# Jurnalul Oficial C 383/2011

| | ISSN 1977-1029
  doi:10.3000/19771029.C_2011.383.ron |
| --- | --- |
| Jurnalul Oficial
  al Uniunii Europene | C 383 |
| | |
| Ediţia în limba română | Comunicări şi informări | Anul 5430 decembrie 2011 |

ISSN 1977-1029

doi:10.3000/19771029.C_2011.383.ron

Jurnalul Oficial

al Uniunii Europene

C 383

Ediţia în limba română

Comunicări şi informări

Anul 5430 decembrie 2011

---

| Informarea nr. | Cuprins | Pagina |
| --- | --- | --- |
| | IV   Informări |
| | INFORMĂRI PROVENIND DE LA INSTITUȚIILE, ORGANELE ȘI ORGANISMELE UNIUNII EUROPENE |
| | Comisia Europeană |
| 2011/C 383/01 | Rezumatul deciziilor Uniunii Europene privind autorizațiile de introducere pe piață pentru medicamentele de la 1 septembrie 2011 până la 31 octombrie 2011[Publicat în temeiul articolului 13 sau al articolului 38 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului] | 1 |
| 2011/C 383/02 | Rezumatul deciziilor Uniunii Europene privind autorizațiile de introducere pe piață pentru medicamentele de la 1 septembrie 2011 până la 31 octombrie 2011(Deciziile luate în temeiul articolului 34 din Directiva 2001/83/CE sau al articolului 38 din Directiva 2001/82/CE) | 17 |

Informarea nr.

Cuprins

Pagina

IV   Informări

INFORMĂRI PROVENIND DE LA INSTITUȚIILE, ORGANELE ȘI ORGANISMELE UNIUNII EUROPENE

Comisia Europeană

2011/C 383/01

Rezumatul deciziilor Uniunii Europene privind autorizațiile de introducere pe piață pentru medicamentele de la 1 septembrie 2011 până la 31 octombrie 2011[Publicat în temeiul articolului 13 sau al articolului 38 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului]

[Publicat în temeiul articolului 13 sau al articolului 38 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului]

1

2011/C 383/02

Rezumatul deciziilor Uniunii Europene privind autorizațiile de introducere pe piață pentru medicamentele de la 1 septembrie 2011 până la 31 octombrie 2011(Deciziile luate în temeiul articolului 34 din Directiva 2001/83/CE sau al articolului 38 din Directiva 2001/82/CE)

(Deciziile luate în temeiul articolului 34 din Directiva 2001/83/CE sau al articolului 38 din Directiva 2001/82/CE)

17

| RO | |
| --- | --- |

RO

---

IV Informări

INFORMĂRI PROVENIND DE LA INSTITUȚIILE, ORGANELE ȘI ORGANISMELE UNIUNII EUROPENE

Comisia Europeană

| 30.12.2011 | RO | Jurnalul Oficial al Uniunii Europene | C 383/1 |
| --- | --- | --- | --- |

30.12.2011

RO

Jurnalul Oficial al Uniunii Europene

C 383/1

---

Rezumatul deciziilor Uniunii Europene privind autorizațiile de introducere pe piață pentru medicamentele de la 1 septembrie 2011 până la 31 octombrie 2011

[Publicat în temeiul articolului 13 sau al articolului 38 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului
   (1)
  ]

2011/C 383/01

—   Emiterea unei autorizații de introducere pe piață (articolul 13 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului): Acceptat

| Data deciziei | Denumirea medicamentului | DCI (Denumirea Comună Internațională) | Titularul autorizației de introducere pe piață | Numărul de înregistrare în Registrul comunitar | Formă farmaceutică | Codul ATC (Codul Anatomic-Terapeutic-Chimic) | Data notificării |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 2.9.2011 | Vibativ | telavancin | Astellas Pharma Europe B.V. |
| Elisabethhof 19, |
| NL-2353 EW Leiderdorp, |
| Nederland |

Data deciziei

Denumirea medicamentului

DCI (Denumirea Comună Internațională)

Titularul autorizației de introducere pe piață

Numărul de înregistrare în Registrul comunitar

Formă farmaceutică

Codul ATC (Codul Anatomic-Terapeutic-Chimic)

Data notificării

2.9.2011

Vibativ

telavancin

Astellas Pharma Europe B.V.

Elisabethhof 19,

NL-2353 EW Leiderdorp,

Nederland

EU/1/11/705/001-002

Pulbere pentru concentrat pentru soluție perfuzabilă

J01XA03

6.9.2011

2.9.2011

Votubia

Everolimus

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

Novartis Europharm Limited

Wimblehurst Road, Horsham,

West Sussex,

RH12 5AB,

United Kingdom

EU/1/11/710/001-007

Comprimat

L01XE10

6.9.2011

5.9.2011

Zytiga

abirateronă

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

Janssen-Cilag International NV

Turnhoutseweg 30,

B-2340 Beerse,

België

EU/1/11/714/001

Comprimat

L02BX03

7.9.2011

16.9.2011

Dexdor

dexmedetomidină

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

Orion Corporation

Orionintie 1,

FI-02200 Espoo,

Suomi

EU/1/11/718/001-006

Concentrat pentru soluție perfuzabilă

N05CM18

21.9.2011

19.9.2011

Incivo

telaprevir

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

Janssen-Cilag International NV

Turnhoutseweg 30,

B-2340 Beerse,

België

EU/1/11/720/001

Comprimat filmat

Pending

22.9.2011

30.9.2011

Pramipexole Accord

Pramipexol

| Accord Healthcare Limited |
| --- |
| 5th Floor Charles House, 108/110 Finchley road, |
| London |
| NW3 5JJ, |
| United Kingdom |

Accord Healthcare Limited

5th Floor Charles House, 108/110 Finchley road,

London

NW3 5JJ,

United Kingdom

EU/1/11/728/001-010

Comprimat

N04BC05

4.10.2011

3.10.2011

Levetiracetam Accord

Levetiracetam

| Accord Healthcare Limited |
| --- |
| 5th Floor Charles House, 108/110 Finchley road, |
| London |
| NW3 5JJ, |
| United Kingdom |

Accord Healthcare Limited

5th Floor Charles House, 108/110 Finchley road,

London

NW3 5JJ,

United Kingdom

EU/1/11/712/001-028

Comprimat filmat

N03AX14

5.1.2011

3.10.2011

Levetiracetam Actavis

Levetiracetam

| Actavis Group PTC ehf. |
| --- |
| Reykjavikurvegur 76-78, |
| 220 Hafnarfjordur, |
| Iceland |

Actavis Group PTC ehf.

Reykjavikurvegur 76-78,

220 Hafnarfjordur,

Iceland

EU/1/11/713/001-040

Comprimat filmat

N03AX14

5.10.2011

3.10.2011

Matever

Levetiracetam

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

Pharmathen S.A.

6 Dervenakion,

15351 Pallini Attiki,

Ελλάδα

EU/1/11/711/001-030

Comprimat filmat

Concentrat pentru soluție perfuzabilă

N03AX14

6.10.2011

3.10.2011

Telmisartan Teva Pharma

telmisartan

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

Teva Pharma B.V.

Computerweg 10,

3542 DR Utrecht,

Nederland

EU/1/11/719/001-060

Comprimat

C09CA07

5.10.2011

27.10.2011

Eurartesim

dihidroartemisinină / tetrafosfat de piperachină

| Sigma-Tau Industrie Farmaceutiche Riunite S.p.A |
| --- |
| Viale Shakespeare 47, |
| 00144 Rome, |
| Italia |

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A

Viale Shakespeare 47,

00144 Rome,

Italia

EU/1/11/716/001-005

Comprimat filmat

P01BF05

2.11.2011

—   Modificarea unei autorizații de introducere pe piață (articolul 13 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului): Acceptat

| Data deciziei | Denumirea medicamentului | Titularul autorizației de introducere pe piață | Numărul de înregistrare în Registrul comunitar | Data notificării |
| --- | --- | --- | --- | --- |
| 2.9.2011 | CoAprovel | Sanofi Pharma Bristol-Myers Squibb SNC |
| 174 avenue de France - |
| 75013 Paris, |
| France |

Data deciziei

Denumirea medicamentului

Titularul autorizației de introducere pe piață

Numărul de înregistrare în Registrul comunitar

Data notificării

2.9.2011

CoAprovel

Sanofi Pharma Bristol-Myers Squibb SNC

174 avenue de France -

75013 Paris,

France

EU/1/98/086/001-034

6.9.2011

2.9.2011

Lucentis

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

Novartis Europharm Ltd

Wimblehurst Road, Horsham, West Sussex

RH12 5AB,

United Kingdom

EU/1/06/374/001

6.9.2011

2.9.2011

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

6.9.2011

5.9.2011

Advagraf

| 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/1/07/387/001-026

7.9.2011

5.9.2011

Aflunov

| 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/1/10/658/001-002

7.9.2011

5.9.2011

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

7.9.2011

5.9.2011

Cayston

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

Gilead Sciences International Limited

Granta Park, Abington,

Cambridge

CB21 6GT,

United Kingdom

EU/1/09/543/001-002

7.9.2011

5.9.2011

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

7.9.2011

5.9.2011

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

7.9.2011

5.9.2011

Removab

| Fresenius Biotech GmbH |
| --- |
| Am Haag 6-7, |
| D-82166 Graefelfing, |
| Deutschland |

Fresenius Biotech GmbH

Am Haag 6-7,

D-82166 Graefelfing,

Deutschland

EU/1/09/512/001-002

7.9.2011

5.9.2011

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

7.9.2011

5.9.2011

Viracept

| 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/1/97/054/001

EU/1/97/054/004-005

7.9.2011

7.9.2011

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

9.9.2011

7.9.2011

Circadin

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

RAD Neurim Pharmaceuticals EEC Limited

One Forbury Square, The Forbury, Reading,

Berkshire

RG1 3EB,

United Kingdom

EU/1/07/392/003

13.9.2011

7.9.2011

Irbesartan HCT Winthrop

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

Sanofi-Aventis

174, avenue de France,

F-75013 Paris,

France

EU/1/06/377/001-028

9.9.2011

13.9.2011

Ammonaps

| Swedish Orphan Biovitrum International AB |
| --- |
| SE-11276 Stockholm, |
| Sverige |

Swedish Orphan Biovitrum International AB

SE-11276 Stockholm,

Sverige

EU/1/99/120/003-004

15.9.2011

13.9.2011

Luminity

| Lantheus MI UK Limited |
| --- |
| Festival House - 39 Oxford Street - Newbury - |
| Berkshire |
| RG14 1JG - |
| United Kingdom |

Lantheus MI UK Limited

Festival House - 39 Oxford Street - Newbury -

Berkshire

RG14 1JG -

United Kingdom

EU/1/06/361/001-002

15.9.2011

13.9.2011

Raloxifene Teva

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

Teva Pharma B.V.

