
| Via della Libertà 30 |
| 100 95 Grugliasco |
| Italija |

Solvay Pharma Spa

Via della Libertà 30

100 95 Grugliasco

Italija

Fulcro

200 mg

kapsula

peroralno

IT - Italija

| Francia Farmaceutici Industria Farmaco Biologica Srl |
| --- |
| Via dei Pestagalli, 7 |
| 20138 MILANO |
| Italija |

Francia Farmaceutici Industria Farmaco Biologica Srl

Via dei Pestagalli, 7

20138 MILANO

Italija

Tilene

100 mg

kapsula

peroralno

IT - Italija

| Salus Researches Spa |
| --- |
| Via Aurelia, 58 |
| 00165 ROMA |
| Italija |

Salus Researches Spa

Via Aurelia, 58

00165 ROMA

Italija

Nolipax

100 mg

kapsula

peroralno

IT - Italija

| Teofarma Srl Via Fratelli Cervi, 8 - Valle Salimbene 27010 Pavia |
| --- |
| Italija |

Teofarma Srl Via Fratelli Cervi, 8 - Valle Salimbene 27010 Pavia

Italija

Lipofene

100 mg

kapsula

peroralno

IT - Italija

| Winthrop Pharmaceuticals Italia Srl Viale Bodio, 37/B 20158 MILANO |
| --- |
| Italija |

Winthrop Pharmaceuticals Italia Srl Viale Bodio, 37/B 20158 MILANO

Italija

Fenofibrato Winthrop

200 mg

kapsula

peroralno

IT - Italija

| Solvay Pharma Spa |
| --- |
| Via della Libertà 30 |
| 100 95 Grugliasco |
| Italija |

Solvay Pharma Spa

Via della Libertà 30

100 95 Grugliasco

Italija

Fulcrosupra

145 mg

filmsko obložena tableta

peroralno

IT - Italija

| Solvay Pharma Spa |
| --- |
| Via della Libertà 30 |
| 100 95 Grugliasco |
| Italija |

Solvay Pharma Spa

Via della Libertà 30

100 95 Grugliasco

Italija

Fulcrosupra

160 mg

filmsko obložena tableta

peroralno

IT - Italija

| Solvay Pharma Spa |
| --- |
| Via della Libertà 30 |
| 100 95 Grugliasco |
| Italija |

Solvay Pharma Spa

Via della Libertà 30

100 95 Grugliasco

Italija

Fenolibs

145 mg

filmsko obložena tableta

peroralno

IT - Italija

| Solvay Pharma Spa |
| --- |
| Via della Libertà 30 |
| 100 95 Grugliasco |
| Italija |

Solvay Pharma Spa

Via della Libertà 30

100 95 Grugliasco

Italija

Liperial

145 mg

filmsko obložena tableta

peroralno

LT - Litva

| UAB PharmaSwiss |
| --- |
| Šeimyniškių 21B |
| LT-09200 Vilnius |
| Litva |

UAB PharmaSwiss

Šeimyniškių 21B

LT-09200 Vilnius

Litva

Fenolip

160 mg

trda kapsula

peroralno

LT - Litva

| Laboratoires Fournier S. A. |
| --- |
| 28 Boulevard Clemenceau |
| 21000 Dijon |
| Francija |

Laboratoires Fournier S. A.

28 Boulevard Clemenceau

21000 Dijon

Francija

Lipanthyl 200 M

200 mg

trda kapsula

peroralno

LU - Luksemburg

| Leurquin Mediolanum Lab. |
| --- |
| 68-88, rue Ampere |
| (Z.I. Chanaux) |
| 93330 Neuilly-sur-Seine |
| Francija |

Leurquin Mediolanum Lab.

68-88, rue Ampere

(Z.I. Chanaux)

93330 Neuilly-sur-Seine

Francija

Fegenor

67 mg

trda kapsula

peroralno

LU - Luksemburg

| Leurquin Mediolanum Lab. |
| --- |
| 68-88, rue Ampere |
| (Z.I. Chanaux) |
| 93330 Neuilly-sur-Seine |
| Francija |

Leurquin Mediolanum Lab.

68-88, rue Ampere

(Z.I. Chanaux)

93330 Neuilly-sur-Seine

Francija

Fegenor

200 mg

trda kapsula

peroralno

LU - Luksemburg

| S.M.B. |
| --- |
| 26-28, rue de la Pastorale |
| B- 1080 Bruxelles |
| Belgija |

S.M.B.

26-28, rue de la Pastorale

B- 1080 Bruxelles

Belgija

Fenogal-200

200 mg

trda kapsula

peroralno

LU - Luksemburg

| S.M.B. |
| --- |
| 26-28, rue de la Pastorale |
| B- 1080 Bruxelles |
| Belgija |

S.M.B.

26-28, rue de la Pastorale

B- 1080 Bruxelles

Belgija

Fenogal-267

267 mg

trda kapsula

peroralno

LU - Luksemburg

| Eurogenerics SA |
| --- |
| Esplanade Heysel, B22 |
| B- 1020 Bruxelles |
| Belgija |

Eurogenerics SA

Esplanade Heysel, B22

B- 1020 Bruxelles

Belgija

Fenofibrate EG

67 mg

trda kapsula

peroralno

LU - Luksemburg

| Solvay Pharma S.A. |
| --- |
| Avenue du Brg. E. Demunter 3 |
| B- 1090 Bruxelles |
| Belgija |

Solvay Pharma S.A.

Avenue du Brg. E. Demunter 3

B- 1090 Bruxelles

Belgija

Lipanthyl 67 Micronised

67 mg

trda kapsula

peroralno

LU - Luksemburg

| Solvay Pharma S.A. |
| --- |
| Avenue du Brg. E. Demunter 3 |
| B- 1090 Bruxelles |
| Belgija |

Solvay Pharma S.A.

Avenue du Brg. E. Demunter 3

B- 1090 Bruxelles

Belgija

Lipanthyl 200 Micronised

200 mg

trda kapsula

peroralno

LU - Luksemburg

| Solvay Pharma S.A. |
| --- |
| Avenue du Brg. E. Demunter 3 |
| B- 1090 Bruxelles |
| Belgija |

Solvay Pharma S.A.

Avenue du Brg. E. Demunter 3

B- 1090 Bruxelles

Belgija

Lipanthyl 267 Micronised

267 mg

trda kapsula

peroralno

LU - Luksemburg

| Solvay Pharma S.A. |
| --- |
| Avenue du Brg. E. Demunter 3 |
| B- 1090 Bruxelles |
| Belgija |

Solvay Pharma S.A.

Avenue du Brg. E. Demunter 3

B- 1090 Bruxelles

Belgija

Lipanthyl Supra

160 mg

filmsko obložena tableta

peroralno

LU - Luksemburg

| Solvay Pharma S.A. |
| --- |
| Avenue du Brg. E. Demunter 3 |
| B- 1090 Bruxelles |
| Belgija |

Solvay Pharma S.A.

Avenue du Brg. E. Demunter 3

B- 1090 Bruxelles

Belgija

Lipanthyl Supra

215 mg

filmsko obložena tableta

peroralno

LU - Luksemburg

| Solvay Pharma S.A. |
| --- |
| Avenue du Brg. E. Demunter 3 |
| B- 1090 Bruxelles |
| Belgija |

Solvay Pharma S.A.

Avenue du Brg. E. Demunter 3

B- 1090 Bruxelles

Belgija

Lipanthyl Nano

145 mg

filmsko obložena tableta

peroralno

LU - Luksemburg

| Solvay Pharma S.A. |
| --- |
| Avenue du Brg. E. Demunter 3 |
| B- 1090 Bruxelles |
| Belgija |

Solvay Pharma S.A.

Avenue du Brg. E. Demunter 3

B- 1090 Bruxelles

Belgija

Liperial

145 mg

filmsko obložena tableta

peroralno

LV - Latvija

| SIA PharmaSwiss Latvija |
| --- |
| Gertrudes iela 54-5 |
| Riga, LV-1011 |
| Latvija |

SIA PharmaSwiss Latvija

Gertrudes iela 54-5

Riga, LV-1011

Latvija

Fenolip 160 mg hard capsules

160 mg

trda kapsula

peroralno

LV - Latvija

| Laboratoires Fournier S.A. |
| --- |
| Boulevard Clemenceau 28 |
| 21000 Dijon |
| Francija |

Laboratoires Fournier S.A.

Boulevard Clemenceau 28

21000 Dijon

Francija

Lipanthyl 200 mg hard capsules

200 mg

trda kapsula

peroralno

PL - Poljska

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| Leiden 2333 CR |
| Nizozemska |

Apotex Europe B.V.

Darwinweg 20

Leiden 2333 CR

Nizozemska

Apo-Feno 100

100 mg

kapsula

peroralno

PL - Poljska

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| Leiden |
| 2333 CR |
| Nizozemska |

Apotex Europe B.V.

Darwinweg 20

Leiden

2333 CR

Nizozemska

Apo-Feno 200M

200 mg

trda kapsula

peroralno

PL - Poljska

| VEDIM Sp. z o.o. |
| --- |
| 8 Kruczkowskiego St., |
| 00-308 Warsaw |
| Poljska |

VEDIM Sp. z o.o.

8 Kruczkowskiego St.,

00-308 Warsaw

Poljska

Fenardin

267 mg

trda kapsula

peroralno

PL - Poljska

| VEDIM Sp. z o.o. |
| --- |
| 8 Kruczkowskiego st. |
| 00-308 Warsaw |
| Poljska |

VEDIM Sp. z o.o.

8 Kruczkowskiego st.

00-308 Warsaw

Poljska

Fenardin

160 mg

trda kapsula

peroralno

PL - Poljska

| ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3, Ulm, |
| D-89079 |
| Nemčija |

ratiopharm GmbH

Graf-Arco-Strasse 3, Ulm,

D-89079

Nemčija

Fenoratio 100

100 mg

kapsula

peroralno

PL - Poljska

| ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| 89079 Ulm |
| Nemčija |

ratiopharm GmbH

Graf-Arco-Strasse 3

89079 Ulm

Nemčija

Fenoratio Retard

250 mg

kapsula s podaljšanim sproščanjem

peroralno

PL - Poljska

| Grodziskie Zakłady Farmaceutyczne „Polfa” Sp. z o.o. |
| --- |
| 5 ks. J. Poniatowskiego St. |
| 05-825 Grodzisk Mazowiecki |
| Poljska |

Grodziskie Zakłady Farmaceutyczne „Polfa” Sp. z o.o.

5 ks. J. Poniatowskiego St.

05-825 Grodzisk Mazowiecki

Poljska

Grofibrat

100 mg

kapsula

peroralno

PL - Poljska

| Grodziskie Zakłady Farmaceutyczne „Polfa“ Sp. z o.o. |
| --- |
| 5 ks. J. Poniatowskiego St., |
| 05-825 Grodzisk Mazowiecki |
| Poljska |

Grodziskie Zakłady Farmaceutyczne „Polfa“ Sp. z o.o.

5 ks. J. Poniatowskiego St.,

05-825 Grodzisk Mazowiecki

Poljska

Grofibrat 200

200 mg

kapsula

peroralno

PL - Poljska

| Laboratoires Fournier S.A. |
| --- |
| Bd Clemenceau 28 |
| Dijon, F-21000 |
| Francija |

Laboratoires Fournier S.A.

Bd Clemenceau 28

Dijon, F-21000

Francija

Lipanthyl

100 mg

kapsula

peroralno

PL - Poljska

| Laboratoires Fournier S.A. |
| --- |
| Bd Clemenceau 28 |
| Dijon, F-21000 |
| Francija |

Laboratoires Fournier S.A.

Bd Clemenceau 28

Dijon, F-21000

Francija

Lipanthyl 200M

200 mg

kapsula

peroralno

PL - Poljska

| Laboratoires Fournier S.A. |
| --- |
| Bd Clemenceau 28 |
| Dijon, F-21000 |
| Francija |

Laboratoires Fournier S.A.

Bd Clemenceau 28

Dijon, F-21000

Francija

Lipanthyl 267M

267 mg

kapsula

peroralno

PL - Poljska

| Laboratoires Fournier S.A. |
| --- |
| Bd Clemenceau 28 |
| Dijon, F-21000 |
| Francija |

Laboratoires Fournier S.A.

Bd Clemenceau 28

Dijon, F-21000

Francija

Lipanthyl NT 145

145 mg

filmsko obložena tableta

peroralno

PL - Poljska

| Laboratoires Fournier S.A. |
| --- |
| Bd Clemenceau 28 |
| Dijon, F-21000 |
| Francija |

Laboratoires Fournier S.A.

Bd Clemenceau 28

Dijon, F-21000

Francija

Lipanthyl Supra 160

160 mg

filmsko obložena tableta

peroralno

PL - Poljska

| Laboratoires Fournier S.A. |
| --- |
| Bd Clemenceau 28 |
| Dijon, F-21000 |
| Francija |

Laboratoires Fournier S.A.

Bd Clemenceau 28

Dijon, F-21000

Francija

Lipanthyl Supra 215 mg

215 mg

filmsko obložena tableta

peroralno

PL - Poljska

| Laboratoires Fournier S.A. |
| --- |
| Bd Clemenceau 28 |
| Dijon, F-21000 |
| Francija |

Laboratoires Fournier S.A.

Bd Clemenceau 28

Dijon, F-21000

Francija

Xafenor 145

145 mg

filmsko obložena tableta

peroralno

PT - Portugalskaska

| Abbot II Products, Lda. Empreendimento Lagoas Park. Edifício 5C - 6o |
| --- |
| 2740-298 Porto Salvo |
| Portugalska |

Abbot II Products, Lda. Empreendimento Lagoas Park. Edifício 5C - 6o

2740-298 Porto Salvo

Portugalska

Catalip

200 mg

kapsula

peroralno

PT - Portugalskaska

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

Laboratórios Vitória, S.A.

Rua Elias Garcia, 28 - Venda Nova

2700-327 Amadora

Portugalska

Lipofen

100 mg

kapsula

peroralno

PT - Portugalskaska

| Abbot II Products, Lda. Empreendimento Lagoas Park. Edifício 5C - 6o |
| --- |
| 2740-298 Porto Salvo |
| Portugalska |

Abbot II Products, Lda. Empreendimento Lagoas Park. Edifício 5C - 6o

2740-298 Porto Salvo

Portugalska

Supralip 160 mg

160 mg

tableta s prirejenim sproščanjem

peroralno

PT - Portugalskaska

| Solvay Farma, Lda. Empreendimento Lagoas Park. Edifício 5C - 6o |
| --- |
| 2740-298 Porto Salvo |
| Portugalska |

Solvay Farma, Lda. Empreendimento Lagoas Park. Edifício 5C - 6o

2740-298 Porto Salvo

Portugalska

Apteor

160 mg

tableta s prirejenim sproščanjem

peroralno

PT - Portugalskaska

| Solvay Farma, Lda. |
| --- |
| Empreendimento Lagoas Park. Edifício 5C - 6o |
| 2740-298 Porto Salvo |
| Portugalska |

Solvay Farma, Lda.

Empreendimento Lagoas Park. Edifício 5C - 6o

2740-298 Porto Salvo

Portugalska

Catalip 267 Micronizado

267 mg

kapsula

peroralno

PT - Portugalskaska

| Winthrop Farmacêutica Portugalska,Lda. Empreendimento Lagoas Park, Edifício 7 - 2o/3o |
| --- |
| 2740-264 Porto Salvo |
| Portugalska |

Winthrop Farmacêutica Portugalska,Lda. Empreendimento Lagoas Park, Edifício 7 - 2o/3o

2740-264 Porto Salvo

Portugalska

Fenofibrato Winthrop 200 mg Cápsulas

200 mg

kapsula

peroralno

PT - Portugalskaska

| Alpharma ApS |
| --- |
| Rua Virgílio Correia, 11 – A |
| 1600-219 Lisboa |
| Portugalska |

Alpharma ApS

Rua Virgílio Correia, 11 – A

1600-219 Lisboa

Portugalska

Fenofibrato Alpharma 200 mg Cápsulas

200 mg

kapsula

peroralno

PT - Portugalskaska

| Solvay Farma, Lda. Empreendimento Lagoas Park. Edifício 5C - 6o |
| --- |
| 2740-298 Porto Salvo |
| Portugalska |

Solvay Farma, Lda. Empreendimento Lagoas Park. Edifício 5C - 6o

2740-298 Porto Salvo

Portugalska

Supralip 145 mg

145 mg

filmsko obložena tableta

peroralno

PT - Portugalskaska

| Solvay Farma |
| --- |
| Lda. Empreendimento Lagoas Park. Edifício 5C - 6o |
| 2740-298 Porto Salvo |
| Portugalska |

Solvay Farma

Lda. Empreendimento Lagoas Park. Edifício 5C - 6o

2740-298 Porto Salvo

Portugalska

Lipanthyl 145 mg

145 mg

filmsko obložena tableta

peroralno

PT - Portugalskaska

| Solvay Farma |
| --- |
| Lda. Empreendimento Lagoas Park Edifício 5C - 6o |
| 2740-298 Porto Salvo |
| Portugalska |

Solvay Farma

Lda. Empreendimento Lagoas Park Edifício 5C - 6o

2740-298 Porto Salvo

Portugalska

Apteor 145 mg

145 mg

filmsko obložena tableta

peroralno

PT - Portugalskaska

| Winthrop Farmacêutica Portugalska |
| --- |
| Lda. Empreendimento Lagoas Park |
| Edifício 7 - 2o/3o |
| 2740-264 Porto Salvo |
| Portugalska |

Winthrop Farmacêutica Portugalska

Lda. Empreendimento Lagoas Park

Edifício 7 - 2o/3o

2740-264 Porto Salvo

Portugalska

Fenofibrato Winthrop 267 mg Cápsulas

267 mg

kapsula

peroralno

RO - Romunija

| LABORATOIRES FOURNIER S.A. |
| --- |
| 28 Bd. Clemenceau |
| 21000 Dijon |
| Francija |

LABORATOIRES FOURNIER S.A.