Computerweg 10,

3542 DR Utrecht,

Nederland

EU/1/10/627/001-003

15.9.2011

13.9.2011

Synagis

| 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/1/99/117/001-002

15.9.2011

13.9.2011

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

15.9.2011

13.9.2011

Zypadhera

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

Eli Lilly Nederland B.V.

Grootslag 1-5,

NL-3991 RA Houten,

Nederland

EU/1/08/479/001-003

16.9.2011

16.9.2011

Aerius

| 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/1/00/160/001-013

EU/1/00/160/022-034

EU/1/00/160/036-069

21.9.2011

16.9.2011

Angiox

| The Medicines Company UK Ltd |
| --- |
| 115 L Milton Park, Abingdon, |
| Oxfordshire, |
| OX14 4SA, |
| United Kingdom |

The Medicines Company UK Ltd

115 L Milton Park, Abingdon,

Oxfordshire,

OX14 4SA,

United Kingdom

EU/1/04/289/001

20.9.2011

16.9.2011

Azomyr

| 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/1/00/157/001-013

EU/1/00/157/022-067

21.9.2011

16.9.2011

Azopt

| 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/1/00/129/001-003

20.9.2011

16.9.2011

Ilaris

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

Novartis Europharm Ltd

Wimblehurst Road, Horsham,

West Sussex

RH12 5AB,

United Kingdom

EU/1/09/564/001-003

20.9.2011

16.9.2011

Myclausen

| Herbert J. Passauer GmbH & Co. KG |
| --- |
| Stubenrauchstrasse 33, |
| 14167 Berlin, |
| Deutschland |

Herbert J. Passauer GmbH & Co. KG

Stubenrauchstrasse 33,

14167 Berlin,

Deutschland

EU/1/10/647/001-004

20.9.2011

16.9.2011

Neoclarityn

| 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/1/00/161/001-013

EU/1/00/161/022-067

21.9.2011

16.9.2011

NeuroBloc

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

Eisai Limited

European Knowledge Centre, Mosquito Way, Hatfield,

Hertfordshire,

AL10 9SN,

United Kingdom

EU/1/00/166/001-003

20.9.2011

16.9.2011

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

21.9.2011

16.9.2011

Resolor

| Shire-Movetis NV |
| --- |
| Veedjik 58 (1004), |
| B-2300 Turnhout, |
| Belgium |

Shire-Movetis NV

Veedjik 58 (1004),

B-2300 Turnhout,

Belgium

EU/1/09/581/001-008

21.9.2011

16.9.2011

Suboxone

| RB Pharmaceuticals Limited |
| --- |
| 103-105 Bath Road, Slough, |
| Berkshire, |
| SL1 3UH, |
| United Kingdom |

RB Pharmaceuticals Limited

103-105 Bath Road, Slough,

Berkshire,

SL1 3UH,

United Kingdom

EU/1/06/359/001-004

20.9.2011

16.9.2011

Viramune

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

Boehringer Ingelheim International GmbH

Binger Strasse 173-

D - 55216 Ingelheim am Rhein,

Deutschland

EU/1/97/055/001-009

26.9.2011

19.9.2011

Byetta

| 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/1/06/362/001-004

22.9.2011

19.9.2011

Docetaxel Winthrop

| Aventis Pharma S.A. |
| --- |
| 20 avenue Raymond Aron, |
| F-92165 Antony Cedex, |
| France |

Aventis Pharma S.A.

20 avenue Raymond Aron,

F-92165 Antony Cedex,

France

EU/1/07/384/001-005

22.9.2011

19.9.2011

Ifirmasta

| 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/1/08/480/001-018

22.9.2011

19.9.2011

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

22.9.2011

19.9.2011

Zonegran

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

Eisai Limited

European Knowledge Centre, Mosquito Way, Hatfield,

Hertfordshire,

AL10 9SN,

United Kingdom

EU/1/04/307/001-021

22.9.2011

22.9.2011

Clopidogrel DURA

| Mylan dura GmbH |
| --- |
| Wittichstraße 6, |
| D-64295 Darmstadt, |
| Deutschland |

Mylan dura GmbH

Wittichstraße 6,

D-64295 Darmstadt,

Deutschland

EU/1/09/560/001-009

26.9.2011

22.9.2011

Ixiaro

| Intercell AG |
| --- |
| Campus Vienna Biocenter 3 |
| A-1030 Wien, |
| Österreich |

Intercell AG

Campus Vienna Biocenter 3

A-1030 Wien,

Österreich

EU/1/08/501/001-002

26.9.2011

22.9.2011

Leflunomide ratiopharm

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

ratiopharm GmbH

Graf-Arco-Straße 3,

D-89079 Ulm,

Deutschland

EU/1/10/654/001-004

26.9.2011

22.9.2011

Pergoveris

| Merck Serono Europe Limited |
| --- |
| 56, Marsh Wall, |
| London |
| E14 9TP, |
| United Kingdom |

Merck Serono Europe Limited

56, Marsh Wall,

London

E14 9TP,

United Kingdom

EU/1/07/396/001-003

26.9.2011

22.9.2011

RoActemra

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

Roche Registration Limited

6 Falcon Way, Shire Park,

Welwyn Garden City,

AL7 1TW,

United Kingdom

EU/1/08/492/001-006

26.9.2011

22.9.2011

Taxotere

| Aventis Pharma S.A. |
| --- |
| 20 avenue Raymond Aron, |
| F-92165 Antony Cedex, |
| France |

Aventis Pharma S.A.

20 avenue Raymond Aron,

F-92165 Antony Cedex,

France

EU/1/95/002/001-005

27.9.2011

30.9.2011

Aerinaze

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

SP Europe

Rue de Stalle, 73,

1180 Bruxelles,

Belgique -

Stallestraat, 73 -

1180 Brussel,

België

EU/1/07/399/001-006

4.10.2011

3.10.2011

Elaprase

| Shire Human Genetic Therapies AB |
| --- |
| Svärdvägen 11D, |
| 18233 Danderyd, |
| Sverige |

Shire Human Genetic Therapies AB

Svärdvägen 11D,

18233 Danderyd,

Sverige

EU/1/06/365/001-003

5.10.2011

3.10.2011

Lysodren

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

Laboratoire HRA Pharma

15, rue Béranger,

75003 Paris,

France

EU/1/04/273/001

5.10.2011

3.10.2011

Sprycel

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

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road,

Uxbridge

UB8 1DH,

United Kingdom

EU/1/06/363/001-015

5.10.2011

3.10.2011

Xagrid

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

Shire Pharmaceutical Contracts Ltd

Hampshire International Business Park, Chineham, Basingstoke,

Hampshire

RG24 8EP,

United Kingdom

EU/1/04/295/001

5.10.2011

6.10.2011

NeoRecormon

| 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/1/97/031/001-046

10.10.2011

6.10.2011

Noxafil

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

SP Europe

Rue de Stalle, 73,

1180 Bruxelles,

Belgique -

Stallestraat, 73 -

1180 Brussel,

België

EU/1/05/320/001

10.10.2011

6.10.2011

Sildenafil Actavis

| Actavis Group PTC ehf. |
| --- |
| Reykjavikurvegur 76-78, |
| 220 Hafnarfjordur, |
| Iceland |

Actavis Group PTC ehf.

Reykjavikurvegur 76-78,

220 Hafnarfjordur,

Iceland

EU/1/09/595/001-015

10.10.2011

6.10.2011

Sustiva

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

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road,

Uxbridge

UB8 1DH,

United Kingdom

EU/1/99/110/001-005

EU/1/99/110/008-010

10.10.2011

6.10.2011

Topotecan Hospira

| 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/1/10/633/001-002

10.10.2011

12.10.2011

Celsentri

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

ViiV Healthcare UK Ltd

980 Great West Road, Brentford,

Middlesex,

TW8 9GS,

United Kingdom

EU/1/07/418/001-010

13.10.2011

12.10.2011

Galvus

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

Novartis Europharm Ltd

Wimblehurst Road, Horsham,

West Sussex

RH12 5AB,

United Kingdom

EU/1/07/414/001-010

EU/1/07/414/018

14.10.2011

12.10.2011

Invega

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

Janssen-Cilag International NV

Turnhoutseweg, 30 -

2340 Beerse –

België

EU/1/07/395/001-095

14.10.2011

12.10.2011

Jalra

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

Novartis Europharm Ltd

Wimblehurst Road, Horsham,

West Sussex

RH12 5AB,

United Kingdom

EU/1/08/485/001-011

14.10.2011

12.10.2011

Rilonacept Regeneron

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

Regeneron UK Limited

40 Bank Street,

London,

E14 5DS

United Kingdom

EU/1/09/582/001

14.10.2011

12.10.2011

Stelara

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

Janssen-Cilag International NV

Turnhoutseweg, 30 -

2340 Beerse –

België

EU/1/08/494/001-004

14.10.2011

12.10.2011

Teysuno

| Taiho Pharma Europe, Limited |
| --- |
| 55 Colmore Row, Birmingham, |
| West Midlands, |
| B3 2AS, |
| United Kingdom |

Taiho Pharma Europe, Limited

55 Colmore Row, Birmingham,

West Midlands,

B3 2AS,

United Kingdom

EU/1/11/669/001-004

14.1.2011

12.10.2011

Xeplion

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

Janssen-Cilag International NV

Turnhoutseweg 30,

B-2340 Beerse,

België

EU/1/11/672/001-006

14.10.2011

12.10.2011

Xiliarx

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

Novartis Europharm Ltd

Wimblehurst Road, Horsham,

West Sussex

RH12 5AB,

United Kingdom

EU/1/08/486/001-011

14.10.2011

17.10.2011

Docetaxel Teva

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

Teva Pharma B.V.

Computerweg 10,

3542 DR Utrecht,

Nederland

EU/1/09/611/001-002

19.10.2011

20.10.2011

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

24.10.2011

20.10.2011

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

24.10.2011

20.10.2011

Mircera

| 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/1/07/400/008-013

EU/1/07/400/017-024

24.10.2011

20.10.2011

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

24.10.2011

20.10.2011

Zypadhera

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

Eli Lilly Nederland B.V.

Grootslag 1-5,

NL-3991 RA Houten,

Nederland

EU/1/08/479/001-003

24.10.2011

20.10.2011

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/1/96/022/002

EU/1/96/022/004

EU/1/96/022/006

EU/1/96/022/009-012

EU/1/96/022/014

EU/1/96/022/016-017

EU/1/96/022/019-040

28.9.2011

20.10.2011

Zyprexa Velotab

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

Eli Lilly Nederland B.V.

Grootslag 1-5,

3991 RA Houten,

Nederland

EU/1/99/125/001-020

28.9.2011

24.10.2011

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

26.10.2011

24.10.2011

Avonex

| Biogen Idec Ltd |
| --- |
| Innovation House, |
| 70 Norden Road, Maidenhead, |
| Berkshire |
| SL6 4AY, |
| United Kingdom |

Biogen Idec Ltd

Innovation House,

70 Norden Road, Maidenhead,

Berkshire

SL6 4AY,

United Kingdom

EU/1/97/033/002-006

26.10.2011

24.10.2011

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

26.10.2011

24.10.2011

Daxas

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

Nycomed GmbH

Byk-Gulden-Str. 2,

D-78467 Konstanz,

Deutschland

EU/1/10/636/001-007

26.10.2011

24.10.2011

Docetaxel Winthrop

| Aventis Pharma S.A. |
| --- |
| 20 avenue Raymond Aron, |
| F-92165 Antony Cedex, |
| France |

Aventis Pharma S.A.

20 avenue Raymond Aron,

F-92165 Antony Cedex,

France

EU/1/07/384/001-005

26.10.2011

24.10.2011

Ebixa

| H. Lundbeck A/S |
| --- |
| Ottiliavej 9, |
| DK-2500 Valby, |
| Danmark |

H. Lundbeck A/S

Ottiliavej 9,

DK-2500 Valby,

Danmark

EU/1/02/219/001-049

26.10.2011

24.10.2011

Efient

| 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/1/08/503/001-016

26.10.2011

24.10.2011

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

27.10.2011

24.10.2011

Erbitux

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

Merck KGaA

Frankfurter Straße 250,

64271 Darmstadt,

Deutschland

EU/1/04/281/001-005

26.10.2011

24.10.2011

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

26.10.2011

24.10.2011

Icandra

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

Novartis Europharm Ltd

Wimblehurst Road, Horsham,

West Sussex

RH12 5AB,

United Kingdom

EU/1/08/484/001-018

26.10.2011

24.10.2011

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

27.10.2011

24.10.2011

Irbesartan HCT Winthrop

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

Sanofi-Aventis

174, avenue de France,

F-75013 Paris,

France

EU/1/06/377/001-028

26.10.2011

24.10.2011

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

26.10.2011

24.10.2011

Kivexa

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

ViiV Healthcare UK Ltd

980 Great West Road, Brentford,

Middlesex,

TW8 9GS,

United Kingdom

EU/1/04/298/001-003

26.10.2011

24.10.2011

Levemir

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

Novo Nordisk A/S

Novo Allé,

DK-2880 Bagsvaerd,

Danmark

EU/1/04/278/001-016

26.10.2011

24.10.2011

Lyrica

| Pfizer Ltd |
| --- |
| Ramsgate Road, |
| Sandwich, |
| Kent |
| CT 139NJ, |
| United Kingdom |

Pfizer Ltd

Ramsgate Road,

Sandwich,

Kent

CT 139NJ,

United Kingdom

EU/1/04/279/001-044

26.10.2011

24.10.2011

Nexavar

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

Bayer Pharma AG

Berlin 13342,

Deutschland

EU/1/06/342/001

26.10.2011

24.10.2011

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/1/09/545/001-015

26.10.2011

24.10.2011

Prevenar 13

| Wyeth-Lederle Vaccines S.A. |
| --- |
| Pleinlaan 17 Boulevard de la Plaine, |
| 1050 Brussels - Bruxelles, |
| Belgïe-Belgique |

Wyeth-Lederle Vaccines S.A.

Pleinlaan 17 Boulevard de la Plaine,

1050 Brussels - Bruxelles,

Belgïe-Belgique

EU/1/09/590/001-006

26.10.2011

24.10.2011

Revatio

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

Pfizer Limited

Sandwich,

Kent,

CT13 9NJ,

United Kingdom

EU/1/05/318/001

26.10.2011

24.10.2011

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

26.10.2011

24.10.2011

Starlix

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

Novartis Europharm Ltd

Wimblehurst Road, Horsham,

West Sussex

RH12 5AB,

United Kingdom

EU/1/01/174/001-021

26.10.2011

24.10.2011

Sycrest

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

N.V. Organon

Kloosterstraat 6,

5349 AB Oss,

Nederland

EU/1/10/640/001-006

26.10.2011

24.10.2011

Toviaz

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

Pfizer Limited

Ramsgate Road,

Sandwich,

Kent

CT13 9NJ,

United Kingdom

EU/1/07/386/001-018

26.10.2011

24.10.2011

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

26.10.2011

24.10.2011

Ziagen

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

ViiV Healthcare UK Ltd

980 Great West Road, Brentford,

Middlesex,

TW8 9GS,

United Kingdom

EU/1/99/112/001-002

26.10.2011

27.10.2011

Advagraf

| 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/1/07/387/001-026

4.11.2011

27.10.2011

Axura

| Merz Pharmaceuticals GmbH |
| --- |
| Eckenheimer Landstr. 100, |
| D-60318 Frankfurt/Main – |
| Deutschland |

Merz Pharmaceuticals GmbH

Eckenheimer Landstr. 100,

D-60318 Frankfurt/Main –

Deutschland

EU/1/02/218/001-003

EU/1/02/218/005-030

4.11.2011

27.10.2011

Ceprotin

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

Baxter AG

Industriestraße 67,

A - 1221 Wien,

Österreich

EU/1/01/190/001-002

4.11.2011

27.10.2011

Eucreas

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

Novartis Europharm Ltd

Wimblehurst Road, Horsham,

West Sussex

RH12 5AB,

United Kingdom

EU/1/07/425/001-018

4.11.2011

27.10.2011

Exalief

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

BIAL - Portela & Ca, SA

A Av. da Siderurgia Nacional

4745-457 S. Mamede do Coronado –

Portugal

EU/1/09/520/001-020

4.11.2011

27.10.2011

Galvus

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

Novartis Europharm Ltd

Wimblehurst Road, Horsham,

West Sussex

RH12 5AB,

United Kingdom

EU/1/07/414/001-010

EU/1/07/414/018

4.11.2011

27.10.2011

Jalra

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

Novartis Europharm Ltd

Wimblehurst Road, Horsham,

West Sussex

RH12 5AB,

United Kingdom

EU/1/08/485/001-011

4.11.2011

27.10.2011

Leflunomide Winthrop

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

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main,

Deutschland

EU/1/09/604/001-010

1.11.2011

27.10.2011

Mixtard

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

Novo Nordisk A/S

Novo Allé,

DK-2880 Bagsvaerd,

Danmark

EU/1/02/231/030-032

1.11.2011

27.10.2011

Rapiscan

| Rapidscan Pharma Solutions EU Ltd. |
| --- |
| Regent's Place, 338 Euston Road, |
| London |
| NW1 3BT, |
| UK |

Rapidscan Pharma Solutions EU Ltd.