28 Bd. Clemenceau

21000 Dijon

Francija

LIPANTHYL® 100

100 mg

kapsula

peroralno

RO - Romunija

| LABORATOIRES FOURNIER S.A. |
| --- |
| 28 Bd. Clemenceau |
| 21000 Dijon |
| Francija |

LABORATOIRES FOURNIER S.A.

28 Bd. Clemenceau

21000 Dijon

Francija

FENOX 160 mg

160 mg

filmsko obložena tableta s prirejenim sproščanjem

peroralno

RO - Romunija

| S.C. VIM SPECTRUM S.R.L., |
| --- |
| Șoseaua Sighișoarei, Nr. 409, Corunca, jud Mureș |
| Romunija |

S.C. VIM SPECTRUM S.R.L.,

Șoseaua Sighișoarei, Nr. 409, Corunca, jud Mureș

Romunija

LIPIVIM

200 mg

kapsula (z mikroniziranim praškom)

peroralno

RO - Romunija

| LABORATOIRES FOURNIER S.A. 28, Bd. Clemenceau |
| --- |
| 21000 Dijon |
| Francija |

LABORATOIRES FOURNIER S.A. 28, Bd. Clemenceau

21000 Dijon

Francija

LIPANTHYL 67 M capsule

67 mg

kapsula

peroralno

RO - Romunija

| LABORATOIRES FOURNIER S.A. 28, Bd. Clemenceau |
| --- |
| 21000 Dijon |
| Francija |

LABORATOIRES FOURNIER S.A. 28, Bd. Clemenceau

21000 Dijon

Francija

LIPANTHYL 267 M capsule

267 mg

kapsula

peroralno

RO - Romunija

| S.C. TERAPIA S.A. |
| --- |
| Str. Fabricii Nr. 124, |
| Cluj-Napoca |
| România |

S.C. TERAPIA S.A.

Str. Fabricii Nr. 124,

Cluj-Napoca

România

LIPOFIB 160 mg

160 mg

kapsula

peroralno

RO - Romunija

| S.C. TERAPIA S.A. |
| --- |
| Str. Fabricii Nr. 124 |
| Cluj-Napoca |
| România |

S.C. TERAPIA S.A.

Str. Fabricii Nr. 124

Cluj-Napoca

România

LIPOFIB 200 mg

200 mg

kapsula

peroralno

RO - Romunija

| LABORATOIRES FOURNIER S.A. |
| --- |
| 28 Bd. Clemenceau |
| 21000 Dijon |
| Francija |

LABORATOIRES FOURNIER S.A.

28 Bd. Clemenceau

21000 Dijon

Francija

LIPANTHYL PENTA 145 mg

145 mg

filmsko obložena tableta

peroralno

RO - Romunija

| LABORATOIRES FOURNIER S.A. |
| --- |
| 28 Bd. Clemenceau |
| 21000 Dijon, |
| Francija |

LABORATOIRES FOURNIER S.A.

28 Bd. Clemenceau

21000 Dijon,

Francija

TRICOR 145 mg

145 mg

filmsko obložena tableta

peroralno

RO - Romunija

| S.C. TERAPIA S.A. |
| --- |
| Str. Fabricii Nr. 124 |
| Cluj-Napoca |
| Romunija |

S.C. TERAPIA S.A.

Str. Fabricii Nr. 124

Cluj-Napoca

Romunija

LIPOFIB 67 mg

67 mg

kapsula

peroralno

RO - Romunija

| S.C. TERAPIA S.A. |
| --- |
| Str. Fabricii Nr. 124 |
| Cluj-Napoca |
| Romunija |

S.C. TERAPIA S.A.

Str. Fabricii Nr. 124

Cluj-Napoca

Romunija

FENOFIBRAT TERAPIA 200 mg

200 mg

kapsula

peroralno

RO - Romunija

| S.C. TERAPIA S.A. |
| --- |
| Str. Fabricii Nr. 124 |
| Cluj-Napoca |
| Romunija |

S.C. TERAPIA S.A.

Str. Fabricii Nr. 124

Cluj-Napoca

Romunija

LIPOFIB 267 mg

267 mg

kapsula

peroralno

RO - Romunija

| S. C. LABORMED PHARMA S. A. |
| --- |
| Splaiul Independenței nr. 319 E |
| Sector 6 |
| București |
| Romunija |

S. C. LABORMED PHARMA S. A.

Splaiul Independenței nr. 319 E

Sector 6

București

Romunija

FENOFIBRAT LPH 200 mg

200 mg

kapsula (z mikroniziranim praškom)

peroralno

RO - Romunija

| S.C. TERAPIA S.A. |
| --- |
| Str. Fabricii Nr. 124 |
| Cluj-Napoca |
| Romunija |

S.C. TERAPIA S.A.

Str. Fabricii Nr. 124

Cluj-Napoca

Romunija

FENOFIBRAT TERAPIA 160 mg

160 mg

filmsko obložena tableta

peroralno

RO - Romunija

| LABORATOIRES FOURNIER S.A. |
| --- |
| 28 Bd. Clémenceau |
| 21 000 Dijon |
| Francija |

LABORATOIRES FOURNIER S.A.

28 Bd. Clémenceau

21 000 Dijon

Francija

LIPANTHYL SUPRA 160 mg

160 mg

filmsko obložena tableta s prirejenim sproščanjem

peroralno

RO - Romunija

| LABORATOIRES FOURNIER S.A. |
| --- |
| 28 Bd. Clémenceau |
| 21 000 Dijon |
| Francija |

LABORATOIRES FOURNIER S.A.

28 Bd. Clémenceau

21 000 Dijon

Francija

LIPANTIL NANO 145 mg

145 mg

filmsko obložena tableta

peroralno

RO - Romunija

| LABORATOIRES FOURNIER S.A. |
| --- |
| 28 Bd. Clémenceau |
| 21 000 Dijon |
| Francija |

LABORATOIRES FOURNIER S.A.

28 Bd. Clémenceau

21 000 Dijon

Francija

Lipanthyl 200 M

200 mg

kapsula

peroralno

SE - Švedska

| Laboratoires Fournier SA |
| --- |
| 28 boulevard Clèmenceau |
| BP 27912 21079 DIJON Cedex |
| Francija |

Laboratoires Fournier SA

28 boulevard Clèmenceau

BP 27912 21079 DIJON Cedex

Francija

Lipanthyl®

67 mg

trda kapsula

peroralno

SE - Švedska

| Laboratoires Fournier SA |
| --- |
| 28 boulevard Clèmenceau |
| BP 27912 21079 DIJON Cedex |
| Francija |

Laboratoires Fournier SA

28 boulevard Clèmenceau

BP 27912 21079 DIJON Cedex

Francija

Lipanthyl®

200 mg

trda kapsula

peroralno

SE - Švedska

| Laboratoires Fournier SA |
| --- |
| 28 boulevard Clèmenceau |
| BP 27912 21079 DIJON Cedex |
| Francija |

Laboratoires Fournier SA

28 boulevard Clèmenceau

BP 27912 21079 DIJON Cedex

Francija

Lipanthyl®

267 mg

trda kapsula

peroralno

SI - Slovenija

| Laboratoires Fournier S.A. |
| --- |
| 28 boulevard Clemenceau |
| Dijon |
| Francija |

Laboratoires Fournier S.A.

28 boulevard Clemenceau

Dijon

Francija

Katalip 250 mg Trda kapsula

250 mg

trda kapsula

peroralno

SK - Slovaška

| Zentiva a.s. |
| --- |
| Nitrianska 100 |
| 920 27 Hlohovec |
| Slovaška |

Zentiva a.s.

Nitrianska 100

920 27 Hlohovec

Slovaška

Febira 200

200 mg

kapsula

peroralno

SK - Slovaška

| Archie Samuel s.r.o. |
| --- |
| Slunná 271/16 |
| 61700 Brno 17 |
| Češka |

Archie Samuel s.r.o.

Slunná 271/16

61700 Brno 17

Češka

Fenofibrate - AS 267 mg

267 mg

trda kapsula

peroralno

SK - Slovaška

| IVAX Pharmaceuticals s.r.o. |
| --- |
| Ostravská 29 |
| 747 70 Opava-Komárov |
| Češka |

IVAX Pharmaceuticals s.r.o.

Ostravská 29

747 70 Opava-Komárov

Češka

Fenofix 200

200 mg

kapsula

peroralno

SK - Slovaška

| LABORATOIRES S.M.B. S.A. |
| --- |
| 26-28 rue de la Pastorale |
| B-1080 Bruxelles |
| Belgija |

LABORATOIRES S.M.B. S.A.

26-28 rue de la Pastorale

B-1080 Bruxelles

Belgija

Fenolip

160 mg

trda kapsula

peroralno

SK - Slovaška

| Laboratoires FOURNIER S.A. |
| --- |
| 28Bd Clemenceau |
| 21000 Dijon |
| Francija |

Laboratoires FOURNIER S.A.

28Bd Clemenceau

21000 Dijon

Francija

LIPANTHYL 200 M

200 mg

trda kapsula

peroralno

SK - Slovaška

| Laboratoires FOURNIER S.A. |
| --- |
| 28Bd Clemenceau |
| 21000 Dijon |
| Francija |

Laboratoires FOURNIER S.A.

28Bd Clemenceau

21000 Dijon

Francija

LIPANTHYL 267 M

267 mg

trda kapsula

peroralno

SK - Slovaška

| Laboratoires FOURNIER S.A. |
| --- |
| 28Bd Clemenceau |
| 21000 Dijon |
| Francija |

Laboratoires FOURNIER S.A.

28Bd Clemenceau

21000 Dijon

Francija

LIPANTHYL NT 145 mg

145 mg

filmsko obložena tableta

peroralno

SK - Slovaška

| Laboratoires FOURNIER S.A. |
| --- |
| 28Bd Clemenceau |
| 21000 Dijon |
| Francija |

Laboratoires FOURNIER S.A.

28Bd Clemenceau

21000 Dijon

Francija

LIPANTHYL SUPRA 160 mg

160 mg

filmsko obložena tableta

peroralno

SK - Slovaška

| Laboratoires FOURNIER S.A. 28Bd Clemenceau 21000 Dijon |
| --- |
| Francija |

Laboratoires FOURNIER S.A. 28Bd Clemenceau 21000 Dijon

Francija

LIPANTHYL SUPRA 215 mg

215 mg

filmsko obložena tableta

peroralno

SK - Slovaška

| PharmaSwiss Ćeská republika s.r.o. Jankovcova 1569/2c |
| --- |
| 170 00 Prague |
| Češka |

PharmaSwiss Ćeská republika s.r.o. Jankovcova 1569/2c

170 00 Prague

Češka

SUPRELIP

200 mg

trda kapsula

peroralno

UK – Velika Britanija

| ACTAVIS UK LIMITED |
| --- |
| WHIDDON VALLEY |
| BARNSTAPLE |
| DEVON EX32 8NS |
| Velika Britanija |

ACTAVIS UK LIMITED

WHIDDON VALLEY

BARNSTAPLE

DEVON EX32 8NS

Velika Britanija

FENOFIBRATE 67MG CAPSULES

67 mg

trda kapsula

peroralno

UK – Velika Britanija

| ACTAVIS UK LIMITED |
| --- |
| WHIDDON VALLEY |
| BARNSTAPLE |
| DEVON EX32 8NS |
| Velika Britanija |

ACTAVIS UK LIMITED

WHIDDON VALLEY

BARNSTAPLE

DEVON EX32 8NS

Velika Britanija

FENOFIBRATE 200MG CAPSULES

200mg

trda kapsula

peroralno

UK – Velika Britanija

| ETHYPHARM |
| --- |
| 17/21 Rue Saint Matthieu |
| Houdan, F-78550 |
| Francija |

ETHYPHARM

17/21 Rue Saint Matthieu

Houdan, F-78550

Francija

FENOFIBRATE 200MG CAPSULES

200 mg

trda kapsula

peroralno

UK – Velika Britanija

| Genus Pharmaceuticals Limited |
| --- |
| Park View House |
| 65 London Road |
| NEWBURY, BERKS RG14 1JN |
| Velika Britanija |

Genus Pharmaceuticals Limited

Park View House

65 London Road

NEWBURY, BERKS RG14 1JN

Velika Britanija

FENOGAL 200MG CAPSULES

200 mg

kapsula

peroralno

UK – Velika Britanija

| Pliva Pharma Limited |
| --- |
| Vision House |
| Bedford Road |
| PETERSFIELD, HANTSGU32 3QB |
| Velika Britanija |

Pliva Pharma Limited

Vision House

Bedford Road

PETERSFIELD, HANTSGU32 3QB

Velika Britanija

FENOFIBRATE MICRO 267MG CAPSULES

267 mg

trda kapsula

peroralno

UK – Velika Britanija

| Ranbaxy (Uk) Limited |
| --- |
| Cp House |
| 97-107 Uxbridge Road |
| EALING, LONDON W5 5TL |
| Velika Britanija |

Ranbaxy (Uk) Limited

Cp House

97-107 Uxbridge Road

EALING, LONDON W5 5TL

Velika Britanija

FENOFIBRATE 67MG CAPSULES

67 mg

trda kapsula

peroralno

UK – Velika Britanija

| Ranbaxy (Uk) Limited |
| --- |
| Cp House |
| 97-107 Uxbridge Road |
| EALING, LONDON W5 5TL |
| Velika Britanija |

Ranbaxy (Uk) Limited

Cp House

97-107 Uxbridge Road

EALING, LONDON W5 5TL

Velika Britanija

FENOFIBRATE 200MG CAPSULES

200 mg

trda kapsula

peroralno

UK – Velika Britanija

| Ranbaxy (Uk) Limited |
| --- |
| Cp House |
| 97-107 Uxbridge Road |
| EALING, LONDON W5 5TL |
| Velika Britanija |

Ranbaxy (Uk) Limited

Cp House

97-107 Uxbridge Road

EALING, LONDON W5 5TL

Velika Britanija

FENOFIBRATE 267MG CAPSULES

267 mg

trda kapsula

peroralno

UK – Velika Britanija

| Ranbaxy (Uk) Limited |
| --- |
| Cp House |
| 97-107 Uxbridge Road |
| EALING, LONDON W5 5TL |
| Velika Britanija |

Ranbaxy (Uk) Limited

Cp House

97-107 Uxbridge Road

EALING, LONDON W5 5TL

Velika Britanija

FENOFIBRATE 67MG CAPSULES

67 mg

trda kapsula

peroralno

UK – Velika Britanija

| Ranbaxy (Uk) Limited |
| --- |
| Cp House |
| 97-107 Uxbridge Road |
| EALING, LONDON W5 5TL |
| Velika Britanija |

Ranbaxy (Uk) Limited

Cp House

97-107 Uxbridge Road

EALING, LONDON W5 5TL

Velika Britanija

FENOFIBRATE 200MG CAPSULES

200 mg

trda kapsula

peroralno

UK – Velika Britanija

| Ranbaxy (Uk) Limited |
| --- |
| Cp House |
| 97-107 Uxbridge Road |
| EALING, LONDON W5 5TL |
| Velika Britanija |

Ranbaxy (Uk) Limited

Cp House

97-107 Uxbridge Road

EALING, LONDON W5 5TL

Velika Britanija

FENOFIBRATE 267MG CAPSULES

267 mg

trda kapsula

peroralno

UK – Velika Britanija

| Solvay Healthcare Limited |
| --- |
| Mansbridge Road, West End, SOUTHAMPTON SO18 3JD |
| Velika Britanija |

Solvay Healthcare Limited

Mansbridge Road, West End, SOUTHAMPTON SO18 3JD

Velika Britanija

LIPANTIL MICRO 67

67 mg

kapsula

peroralno

UK – Velika Britanija

| Solvay Healthcare Limited |
| --- |
| Mansbridge Road, West End, SOUTHAMPTON SO18 3JD |
| Velika Britanija |