Regent's Place, 338 Euston Road,

London

NW1 3BT,

UK

EU/1/10/643/001

4.11.2011

27.10.2011

Rasilamlo

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

Novartis Europharm Ltd

Wimblehurst Road, Horsham,

West Sussex,

RH12 5AB,

United Kingdom

EU/1/11/686/001-056

4.11.2011

27.10.2011

Riprazo

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

Novartis Europharm Ltd

Wimblehurst Road, Horsham,

West Sussex

RH12 5AB,

United Kingdom

EU/1/07/409/001-040

1.11.2011

27.10.2011

Riprazo HCT

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

Novartis Europharm Limited

Wimblehurst Road, Horsham,

West Sussex,

RH12 5AB,

United Kingdom

EU/1/11/680/001-080

4.11.2011

27.10.2011

Sprimeo

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

Novartis Europharm Ltd

Wimblehurst Road, Horsham,

West Sussex

RH12 5AB,

United Kingdom

EU/1/07/407/001-040

1.11.2011

27.10.2011

Sprimeo HCT

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

Novartis Europharm Limited

Wimblehurst Road, Horsham,

West Sussex,

RH12 5AB,

United Kingdom

EU/1/11/683/001-080

4.11.2011

27.10.2011

Taxotere

| Aventis Pharma S.A. |
| --- |
| 20 avenue Raymond Aron, |
| F-92165 Antony Cedex, |
| France |

Aventis Pharma S.A.

20 avenue Raymond Aron,

F-92165 Antony Cedex,

France

EU/1/95/002/001-005

4.11.2011

27.10.2011

Tygacil

| 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/1/06/336/001

4.11.2011

27.10.2011

Xiliarx

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

Novartis Europharm Ltd

Wimblehurst Road, Horsham,

West Sussex

RH12 5AB,

United Kingdom

EU/1/08/486/001-011

4.11.2011

—   Retragerea unei autorizații de introducere pe piață (articolul 13 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului)

| Data deciziei | Denumirea medicamentului | Titularul autorizației de introducere pe piață | Numărul de înregistrare în Registrul comunitar | Data notificării |
| --- | --- | --- | --- | --- |
| 3.10.2011 | Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals | GlaxoSmithKline Biologicals S.A. |
| Rue de l'Institut 89, |
| 1330 Rixensart, |
| Belgique |

Data deciziei

Denumirea medicamentului

Titularul autorizației de introducere pe piață

Numărul de înregistrare în Registrul comunitar

Data notificării

3.10.2011

Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals

GlaxoSmithKline Biologicals S.A.

Rue de l'Institut 89,

1330 Rixensart,

Belgique

EU/1/08/478/001

5.10.2011

17.10.2011

Ablavar

| TMC Pharma Services Ltd. |
| --- |
| Lodge Farm Barn, Elvetham Park Estate, |
| Fleet Road, Hartley Wintney, |
| Hampshire, |
| RG27 8AS, |
| United Kingdom |

TMC Pharma Services Ltd.

Lodge Farm Barn, Elvetham Park Estate,

Fleet Road, Hartley Wintney,

Hampshire,

RG27 8AS,

United Kingdom

EU/1/05/313/001-009

19.10.2011

—   Emiterea unei autorizații de introducere pe piață (articolul 38 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului
   (2)
  ): Acceptat

| Data deciziei | Denumirea medicamentului | DCI (Denumirea Comună Internațională) | Titularul autorizației de introducere pe piață | Numărul de înregistrare în Registrul comunitar | Formă farmaceutică | Codul ATC (Codul Anatomic-Terapeutic-Chimic) | Data notificării |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 7.9.2011 | Nobivac Myxo-RHD | Virus viu, vector de mixomatoza, tulpina 009 | Intervet International B.V. |
| Wim de Körverstraat 35, |
| 5831 AN Boxmeer, |
| Nederland |

Data deciziei

Denumirea medicamentului

DCI (Denumirea Comună Internațională)

Titularul autorizației de introducere pe piață

Numărul de înregistrare în Registrul comunitar

Formă farmaceutică

Codul ATC (Codul Anatomic-Terapeutic-Chimic)

Data notificării

7.9.2011

Nobivac Myxo-RHD

Virus viu, vector de mixomatoza, tulpina 009

Intervet International B.V.

Wim de Körverstraat 35,

5831 AN Boxmeer,

Nederland

EU/2/11/132/001-004

Liofilizat și solvent pentru suspensie injectabilă

QI08AD

9.9.2011

13.9.2011

Recocam

Meloxicam

| CF Pharma Limited |
| --- |
| Unit 622, Northern Extension, |
| Waterford, |
| Ireland |

CF Pharma Limited

Unit 622, Northern Extension,

Waterford,

Ireland

EU/2/11/133/001-003

Soluție injectabilă

QM01AC06

15.9.2011

6.10.2011

Recuvyra

fentanil

| Nexcyon Pharmaceuticals Ltd. |
| --- |
| Bank Barn, How Mill, |
| Brampton, |
| Cumbria |
| CA8 9JY, |
| UNITED KINGDOM |

Nexcyon Pharmaceuticals Ltd.

Bank Barn, How Mill,

Brampton,

Cumbria

CA8 9JY,

UNITED KINGDOM

EU/2/11/127/001

Soluție transdermică

QN02AB03

11.10.2011

—   Modificarea unei autorizații de introducere pe piață (articolul 38 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului): Acceptat

| Data deciziei | Denumirea medicamentului | Titularul autorizației de introducere pe piață | Numărul de înregistrare în Registrul comunitar | Data notificării |
| --- | --- | --- | --- | --- |
| 5.9.2011 | Improvac | Pfizer Limited |
| Ramsgate Road, |
| Sandwich, |
| Kent |
| CT13 9NJ, |
| United Kingdom |

Data deciziei

Denumirea medicamentului

Titularul autorizației de introducere pe piață

Numărul de înregistrare în Registrul comunitar

Data notificării

5.9.2011

Improvac

Pfizer Limited

Ramsgate Road,

Sandwich,

Kent

CT13 9NJ,

United Kingdom

EU/2/09/095/001-006

7.9.2011

13.9.2011

Cortavance

| VIRBAC S.A. |
| --- |
| 1ère Avenue 2065 m L.I.D. - |
| 06516 Carros – |
| France |

VIRBAC S.A.

1ère Avenue 2065 m L.I.D. -

06516 Carros –

France

EU/2/06/069/001

15.9.2011

16.9.2011

Loxicom

| Norbrook Laboratories Limited |
| --- |
| Station Works, Newry, |
| Co. Down, |
| BT35 6JP, |
| United Kindgom |

Norbrook Laboratories Limited

Station Works, Newry,

Co. Down,

BT35 6JP,

United Kindgom

EU/2/08/090/001-026

20.9.2011

16.9.2011

Porcilis Pesti

| 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/2/99/016/001-006

21.9.2011

19.9.2011

ZULVAC 1 + 8 Ovis

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

Pfizer Limited

Ramsgate Road, Sandwich,

Kent

CT13 9NJ,

United Kingdom

EU/2/11/120/001-003

22.9.2011

20.10.2011

Suprelorin

| VIRBAC S.A. |
| --- |
| 1ère Avenue 2065 m L.I.D. - |
| 06516 Carros – |
| France |

VIRBAC S.A.

1ère Avenue 2065 m L.I.D. -

06516 Carros –

France

EU/2/07/072/003-004

24.10.2011

24.10.2011

Meloxoral

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

Le Vet B.V.

Wilgenweg 7,

3421 TV

Oudewater,

Nederland

EU/2/10/111/001-007

26.10.2011

Oricine este interesat să consulte raportul public de evaluare al medicamentului în cauză și deciziile aferente este invitat să contacteze:

| 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)  JO L 136, 30.4.2004, p. 1.

(2)  JO L 136, 30.4.2004, p. 1.

---

| 30.12.2011 | RO | Jurnalul Oficial al Uniunii Europene | C 383/17 |
| --- | --- | --- | --- |

30.12.2011

RO

Jurnalul Oficial al Uniunii Europene

C 383/17

---

Rezumatul deciziilor Uniunii Europene privind autorizațiile de introducere pe piață pentru medicamentele de la 1 septembrie 2011 până la 31 octombrie 2011

(Deciziile luate în temeiul articolului 34 din Directiva 2001/83/CE
   (1)
  sau al articolului 38 din Directiva 2001/82/CE
   (2)
  )

2011/C 383/02

—   Emiterea, prelungirea sau modificarea unei autorizații naționale de introducere pe piață

| Data deciziei | Denumirea medicamentului (medicamentelor) | Titularul (titularii) autorizației de introducere pe piață | Statul membru în cauză | Data notificării |
| --- | --- | --- | --- | --- |
| 7.10.2011 | Norvasc and associated names | A se vedea anexa I | A se vedea anexa I | 10.10.2011 |
| 20.10.2011 | Synulox Lactating Cow Art 34 | A se vedea anexa II | A se vedea anexa II | 21.10.2011 |
| 13.9.2011 | Dexrazoxane - Art 31 | A se vedea anexa III | A se vedea anexa III | 15.9.2011 |
| 2.9.2011 | Diflucan and associated names - Art 30 | A se vedea anexa IV | A se vedea anexa IV | 5.9.2011 |
| 24.10.2011 | Dexamethasone Alapis - Art 29 | A se vedea anexa V | A se vedea anexa V | 25.10.2011 |

Data deciziei

Denumirea medicamentului (medicamentelor)