Solvay Healthcare Limited

Mansbridge Road, West End, SOUTHAMPTON SO18 3JD

Velika Britanija

SUPRALIP 160 FILM-COATED TABLETS

160 mg

filmsko obložena tableta

peroralno

UK – Velika Britanija

| Solvay Healthcare Limited |
| --- |
| Mansbridge Road, West End, SOUTHAMPTON SO18 3JD |
| Velika Britanija |

Solvay Healthcare Limited

Mansbridge Road, West End, SOUTHAMPTON SO18 3JD

Velika Britanija

LIPANTIL MICRO 200

200 mg

kapsula

peroralno

UK – Velika Britanija

| Solvay Healthcare Limited |
| --- |
| Mansbridge Road, West End, SOUTHAMPTON SO18 3JD |
| Velika Britanija |

Solvay Healthcare Limited

Mansbridge Road, West End, SOUTHAMPTON SO18 3JD

Velika Britanija

LIPANTIL® MICRO 267

267 mg

kapsula

peroralno

UK – Velika Britanija

| TILLOMED LABORATORIES LIMITED |
| --- |
| 3 Howard Road, Eaton Socon |
| St. Neots, Cambridgeshire |
| PE19 8ET |
| Velika Britanija |

TILLOMED LABORATORIES LIMITED

3 Howard Road, Eaton Socon

St. Neots, Cambridgeshire

PE19 8ET

Velika Britanija

FENOFIBRATE 200MG CAPSULES

200 mg

trda kapsula

peroralno

UK – Velika Britanija

| WINTHROP |
| --- |
| Pharmaceuticals Uk Limited |
| One Onslow Street |
| Guildford, Surrey GU1 4YS |
| Velika Britanija |

WINTHROP

Pharmaceuticals Uk Limited

One Onslow Street

Guildford, Surrey GU1 4YS

Velika Britanija

FENOFIBRATE 267 MG CAPSULES

267 mg

trda kapsula

peroralno

Zdravila, ki vsebujejo zdravilno učinkovino bezafibrat in imajo dovoljenje za promet v EU

| Država članica(EU/EEA) | Imetnik dovoljenja za promet | Izmišljeno ime | Jakost | Farmacevtska oblika | Pot uporabe zdravila |
| --- | --- | --- | --- | --- | --- |
| AT - Avstrija | Arcana Arzneimittel GmbH |
| Hütteldorfer Straße 299 |
| A-1140 Wien |
| Avstrija |

Država članica(EU/EEA)

Imetnik dovoljenja za promet

Izmišljeno ime

Jakost

Farmacevtska oblika

Pot uporabe zdravila

AT - Avstrija

Arcana Arzneimittel GmbH

Hütteldorfer Straße 299

A-1140 Wien

Avstrija

Bezafibrat „Arcana“ retard 400 mg - Filmtabletten

400 mg

filmsko obložena tableta

peroralno

AT - Avstrija

| Genericon Pharma GmbH |
| --- |
| Hafnerstraße 211 |
| A-8054 Graz |
| Avstrija |

Genericon Pharma GmbH

Hafnerstraße 211

A-8054 Graz

Avstrija

Bezafibrat „Genericon“ 200 mg - Dragees

200 mg

filmsko obložena tableta

peroralno

AT - Avstrija

| Genericon Pharma GmbH |
| --- |
| Hafnerstraße 211 |
| A-8054 Graz |
| Avstrija |

Genericon Pharma GmbH

Hafnerstraße 211

A-8054 Graz

Avstrija

Bezafibrat „Genericon“ retard 400 mg - Filmtabletten

400 mg

filmsko obložena tableta

peroralno

AT - Avstrija

| 1A Pharma GmbH |
| --- |
| Stella-Klein-Löw-Weg 17, A-1020 Wien |
| Avstrija |

1A Pharma GmbH

Stella-Klein-Löw-Weg 17, A-1020 Wien

Avstrija

Bezafibrat „1A Pharma“ retard 400 mg - Filmtabletten

400 mg

filmsko obložena tableta

peroralno

AT - Avstrija

| Ratiopharm Arzneimittel |
| --- |
| Vertriebs-GmbH |
| Albert-Schweitzer Gasse 3 A |
| 1140 Wien |
| Avstrija |

Ratiopharm Arzneimittel

Vertriebs-GmbH

Albert-Schweitzer Gasse 3 A

1140 Wien

Avstrija

Bezafibrat „ratiopharm“ retard 400 mg - Filmtabletten

400 mg

tableta s podaljšanim sproščanjem

peroralno

AT - Avstrija

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegur 76-78 |
| IS- 220 Hafnarfjördur |
| Islandija |

Actavis Group PTC ehf

Reykjavikurvegur 76-78

IS- 220 Hafnarfjördur

Islandija

Bezalip 200 mg - Filmtabletten

200 mg

filmsko obložena tableta

peroralno

AT - Avstrija

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegur 76-78 |
| IS- 220 Hafnarfjördur |
| Islandija |

Actavis Group PTC ehf

Reykjavikurvegur 76-78

IS- 220 Hafnarfjördur

Islandija

Bezalip retard 400 mg - Filmtabletten

400 mg

filmsko obložena tableta

peroralno

AT - Avstrija

| Genericon Pharma GmbH |
| --- |
| Hafnerstraße 211 |
| A-8054 Graz |
| Avstrija |

Genericon Pharma GmbH

Hafnerstraße 211

A-8054 Graz

Avstrija

Bezaretard „Genericon“ 400 mg - Filmtabletten

400 mg

filmsko obložena tableta

peroralno

AT - Avstrija

| Stada Arzneimittel GmbH |
| --- |
| Muthgasse 36 |
| A-1190 Wien |
| Avstrija |

Stada Arzneimittel GmbH

Muthgasse 36

A-1190 Wien

Avstrija

Bezastad 200 mg - Filmtabletten

200 mg

filmsko obložena tableta

peroralno

AT - Avstrija

| Stada Arzneimittel GmbH |
| --- |
| Muthgasse 36 |
| A-1190 Wien |
| Avstrija |

Stada Arzneimittel GmbH

Muthgasse 36

A-1190 Wien

Avstrija

Bezastad retard 400 mg - Filmtabletten

400 mg

filmsko obložena tableta

peroralno

BE - Belgija

| ACTAVIS GROUP PTC EHF |
| --- |
| Reykjavikuregur 76-78 |
| 220 Hafnarfjordur |
| Islandija |

ACTAVIS GROUP PTC EHF

Reykjavikuregur 76-78

220 Hafnarfjordur

Islandija

CEDUR

200 mg

obložena tableta

peroralno

BE - Belgija

| ACTAVIS GROUP PTC EHF |
| --- |
| Reykjavikuregur 76-78 |
| 220 Hafnarfjordur |
| Islandija |

ACTAVIS GROUP PTC EHF

Reykjavikuregur 76-78

220 Hafnarfjordur

Islandija

EULITOP 400 MG

400 mg

tableta

peroralno

CY - Ciper

| REMEDICA LTD |
| --- |
| Aharnon street |
| P.O.Box 51706 |
| 3508 Lemesos |
| Ciper |

REMEDICA LTD

Aharnon street

P.O.Box 51706

3508 Lemesos

Ciper

LACROMID 200 FC TABLETS 200 mg

200 mg

tableta

peroralno

CY - Ciper

| MEDOCHEMIE LTD |
| --- |
| 1-10 Constantinoupoleos street, P.O. Box 51409 |
| 3505 Lemesos |
| Ciper |

MEDOCHEMIE LTD

1-10 Constantinoupoleos street, P.O. Box 51409

3505 Lemesos

Ciper

ZAFIBRAL FC TABLETS 200 mg

200 mg

tableta

peroralno

DE - Nemčija

| 1 A Pharma GmbH |
| --- |
| Keltenring 1 + 3 |
| D-82041 Oberhaching |
| Nemčija |

1 A Pharma GmbH

Keltenring 1 + 3

D-82041 Oberhaching

Nemčija

Bezafibrat 400 ret-1 A Pharma

400 mg

tableta s podaljšanim sproščanjem

peroralno

DE - Nemčija

| AbZ-Pharma GmbH |
| --- |
| Dr.Georg-Spohn-Str. 7 |
| D-89143 Blaubeuren |
| Nemčija |

AbZ-Pharma GmbH

Dr.Georg-Spohn-Str. 7

D-89143 Blaubeuren

Nemčija

Bezafibrat AbZ 200 mg Filmtabletten

200 mg

filmsko obložena tableta

peroralno

DE - Nemčija

| AbZ-Pharma GmbH |
| --- |
| Dr.Georg-Spohn-Str. 7 |
| D-89143 Blaubeuren |
| Nemčija |

AbZ-Pharma GmbH

Dr.Georg-Spohn-Str. 7

D-89143 Blaubeuren

Nemčija

Bezafibrat AbZ 400 mg Retardtabletten

400 mg

filmsko obložena tableta

peroralno

DE - Nemčija

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegur 76-78 |
| IS-220 Hafnarfjördur |
| Islandija |

Actavis Group PTC ehf

Reykjavikurvegur 76-78

IS-220 Hafnarfjördur

Islandija

Cedur

200 mg

filmsko obložena tableta

peroralno

DE - Nemčija

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegur 76-78 |
| IS-220 Hafnarfjördur |
| Islandija |

Actavis Group PTC ehf

Reykjavikurvegur 76-78

IS-220 Hafnarfjördur

Islandija

Cedur retard

400 mg

tableta s podaljšanim sproščanjem

peroralno

DE - Nemčija

| ALIUD PHARMA GmbH |
| --- |
| Gottlieb-Daimler-Str. 19 |
| D-89150 Laichingen |
| Nemčija |

ALIUD PHARMA GmbH

Gottlieb-Daimler-Str. 19

D-89150 Laichingen

Nemčija

Bezafibrat AL 200

200 mg

filmsko obložena tableta

peroralno

DE - Nemčija

| ALIUD PHARMA GmbH |
| --- |
| Gottlieb-Daimler-Str. 19 |
| D-89150 Laichingen |
| Nemčija |

ALIUD PHARMA GmbH

Gottlieb-Daimler-Str. 19

D-89150 Laichingen

Nemčija

Bezafibrat AL 400 retard

400 mg

tableta s podaljšanim sproščanjem

peroralno

DE - Nemčija

| Berlin-Chemie AG |
| --- |
| Glienicker Weg 125 |
| D-12489 Berlin |
| Nemčija |

Berlin-Chemie AG

Glienicker Weg 125

D-12489 Berlin

Nemčija

Regadrin B

200 mg

tableta s podaljšanim sproščanjem

peroralno

DE - Nemčija

| betapharm Arzneimittel GmbH |
| --- |
| Kobelweg 95 |
| D-86156 Augsburg |
| Nemčija |

betapharm Arzneimittel GmbH

Kobelweg 95

D-86156 Augsburg

Nemčija

Bezabeta 400 retard

400 mg

tableta s podaljšanim sproščanjem

peroralno

DE - Nemčija

| CT Arzneimittel GmbH |
| --- |
| Lengeder Str. 42 a |
| D-13407 Berlin |
| Nemčija |

CT Arzneimittel GmbH

Lengeder Str. 42 a

D-13407 Berlin

Nemčija

Bezafibrat-CT 200 mg Filmtabletten

200 mg

filmsko obložena tableta

peroralno

DE - Nemčija

| CT Arzneimittel GmbH |
| --- |
| Lengeder Str. 42 a |
| D-13407 Berlin |
| Nemčija |

CT Arzneimittel GmbH

Lengeder Str. 42 a

D-13407 Berlin

Nemčija

Bezafibrat-CT 400 mg Retardtabletten

400 mg

tableta s podaljšanim sproščanjem

peroralno

DE - Nemčija

| DOCPHARM Arzneimittelvertrieb GmbH & Co.KGaA |
| --- |
| Greschbachstr. 7 |
| D-76229 Karlsruhe |
| Nemčija |

DOCPHARM Arzneimittelvertrieb GmbH & Co.KGaA

Greschbachstr. 7

D-76229 Karlsruhe

Nemčija

Bezadoc PB retard 400 mg

400 mg

tableta s podaljšanim sproščanjem

peroralno

DE - Nemčija

| DOCPHARM Arzneimittelvertrieb GmbH & Co.KGaA |
| --- |
| Greschbachstr. 7 |
| D-76229 Karlsruhe |

DOCPHARM Arzneimittelvertrieb GmbH & Co.KGaA

Greschbachstr. 7

D-76229 Karlsruhe

Nemčija

Bezadoc retard 400 mg

400 mg

tableta s podaljšanim sproščanjem

peroralno

DE - Nemčija

| Hennig Arzneimittel GmbH & Co.KG |
| --- |
| Liebigstr. 1-2 |
| D-65439 Floersheim |
| Nemčija |

Hennig Arzneimittel GmbH & Co.KG

Liebigstr. 1-2

D-65439 Floersheim

Nemčija

Befibrat 200 mg Dragees

200 mg

tableta s podaljšanim sproščanjem

peroralno

DE - Nemčija

| Hennig Arzneimittel GmbH & Co.KG |
| --- |
| Liebigstr. 1-2 |
| D-65439 Floersheim |
| Nemčija |

Hennig Arzneimittel GmbH & Co.KG

Liebigstr. 1-2

D-65439 Floersheim

Nemčija

Befibrat 400 mg retard Filmtabletten

400 mg

filmsko obložena tableta

peroralno

DE - Nemčija

| Heumann Pharma GmbH & Co. Generica KG |
| --- |
| Südwestpark 50 |
| D-90449 Nürnberg |
| Nemčija |

Heumann Pharma GmbH & Co. Generica KG

Südwestpark 50

D-90449 Nürnberg

Nemčija

Bezafibrat 200 Heumann

200 mg

filmsko obložena tableta

peroralno

DE - Nemčija

| Heumann Pharma GmbH & Co. Generica KG |
| --- |
| Südwestpark 50 |
| D-90449 Nürnberg |
| Nemčija |

Heumann Pharma GmbH & Co. Generica KG

Südwestpark 50

D-90449 Nürnberg

Nemčija

Bezafibrat 400 retard Heumann

400 mg

tableta s podaljšanim sproščanjem

peroralno

DE - Nemčija

| HEXAL AG |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |
| Nemčija |

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Nemčija

Bezafibrat HEXAL 400 mg retard Retardtabletten

400 mg

tableta s podaljšanim sproščanjem

peroralno

DE - Nemčija

| Mylan dura GmbH |
| --- |
| Wittichstr. 6 D |
| 64295 Darmstadt |
| Nemčija |

Mylan dura GmbH

Wittichstr. 6 D

64295 Darmstadt

Nemčija

Bezafibrat dura 400 mg Retardtabletten

400 mg

tableta s podaljšanim sproščanjem

peroralno

DE - Nemčija

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |
| Nemčija |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Nemčija

Bezafibrat-ratiopharm 200 mg Filmtabletten

200 mg

filmsko obložena tableta

peroralno

DE - Nemčija

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Bezafibrat-ratiopharm 400 mg Retardtabletten

400 mg

tableta s podaljšanim sproščanjem

peroralno

DE - Nemčija

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 11 |
| D-83607 Holzkirchen |
| Nemčija |

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

D-83607 Holzkirchen

Nemčija

Bezafibrat Sandoz 400 mg Retardtabletten

400 mg

tableta s podaljšanim sproščanjem

peroralno

DE - Nemčija

| Stadapharm GmbH |
| --- |
| Stadastr. 2-18 |
| D-61118 Bad Vilbel |
| Nemčija |

Stadapharm GmbH

Stadastr. 2-18

D-61118 Bad Vilbel

Nemčija

Bezafibrat Stada 200 mg überzogene Tabletten

200 mg

filmsko obložena tableta

peroralno

DE - Nemčija

| Stadapharm GmbH |
| --- |
| Stadastr. 2-18 |
| D-61118 Bad Vilbel |
| Nemčija |

Stadapharm GmbH

Stadastr. 2-18

D-61118 Bad Vilbel

Nemčija

Bezafibrat Stada 400 mg Retardtabletten

400 mg

tableta s podaljšanim sproščanjem

peroralno

DE - Nemčija

| TAD Pharma GmbH |
| --- |
| Heinz-Lohmann-Str. 5 D |
| 27472 Cuxhaven |
| Nemčija |

TAD Pharma GmbH

Heinz-Lohmann-Str. 5 D

27472 Cuxhaven

Nemčija

Lipox Bezafibrat 400 mg Retardtabletten

400 mg

tableta s podaljšanim sproščanjem

peroralno

DE - Nemčija

| TAD Pharma GmbH |
| --- |
| Heinz-Lohmann-Str. 5 |
| D-27472 Cuxhaven |
| Nemčija |

TAD Pharma GmbH

Heinz-Lohmann-Str. 5

D-27472 Cuxhaven

Nemčija

Lipox Bezafibrat 400 mg Retardtabletten

400 mg

tableta s podaljšanim sproščanjem

peroralno

DE - Nemčija

| Wörwag Pharma GmbH & Co. KG |
| --- |
| Calwer Str. 7 |
| D-71034 Böblingen |
| Nemčija |

Wörwag Pharma GmbH & Co. KG

Calwer Str. 7

D-71034 Böblingen

Nemčija

Bezagamma 200

200 mg

filmsko obložena tableta

peroralno

DE - Nemčija

| Wörwag Pharma GmbH & Co. KG |
| --- |
| Calwer Str. 7 |
| D-71034 Böblingen |
| Nemčija |

Wörwag Pharma GmbH & Co. KG

Calwer Str. 7

D-71034 Böblingen

Nemčija

Bezagamma 400 retard

400 mg

tableta s podaljšanim sproščanjem

peroralno

EL - Grčija

| ACTAVIS GROUP PTC EHF., ICELAND |
| --- |
| Reykjavikurvegur 76-78, |
| 220, Hafnarfjordur |
| Islandija |

ACTAVIS GROUP PTC EHF., ICELAND

Reykjavikurvegur 76-78,

220, Hafnarfjordur

Islandija

BEZALIP

400 MG/TAB

tableta s podaljšanim sproščanjem

peroralno

ES - Španija

| ACTAVIS ŠPANIJA, S.A. |
| --- |
| Perú 8 |
| 28290 Las Matas |
| Madrid |
| ŠPANIJA |

ACTAVIS ŠPANIJA, S.A.

Perú 8

28290 Las Matas

Madrid

ŠPANIJA

EULITOP

200 mg

tableta

peroralno

ES - Španija

| ACTAVIS ŠPANIJA |
| --- |
| S.A.Rivera del Loira |
| 46 - Bussines Centre Regus Office 525 Madrid |
| Španija |

ACTAVIS ŠPANIJA

S.A.Rivera del Loira

46 - Bussines Centre Regus Office 525 Madrid

Španija

EULITOP RETARD

400 mg

filmsko obložena tableta

peroralno

ES - Španija

| BIAL INDUSTRIAL FARMACEUTICA S.A. Alameda de Urquijo |
| --- |
| 27 Bilbao |
| Španija |

BIAL INDUSTRIAL FARMACEUTICA S.A. Alameda de Urquijo

27 Bilbao

Španija

DIFATEROL RETARD

400 mg

filmsko obložena tableta

peroralno

FI - Finska

| Actavis |
| --- |
| Actavis Group PTC ehf Reykjavikurvegi 76-78 |
| 220 Hafnarfjordur |
| Islandija |

Actavis

Actavis Group PTC ehf Reykjavikurvegi 76-78

220 Hafnarfjordur

Islandija

BEZALIP

400 mg

tableta s podaljšanim sproščanjem

peroralno

FR - Francija

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| 220 Hafnarfjördur |
| Islandija |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur

Islandija

BEFIZAL 200 mg, comprimé pelliculé

200 mg

filmsko obložena tableta

peroralno

FR - Francija

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| 220 Hafnarfjördur |
| Islandija |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur

Islandija

BEFIZAL L.P. 400 mg, comprimé enrobé à libération prolongée

400 mg

tableta s podaljšanim sproščanjem

peroralno

FR - Francija

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| 220 Hafnarfjördur |
| Islandija |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur

Islandija

BEZAFIBRATE ACTAVIS 200 mg, comprimé pelliculé

200 mg

filmsko obložena tableta

peroralno

FR - Francija

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| 220 Hafnarfjördur |
| Islande |
| Islandija |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur

Islande

Islandija

BEZAFIBRATE ACTAVIS L.P. 400 mg, comprimé enrobé à libération prolongée

400 mg

tableta s podaljšanim sproščanjem

peroralno

HU - Madžarska

| Actavis Group PTC ehf. |
| --- |
| Reykjavikurvegur 76-78. |
| IS-220 |
| Islandija |

Actavis Group PTC ehf.

Reykjavikurvegur 76-78.

IS-220

Islandija

Bezalip

400mg

filmsko obložena tableta s podaljšanim sproščanjem

peroralno

IT – Italija

| Actavis Italija Spa |
| --- |
| Viale Luigi Pasteur |
| 10 - Nerviano – 20014 |
| MILANO |
| Italija |

Actavis Italija Spa

Viale Luigi Pasteur

10 - Nerviano – 20014

MILANO

Italija

Bezalip

400 mg

obložena tableta s podaljšanim sproščanjem

peroralno

IT – Italija

| Actavis Italija Spa |
| --- |
| Viale Luigi Pasteur, 10 – |
| Nerviano – |
| 20014 MILANO |
| Italija |

Actavis Italija Spa

Viale Luigi Pasteur, 10 –

Nerviano –

20014 MILANO

Italija

Bezalip

200 mg

filmsko obložena tableta

peroralno

IT – Italija

| Eg Spa |
| --- |
| Via Scarlatti Domenico, 31 |
| 20124 MILANO |
| Italija |

Eg Spa

Via Scarlatti Domenico, 31

20124 MILANO

Italija

Bezafibrato Eg

400 mg

tableta s podaljšanim sproščanjem

peroralno

IT – Italija

| Vecchi & Piam Sapa |
| --- |
| Via Padre Semeria, 5 |
| 16131 GENOVA |
| Italija |

Vecchi & Piam Sapa

Via Padre Semeria, 5

16131 GENOVA

Italija

Hadiel

400 mg

obložena tableta s podaljšanim sproščanjem

peroralno

LU - Luksemburg

| Hexal AG |
| --- |
| Industriestrasse, 25 |
| D- 83607 Holzkirchen |
| Nemčija |

Hexal AG

Industriestrasse, 25

D- 83607 Holzkirchen

Nemčija

Benzafibrat Hexal Retard

400 mg

filmsko obložena tableta

peroralno

LU - Luksemburg

| Actavis Group PLC Reykjavikurvegur 76-78 |
| --- |
| IS- 220 Hafnarfjordur |
| Islandija |

Actavis Group PLC Reykjavikurvegur 76-78

IS- 220 Hafnarfjordur

Islandija

Cedur

200 mg

filmsko obložena tableta

peroralno

LU - Luksemburg

| Actavis Group PLC |
| --- |
| Reykjavikurvegur 76-78 |
| IS- 220 Hafnarfjordur |
| Islandija |

Actavis Group PLC

Reykjavikurvegur 76-78

IS- 220 Hafnarfjordur

Islandija

Eulitop

400 mg

tableta

peroralno

MT - Malta

| Hennig Arzneimittel GmbH & Co. KG Liebigstrasse 1-2 |
| --- |
| 65439 Flörsheim |
| Nemčija |

Hennig Arzneimittel GmbH & Co. KG Liebigstrasse 1-2

65439 Flörsheim

Nemčija

Befibrat

400 mg

obložena tableta z zadržanim sproščanjem

peroralno

NL - Nizozemska

| Actavis Group PTC ehf, Reykjavíkurvegi 76-78 |
| --- |
| 220 Hafnarfjördur |
| Islandija |

Actavis Group PTC ehf, Reykjavíkurvegi 76-78

220 Hafnarfjördur

Islandija

Bezalip, tabletten 200 mg, RVG 15982

200 mg

tableta

peroralno

NL - Nizozemska

| Actavis Group PTC ehf, Reykjavíkurvegi 76-78 |
| --- |
| 220 Hafnarfjördur |
| Islandija |

Actavis Group PTC ehf, Reykjavíkurvegi 76-78

220 Hafnarfjördur

Islandija

Bezalip Retard, tabletten met gereguleerde afgifte 400 mg, RVG 18388

400 mg

tableta s prirejenim sproščanjem

peroralno

PT - Portugalskaska

| Actavis Group PTC ehf. Reykjavíkurvegi, 76-78 |
| --- |
| IS-220 Hafnarfjörour |

Actavis Group PTC ehf. Reykjavíkurvegi, 76-78

IS-220 Hafnarfjörour

Bezalip

200 mg

filmsko obložena tableta

peroralno

PT - Portugalska

| Actavis Group PTC ehf. Reykjavíkurvegi, 76-78 |
| --- |
| IS-220 Hafnarfjörour |
| Islandija |

Actavis Group PTC ehf. Reykjavíkurvegi, 76-78

IS-220 Hafnarfjörour

Islandija

Bezalip Retard

400 mg

tableta s podaljšanim sproščanjem

peroralno

RO - Romunija

| S.C. ARENA GROUP S.A. |
| --- |
| Str. Ștefan Mihăileanu Nr.31, |
| Sector 2 |
| București |
| Romunija |

S.C. ARENA GROUP S.A.

Str. Ștefan Mihăileanu Nr.31,

Sector 2

București

Romunija

BEZAFIBRAT ARENA 200 mg

200 mg

tableta

peroralno

RO - Romunija

| S.C. SLAVIA PHARM S.R.L. |
| --- |
| B-dul Theodor Pallady nr. 44C |
| Sector 3, București |
| Romunija |

S.C. SLAVIA PHARM S.R.L.

B-dul Theodor Pallady nr. 44C

Sector 3, București

Romunija

BEZAFIBRAT SLAVIA 200 mg

200 mg

tableta

peroralno

RO - Romunija

| BERLIN CHEMIE AG |
| --- |
| (MENARINI GROUP) |
| Glienicker Weg 125-127 |
| 12489 Berlin |
| Nemčija |

BERLIN CHEMIE AG

(MENARINI GROUP)

Glienicker Weg 125-127

12489 Berlin

Nemčija

REGADRIN® B

200 mg

obložena tableta

peroralno

SE - Švedska

| Actavis Group PTC ehf., Reykjavikurvegur 76-78 |
| --- |
| 220 Hafnarfjördur |
| Islandija |

Actavis Group PTC ehf., Reykjavikurvegur 76-78

220 Hafnarfjördur

Islandija

Bezalip®

200 mg

filmsko obložena tableta

peroralno

SE - Švedska

| Actavis Group PTC ehf., Reykjavikurvegur 76-78 220 Hafnarfjördur, |
| --- |
| Islandija |

Actavis Group PTC ehf., Reykjavikurvegur 76-78 220 Hafnarfjördur,

Islandija

Bezalip® Retard

400 mg

depo tableta

peroralno

UK – Velika Britanija

| Actavis Group Ptc Ehf, Reykjavikurvegi 76-78 |
| --- |
| Hafnarfirdi, Is-220, |
| Islandija |

Actavis Group Ptc Ehf, Reykjavikurvegi 76-78

Hafnarfirdi, Is-220,

Islandija

BEZALIP

200 mg

obložena tableta

peroralno

UK – Velika Britanija

| Actavis Group Ptc Ehf, Reykjavikurvegi 76-78 |
| --- |
| Hafnarfirdi, Is-220 |
| Islandija |

Actavis Group Ptc Ehf, Reykjavikurvegi 76-78

Hafnarfirdi, Is-220

Islandija

BEZALIP MONO

400 mg

tableta s prirejenim sproščanjem

peroralno

UK – Velika Britanija

| Archimedes Pharma Uk Limited |
| --- |
| Bishops Weald House |
| Albion Way, Horsham, |
| West Sussex RH12 1AH |
| Velika Britanija |

Archimedes Pharma Uk Limited

Bishops Weald House

Albion Way, Horsham,

West Sussex RH12 1AH

Velika Britanija

ZIMBACOL XL

400 mg

tableta s prirejenim sproščanjem

peroralno

UK – Velika Britanija

| Generics (Uk) Limited |
| --- |
| Station Close |
| Potters Bar, |
| HERTS EN6 1TL |
| Velika Britanija |

Generics (Uk) Limited

Station Close

Potters Bar,

HERTS EN6 1TL

Velika Britanija

BEZAGEN XL TABLETS 400MG

400 mg

tableta

peroralno

UK – Velika Britanija

| Generics (Uk) Limited |
| --- |
| Station Close |
| Potters Bar, |
| HERTS EN6 1TL |
| Velika Britanija |

Generics (Uk) Limited

Station Close

Potters Bar,

HERTS EN6 1TL

Velika Britanija

BEZAFIBRATE TABLETS 200 MG

200 mg

filmsko obložena tableta

peroralno

UK – Velika Britanija

| Pliva Pharma Limited |
| --- |
| Vision House |
| Bedford Road |
| Petersfield |
| HANTS GU32 3QB |
| Velika Britanija |

Pliva Pharma Limited

Vision House

Bedford Road

Petersfield

HANTS GU32 3QB

Velika Britanija

BEZAFIBRATE TABLETS 200 MG

200 mg

tableta

peroralno

UK – Velika Britanija

| RATIOPHARM GMBH |
| --- |
| Graf-Arco Strasse 3 |
| Ulm, D-89079 |
| Nemčija |

RATIOPHARM GMBH

Graf-Arco Strasse 3

Ulm, D-89079

Nemčija

BEZAFIBRATE 200MG TABLETS

200 mg

filmsko obložena tableta

peroralno

UK – Velika Britanija

| SANDOZ LIMITED |
| --- |
| 37 Woolmer Way, |
| Borden, Hampshire GU35 9QE |
| Velika Britanija |

SANDOZ LIMITED

37 Woolmer Way,

Borden, Hampshire GU35 9QE

Velika Britanija

BEZATARD XL 400MG MODIFIED RELEASE TABLETS

400 mg

tableta s prirejenim sproščanjem

peroralno

Zdravila, ki vsebuejo zdravilno učinkovino ciprofibrat in imajo dovoljenje za promet v EU

| Država članica (EU/EEA) | Imetnik dovoljenja za promet | Izmišljeno ime | Jakost | Farmacevtska oblika | Pot uporabe zdravila |
| --- | --- | --- | --- | --- | --- |
| BE - Belgija | SANOFI-AVENTIS BELGIJA N.V. |
| Culliganlaan 1C |
| 1831 Diegem |
| Belgija |

Država članica (EU/EEA)

Imetnik dovoljenja za promet

Izmišljeno ime

Jakost

Farmacevtska oblika

Pot uporabe zdravila

BE - Belgija

SANOFI-AVENTIS BELGIJA N.V.

Culliganlaan 1C

1831 Diegem

Belgija

CIPROFIBRATE MYLAN 100 MG

100 mg

trda kapsula

peroralno

BE - Belgija

| SANOFI-AVENTIS BELGIJA N.V. |
| --- |
| Culliganlaan 1C |
| 1831 Diegem |
| Belgija |

SANOFI-AVENTIS BELGIJA N.V.

Culliganlaan 1C

1831 Diegem

Belgija

HYPERLIPEN 100 MG

100 mg

trda kapsula

peroralno

BG - Bolgarija

| Sanofi-Aventis |
| --- |
| Bulgaria EOOD |
| Blvd. Alexander Stamboliyski No 103, Office Building Sofia Tower, 8th floor, 1303 Sofia |
| Bulgaria |

Sanofi-Aventis

Bulgaria EOOD

Blvd. Alexander Stamboliyski No 103, Office Building Sofia Tower, 8th floor, 1303 Sofia

Bulgaria

Lipanor

100 mg

trda kapsula

peroralno

CY - Ciper

| SANOFI AVENTIS CIPER LTD |
| --- |
| Charalambou Mouskou 14 |
| 2015 Strovolos |
| Ciper |

SANOFI AVENTIS CIPER LTD

Charalambou Mouskou 14

2015 Strovolos

Ciper

MODALIM TABLETS 100 mg

100 mg

tableta

peroralno

CZ - Češka

| sanofi-aventis s.r.o. |
| --- |
| Evropská 846/176a |
| 160 00 Praha 6 |
| Češka |

sanofi-aventis s.r.o.