Titularul (titularii) autorizației de introducere pe piață

Statul membru în cauză

Data notificării

7.10.2011

Norvasc and associated names

A se vedea anexa I

A se vedea anexa I

10.10.2011

20.10.2011

Synulox Lactating Cow Art 34

A se vedea anexa II

A se vedea anexa II

21.10.2011

13.9.2011

Dexrazoxane - Art 31

A se vedea anexa III

A se vedea anexa III

15.9.2011

2.9.2011

Diflucan and associated names - Art 30

A se vedea anexa IV

A se vedea anexa IV

5.9.2011

24.10.2011

Dexamethasone Alapis - Art 29

A se vedea anexa V

A se vedea anexa V

25.10.2011

—   Eliberarea unei autorizații de introducere pe piață - lista cererilor refuzate

| Data deciziei | Denumirea medicamentului (medicamentelor) | Titularul (titularii) autorizației de introducere pe piață | Statul membru în cauză | Data notificării |
| --- | --- | --- | --- | --- |
| 22.9.2011 | Canazole Clotrimazole Cream 1 % w/w - Art. 29 | A se vedea anexa VI | A se vedea anexa VI | 23.9.2011 |

Data deciziei

Denumirea medicamentului (medicamentelor)

Titularul (titularii) autorizației de introducere pe piață

Statul membru în cauză

Data notificării

22.9.2011

Canazole Clotrimazole Cream 1 % w/w - Art. 29

A se vedea anexa VI

A se vedea anexa VI

23.9.2011

—   Suspendarea unei autorizații naționale de introducere pe piață

| Data deciziei | Denumirea medicamentului (medicamentelor) | Titularul (titularii) autorizației de introducere pe piață | Statul membru în cauză | Data notificării |
| --- | --- | --- | --- | --- |
| 22.9.2011 | Canazole Clotrimazole Cream 1 % w/w - Art. 29 | A se vedea anexa VI | A se vedea anexa VI | 23.9.2011 |
| 16.9.2011 | Goserelin cell pharm 3,6 mg Implantat and associated names | A se vedea anexa VII | A se vedea anexa VII | 20.9.2011 |
| 16.9.2011 | Novimp 3,6 mg Implantat and associated names - Ref. Art.36 | A se vedea anexa VIII | A se vedea anexa VIII | 19.9.2011 |
| 16.9.2011 | Novosis Goserelin 3,6 mg Implantat and associated names | A se vedea anexa IX | A se vedea anexa IX | 19.9.2011 |

Data deciziei

Denumirea medicamentului (medicamentelor)

Titularul (titularii) autorizației de introducere pe piață

Statul membru în cauză

Data notificării

22.9.2011

Canazole Clotrimazole Cream 1 % w/w - Art. 29

A se vedea anexa VI

A se vedea anexa VI

23.9.2011

16.9.2011

Goserelin cell pharm 3,6 mg Implantat and associated names

A se vedea anexa VII

A se vedea anexa VII

20.9.2011

16.9.2011

Novimp 3,6 mg Implantat and associated names - Ref. Art.36

A se vedea anexa VIII

A se vedea anexa VIII

19.9.2011

16.9.2011

Novosis Goserelin 3,6 mg Implantat and associated names

A se vedea anexa IX

A se vedea anexa IX

19.9.2011

---

(1)  JO L 311, 28.11.01, p. 67.

(2)  JO L 311, 28.11.01, p. 1.

---

ANEXA I

LISTA CU DENUMIRILE COMERCIALE, FORMELE FARMACEUTICE, CONCENTRAȚIILE, CALEA DE ADMINISTRARE A MEDICAMENTULUI, DEȚINĂTORII AUTORIZAȚIEI DE PUNERE PE PIAȚĂ ÎN STATELE MEMBRE

| Statul Membru UE/SEE | Deținătorul autorizației de punere pe piață | Numele inventat | Concentrația | Forma farmaceutică | Calea de administrare |
| --- | --- | --- | --- | --- | --- |
| Austria | Pfizer Corporation Austria Ges.m.b.H. |
| Floridsdorfer Hauptstrasse 1 |
| A - 1210 Wien |
| Austria |

Statul Membru UE/SEE

Deținătorul autorizației de punere pe piață

Numele inventat

Concentrația

Forma farmaceutică

Calea de administrare

Austria

Pfizer Corporation Austria Ges.m.b.H.

Floridsdorfer Hauptstrasse 1

A - 1210 Wien

Austria

Norvasc 5 mg - Tabletten

5 mg

Comprimate

Orală

Austria

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

Pfizer Corporation Austria Ges.m.b.H.

Floridsdorfer Hauptstrasse 1

A - 1210 Wien

Austria

Norvasc 10 mg - Tabletten

10 mg

Comprimate

Orală

Belgia

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

Pfizer SA

Boulevard de la Plaine 17,

B-1050 Brussels

Belgium

Amlor

5 mg

Capsule

Orală

Belgia

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

Pfizer SA

Boulevard de la Plaine 17,

B-1050 Brussels

Belgium

Amlor

10 mg

Capsule

Orală

Bulgaria

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

Pfizer Europe MA EEIG,

Ramsgate Road,

Sandwich,

Kent,

CT13 9NJ,

United Kingdom

Norvasc

5 mg

Comprimate

Orală

Bulgaria

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

Pfizer Europe MA EEIG,

Ramsgate Road,

Sandwich,

Kent,

CT13 9NJ,

United Kingdom

Norvasc

10 mg

Comprimate

Orală

Cipru

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

Pfizer Hellas A. E.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens,

Greece

Norvasc

5 mg

Capsule

Orală

Cipru

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

Pfizer Hellas A. E.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens,

Greece

Norvasc

10

Capsule

Orală

Danemarca

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

Pfizer ApS,

Lautrupvang 8,

2750 Ballerup,

Denmark

Norvasc

5 mg

Comprimate

Orală

Danemarca

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

Pfizer ApS,

Lautrupvang 8,

2750 Ballerup,

Denmark

Norvasc

10 mg

Comprimate

Orală

Danemarca

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

Pfizer ApS,

Lautrupvang 8,

2750 Ballerup,

Denmark

Amlodipine Pfizer

5 mg

Comprimate

Orală

Danemarca

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

Pfizer ApS,

Lautrupvang 8,

2750 Ballerup,

Denmark

Amlodipine Pfizer

10 mg

Comprimate

Orală

Estonia

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

Pfizer Europe MA EEIG,

Ramsgate Road,

Sandwich,

Kent,

CT13 9NJ,

United Kingdom

Norvasc

5 mg

Comprimate

Orală

Estonia

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

Pfizer Europe MA EEIG,

Ramsgate Road,

Sandwich,

Kent,

CT13 9NJ,

United Kingdom

Norvasc

10 mg

Comprimate

Orală

Finlanda

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

Pfizer Oy,

Tietokuja 4,

00330 Helsinki,

Finland

Norvasc

5 mg

Comprimate

Orală

Finlanda

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

Pfizer Oy,

Tietokuja 4,

00330 Helsinki,

Finland

Norvasc

10 mg

Comprimate

Orală

Franța

| Pfizer Holding France |
| --- |
| 23-25 Avenue du Docteur Lannelongue |
| 75014 Paris |
| France |

Pfizer Holding France

23-25 Avenue du Docteur Lannelongue

75014 Paris

France

Amlor

5 mg

Capsule

Orală

Franța

| Pfizer Holding France |
| --- |
| 23-25 Avenue du Docteur Lannelongue |
| 75014 Paris |
| France |

Pfizer Holding France

23-25 Avenue du Docteur Lannelongue

75014 Paris

France

Amlor

10 mg

Capsule

Orală

Germania

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

Pfizer Pharma GmbH,

Linkstraße 10

10785 Berlin,

Germany

Norvasc 5 mg

5 mg

Comprimate

Orală

Germania

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

Pfizer Pharma GmbH,

Linkstraße 10

10785 Berlin,

Germany

Norvasc 10 mg

10 mg

Comprimate

Orală

Grecia

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

Pfizer Hellas A. E.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens,

Greece

Norvasc

5 mg

Capsule

Orală

Grecia

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

Pfizer Hellas A. E.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens,

Greece

Norvasc

10 mg

Capsule

Orală

Ungaria

| Pfizer KFT, |
| --- |
| Budapest, |
| Alkotás u. 53 |
| 1123 |
| Hungary |

Pfizer KFT,

Budapest,

Alkotás u. 53

1123

Hungary

Norvasc

5 mg

Comprimate

Orală

Ungaria

| Pfizer KFT, |
| --- |
| Budapest, |
| Alkotás u. 53 |
| 1123 |
| Hungary |

Pfizer KFT,

Budapest,

Alkotás u. 53

1123

Hungary

Norvasc

10 mg

Comprimate

Orală

Islanda

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

Pfizer ApS,

Lautrupvang 8,

2750 Ballerup,

Denmark

Norvasc

5 mg

Comprimate

Orală

Islanda

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

Pfizer ApS,

Lautrupvang 8,

2750 Ballerup,

Denmark

Norvasc

10 mg

Comprimate

Orală

Irlanda

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

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Istin

5 mg

Comprimate

Orală

Irlanda

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

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Istin

10 mg

Comprimate

Orală

Irlanda

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

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Amlodipine besilate 5 mg tablets

5 mg

Comprimate

Orală

Irlanda

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

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Amlodipine besilate 10 mg tablets