Evropská 846/176a

160 00 Praha 6

Češka

LIPANOR

100 MG

trda kapsula

EL - Grčija

| Sanofi-Aventis Aebe |
| --- |
| Syngrou Avenue 348, |
| Building A, |
| Kallithea 176 74 |
| Attiki |
| Grčija |

Sanofi-Aventis Aebe

Syngrou Avenue 348,

Building A,

Kallithea 176 74

Attiki

Grčija

SAVILEN

100 MG/CAP

trda kapsula

peroralno

ET - Estonija

| Sanofi-Aventis |
| --- |
| Estonia |
| OÜ |
| Pärnu mnt 139E/211317 Tallinn |
| Estonia |

Sanofi-Aventis

Estonia

OÜ

Pärnu mnt 139E/211317 Tallinn

Estonia

LIPANOR

100 mg

trda kapsula

peroralno

FR - Francija

| Sanofi Aventis Francija |
| --- |
| 1-13 Bd Romain Rolland |
| 75014 Paris |
| Francija |

Sanofi Aventis Francija

1-13 Bd Romain Rolland

75014 Paris

Francija

LIPANOR 100 mg, gélule

100 mg

kapsula

peroralno

FR - Francija

| Biogaran |
| --- |
| 15, bd Charles de Gaulle |
| 92700 Colombes |
| Francija |

Biogaran

15, bd Charles de Gaulle

92700 Colombes

Francija

CIPROFIBRATE ALMUS 100 mg, gélule

100 mg

kapsula

peroralno

FR - Francija

| Arrow |
| --- |
| 26, avenue Tony Garnier |
| 69007 Lyon |
| Francija |

Arrow

26, avenue Tony Garnier

69007 Lyon

Francija

CIPROFIBRATE ARROW 100 mg, gélule

100 mg

kapsula

peroralno

FR - Francija

| Biogaran |
| --- |
| 15, bd Charles de Gaulle |
| 92700 Colombes |
| Francija |

Biogaran

15, bd Charles de Gaulle

92700 Colombes

Francija

CIPROFIBRATE BIOGARAN 100 mg, gélule

100 mg

kapsula

peroralno

FR - Francija

| Mylan SAS |
| --- |
| 117, allée des Parcs |
| 69800 Saint Priest |
| Francija |

Mylan SAS

117, allée des Parcs

69800 Saint Priest

Francija

CIPROFIBRATE MYLAN 100 mg, gélule

100 mg

kapsula

peroralno

FR - Francija

| Qualimed |
| --- |
| 117, allée des Parcs |
| 69800 Saint Priest |
| Francija |

Qualimed

117, allée des Parcs

69800 Saint Priest

Francija

CIPROFIBRATE QUALIMED 100 mg, gélule

100 mg

kapsula

peroralno

FR - Francija

| Laboratoire Ratiopharm |
| --- |
| 19, Bd Paul Vaillant Couturier |
| 94200 Ivry sur Seine |
| Francija |

Laboratoire Ratiopharm

19, Bd Paul Vaillant Couturier

94200 Ivry sur Seine

Francija

CIPROFIBRATE RATIOPHARM 100 mg, gélule

100 mg

kapsula

peroralno

FR - Francija

| Biogaran |
| --- |
| 15 |
| bd Charles de Gaulle |
| 92700 Colombes |
| Francija |

Biogaran

15

bd Charles de Gaulle

92700 Colombes

Francija

CIPROFIBRATE REF 100 mg, gélule

100 mg

kapsula

peroralno

FR - Francija

| Ranbaxy Pharmacie Génériques |
| --- |
| 11-15 Quai Dion Bouton |
| 92800 Puteaux |
| Francija |

Ranbaxy Pharmacie Génériques

11-15 Quai Dion Bouton

92800 Puteaux

Francija

CIPROFIBRATE RPG 100 mg, gélule

100 mg

kapsula

peroralno

FR - Francija

| Sandoz |
| --- |
| 49, av. Pompidou |
| 92300 Levallois-Perret |
| Francija |

Sandoz

49, av. Pompidou

92300 Levallois-Perret

Francija

CIPROFIBRATE SANDOZ 100 mg, gélule

100 mg

kapsula

peroralno

FR - Francija

| TEVA SANTE |
| --- |
| Le Palatin 1 |
| 1 cours du Triangle |
| 92936 Paris La Défense Cedex |
| Francija |

TEVA SANTE

Le Palatin 1

1 cours du Triangle

92936 Paris La Défense Cedex

Francija

CIPROFIBRATE TEVA 100 mg, gélule

100 mg

kapsula

peroralno

FR - Francija

| Sanofi Aventis Francija |
| --- |
| 1-13 Bd Romain Rolland |
| 75014 Paris |
| Francija |

Sanofi Aventis Francija

1-13 Bd Romain Rolland

75014 Paris

Francija

CIPROFIBRATE WINTHROP 100 mg, gélule

100 mg

kapsula

peroralno

HU - Madžarska

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

sanofi-aventis zrt.

Tó u. 1-5.

1045 Budapest

Madžarska

Lipanor

100 mg

trda kapsula

peroralno

LT - Litva

| UAB Sanofi - Aventis Lietuva |
| --- |
| A. Juozapaviciaus 6/2 |
| LT-09310 Vilnius |
| Litva |

UAB Sanofi - Aventis Lietuva

A. Juozapaviciaus 6/2

LT-09310 Vilnius

Litva

Lipanor

100 mg

trda kapsula

peroralno

LU - Luksemburg

| Sanofi-Synthélabo SA |
| --- |
| Twin Squares, |
| Navona Building |
| B- 1831 Diegem |

Sanofi-Synthélabo SA

Twin Squares,

Navona Building

B- 1831 Diegem

Hyperlipen

100 mg

trda kapsula

peroralno

LV - Latvija

| Sanofi-aventis Latvija SIA |
| --- |
| Kr.Valdemara Str. 33-8 |
| Riga, LV-1010 |
| Latvija |

Sanofi-aventis Latvija SIA

Kr.Valdemara Str. 33-8

Riga, LV-1010

Latvija

Lipanor 100 mg capsules, hard

100 mg

trda kapsula

peroralno

NL - Nizozemska

| Sanofi-Aventis Nizozemska B.V. Kampenringweg 45 D-E |
| --- |
| 2803 PE Gouda |
| The Nederlands |

Sanofi-Aventis Nizozemska B.V. Kampenringweg 45 D-E

2803 PE Gouda

The Nederlands

Modalim, tabletten 100 mg, RVG 17863

100 mg

tableta

peroralno

PL - Poljska

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

Sanofi-Aventis Francija

boulevard Romain Rolland 1-13,

F-75014 Paris,

Francija

Lipanor

100 mg

kapsula

peroralno

PT - Portugalskaska

| Sanofi-Aventis - Produtos Farmacêuticos, S.A Empreendimento Lagoas Park, Edifício 7 - 3o |
| --- |
| 2740-299 Porto Salvo |
| Portugalska |

Sanofi-Aventis - Produtos Farmacêuticos, S.A Empreendimento Lagoas Park, Edifício 7 - 3o

2740-299 Porto Salvo

Portugalska

Lipanor

100 mg

kapsula

peroralno

PT - Portugalskaska

| Winthrop Farmacêutica Portugalska, Lda. Empreendimento Lagoas Park |
| --- |
| Edifício 7 - 2o/3o |
| 2740-299 Porto Salvo |
| Portugalska |

Winthrop Farmacêutica Portugalska, Lda. Empreendimento Lagoas Park

Edifício 7 - 2o/3o

2740-299 Porto Salvo

Portugalska

Fibranin

100 mg

kapsula

peroralno

RO - Romunija

| sanofi-aventis Francija |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Francija |

sanofi-aventis Francija

1-13, boulevard Romain Rolland

75014 Paris

Francija

LIPANOR® 100 mg

100 mg

kapsula

peroralno

SK - Slovaška

| sanofi-aventis Slovaška s.r.o. |
| --- |
| Žilinská 7-9 |
| 81105 Bratislava |
| Slovaška |

sanofi-aventis Slovaška s.r.o.

Žilinská 7-9

81105 Bratislava

Slovaška

LIPANOR 100 mg

100 mg

kapsula

peroralno

UK – Velika Britanija

| Winthrop Pharmaceuticals Uk Limited |
| --- |
| One Onslow Street |
| Guildford, Surrey GU1 4YS |
| Velika Britanija |

Winthrop Pharmaceuticals Uk Limited

One Onslow Street

Guildford, Surrey GU1 4YS

Velika Britanija

CIPROFIBRATE 100MG TABLETS

100 mg

tableta

peroralno

Zdravila, ki vsebuejo zdravilno učinkovino gemfibrozil in imajo dovoljenje za promet v EU

| Država članica(EU/EEA) | Imetnik dovoljenja za promet | Izmišljeno ime | Jakost | Farmacevtska oblika | Pot uporabe zdravila |
| --- | --- | --- | --- | --- | --- |
| AT - Avstrija | Pfizer Corporation |
| Avstrija GmbH |
| Floridsdorfer Hauptstraße 1 |
| A-1210 Wien |
| Avstrija |

Država članica(EU/EEA)

Imetnik dovoljenja za promet

Izmišljeno ime

Jakost

Farmacevtska oblika

Pot uporabe zdravila

AT - Avstrija

Pfizer Corporation

Avstrija GmbH

Floridsdorfer Hauptstraße 1

A-1210 Wien

Avstrija

Gevilon 450 mg - Filmtabletten

450 mg

filmsko obložena tableta

peroralno

CY - Ciper

| MEDOCHEMIE LTD |
| --- |
| 1-10 Constantinoupoleos street |
| P.O.Box 51409 |
| 3505 Lemesos |
| Ciper |

MEDOCHEMIE LTD

1-10 Constantinoupoleos street

P.O.Box 51409

3505 Lemesos

Ciper

IPOLIPID CAPSULES 300mg

300 mg

kapsula

peroralno

CY - Ciper

| MEDOCHEMIE LTD, 1-10 Constantinoupoleos street P.O.Box 51409 |
| --- |
| 3505 Lemesos |
| Ciper |

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street P.O.Box 51409

3505 Lemesos

Ciper

IPOLIPID CAPSULES 600mg

600 mg

kapsula

peroralno

CY - Ciper

| REMEDICA LTD |
| --- |
| Aharnon street |
| P.O.Box 51706 |
| 3508 Lemesos |
| Ciper |

REMEDICA LTD

Aharnon street

P.O.Box 51706

3508 Lemesos

Ciper

LIPOFOR CAPSULES 300mg

300 mg

kapsula

peroralno

CY - Ciper

| REMEDICA LTD |
| --- |
| Aharnon street |
| P.O.Box 51706 |
| 3508 Lemesos |
| Ciper |

REMEDICA LTD

Aharnon street

P.O.Box 51706

3508 Lemesos

Ciper

LIPOFOR CAPSULES 600mg

600 mg

kapsula

peroralno

DE - Nemčija

| 1 A Pharma GmbH |
| --- |
| Keltenring 1 + 3 |
| D-82041 Oberhaching |
| Nemčija |

1 A Pharma GmbH

Keltenring 1 + 3

D-82041 Oberhaching

Nemčija

Gemfi 450-1 A Pharma

450 mg

filmsko obložena tableta

peroralno

DE - Nemčija

| 1 A Pharma GmbH |
| --- |
| Keltenring 1 + 3 |
| D-82041 Oberhaching |
| Nemčija |

1 A Pharma GmbH

Keltenring 1 + 3

D-82041 Oberhaching

Nemčija

Gemif 600-1 A Pharma

600 mg

filmsko obložena tableta

peroralno

DE - Nemčija

| Pfizer Pharma GmbH |
| --- |
| Linkstr. 10 |
| D-10785 Berlin |
| Nemčija |

Pfizer Pharma GmbH

Linkstr. 10

D-10785 Berlin

Nemčija

Gevilon 600mg

600 mg

filmsko obložena tableta

peroralno

DE - Nemčija

| Pfizer Pharma GmbH |
| --- |
| Linkstr. 10 D |
| D- 10785 Berlin |
| Nemčija |

Pfizer Pharma GmbH

Linkstr. 10 D

D- 10785 Berlin

Nemčija

Gevilon Uno

900 mg

filmsko obložena tableta

peroralno

DE - Nemčija

| TAD Pharma GmbH |
| --- |
| Heinz-Lohmann-Str. 5 |
| D-27472 Cuxhaven |
| Nemčija |

TAD Pharma GmbH

Heinz-Lohmann-Str. 5

D-27472 Cuxhaven

Nemčija

Lipox Gemfi 450mg

450 mg

filmsko obložena tableta

peroralno

DE - Nemčija

| TAD Pharma GmbH |
| --- |
| Heinz-Lohmann-Str. 5 |
| D-27472 Cuxhaven |
| Nemčija |

TAD Pharma GmbH

Heinz-Lohmann-Str. 5

D-27472 Cuxhaven

Nemčija

Lipox Gemfi 600mg

600 mg

filmsko obložena tableta

peroralno

DK - Danska

| Alternova A/S |
| --- |
| Lodhusvej 11 |
| 4230 Skælskør |
| Denmark |

Alternova A/S

Lodhusvej 11

4230 Skælskør

Denmark

Gemfibrozil «Alternova»

600 mg

filmsko obložena tableta

peroralno

DK - Danska

| Alternova A/S |
| --- |
| Lodhusvej 11 |
| 4230 Skælskør |
| Denmark |

Alternova A/S

Lodhusvej 11

4230 Skælskør

Denmark

Gemfibrozil «Alternova»

900 mg

filmsko obložena tableta

peroralno

DK - Danska

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

Pfizer ApS

Lautrupvang 8

2750 Ballerup

Denmark

Lopid

300 mg

trda kapsula

peroralno

DK - Danska

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

Pfizer ApS

Lautrupvang 8

2750 Ballerup

Denmark

Lopid

450 mg

filmsko obložena tableta

peroralno

DK - Danska

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

Pfizer ApS

Lautrupvang 8

2750 Ballerup

Denmark

Lopid

600 mg

filmsko obložena tableta

peroralno

EL - Grčija

| PFIZER HELLAS S.A. |
| --- |
| Messogion Avenue 243 |
| Neo Psychiko 154 51 |
| Grčija |

PFIZER HELLAS S.A.

Messogion Avenue 243

Neo Psychiko 154 51

Grčija

LOPID

600 MG/TAB

filmsko obložena tableta

peroralno

EL - Grčija

| PFIZER HELLAS S.A. |
| --- |
| Messogion Avenue 243 |
| Neo Psychiko 154 51 |
| Grčija |

PFIZER HELLAS S.A.

Messogion Avenue 243

Neo Psychiko 154 51

Grčija

LOPID

900 MG/TAB

filmsko obložena tableta

peroralno

EL - Grčija

| FINIXPHARM EPE |
| --- |
| Dervenakion 38 and Sahini str |
| Gerakas Attikis 153 44 |
| Grčija |

FINIXPHARM EPE

Dervenakion 38 and Sahini str

Gerakas Attikis 153 44

Grčija

HOBATOLEX

600 MG/TAB

filmsko obložena tableta

peroralno

EL - Grčija

| ANFARM HELLAS S.A. |
| --- |
| Perikleous 53-57 |
| Gerakas Attikis 153 44 |
| Grčija |

ANFARM HELLAS S.A.

Perikleous 53-57

Gerakas Attikis 153 44

Grčija

FIBROLIP

600 MG/TAB

filmsko obložena tableta

peroralno

EL - Grčija

| MEDICHROM S.A. |
| --- |
| 6th Km Markopolou-Koropi Avenue |
| Markopoulo Mesogeion 19003 |
| Grčija |

MEDICHROM S.A.

6th Km Markopolou-Koropi Avenue

Markopoulo Mesogeion 19003

Grčija

GEMLIPID-MEDICHROM

600 MG/TAB

filmsko obložena tableta

peroralno

EL - Grčija

| COSMOPHARM EPE |
| --- |
| P.O. Box 42 |
| Korinthos 20100 |
| Grčija |

COSMOPHARM EPE

P.O. Box 42

Korinthos 20100

Grčija

PRELISIN

600 MG/TAB

filmsko obložena tableta

peroralno

EL - Grčija

| KLEVA AFBEE |
| --- |
| Parnithos Avenue 189 |
| Aharnes Attikis 136 75 |
| Grčija |

KLEVA AFBEE

Parnithos Avenue 189

Aharnes Attikis 136 75

Grčija

NOXOBRAN

600 MG/TAB

filmsko obložena tableta

peroralno

EL - Grčija

| KLEVA AFBEE |
| --- |
| Parnithos Avenue 189 |
| Aharnes Attikis 136 75 |
| Grčija |

KLEVA AFBEE

Parnithos Avenue 189

Aharnes Attikis 136 75

Grčija

NOXOBRAN

900 MG/TAB

filmsko obložena tableta

peroralno

EL - Grčija

| GAP S.A. |
| --- |
| Agisilaou 46 |
| Agios Dimitrios 17341 |
| Grčija |

GAP S.A.

Agisilaou 46

Agios Dimitrios 17341

Grčija

LISOLIP

600 MG/TAB

filmsko obložena tableta

peroralno

EL - Grčija

| HRISPA ALFA PHARMACEUTICALS S.A. |
| --- |
| (ΧΡΙΣΠΑ ΑΛΦΑ ΦΑΡΜ/ΚΗ Α.Ε.) |
| 16th Km Marathonos Avenue |
| Pallini Attikis 153 44 |
| Grčija |

HRISPA ALFA PHARMACEUTICALS S.A.

(ΧΡΙΣΠΑ ΑΛΦΑ ΦΑΡΜ/ΚΗ Α.Ε.)

16th Km Marathonos Avenue

Pallini Attikis 153 44

Grčija

TEROSTRANT

600 MG/TAB

filmsko obložena tableta

peroralno

EL - Grčija

| BIOSPRAY ABEE |
| --- |
| 18th Km Marathonos Avenue |
| Pallini Attikis 153 44 |
| Grčija |

BIOSPRAY ABEE

18th Km Marathonos Avenue

Pallini Attikis 153 44

Grčija

PARNOXIL

600 MG/TAB

filmsko obložena tableta

peroralno

EL - Grčija

| SPECIFAR ABEE |
| --- |
| 28th October str 1 |
| Agia Barbara 123 51 |
| Grčija |

SPECIFAR ABEE

28th October str 1

Agia Barbara 123 51

Grčija

FIBROSPES

600 MG/TAB

filmsko obložena tableta

peroralno

EL - Grčija

| PHARMACEUTICAL INDUSTRY E.G. KORONIS S.A. |
| --- |
| Dilou str 9 |
| Peristeri 121 34 |
| Grčija |

PHARMACEUTICAL INDUSTRY E.G. KORONIS S.A.

Dilou str 9

Peristeri 121 34

Grčija

EKLIPID

600 MG/TAB

filmsko obložena tableta

peroralno

EL - Grčija

| KLEVA AFBEE |
| --- |
| Parnithos Avenue 189 |
| Aharnes Attikis 136 75 |
| Grčija |

KLEVA AFBEE

Parnithos Avenue 189

Aharnes Attikis 136 75

Grčija

ANTILIPID

600 MG/TAB

filmsko obložena tableta

peroralno

EL - Grčija

| MED-ONE AFBEE |
| --- |
| Agiou Petrou 30 and Epameinonda |
| Aharnes 136 75 |
| Grčija |

MED-ONE AFBEE

Agiou Petrou 30 and Epameinonda

Aharnes 136 75

Grčija

GINETON

600 MG/TAB

filmsko obložena tableta

peroralno

ES - Španija

| BEXAL FARMACEUTICA, S.A Centro Empresarial Osa Mayor. Avda. Osa Mayor, 4 - Area BAravaca 28023 (Madrid) |
| --- |
| Španija |

BEXAL FARMACEUTICA, S.A Centro Empresarial Osa Mayor. Avda. Osa Mayor, 4 - Area BAravaca 28023 (Madrid)

Španija

GEMFIBROZILO BEXAL

600 mg

filmsko obložena tableta

peroralno

ES - Španija

| FERMON, S.L.Alfonso XII, |
| --- |
| 587 Badalona |
| 08918 BARCELONA |
| Španija |

FERMON, S.L.Alfonso XII,

587 Badalona

08918 BARCELONA

Španija

GEMFIBROZILO FERMON

600 mg

filmsko obložena tableta

peroralno

ES - Španija

| FERMON, S.L.Alfonso XII, 587 Badalona |
| --- |
| 08918 BARCELONA |
| Španija |

FERMON, S.L.Alfonso XII, 587 Badalona

08918 BARCELONA

Španija

GEMFIBROZILO FERMON

900 mg

filmsko obložena tableta

peroralno

ES - Španija

| LABORATORIO STADA, S.L.Frederic Mompou, |
| --- |
| 5 Sant Just Desvern 08960 BARCELONA |
| Španija |

LABORATORIO STADA, S.L.Frederic Mompou,

5 Sant Just Desvern 08960 BARCELONA

Španija

GEMFIBROZILO STADA

600 mg

filmsko obložena tableta

peroralno

ES - Španija

| LABORATORIO STADA, S.L.Frederic Mompou, |
| --- |
| 5 Sant Just Desvern 08960 BARCELONA |
| Španija |

LABORATORIO STADA, S.L.Frederic Mompou,

5 Sant Just Desvern 08960 BARCELONA

Španija

GEMFIBROZILO STADA

900 mg

filmsko obložena tableta

peroralno

ES - Španija

| USO RACIONAL |
| --- |
| S.L.Ferraz, 10 - 1o Izda. |
| 28008 Madrid |
| Španija |

USO RACIONAL

S.L.Ferraz, 10 - 1o Izda.

28008 Madrid

Španija

GEMFIBROZILO UR

900 mg

filmsko obložena tableta

peroralno

ES - Španija

| USO RACIONAL |
| --- |
| S.L.Ferraz, 10 - 1o Izda. |
| 28008 Madrid |
| Španija |

USO RACIONAL

S.L.Ferraz, 10 - 1o Izda.

28008 Madrid

Španija

GEMFIBROZILO UR

600 mg

filmsko obložena tableta

peroralno

ES - Španija

| PARKE DAVIS |
| --- |
| Avda. de Europa, 20 B. Parque Empresarial La Moraleja Alcobendas MADRID |
| Španija |

PARKE DAVIS

Avda. de Europa, 20 B. Parque Empresarial La Moraleja Alcobendas MADRID

Španija

LOPID

600 mg

filmsko obložena tableta

peroralno

ES - Španija

| PARKE DAVIS, Avda. de Europa, 20 B. Parque Empresarial La Moraleja Alcobendas MADRID |
| --- |
| Španija |

PARKE DAVIS, Avda. de Europa, 20 B. Parque Empresarial La Moraleja Alcobendas MADRID

Španija

LOPID

900 mg

filmsko obložena tableta

peroralno

ES - Španija

| LABORATORIOS MENARINI S.A Alfonso XII |
| --- |
| 587 Badalona |
| 08918 BARCELONA |
| Španija |

LABORATORIOS MENARINI S.A Alfonso XII

587 Badalona

08918 BARCELONA

Španija

TRIALMIN

600 mg

filmsko obložena tableta

peroralno

ES - Španija

| LABORATORIOS MENARINI S.A Alfonso XII, 587 Badalona |
| --- |
| 08918 BARCELONA |
| Španija |

LABORATORIOS MENARINI S.A Alfonso XII, 587 Badalona

08918 BARCELONA

Španija

TRIALMIN

900 mg

filmsko obložena tableta

peroralno

ES - Španija

| QUIMIFAR, S.A.Comadran, |
| --- |
| 37 Barbera del Valles |
| 08210 BARCELONA |
| Španija |

QUIMIFAR, S.A.Comadran,

37 Barbera del Valles

08210 BARCELONA

Španija

PILDER

600 mg

filmsko obložena tableta

peroralno

FI - Finska

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

Pfizer Oy

Tietokuja 4

00330 Helsinki

Finland

LOPID

300 mg

kapsula

peroralno

FI - Finska

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

Pfizer Oy

Tietokuja 4

00330 Helsinki

Finland

LOPID

600 mg

kapsula

peroralno

FR - Francija

| Pfizer Holding Francija |
| --- |
| 23-25, avenue du Docteur Lannelongue |
| 75014 Paris |
| Francija |

Pfizer Holding Francija

23-25, avenue du Docteur Lannelongue

75014 Paris

Francija

LIPUR 450 mg, comprimé pelliculé

450 mg

filmsko obložena tableta

peroralno

HU - Madžarska

| TEVA Magyarország zrt. |
| --- |
| Rákóczi út 70-72. |
| 1074 Budapest |
| Madžarska |

TEVA Magyarország zrt.

Rákóczi út 70-72.

1074 Budapest

Madžarska

Minilip

600 mg

filmsko obložena tableta

peroralno

HU - Madžarska

| PannonPharma Kft. |
| --- |
| Pannonpharma út 1. |
| 7720 Pécsvárad |
| Madžarska |

PannonPharma Kft.

Pannonpharma út 1.

7720 Pécsvárad

Madžarska

Innogem

300 mg

trda kapsula

peroralno

HU - Madžarska

| PannonPharma Kft. |
| --- |
| Pannonpharma út 1. |
| 7720 Pécsvárad |
| Madžarska |

PannonPharma Kft.

Pannonpharma út 1.

7720 Pécsvárad

Madžarska

Innogem

600 mg

filmsko obložena tableta

peroralno

IE - Irska

| Pfizer Healthcare Ireland |
| --- |
| 9 Riverwalk |
| National Digital Park |
| Citywest Business Campus |
| Dublin 24 |
| Ireland |

Pfizer Healthcare Ireland

9 Riverwalk

National Digital Park

Citywest Business Campus

Dublin 24

Ireland

UK ADDRESS:

| Pfizer Ltd., Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS, |
| --- |
| UK |

Pfizer Ltd., Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS,

UK

Lopid 300 mg capsules

300 mg

trda kapsula

peroralno

IE - Irska

| Pfizer Healthcare Ireland |
| --- |
| 9 Riverwalk |
| National Digital Park |
| Citywest Business Campus |
| Dublin 24 |
| Ireland |

Pfizer Healthcare Ireland

9 Riverwalk

National Digital Park

Citywest Business Campus

Dublin 24

Ireland

UK ADDRESS:

| Pfizer Ltd., Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS |
| --- |
| UK |

Pfizer Ltd., Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS

UK

Lopid 600 mg film-coated tablets

600 mg

filmsko obložena tableta

peroralno

IS - Islandija

| Pfizer Aps |
| --- |
| Lautrupsvang 8 |
| 2750 Ballerud |
| Denmark |

Pfizer Aps

Lautrupsvang 8

2750 Ballerud

Denmark

Lopid

600 mg

filmsko obložena tableta

peroralno

IS - Islandija

| Pfizer Aps |
| --- |
| Lautrupsvang 8 |
| 2750 Ballerud |
| Denmark |

Pfizer Aps

Lautrupsvang 8

2750 Ballerud

Denmark

Lopid

300 mg

trda kapsula

peroralno

IT - Italija

| Biores Italia Srl |
| --- |
| Via Vittorio Grassi, 13 – |
| La Rustica |
| 00155 ROMA |
| Italija |

Biores Italia Srl

Via Vittorio Grassi, 13 –

La Rustica

00155 ROMA

Italija

Lipogen

900 mg

tableta

peroralno

IT - Italija

| Biores Italia Srl |
| --- |
| Via Vittorio Grassi, 13 – |
| La Rustica |
| 00155 ROMA |
| Italija |

Biores Italia Srl

Via Vittorio Grassi, 13 –

La Rustica

00155 ROMA

Italija

Lipogen

1 200 mg

zrnca

peroralno

IT - Italija

| Boniscontro & Gazzone Srl |
| --- |
| Via Pavia, 6 |
| 20136 MILANO |
| Italija |

Boniscontro & Gazzone Srl

Via Pavia, 6

20136 MILANO

Italija

Genozil

600 mg

filmsko obložena tableta

peroralno

IT - Italija

| Boniscontro & Gazzone Srl |
| --- |
| Via Pavia, 6 |
| 20136 MILANO |
| Italija |

Boniscontro & Gazzone Srl

Via Pavia, 6

20136 MILANO

Italija

Genozil

900 mg

filmsko obložena tableta

peroralno

IT - Italija

| C.T. Laboratorio Farmaceutico S |
| --- |
| Strada Solaro, 75/77 |
| Villa Sayonara, Sanremo – IMPERIA |
| Italija |

C.T. Laboratorio Farmaceutico S

Strada Solaro, 75/77

Villa Sayonara, Sanremo – IMPERIA

Italija

Fibrocit

900 mg

tableta

peroralno

IT - Italija

| C.T. Laboratorio Farmaceutico Srl Strada Solaro, 75/77 |
| --- |
| Villa Sayonara, Sanremo – IMPERIA |
| Italija |

C.T. Laboratorio Farmaceutico Srl Strada Solaro, 75/77

Villa Sayonara, Sanremo – IMPERIA

Italija

Fibrocit

600 mg

tableta

peroralno

IT - Italija

| Doc Generici Srl |
| --- |
| Via Manuzio, 7 |
| 20124 MILANO |
| Italija |

Doc Generici Srl

Via Manuzio, 7

20124 MILANO

Italija

Gemfibrozil

900 mg

tableta

peroralno

IT - Italija

| Doc Generici Srl |
| --- |
| Via Manuzio, 7 |
| 20124 MILANO |
| Italija |

Doc Generici Srl

Via Manuzio, 7

20124 MILANO

Italija

Gemfibrozil

600 mg

tableta

peroralno

IT - Italija

| Eg Spa |
| --- |
| Via Scarlatti Domenico, 31 |
| 20124 MILANO |
| Italija |

Eg Spa

Via Scarlatti Domenico, 31

20124 MILANO

Italija

Gemfibrozil Eg

900 mg

tableta

peroralno

IT - Italija

| Eg Spa |
| --- |
| Via Scarlatti Domenico, 31 |
| 20124 MILANO |
| Italija |

Eg Spa

Via Scarlatti Domenico, 31

20124 MILANO

Italija

Gemfibrozil Eg

600 mg

tableta

peroralno

IT - Italija

| Eg Spa |
| --- |
| Via Scarlatti Domenico, 31 |
| 20124 MILANO |
| Italija |

Eg Spa

Via Scarlatti Domenico, 31

20124 MILANO

Italija

Gemfibrozil Eg

1 200 mg

zrnca

peroralno

IT - Italija

| Get Srl Via Dante Alighieri, 73 18038 Sanremo – IMPERIA |
| --- |
| Italija |

Get Srl Via Dante Alighieri, 73 18038 Sanremo – IMPERIA

Italija

Gemfibrozil

900 mg

obložena tableta

peroralno

IT - Italija

| Get Srl |
| --- |
| Via Dante Alighieri, 73 |
| 18038 Sanremo – IMPERIA |
| Italija |

Get Srl

Via Dante Alighieri, 73

18038 Sanremo – IMPERIA

Italija

Gemfibrozil

600 mg

obložena tableta

peroralno

IT - Italija

| Pfizer Italia Srl |
| --- |
| Via Isonzo, 71 |
| 04100 – LATINA |
| Italija |

Pfizer Italia Srl

Via Isonzo, 71

04100 – LATINA

Italija

Lopid

900 mg

obložena tableta

peroralno

IT - Italija

| Pfizer Italia Srl |
| --- |
| Via Isonzo, 71 |
| 04100 – LATINA |
| Italija |

Pfizer Italia Srl

Via Isonzo, 71

04100 – LATINA

Italija

Lopid

600 mg

obložena tableta

peroralno

IT - Italija

| Ratiopharm GmbH |
| --- |
| Graf-Arco Strasse 3 |
| D-89079 ULM – |
| Nemčija |

Ratiopharm GmbH

Graf-Arco Strasse 3

D-89079 ULM –

Nemčija

Gemfibrozil

900 mg

tableta

peroralno

IT - Italija

| Ratiopharm Gmbh Graf-Arco Strasse 3 D-89079 ULM |
| --- |
| Nemčija |

Ratiopharm Gmbh Graf-Arco Strasse 3 D-89079 ULM

Nemčija

Gemfibrozil

600 mg

tableta

peroralno

IT - Italija

| Ratiopharm Gmbh Graf-Arco Strasse 3 D-89079 ULM |
| --- |
| Nemčija |

Ratiopharm Gmbh Graf-Arco Strasse 3 D-89079 ULM

Nemčija

Gemfibrozil

1 200 mg

zrnca

peroralno

IT - Italija

| Sandoz Spa Largo Umberto Boccioni, 1 21040 Origgio – VARESE |
| --- |
| Italija |

Sandoz Spa Largo Umberto Boccioni, 1 21040 Origgio – VARESE

Italija

Gemfibrozil

900 mg

tableta

peroralno

IT - Italija

| Sandoz Spa Largo Umberto Boccioni, 1 21040 Origgio – VARESE |
| --- |
| Italija |

Sandoz Spa Largo Umberto Boccioni, 1 21040 Origgio – VARESE

Italija

Gemfibrozil

600 mg

tableta

peroralno

IT - Italija

| Teofarma Srl Via Fratelli Cervi, 8 – |
| --- |
| Valle Salimbene |
| 27010 Pavia |
| Italija |

Teofarma Srl Via Fratelli Cervi, 8 –

Valle Salimbene

27010 Pavia

Italija

Genlip

900 mg

tableta

peroralno

IT - Italija

| Teofarma Srl |
| --- |
| Via Fratelli Cervi, 8 – |
| Valle Salimbene |
| 27010 Pavia |
| Italija |

Teofarma Srl

Via Fratelli Cervi, 8 –

Valle Salimbene

27010 Pavia

Italija

Genlip

600 mg

tableta

peroralno

IT - Italija

| Teva Italia Srl |
| --- |
| Via Messina, 38 |
| 20154 MILANO |
| Italija |

Teva Italia Srl

Via Messina, 38

20154 MILANO

Italija

Gemfibrozil

900 mg

filmsko obložena tableta

peroralno

IT - Italija

| Teva Italia Srl |
| --- |
| Via Messina, 38 |
| 20154 MILANO |
| Italija |

Teva Italia Srl

Via Messina, 38

20154 MILANO

Italija

Gemfibrozil

600 mg

filmsko obložena tableta

peroralno

NL - Nizozemska

| Pfizer B.V. |
| --- |
| Rivium Westlaan 142 |
| 2909 LD Capelle a/d Ijssel |
| The Nizozemska |

Pfizer B.V.

Rivium Westlaan 142

2909 LD Capelle a/d Ijssel

The Nizozemska

Lopid 300 mg, harde capsules, RVG 32546

300 mg

trda kapsula

peroralno

NL - Nizozemska

| Pfizer B.V. |
| --- |
| Rivium Westlaan 142 |
| 2909 LD Capelle a/d Ijssel |
| The Nizozemska |

Pfizer B.V.

Rivium Westlaan 142

2909 LD Capelle a/d Ijssel

The Nizozemska

Lopid 450 mg, filmomhulde tabletten, RVG 32547

450 mg

filmsko obložena tableta

peroralno

NL - Nizozemska

| Pfizer B.V. |
| --- |
| Rivium Westlaan 142 |
| 2909 LD Capelle a/d Ijssel |
| The Nizozemska |

Pfizer B.V.

Rivium Westlaan 142

2909 LD Capelle a/d Ijssel

The Nizozemska

Lopid 600, filmomhulde tabletten 600 mg, RVG 13827

600 mg

filmsko obložena tableta

peroralno

NL - Nizozemska

| Pfizer B.V. |
| --- |
| Rivium Westlaan 142 |
| 2909 LD Capelle a/d Ijssel |
| The Nizozemska |

Pfizer B.V.