10 mg

Comprimate

Orală

Italia

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

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina –

Italy

Norvasc

5 mg

Comprimate

Orală

Italia

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

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina,

Italy

Norvasc

10 mg

Comprimate

Orală

Italia

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

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina,

Italy

Monopina

5 mg

Comprimate

Orală

Italia

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

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina -

Italy

Monopina

10 mg

Comprimate

Orală

Letonia

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

Pfizer Limited,

Ramsgate Road,

Sandwich,

Kent

CT13 9NJ,

United Kingdom

Norvasc 5 mg

5 mg

Comprimate

Orală

Letonia

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

Pfizer Limited,

Ramsgate Road,

Sandwich,

Kent

CT13 9NJ,

United Kingdom

Norvasc 10 mg

10 mg

Comprimate

Orală

Lituania

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

Pfizer Europe MA EEIG,

Ramsgate Road,

Sandwich,

Kent,

CT13 9NJ,

United Kingdom

Norvasc

5 mg

Comprimate

Orală

Lituania

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

Pfizer Europe MA EEIG,

Ramsgate Road,

Sandwich,

Kent,

CT13 9NJ,

United Kingdom

Norvasc

10 mg

Comprimate

Orală

Lituania

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

Pfizer Europe MA EEIG,

Ramsgate Road,

Sandwich,

Kent,

CT13 9NJ,

United Kingdom

Norvasc

5 mg

Capsule

Orală

Lituania

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

Pfizer Europe MA EEIG,

Ramsgate Road,

Sandwich,

Kent,

CT13 9NJ,

United Kingdom

Norvasc

10 mg

Capsule

Orală

Luxemburg

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

Pfizer SA

Boulevard de la Plaine 17

B-1050 Brussels,

Belgium

Amlor

5 mg

Capsule

Orală

Luxemburg

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

Pfizer SA

Boulevard de la Plaine 17

B-1050 Brussels,

Belgium

Amlor

10 mg

Capsule

Orală

Malta

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

Pfizer Hellas S.A.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens,

Greece

Istin

5 mg

Comprimate

Orală

Malta

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

Pfizer Hellas S.A.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens,

Greece

Istin

10 mg

Comprimate

Orală

Olanda

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

Pfizer bv

Rivium Westlaan 142

2909 LD Capelle a/d IJssel

The Netherlands

Norvasc 5

5 mg

Comprimate

Orală

Olanda

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

Pfizer bv

Rivium Westlaan 142

2909 LD Capelle a/d IJssel

The Netherlands

Norvasc 10

10 mg

Comprimate

Orală

Norvegia

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

Pfizer AS

Pb. 3

1324 Lysaker

Norway

Norvasc

5 mg

Comprimate

Orală

Norvegia

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

Pfizer AS

Pb. 3

1324 Lysaker

Norway

Norvasc

10 mg

Comprimate

Orală

Polonia

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

Pfizer Europe MA EEIG,

Ramsgate Road,

Sandwich,

Kent,

CT13 9NJ,

United Kingdom

Norvasc

5 mg

Comprimate

Orală

Polonia

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

Pfizer Europe MA EEIG,

Ramsgate Road,

Sandwich,

Kent,

CT13 9NJ,

United Kingdom

Norvasc

10 mg

Comprimate

Orală

Portugalia

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

Laboratorios Pfizer, Lda.,

Lagoas Park, Edifício 10,

2740-271 Porto Salvo,

Portugal

Norvasc

5 mg

Comprimate

Orală

Portugalia

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

Laboratorios Pfizer, Lda.,

Lagoas Park, Edifício 10,

2740-271 Porto Salvo,

Portugal

Norvasc

10 mg

Comprimate

Orală

România

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

Pfizer Europe MA EEIG,

Ramsgate Road,

Sandwich,

Kent,

CT13 9NJ,

United Kingdom

Norvasc 5 mg capsule

5 mg

Capsule

Orală

România

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

Pfizer Europe MA EEIG,

Ramsgate Road,

Sandwich,

Kent,

CT13 9NJ,

United Kingdom

Norvasc 10 mg capsule

10 mg

Capsule

Orală

România

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

Pfizer Europe MA EEIG,

Ramsgate Road,

Sandwich,

Kent,

CT13 9NJ,

United Kingdom

Norvasc 5 mg

5 mg

Comprimate

Orală

România

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

Pfizer Europe MA EEIG,

Ramsgate Road,

Sandwich,

Kent,

CT13 9NJ,

United Kingdom

Norvasc 10 mg

10 mg

Comprimate

Orală

Republica Slovacă

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

Pfizer Europe MA EEIG,

Ramsgate Road,

Sandwich,

Kent,

CT13 9NJ,

United Kingdom

Norvasc

5 mg

Comprimate

Orală

Republica Slovacă

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

Pfizer Europe MA EEIG,

Ramsgate Road,

Sandwich,

Kent,

CT13 9NJ,

United Kingdom

Norvasc

10 mg

Comprimate

Orală

Slovenia

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

Pfizer Luxembourg SARL,

51, Avenue J. F. Kennedy,

L-1855 Luxembourg

Norvasc 5 mg tablete

5 mg

Comprimate

Orală

Slovenia

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

Pfizer Luxembourg SARL,

51, Avenue J. F. Kennedy,

L-1855 Luxembourg

Norvasc 10 mg tablete

10 mg

Comprimate

Orală

Spania

| PFIZER, S.A. |
| --- |
| Av. De Europa, 20-B |
| Parque Empresarial „La MOraleja” |
| 28108 ALCOBENDAS Madrid, |
| Spain |

PFIZER, S.A.

Av. De Europa, 20-B

Parque Empresarial „La MOraleja”

28108 ALCOBENDAS Madrid,

Spain

Norvas 5 mg comprimidos

5 mg

Comprimate

Orală

Spania

| PFIZER, S.A. |
| --- |
| Av. De Europa, 20-B |
| Parque Empresarial „La MOraleja” |
| 28108 ALCOBENDAS Madrid, |
| Spain |

PFIZER, S.A.

Av. De Europa, 20-B

Parque Empresarial „La MOraleja”

28108 ALCOBENDAS Madrid,

Spain

Norvas 10 mg comprimidos

10 mg

Comprimate

Orală

Spania

| PHARMACIA GRUPO PFIZER, S.L. |
| --- |
| Av. De Europa, 20-B |
| Parque Empresarial „La MOraleja” |
| 28108 ALCOBENDAS Madrid, |
| Spain |

PHARMACIA GRUPO PFIZER, S.L.

Av. De Europa, 20-B

Parque Empresarial „La MOraleja”

28108 ALCOBENDAS Madrid,

Spain

Amlodipino Pharmacia 5 mg comprimidos

5 mg

Comprimate

Orală

Spania

| PHARMACIA GRUPO PFIZER, S.L. |
| --- |
| Av. De Europa, 20-B |
| Parque Empresarial „La MOraleja” |
| 28108 ALCOBENDAS Madrid, |
| Spain |

PHARMACIA GRUPO PFIZER, S.L.

Av. De Europa, 20-B

Parque Empresarial „La MOraleja”

28108 ALCOBENDAS Madrid,

Spain

Amlodipino Pharmacia 10 mg comprimidos

10 mg

Comprimate

Orală

Suedia

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

Pfizer AB

191 90 Sollentuna

Sweden

Norvasc

5 mg

Comprimate

Orală

Suedia

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

Pfizer AB

191 90 Sollentuna

Sweden

Norvasc

10 mg

Comprimate

Orală

Marea Britanie

| Pfizer Limited, |
| --- |
| Ramsgate Road, |
| Sandwich, |
| United Kingdom |

Pfizer Limited,

Ramsgate Road,

Sandwich,

United Kingdom

Istin

5 mg

Comprimate

Orală

Marea Britanie

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

Pfizer Limited,

Ramsgate Road,

Sandwich,

Kent,

CT13 9NJ,

United Kingdom

Istin

10 mg

Comprimate

Orală

---

ANEXA II

LISTA NUMELOR, FORMELOR FARMACEUTICE, CONCENTRATIILE PRODUSELOR MEDICINALE VETERINARE, SPECILLE ANIMALE, TIMP DE ASTEPTARE, DETINATORILOR AUTORIZATIEI DE COMERCIALIZARE IN STATELE MEMBRE

| Statul Membru EU/EEA | Detinatorul Autorizatiei de Comercializare | Nume | INN | Concentratii | Forma farmaceutica | Speciile Animale | Timp de asteptare
  (carne si lapte) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Pfizer Corporation Austria GmbH |
| Floridsdorfer Hauptstraße 1 |
| 1210 Wien |
| Austria |

Statul Membru EU/EEA

Detinatorul Autorizatiei de Comercializare

Nume

INN

Concentratii

Forma farmaceutica

Speciile Animale

Timp de asteptare

(carne si lapte)

Austria

Pfizer Corporation Austria GmbH

Floridsdorfer Hauptstraße 1

1210 Wien

Austria

Synulox comp - Injektoren für Kühe

Amoxicillin (as amoxicillin trihydrate)

200 mg

Suspensie intramamara

Bovine

Carne si organe: 4 zile

Lapte: 3 zile

Clavulanic acid (as potassium clavulanate)

50 mg

Prednisolone

10 mg

Bulgaria

| Pfizer Animal Health MA EEIG |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| Marea Britanie |

Pfizer Animal Health MA EEIG

Ramsgate Road

Sandwich

Kent

CT13 9NJ

Marea Britanie

Synulox Lactating Cow

Amoxicillin (as amoxicillin trihydrate)

200 mg

Suspensie intramamara

Bovine

Carne: 7 zile

Lapte: 60 ore

In combinatie cu Synulox RTU:

Carne:42 zile

Lapte 60 ore

Clavulanic acid (as potassium clavulanate)

50 mg

Prednisolone

10 mg

Cipru

| PFIZER HELLAS AE |
| --- |
| Mesogeion Ave. 243 |
| 154 51 Neo Psichiko |
| Athens |
| Grecia |

PFIZER HELLAS AE

Mesogeion Ave. 243

154 51 Neo Psichiko

Athens

Grecia

SYNULOX LC

Amoxicillin (as amoxicillin trihydrate)

200 mg

Suspensie intramamara

Bovine

Tesuturi moi: 4 zile

Lapte: 72 ore

Clavulanic acid (as potassium clavulanate)

50 mg

Prednisolone

10 mg

Republica Ceha

| Pfizer, spol. s r.o. |
| --- |
| Veterinární divize – Anumal Health |
| Stroupežnického 17 |
| 150 00 Praha 5 |
| Republica Ceha |

Pfizer, spol. s r.o.