Rivium Westlaan 142

2909 LD Capelle a/d Ijssel

The Nizozemska

Lopid 900, filmomhulde tabletten 900 mg, RVG 16455

900 mg

filmsko obložena tableta

peroralno

NL - Nizozemska

| Pharmachemie BV |
| --- |
| P.O.Box 552, |
| 2003 RN Haarlem |
| The Nizozemska |

Pharmachemie BV

P.O.Box 552,

2003 RN Haarlem

The Nizozemska

Gemfibrozil 600 PCH, omhulde tabletten 600 mg, RVG 25031

600 mg

filmsko obložena tableta

peroralno

NL - Nizozemska

| Pharmachemie BV |
| --- |
| P.O.Box 552, |
| 2003 RN Haarlem |
| The Nizozemska |

Pharmachemie BV

P.O.Box 552,

2003 RN Haarlem

The Nizozemska

Gemfibrozil 900 PCH, omhulde tabletten 900 mg, RVG 25032

900 mg

filmsko obložena tableta

peroralno

NL - Nizozemska

| Actavis BV |
| --- |
| P.O. Box 313, |
| 3740 AH Baarn |
| The Nizozemska |

Actavis BV

P.O. Box 313,

3740 AH Baarn

The Nizozemska

Gemfibrozil Actavis 600 mg tabletten, omhulde tabletten, RVG 26283

600 mg

filmsko obložena tableta

peroralno

NL - Nizozemska

| Actavis BV |
| --- |
| P.O. Box 313, |
| 3740 AH Baarn, |
| The Nizozemska |

Actavis BV

P.O. Box 313,

3740 AH Baarn,

The Nizozemska

Gemfibrozil Actavis 900 mg tabletten, omhulde tabletten, RVG 26284

900 mg

filmsko obložena tableta

peroralno

NL - Nizozemska

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| The Nizozemska |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Nizozemska

Gemfibrozil Apotex 600 mg, tabletten, RVG 24878

600 mg

filmsko obložena tableta

peroralno

NL - Nizozemska

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| The Nizozemska |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Nizozemska

Gemfibrozil Apotex 900 mg, tabletten, RVG 24879

900 mg

filmsko obložena tableta

peroralno

NL - Nizozemska

| Centrafarm Services B.V. |
| --- |
| Postbus 289 |
| 4870 AG Etten-Leur |
| The Nizozemska |

Centrafarm Services B.V.

Postbus 289

4870 AG Etten-Leur

The Nizozemska

Gemfibrozil CF 600 mg, omhulde tabletten, RVG 25184

600 mg

filmsko obložena tableta

peroralno

NL - Nizozemska

| Centrafarm Services B.V., Postbus 289 |
| --- |
| 4870 AG Etten-Leur |
| The Nizozemska |

Centrafarm Services B.V., Postbus 289

4870 AG Etten-Leur

The Nizozemska

Gemfibrozil CF 900 mg, omhulde tabletten, RVG 25185

900 mg

filmsko obložena tableta

peroralno

NL - Nizozemska

| Mylan B.V. |
| --- |
| Dieselweg 25 |
| 3752 LB Bunschoten |
| The Nizozemska |

Mylan B.V.

Dieselweg 25

3752 LB Bunschoten

The Nizozemska

Gemfibrozil Mylan 600 mg, tabletten, RVG 29616

600 mg

tableta

peroralno

NL - Nizozemska

| Mylan B.V. |
| --- |
| Dieselweg 25 |
| 3752 LB Bunschoten |
| The Nizozemska |

Mylan B.V.

Dieselweg 25

3752 LB Bunschoten

The Nizozemska

Gemfibrozil Mylan 900 mg, tabletten, RVG 29617

900 mg

tableta

peroralno

NL - Nizozemska

| Ratiopharm Nederland BV |
| --- |
| Ronde Tocht 11 |
| 1507 CC Zaandam |
| The Nizozemska |

Ratiopharm Nederland BV

Ronde Tocht 11

1507 CC Zaandam

The Nizozemska

Gemfibrozil Ratiopharm 600 mg, omhulde tabletten, RVG 29232

600 mg

filmsko obložena tableta

peroralno

NL - Nizozemska

| Ratiopharm Nederland BV |
| --- |
| Ronde Tocht 11 |
| 1507 CC Zaandam |
| The Nizozemska |

Ratiopharm Nederland BV

Ronde Tocht 11

1507 CC Zaandam

The Nizozemska

Gemfibrozil Ratiopharm 900 mg, omhulde tabletten, RVG 29233

900 mg

filmsko obložena tableta

peroralno

NL - Nizozemska

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| The Nizozemska |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

The Nizozemska

Gemfibrozil Sandoz 600 mg, filmomhulde tabletten, RVG 21426

600 mg

filmsko obložena tableta

peroralno

NL - Nizozemska

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| The Nizozemska |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

The Nizozemska

Gemfibrozil Sandoz tablet 600, omhulde tabletten 600 mg, RVG 25182

600 mg

filmsko obložena tableta

peroralno

NL - Nizozemska

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| The Nizozemska |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

The Nizozemska

Gemfibrozil Sandoz tablet 900, omhulde tabletten 900 mg, RVG 25183

900 mg

filmsko obložena tableta

peroralno

PT - Portugalskaska

| Angelfarma Lda. |
| --- |
| Rua João Chagas, 53 |
| Piso 3 1495-764 Cruz Quebrada – Dafundo |
| Portugalska |

Angelfarma Lda.

Rua João Chagas, 53

Piso 3 1495-764 Cruz Quebrada – Dafundo

Portugalska

Lipoite Forte

600 mg

trda kapsula

peroralno

PT - Portugalskaska

| Laboratórios Pfizer, Lda. |
| --- |
| Lagoas Park, Edifício 10 |
| 2740-271 Porto Salvo |
| Portugalska |

Laboratórios Pfizer, Lda.

Lagoas Park, Edifício 10

2740-271 Porto Salvo

Portugalska

Lopid

300 mg

kapsula

peroralno

PT - Portugalskaska

| Laboratórios Pfizer,Lda. |
| --- |
| Lagoas Park, Edifício 10 |
| 2740-271 Porto Salvo |
| Portugalska |

Laboratórios Pfizer,Lda.

Lagoas Park, Edifício 10

2740-271 Porto Salvo

Portugalska

Lopid 600

600 mg

filmsko obložena tableta

peroralno

PT - Portugalskaska

| Generis Farmacêutica, S.A. Office Park da Beloura |
| --- |
| Edifício 4 |
| Quinta da Beloura |
| 2710-444 Sintra |
| Portugalska |

Generis Farmacêutica, S.A. Office Park da Beloura

Edifício 4

Quinta da Beloura

2710-444 Sintra

Portugalska

Gemfibrozil Generis

600 mg

filmsko obložena tableta

peroralno

PT - Portugalskaska

| Generis Farmacêutica S.A. Office Park da Beloura |
| --- |
| Edifício 4, Quinta da Belou |
| 2710-444 Sinta |
| Portugalska |

Generis Farmacêutica S.A. Office Park da Beloura

Edifício 4, Quinta da Belou

2710-444 Sinta

Portugalska

Gemfibrozil Generis

900 mg

filmsko obložena tableta

peroralno

SE - Švedska

| Sandoz A/S |
| --- |
| C.F. Tietgens |
| Boulevard 40 |
| DK-5220 Odense SØ |
| Denmark |

Sandoz A/S

C.F. Tietgens

Boulevard 40

DK-5220 Odense SØ

Denmark

Gemfibrozil Sandoz

450 mg

filmsko obložena tableta

peroralno

SE - Švedska

| Sandoz A/S |
| --- |
| C.F.Tietgens |
| Boulevard 40 |
| DK-5220 Odense SØ |
| Denmark |

Sandoz A/S

C.F.Tietgens

Boulevard 40

DK-5220 Odense SØ

Denmark

Gemfibrozil Sandoz

600mg

filmsko obložena tableta

peroralno

SE - Švedska

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

Pfizer AB

191 90 Sollentuna

Sweden

Lopid

300 mg

trda kapsula

peroralno

SE - Švedska

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

Pfizer AB

191 90 Sollentuna

Sweden

Lopid

450 mg

filmsko obložena tableta

peroralno

SE - Švedska

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

Pfizer AB

191 90 Sollentuna

Sweden

Lopid

600 mg

filmsko obložena tableta

peroralno

SI - Slovenija

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

Lek farmacevtska družba d.d., Verovškova 57

SI-1000 Ljubljana

Slovenia

Elmogan 450 mg Filmsko obložena tableta

450 mg

filmsko obložena tableta

peroralno

SK - Slovaška

Medochemie Ltd. 1-10 Constantinoupoleos St. P.O. Box: 51409 3505 Limassol Ciper

IPOLIPID

300 mg

kapsula

peroralno

UK – Velika Britanija

| PFIZER LIMITED. Walton Oaks, Dorking Road, Tadworth, Surrey KT20 7NS |
| --- |
| Velika Britanija, |

PFIZER LIMITED. Walton Oaks, Dorking Road, Tadworth, Surrey KT20 7NS

Velika Britanija,

LOPID CAPSULES 300 MG

300 mg

kapsula

peroralno

UK – Velika Britanija

| PFIZER LIMITED. Walton Oaks, Dorking Road, Tadworth, Surrey KT20 7NS |
| --- |
| Velika Britanija |

PFIZER LIMITED. Walton Oaks, Dorking Road, Tadworth, Surrey KT20 7NS

Velika Britanija

LOPID TABLETS 600 MG

600mg

obložena tableta

peroralno

UK – Velika Britanija

| TEVA PHARMA BV, Industrieweg 23, PO Box 217, 3640 AE Mijdrecht, |
| --- |
| Nizozemska |

TEVA PHARMA BV, Industrieweg 23, PO Box 217, 3640 AE Mijdrecht,

Nizozemska

GEMFIBROZIL TABLETS 600 MG

600 mg

obložena tableta

peroralno

UK – Velika Britanija

| Teva Uk Limited, Brampton Road, Hampden Park, Eastbourne, E Sussex BN22 9AG |
| --- |
| Velika Britanija |

Teva Uk Limited, Brampton Road, Hampden Park, Eastbourne, E Sussex BN22 9AG

Velika Britanija

GEMFIBROZIL CAPSULES 300 MG

300 mg

kapsula

peroralno

UK – Velika Britanija

| TILLOMED LABORATORIES LIMITED |
| --- |
| 3 Howard Road |
| Eaton Socon |
| St. Neots, Cambridgeshire |
| PE19 8ET |
| Velika Britanija |

TILLOMED LABORATORIES LIMITED

3 Howard Road

Eaton Socon

St. Neots, Cambridgeshire

PE19 8ET

Velika Britanija

GEMFIBROZIL TABLETS 600 MG

600 mg

filmsko obložena tableta

peroralno

---

DODATEK V

SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH

| Država članica | Imetnik dovoljenja za promet z zdravilom | Ime zdravila | Jakost | Farmacevtska oblika | Pot uporabe |
| --- | --- | --- | --- | --- | --- |
| Avstrija | Cephalon GmbH |
| Landsberger Straße 94 |
| 80339 München, |
| Germany |

Država članica

Imetnik dovoljenja za promet z zdravilom

Ime zdravila

Jakost

Farmacevtska oblika

Pot uporabe

Avstrija

Cephalon GmbH

Landsberger Straße 94

80339 München,

Germany

Modasomil 100 mg - Tabletten

100 mg

tablete

peroralna uporaba

Avstrija

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

Teva Pharma B.V.

Computerweg 10,

3542 DR Utrecht

The Netherlands

Modafinil TEVA 100 mg Tabletten

100 mg

tablete

peroralna uporaba

Belgija

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

Teva Pharma B.V.

Computerweg 10,

3542 DR Utrecht

The Netherlands

MODAFINIL TEVA 100MG

100 mg

tablete

peroralna uporaba

Belgija

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

N.V. Organon

Kloosterstraat 6,

5349 AB Oss

The Netherlands

PROVIGIL

100 mg

tablete

peroralna uporaba

Ciper

| GENESIS PHARMA (CYPRUS) LTD, |
| --- |
| 2 Amfipoleos, 1st floor, |
| P.O.Box 23638, |
| 2025 Strovolos, Lefkosia, |
| Cyprus |

GENESIS PHARMA (CYPRUS) LTD,

2 Amfipoleos, 1st floor,

P.O.Box 23638,

2025 Strovolos, Lefkosia,

Cyprus

MODIODAL

100 mg

tablete

peroralna uporaba

Republika Češka

| Teva Pharmaceuticals CR, s.r.o. |
| --- |
| Anděl City |
| Radlická 1c |
| 150 00 Praha 5 |
| Czech Republic |

Teva Pharmaceuticals CR, s.r.o.

Anděl City

Radlická 1c

150 00 Praha 5

Czech Republic

Modafinil-Teva 100 mg

100 mg

tablete

peroralna uporaba

Republika Češka

| Torrex Chiesi CZ, s.r.o. |
| --- |
| Na Květnici 33 |
| 140 00 Praha 4 |
| Czech Republic |

Torrex Chiesi CZ, s.r.o.

Na Květnici 33

140 00 Praha 4

Czech Republic

Vigil

100 mg

tablete

peroralna uporaba

Danska

| Cephalon France, |
| --- |
| 20, rue Charles Matigny, |
| 94700 Maisons-Alfort, |
| France |

Cephalon France,

20, rue Charles Matigny,

94700 Maisons-Alfort,

France

Modiodal

100 mg

tablete

peroralna uporaba

Danska

| Teva Denmark A/S, |
| --- |
| Parallelvej 10, |
| 2800 Kongens Lyngby, |
| Denmark |

Teva Denmark A/S,

Parallelvej 10,

2800 Kongens Lyngby,

Denmark

Modafinil „Teva“

100 mg

tablete

peroralna uporaba

Finska

| ORCHID EUROPE LTD |
| --- |
| Building 3, Chiswick park 556, |
| Chiswick High Road |
| London W4 5YA |
| United Kingdom |

ORCHID EUROPE LTD

Building 3, Chiswick park 556,

Chiswick High Road

London W4 5YA

United Kingdom

MODAFINIL

100 mg

tablete

peroralna uporaba

Finska

| ORCHID EUROPE LTD |
| --- |
| Building 3, Chiswick park 556, |
| Chiswick High Road |
| London W4 5YA |
| United Kingdom |

ORCHID EUROPE LTD

Building 3, Chiswick park 556,

Chiswick High Road

London W4 5YA

United Kingdom

MODAFINIL

200 mg

tablete

peroralna uporaba

Francija

| CEPHALON France |
| --- |
| 20, rue Charles Martigny |
| 94701 Maisons-Alfort Cedex |
| France |

CEPHALON France

20, rue Charles Martigny

94701 Maisons-Alfort Cedex

France

MODIODAL 100 mg, comprimé

100 mg

tablete

peroralna uporaba

Francija

| CEPHALON France |
| --- |
| 20, rue Charles Martigny |
| 94701 Maisons-Alfort Cedex |
| France |

CEPHALON France

20, rue Charles Martigny

94701 Maisons-Alfort Cedex

France

MODAFINIL LAFON 100 mg, comprimé

100 mg

tablete

peroralna uporaba

Francija

| TEVA SANTE |
| --- |
| Le Palatin 1 |
| 1, cours du Triangle |
| 92936 Paris la Défense Cedex |
| France |

TEVA SANTE

Le Palatin 1

1, cours du Triangle

92936 Paris la Défense Cedex

France

MODAFINIL TEVA 100 mg, comprimé

100 mg

tablete

peroralna uporaba

Nemčija

| Cephalon Pharma GmbH |
| --- |
| Fraunhoferstr. 9a |
| D-82152 Martinsried |
| Germany |

Cephalon Pharma GmbH

Fraunhoferstr. 9a

D-82152 Martinsried

Germany

Vigil 100 mg Tabletten

100 mg

tablete

peroralna uporaba

Grčija

| GENESIS PHARMA |
| --- |
| Kiffissias Avenue 274 |
| Halandri Athens 152 32 |
| Greece |

GENESIS PHARMA

Kiffissias Avenue 274

Halandri Athens 152 32

Greece

MODIODAL

100 mg/tabl

tablete

peroralna uporaba

Madžarska

| TORREX Chiesi Kft. |
| --- |
| 1052 Budapest |
| Kristóf tér 4. III/1-3. |
| Hungary |

TORREX Chiesi Kft.

1052 Budapest

Kristóf tér 4. III/1-3.