Veterinární divize – Anumal Health

Stroupežnického 17

150 00 Praha 5

Republica Ceha

SYNULOX LC 260 mg intramam. suspension for cattle

Amoxicillin (as amoxicillin trihydrate)

200 mg

Suspensie intramamara

Bovine

Carne: 7 zile

Lapte: 84 ore (7 mulsori)

Clavulanic acid (as potassium clavulanate)

50 mg

Prednisolone

10 mg

Franta

| PFIZER |
| --- |
| 23/25 Avenue Du Docteur Lannelongue |
| 75014 Paris |
| Franta |

PFIZER

23/25 Avenue Du Docteur Lannelongue

75014 Paris

Franta

SYNULOX INTRAMAMMAIRE

Amoxicillin (as amoxicillin trihydrate)

200 mg

Suspensie intramamara

Bovine

Carne: 7 zile

Lapte: 2 zile

Clavulanic acid (as potassium clavulanate)

50 mg

Prednisolone

10 mg

Grecia

| PFIZER HELLAS A.E |
| --- |
| Mesogion Av 242 |
| 154 51 N. Psichiko |
| Athens Grecia |

PFIZER HELLAS A.E

Mesogion Av 242

154 51 N. Psichiko

Athens Grecia

SYNULOX LC

Amoxicillin (as amoxicillin trihydrate)

200 mg

Suspensie intramamara

Bovine

Carne: 3 zile

Lapte: 72 ore

Clavulanic acid (as potassium clavulanate)

50 mg

Prednisolone

10 mg

Ungaria

| Pfizer Kft. |
| --- |
| Budapest |
| Alkotás u. 53. |
| 1123 |
| Ungaria |

Pfizer Kft.

Budapest

Alkotás u. 53.

1123

Ungaria

SYNULOX LC tőgyinfúzió

Amoxicillin (as amoxicillin trihydrate)

200 mg

Suspensie intramamara

Bovine

Tesuturi moi: 4 zile

Lapte: 60 ore

Clavulanic acid (as potassium clavulanate)

50 mg

Prednisolone

10 mg

Islanda

| Pfizer Healthcare Ireland, Trading as Pfizer Animal Health |
| --- |
| Ringaskiddy |
| County Cork |
| Islanda |

Pfizer Healthcare Ireland, Trading as Pfizer Animal Health

Ringaskiddy

County Cork

Islanda

Synulox Lactating Cow Intramammary suspension.

Amoxicillin (as amoxicillin trihydrate)

200 mg

Suspensie intramamara

Bovine

Carne si organe: 7 zile

Lapte: 60 ore

Carne: 7 zile

Lapte (vacile mulse de 2 ori pe zi): 60 de ore (exemplu la a 5a mulsoare) dupa ultimul tratament. În situația oricarei alte rutine de muls, laptele poate fi dat pentru consumul uman numai după aceeași perioadă de la ultimul tratament (ex. mulsori de 3 ori pe zi, laptele poate fi dat pentru consumul uman la a 8-a mulsoare).

In combinatie cu Synulox RTU:

Carne:42 zile

Lapte 80 ore

Clavulanic acid (as potassium clavulanate)

50 mg

Prednisolone

10 mg

Italia

| PFIZER ITALIA |
| --- |
| Via Valbiondone 113 |
| 00188 Roma |
| Italia |

PFIZER ITALIA

Via Valbiondone 113

00188 Roma

Italia

SYNULOX ENDOMAMMARIO

Amoxicillin (as amoxicillin trihydrate)

200 mg

Suspensie intramamara

Bovine

Carne: 4 zile

Lapte 108 ore

Clavulanic acid (as potassium clavulanate)

50 mg

Prednisolone

10 mg

Letonia

| Pfizer Animal Health MA EEIG |
| --- |
| Ramsgate Road |
| Sandwich, |
| Kent |
| CT13 9NJ |
| Marea Britanie |

Pfizer Animal Health MA EEIG

Ramsgate Road

Sandwich,

Kent

CT13 9NJ

Marea Britanie

Synulox LC Suspensija ievadīšanai tesmenī laktējošām govīm

Amoxicillin (as amoxicillin trihydrate)

200 mg

Suspensie intramamara

Bovine

Carne si organe: 7 zile

Lapte (vacile mulse de 2 ori pe zi): 60 de ore (exemplu la a 5a mulsoare) dupa ultimul tratament. În situația oricarei alte rutine de muls, laptele poate fi dat pentru consumul uman numai după aceeași perioadă de la ultimul tratament (ex. mulsori de 3 ori pe zi, laptele poate fi dat pentru consumul uman la a 8-a mulsoare).

In combinatie cu Synulox RTU:

Carne:42 zile

Lapte 60 ore

Clavulanic acid (as potassium clavulanate)

50 mg

Prednisolone

10 mg

Lituania

| Pfizer Animal Health MA EEIG |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| Marea Britanie |

Pfizer Animal Health MA EEIG

Ramsgate Road

Sandwich

Kent

CT13 9NJ

Marea Britanie

SYNULOX LC, intramaminė suspensija

Amoxicillin (as amoxicillin trihydrate)

200 mg

Suspensie intramamara

Bovine

Carne: 7 zile

Lapte: 60 ore

In combinatie cu Synulox RTU:

Carne:42 zile

Lapte 60 ore

Clavulanic acid (as potassium clavulanate)

50 mg

Prednisolone

10 mg

Norvegia

| Pfizer Oy |
| --- |
| Animal Health |
| Tietokuja 4 |
| 00330 Helsinki |
| Finlanda |

Pfizer Oy

Animal Health

Tietokuja 4

00330 Helsinki

Finlanda

Synulox comp. vet

Amoxicillin (as amoxicillin trihydrate)

200 mg

emulsie intramamara

Bovine

Carne: 6 zile

Lapte: 5 zile

Clavulanic acid (as potassium clavulanate)

50 mg

Prednisolone

10 mg

Polonia

| Pfizer Trading Polska Sp. z o. o. |
| --- |
| ul. Rzymowskiego 34 |
| 02–697 Warszawa |
| Polonia |

Pfizer Trading Polska Sp. z o. o.

ul. Rzymowskiego 34

02–697 Warszawa

Polonia

SYNOLUX L.C. (200 mg + 50 mg + 10 mg)/3 g, zawiesina dowymieniowa, bydło

Amoxicillin (as amoxicillin trihydrate)

200 mg

Suspensie intramamara

Bovine

Carne si organe: 4 zile

Lapte: 60 ore

Clavulanic acid (as potassium clavulanate)

50 mg

Prednisolone

10 mg

Portugalia

| Laboratórios Pfizer, Lda |
| --- |
| Lagoas Park -Edifício 10 |
| Porto Salvo |
| 2470 Oeiras |
| Portugalia |

Laboratórios Pfizer, Lda

Lagoas Park -Edifício 10

Porto Salvo

2470 Oeiras

Portugalia

SYNULOX LC suspensão intramamária para bovinos em lactação

Amoxicillin (as amoxicillin trihydrate)

200 mg

Suspensie intramamara

Bovine

Carne si organe: 14 zile

Lapte: 2 zile

Clavulanic acid (as potassium clavulanate)

50 mg

Prednisolone

10 mg

România

| Pfizer Animal Health MA EEIG |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| Marea Britanie |

Pfizer Animal Health MA EEIG

Ramsgate Road

Sandwich

Kent

CT13 9NJ

Marea Britanie

SYNULOX LC, amoxicilină, acid clavulanic, prednisolon, suspensie intramamara pentru vaci in lactatie

Amoxicillin (as amoxicillin trihydrate)

200 mg

Suspensie intramamara

Bovine

Carne si organe: 7 zile

Lapte: 60 ore

In combinatie cu Synulox RTU:

Carne:42 zile

Lapte: 14 zile

Clavulanic acid (as potassium clavulanate)

50 mg

Prednisolone

10 mg

Republica Slovacâ

| Pfizer Luxembourg |
| --- |
| SARL, o.z. |
| Pfizer AH |
| Pribinova 25 |
| 811 09 Bratislava |
| Republica Slovacâ |

Pfizer Luxembourg

SARL, o.z.

Pfizer AH

Pribinova 25

811 09 Bratislava

Republica Slovacâ

Synulox LC 260 mg intramammary suspension

Amoxicillin (as amoxicillin trihydrate)

200 mg

Suspensie intramamara

Bovine

Carne: 7 zile

Lapte: 84 ore (7 mulsori)

Clavulanic acid (as potassium clavulanate)

50 mg

Prednisolone

10 mg

Slovenia

| PFIZER Luxembourg SARL |
| --- |
| 51,Avenue |
| J.F.Kennedy |
| 1855 Luxemburg |

PFIZER Luxembourg SARL

51,Avenue

J.F.Kennedy

1855 Luxemburg

SYNULOX LC intramamarna suspenzija za krave v laktaciji

Amoxicillin (as amoxicillin trihydrate)

200 mg

Suspensie intramamara

Bovine

Carne si organe: 7 zile

Lapte: 60 ore

Clavulanic acid (as potassium clavulanate)

50 mg

Prednisolone

10 mg

Spania

| PFIZER, S.A. |
| --- |
| Avd. Europa 20-B |
| Parque Empresarial La Moraleja |
| 28108 Alcobendas (Madrid) |
| Spania |

PFIZER, S.A.