Hungary

VIGIL

100 mg

tablete

peroralna uporaba

Islandija

| Cephalon France |
| --- |
| 20, rue Charles Martigny |
| 94700 Maisons Alfort |
| France |

Cephalon France

20, rue Charles Martigny

94700 Maisons Alfort

France

Modiodal

100 mg

tablete

peroralna uporaba

Irska

| Cephalon UK Limited |
| --- |
| 1 Albany Place Hyde Way |
| Welwyn Garden City |
| Hertfordshire AL7 3BT |
| United Kingdom |

Cephalon UK Limited

1 Albany Place Hyde Way

Welwyn Garden City

Hertfordshire AL7 3BT

United Kingdom

PROVIGIL 100 mg tablets

100 mg

tablete

peroralna uporaba

Irska

| Cephalon UK Limited |
| --- |
| 1 Albany Place Hyde Way |
| Welwyn Garden City |
| Hertfordshire AL7 3BT |
| United Kingdom |

Cephalon UK Limited

1 Albany Place Hyde Way

Welwyn Garden City

Hertfordshire AL7 3BT

United Kingdom

PROVIGIL 200 mg tablets

200 mg

tablete

peroralna uporaba

Irska

| Teva Pharma B.V. |
| --- |
| Computerweg 10 |
| 3542DR Utrecht |
| The Netherlands |

Teva Pharma B.V.

Computerweg 10

3542DR Utrecht

The Netherlands

Modafinil Teva 100 mg tablet

100 mg

tablete

peroralna uporaba

Italija

| CEPHALON SRL |
| --- |
| Piazza G. Marconi, 25 |
| 00144 ROMA |
| Italia |

CEPHALON SRL

Piazza G. Marconi, 25

00144 ROMA

Italia

PROVIGIL

100 mg

tablete

peroralna uporaba

Italija

| TEVA ITALIA S.R.L. |
| --- |
| Via Messina, 38 |
| 20154 Milano |
| Italia |

TEVA ITALIA S.R.L.

Via Messina, 38

20154 Milano

Italia

MODAFINIL TEVA

100 mg

tablete

peroralna uporaba

Luksemburg

| ORGANON N.V |
| --- |
| Kloosterstraat 6 |
| NL-5349 AB Oss |
| The Netherlands |

ORGANON N.V

Kloosterstraat 6

NL-5349 AB Oss

The Netherlands

PROVIGIL

100 mg

tablete

peroralna uporaba

Nizozemska

| Cephalon France, |
| --- |
| 20 rus Charles Martigny, |
| 94700 Maisons-Alfort, |
| France |

Cephalon France,

20 rus Charles Martigny,

94700 Maisons-Alfort,

France

Modiodal, 100 mg tabletten

100 mg

tablete

peroralna uporaba

Poljska

| Torrex Chiesi Pharma GmbH, |
| --- |
| Gonzagagasse 16/16, |
| A-1010 Vienna, |
| Austria |

Torrex Chiesi Pharma GmbH,

Gonzagagasse 16/16,

A-1010 Vienna,

Austria

Vigil

100 mg

tablete

peroralna uporaba

Portugalska

| Cephalon France |
| --- |
| 20, Rue Charles Martigny |
| 94700 Maisons-Alfort |
| France |

Cephalon France

20, Rue Charles Martigny

94700 Maisons-Alfort

France

Modiodal

100 mg

tablete

peroralna uporaba

Portugalska

| Generis Farmacêutica, S.A. |
| --- |
| Office Park da Beloura, Edifício 4, |
| Quinta da Beloura |
| 2710-444 Sintra |
| Portugal |

Generis Farmacêutica, S.A.

Office Park da Beloura, Edifício 4,

Quinta da Beloura

2710-444 Sintra

Portugal

Modafinil Generis

100 mg

tablete

peroralna uporaba

Slovaška

| Teva Pharmaceuticals CR, s.r.o., |
| --- |
| Radlická 3185/1c |
| 150 00, Prague, |
| Czech Republic |

Teva Pharmaceuticals CR, s.r.o.,

Radlická 3185/1c

150 00, Prague,

Czech Republic

Modafinil-Teva 100 mg

100 mg

tablete

peroralna uporaba

Slovaška

| Torrex Chiesi Pharma GmbH, |
| --- |
| Gonzagagasse 16/16, |
| 1010, Vienna, |
| Austria |

Torrex Chiesi Pharma GmbH,

Gonzagagasse 16/16,

1010, Vienna,

Austria

VIGIL 100 mg

100 mg

tablete

peroralna uporaba

Španija

| CEPHALON FRANCE, |
| --- |
| 20, Rue Charles Martigny |
| 94700 Maisons Alfort |
| France |

CEPHALON FRANCE,

20, Rue Charles Martigny

94700 Maisons Alfort

France

MODIODAL

100 mg

tablete

peroralna uporaba

Španija

| TEVA GENERICOS ESPAÑOLA, S.L |
| --- |
| Guzmán el Bueno 133, |
| Edificio Britania 4oIzq.. |
| 28003 Madrid |
| Spain |

TEVA GENERICOS ESPAÑOLA, S.L

Guzmán el Bueno 133,

Edificio Britania 4oIzq..

28003 Madrid

Spain

MODAFINILO TEVA

100 mg

tablete

peroralna uporaba

Švedska

| Cephalon France, |
| --- |
| 20, rue Charles Martigny |
| 94700 Maisons Alfort |
| France |

Cephalon France,

20, rue Charles Martigny

94700 Maisons Alfort

France

Modiodal®

100 mg

tablete

peroralna uporaba

Švedska

| Teva Sweden AB, |
| --- |
| Box 1070 |
| 251 10 Helsingborg, |
| Sverige |

Teva Sweden AB,

Box 1070

251 10 Helsingborg,

Sverige

Modafinil Teva

100 mg

tablete

peroralna uporaba

Združeno kraljestvo

| Cephalon UK Limited |
| --- |
| 1 Albany Place Hyde Way |
| Welwyn Garden City |
| Hertfordshire AL7 3BT |
| United Kingdon |

Cephalon UK Limited

1 Albany Place Hyde Way

Welwyn Garden City

Hertfordshire AL7 3BT

United Kingdon

Provigil 100 mg Tablets

100 mg

tablete

peroralna uporaba

Združeno kraljestvo

| Cephalon UK Limited |
| --- |
| 1 Albany Place Hyde Way |
| Welwyn Garden City |
| Hertfordshire AL7 3BT |
| United Kingdom |

Cephalon UK Limited

1 Albany Place Hyde Way

Welwyn Garden City

Hertfordshire AL7 3BT

United Kingdom

Provigil 200 mg Tablets

200 mg

tablete

peroralna uporaba

Združeno kraljestvo

| Teva UK Limited, |
| --- |
| Brampton Road, Hampden Park, Eastbourne, |
| East Sussex BN22 9AG |
| United Kingdom |

Teva UK Limited,

Brampton Road, Hampden Park, Eastbourne,

East Sussex BN22 9AG

United Kingdom

Modafinil 100 mg Tablets

100 mg

tablete

peroralna uporaba

---

DODATEK VI

SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVIL, POTI UPORABE ZDRAVILA, PREDLAGATELJEV V DRŽAVAH ČLANICAH

| Država članica EU/EGP | Predlagatelj | Izmišljeno ime Ime | Jakost | Farmacevtska oblika | Pot uporabe zdravila |
| --- | --- | --- | --- | --- | --- |
| Avstrija | ALFRED E. TIEFENBACHER |
| (GmbH & Co. KG) |
| Van-der-Smissen-Strasse 1 |
| 22767 Hamburg |
| Germany |

Država članica EU/EGP

Predlagatelj

Izmišljeno ime Ime

Jakost

Farmacevtska oblika

Pot uporabe zdravila

Avstrija

ALFRED E. TIEFENBACHER

(GmbH & Co. KG)

Van-der-Smissen-Strasse 1

22767 Hamburg

Germany

Galantamin STADA 8 mg Retardtabletten

8 mg

Tableta s podaljšanim sproščanjem

Peroralna uporaba

Avstrija

| ALFRED E. TIEFENBACHER |
| --- |
| (GmbH & Co. KG) |
| Van-der-Smissen-Strasse 1 |
| 22767 Hamburg |
| Germany |

ALFRED E. TIEFENBACHER

(GmbH & Co. KG)

Van-der-Smissen-Strasse 1

22767 Hamburg

Germany

Galantamin STADA 16 mg Retardtabletten

16 mg

Tableta s podaljšanim sproščanjem

Peroralna uporaba

Avstrija

| ALFRED E. TIEFENBACHER |
| --- |
| (GmbH & Co. KG) |
| Van-der-Smissen-Strasse 1 |
| 22767 Hamburg |
| Germany |

ALFRED E. TIEFENBACHER

(GmbH & Co. KG)

Van-der-Smissen-Strasse 1

22767 Hamburg

Germany

Galantamin STADA 24 mg Retardtabletten

24 mg

Tableta s podaljšanim sproščanjem

Peroralna uporaba

Češka

| ALFRED E. TIEFENBACHER |
| --- |
| (GmbH & Co. KG) |
| Van-der-Smissen-Strasse 1 |
| 22767 Hamburg |
| Germany |

ALFRED E. TIEFENBACHER

(GmbH & Co. KG)

Van-der-Smissen-Strasse 1

22767 Hamburg

Germany

GALASTAD 8 mg

8 mg

Tableta s podaljšanim sproščanjem

Peroralna uporaba

Češka

| ALFRED E. TIEFENBACHER |
| --- |
| (GmbH & Co. KG) |
| Van-der-Smissen-Strasse 1 |
| 22767 Hamburg |
| Germany |

ALFRED E. TIEFENBACHER

(GmbH & Co. KG)

Van-der-Smissen-Strasse 1

22767 Hamburg

Germany

GALASTAD 16 mg

16 mg

Tableta s podaljšanim sproščanjem

Peroralna uporaba

Češka

| ALFRED E. TIEFENBACHER |
| --- |
| (GmbH & Co. KG) |
| Van-der-Smissen-Strasse 1 |
| 22767 Hamburg |
| Germany |

ALFRED E. TIEFENBACHER

(GmbH & Co. KG)

Van-der-Smissen-Strasse 1

22767 Hamburg

Germany

GALASTAD 24 mg

24 mg

Tableta s podaljšanim sproščanjem

Peroralna uporaba

Danska

| STADA Arzneimittel GmbH |
| --- |
| Muthgasse 36 |
| 1190 Wien |
| Austria |

STADA Arzneimittel GmbH

Muthgasse 36

1190 Wien

Austria

Galantamin STADA

8 mg

Tableta s podaljšanim sproščanjem

Peroralna uporaba

Danska

| STADA Arzneimittel GmbH |
| --- |
| Muthgasse 36 |
| 1190 Wien |
| Austria |

STADA Arzneimittel GmbH

Muthgasse 36

1190 Wien

Austria

Galantamin STADA

16 mg

Tableta s podaljšanim sproščanjem

Peroralna uporaba

Danska

| STADA Arzneimittel GmbH |
| --- |
| Muthgasse 36 |
| 1190 Wien |
| Austria |

STADA Arzneimittel GmbH

Muthgasse 36

1190 Wien

Austria

Galantamin STADA

24 mg

Tableta s podaljšanim sproščanjem

Peroralna uporaba

Finska

| STADA Arzneimittel AG |
| --- |
| Stadastraße 2-18 |
| 61118 Bad Vilbel |
| Germany |

STADA Arzneimittel AG

Stadastraße 2-18

61118 Bad Vilbel

Germany

Galantamine Stada

8 mg

Tableta s podaljšanim sproščanjem

Peroralna uporaba

Finska

| STADA Arzneimittel AG |
| --- |
| Stadastraße 2-18 |
| 61118 Bad Vilbel |
| Germany |

STADA Arzneimittel AG

Stadastraße 2-18

61118 Bad Vilbel

Germany

Galantamine Stada

16 mg

Tableta s podaljšanim sproščanjem

Peroralna uporaba

Finska

| STADA Arzneimittel AG |
| --- |
| Stadastraße 2-18 |
| 61118 Bad Vilbel |
| Germany |

STADA Arzneimittel AG

Stadastraße 2-18

61118 Bad Vilbel

Germany

Galantamine Stada

24 mg

Tableta s podaljšanim sproščanjem

Peroralna uporaba

Irska

| STADA Arzneimittel GmbH |
| --- |
| Muthgasse 36 |
| 1190 Wien |
| Austria |

STADA Arzneimittel GmbH

Muthgasse 36

1190 Wien

Austria

GALANTAX XL 8 mg prolonged-release tablets

8 mg

Tableta s podaljšanim sproščanjem

Peroralna uporaba

Irska

| STADA Arzneimittel GmbH |
| --- |
| Muthgasse 36 |
| 1190 Wien |
| Austria |

STADA Arzneimittel GmbH

Muthgasse 36

1190 Wien

Austria

GALANTAX XL 16 mg prolonged-release tablets

16 mg

Tableta s podaljšanim sproščanjem

Peroralna uporaba

Irska

| STADA Arzneimittel GmbH |
| --- |
| Muthgasse 36 |
| 1190 Wien |
| Austria |

STADA Arzneimittel GmbH

Muthgasse 36

1190 Wien

Austria

GALANTAX XL 24 mg prolonged-release tablets

24 mg

Tableta s podaljšanim sproščanjem

Peroralna uporaba

Portugalska

| STADA Arzneimittel GmbH |
| --- |
| Muthgasse 36 |
| 1190 Wien |
| Austria |

STADA Arzneimittel GmbH

Muthgasse 36

1190 Wien

Austria

Galantamina Ciclum

8 mg

Tableta s podaljšanim sproščanjem

Peroralna uporaba

Portugalska

| STADA Arzneimittel GmbH |
| --- |
| Muthgasse 36 |
| 1190 Wien |
| Austria |

STADA Arzneimittel GmbH

Muthgasse 36

1190 Wien

Austria

Galantamina Ciclum

16 mg

Tableta s podaljšanim sproščanjem

Peroralna uporaba

Portugalska

| STADA Arzneimittel GmbH |
| --- |
| Muthgasse 36 |
| 1190 Wien |
| Austria |

STADA Arzneimittel GmbH

Muthgasse 36

1190 Wien

Austria

Galantamina Ciclum

24 mg

Tableta s podaljšanim sproščanjem

Peroralna uporaba

Slovaška

| ALFRED E. TIEFENBACHER |
| --- |
| (GmbH & Co. KG) |
| Van-der-Smissen-Strasse 1 |
| 22767 Hamburg |
| Germany |

ALFRED E. TIEFENBACHER

(GmbH & Co. KG)

Van-der-Smissen-Strasse 1

22767 Hamburg

Germany

Galantamine Tiefenbacher 8 mg tablety s predĺženým uvoľňovaním

8 mg

Tableta s podaljšanim sproščanjem

Peroralna uporaba

Slovaška

| ALFRED E. TIEFENBACHER |
| --- |
| (GmbH & Co. KG) |
| Van-der-Smissen-Strasse 1 |
| 22767 Hamburg |
| Germany |

ALFRED E. TIEFENBACHER

(GmbH & Co. KG)

Van-der-Smissen-Strasse 1

22767 Hamburg

Germany

Galantamine Tiefenbacher 16 mg tablety s predĺženým uvoľňovaním

16 mg

Tableta s podaljšanim sproščanjem

Peroralna uporaba

Slovaška

| ALFRED E. TIEFENBACHER |
| --- |
| (GmbH & Co. KG) |
| Van-der-Smissen-Strasse 1 |
| 22767 Hamburg |
| Germany |

ALFRED E. TIEFENBACHER

(GmbH & Co. KG)

Van-der-Smissen-Strasse 1

22767 Hamburg

Germany

Galantamine Tiefenbacher 24 mg tablety s predĺženým uvoľňovaním

24 mg

Tableta s podaljšanim sproščanjem

Peroralna uporaba

Španija

| ALFRED E. TIEFENBACHER |
| --- |
| (GmbH & Co. KG) |
| Van-der-Smissen-Strasse 1 |
| 22767 Hamburg |
| Germany |

ALFRED E. TIEFENBACHER

(GmbH & Co. KG)

Van-der-Smissen-Strasse 1

22767 Hamburg

Germany

GALANTAMINA Tiefenbacher 8 mg comprimidos de liberación prolongada

8 mg

Tableta s podaljšanim sproščanjem

Peroralna uporaba

Španija

| ALFRED E. TIEFENBACHER |
| --- |
| (GmbH & Co. KG) |
| Van-der-Smissen-Strasse 1 |
| 22767 Hamburg |
| Germany |

ALFRED E. TIEFENBACHER

(GmbH & Co. KG)

Van-der-Smissen-Strasse 1

22767 Hamburg

Germany

GALANTAMINA Tiefenbacher 16 mg comprimidos de liberación prolongada

16 mg

Tableta s podaljšanim sproščanjem

Peroralna uporaba

Španija

| ALFRED E. TIEFENBACHER |
| --- |
| (GmbH & Co. KG) |
| Van-der-Smissen-Strasse 1 |
| 22767 Hamburg |
| Germany |

ALFRED E. TIEFENBACHER

(GmbH & Co. KG)

Van-der-Smissen-Strasse 1

22767 Hamburg

Germany

GALANTAMINA Tiefenbacher 24 mg comprimidos de liberación prolongada

24 mg

Tableta s podaljšanim sproščanjem

Peroralna uporaba

---