Avd. Europa 20-B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Spania

SYNULOX LC

Amoxicillin (as amoxicillin trihydrate)

200 mg

Suspensie intramamara

Bovine

Carne: 7 zile

Lapte: 60 ore sau 5 mulsori

Clavulanic acid (as potassium clavulanate)

50 mg

Prednisolone

10 mg

Olanda

| Pfizer |
| --- |
| Rivium Westlaan 142 |
| 2909 LD Capelle a/d |
| Ijssel |
| Olanda |

Pfizer

Rivium Westlaan 142

2909 LD Capelle a/d

Ijssel

Olanda

Avuloxil

Amoxicillin (as amoxicillin trihydrate)

200 mg

Suspensie intramamara

Bovine

Carne: 7 zile

Lapte: 4 zile

Clavulanic acid (as potassium clavulanate)

50 mg

Prednisolone

10 mg

Marea Britanie

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| Marea Britanie |

Pfizer Ltd

Ramsgate Road

Sandwich

Kent

CT13 9NJ

Marea Britanie

Synulox Lactating Cow Intramammary Suspension

Amoxicillin (as amoxicillin trihydrate)

200 mg

Suspensie intramamara

Bovine

Carne: 7 zile

Lapte (vacile mulse de 2 ori pe zi): 60 de ore (exemplu la a 5a mulsoare) dupa ultimul tratament. În situația oricarei alte rutine de muls, laptele poate fi dat pentru consumul uman numai după aceeași perioadă de la ultimul tratament (ex. mulsori de 3 ori pe zi, laptele poate fi dat pentru consumul uman la a 8-a mulsoare).

In combinatie cu Synulox RTU:

Carne:42 zile

Lapte 60 ore

Clavulanic acid (as potassium clavulanate)

50 mg

Prednisolone

10 mg

---

ANEXA III

LISTA CU DENUMIRILE COMERCIALE, FORMELE FARMACEUTICE, CONCENTRAȚIILE, CĂILE DE ADMINISTRARE ALE MEDICAMENTELOR, SOLICITANȚII, DEȚINĂTORII AUTORIZAȚIEI DE PUNERE PE PIAȚĂ ÎN STATELE MEMBRE

| Statul Membru UE/EEA | Deținătorul autorizației de punere pe piață | Numele inventat | Concentrația | Forma farmaceutică | Calea de administrare |
| --- | --- | --- | --- | --- | --- |
| Austria | Novartis Pharma GmbH |
| Stella-Klein-Löw-Weg 17 A |
| 1020 Wien |
| Austria |

Statul Membru UE/EEA

Deținătorul autorizației de punere pe piață

Numele inventat

Concentrația

Forma farmaceutică

Calea de administrare

Austria

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17 A

1020 Wien

Austria

Cardioxane 500 mg - Pulver zur Herstellung einer Infusionslösung

500 mg

Pulbere pentru soluție perfuzabilă

Intravenoasă

Austria

| CYATHUS EXQUIRERE |
| --- |
| Pharmaforschungs GmbH |
| Rudolfsplatz 2/8 |
| 1010 Wien |
| Austria |

CYATHUS EXQUIRERE

Pharmaforschungs GmbH

Rudolfsplatz 2/8

1010 Wien

Austria

Cyrdanax 20 mg/ml Pulver für ein Konzentrat zur Herstellung einer Infusionslösung

20 mg

Pulbere pentru soluție perfuzabilă

Intravenoasă

Austria

| CYATHUS EXQUIRERE |
| --- |
| Pharmaforschungs GmbH |
| Rudolfsplatz 2/8 |
| 1010 Wien |
| Austria |

CYATHUS EXQUIRERE

Pharmaforschungs GmbH

Rudolfsplatz 2/8

1010 Wien

Austria

Enaxozar 20 mg/ml Pulver für ein Konzentrat zur Herstellung einer Infusionslösung

20 mg

Pulbere pentru soluție perfuzabilă

Intravenoasă

Republica Cehă

| Novartis s.r.o. |
| --- |
| GEMINI, budova B |
| Na Pankráci 1724 / 129 |
| CZ-140 00 Praha 4 |
| Czech Republic |

Novartis s.r.o.

GEMINI, budova B

Na Pankráci 1724 / 129

CZ-140 00 Praha 4

Czech Republic

Cardioxane

500 mg

Pulbere pentru soluție injectabilă

Intravenoasă

Republica Cehă

| CYATHUS EXQUIRERE |
| --- |
| Pharmaforschungs GmbH |
| Rudolfsplatz 2/8 |
| 1010 Wien |
| Austria |

CYATHUS EXQUIRERE

Pharmaforschungs GmbH

Rudolfsplatz 2/8

1010 Wien

Austria

Cyrdanax 20 mg/ml prášek pro přípravu infuzního roztoku

20 mg

Pulbere pentru soluție injectabilă

Intravenoasă

Germania

| Novartis Pharma GmbH |
| --- |
| Roonstr. 25 |
| D-90429 Nürnberg |
| Germany |

Novartis Pharma GmbH

Roonstr. 25

D-90429 Nürnberg

Germany

CARDIOXANE 500 mg, Pulver zur Herstellung einer Infusionslösung

500 mg

Pulbere pentru soluție perfuzabilă

Intravenoasă (dacă nu se specifică altceva)

Germania

| CYATHUS EXQUIRERE |
| --- |
| Pharmaforschungs GmbH |
| Rudolfsplatz 2/8 |
| 1010 Wien |
| Austria |

CYATHUS EXQUIRERE

Pharmaforschungs GmbH

Rudolfsplatz 2/8

1010 Wien

Austria

Cyrdanax 20 mg/ml Pulver für ein Konzentrat zur Herstellung einer Infusionslösung

20 mg

Pulbere pentru soluție injectabilă

Intravenoasă

Germania

| CYATHUS EXQUIRERE |
| --- |
| Pharmaforschungs GmbH |
| Rudolfsplatz 2/8 |
| 1010 Wien |
| Austria |

CYATHUS EXQUIRERE

Pharmaforschungs GmbH

Rudolfsplatz 2/8

1010 Wien

Austria

Enaxozar 20 mg/ml Pulver für ein Konzentrat zur Herstellung einer Infusionslösung

20 mg

Pulbere pentru soluție injectabilă

Intravenoasă

Danemarca

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

Novartis Healthcare A/S,

Lyngbyvej 172

DK-2100 Copenhagen Ø

Denmark

Cardioxane

500 mg

Pulbere pentru soluție perfuzabilă

Intravenoasă

Grecia

| NOVARTIS (HELLAS) A.E.B.E. |
| --- |
| 12 km National Highway No 1 |
| Metamorfosi Attikis 14451 |
| Greece |

NOVARTIS (HELLAS) A.E.B.E.

12 km National Highway No 1

Metamorfosi Attikis 14451

Greece

CARDIOXANE

500 mg/vial

Pulbere pentru soluție perfuzabilă

Intravenoasă

Spania

| NOVARTIS FARMACEUTICA, S.A. |
| --- |
| Gran Via de les Corts Catalanes, 764 |
| 08013 Barcelona |
| Spain |

NOVARTIS FARMACEUTICA, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

CARDIOXANE 500 mg polvo para solucion para perfusion

500 mg

Pulbere pentru soluție perfuzabilă

Intravenoasă

Finlanda

| Novartis Finland Oy, |
| --- |
| Metsänneidonkuja 10 |
| 02130 Espoo |
| Finland |

Novartis Finland Oy,

Metsänneidonkuja 10

02130 Espoo

Finland

Cardioxane

500 mg

pulbere pentru soluție perfuzabilă

Intravenoasă

Franța

| NOVARTIS PHARMA SAS |
| --- |
| 2-4, rue Lionel Terray |
| 92500 Rueil-Malmaison |
| FRANCE |

NOVARTIS PHARMA SAS

2-4, rue Lionel Terray

92500 Rueil-Malmaison

FRANCE

CARDIOXANE 500 mg, poudre pour solution pour perfusion

500 mg

pulbere pentru soluție perfuzabilă

Intravenoasă

Franța

| CYATHUS EXQUIRERE |
| --- |
| Pharmaforschungs GmbH |
| Rudolfsplatz 2/8 |
| 1010 Wien |
| Austria |

CYATHUS EXQUIRERE

Pharmaforschungs GmbH

Rudolfsplatz 2/8

1010 Wien

Austria

DEXRAZOXANE CYATHUS 20 mg/ml, poudre pour solution pour perfusion

20 mg

Pulbere pentru soluție injectabilă

Intravenoasă

Ungaria

| Novartis Hungária Kft. Pharma részlege |
| --- |
| Bartók Béla út 43-47. |
| (Bartók-Ház, V. em.) |
| 1114 |
| Budapest |
| Hungary |

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47.

(Bartók-Ház, V. em.)

1114

Budapest

Hungary

CARDIOXANE

500 mg

Pulbere pentru soluție perfuzabilă

Intravenoasă

Ungaria

| CYATHUS EXQUIRERE |
| --- |
| Pharmaforschungs GmbH |
| Rudolfsplatz 2/8 |
| 1010 Wien |
| Austria |

CYATHUS EXQUIRERE

Pharmaforschungs GmbH

Rudolfsplatz 2/8

1010 Wien

Austria

Procard 20 mg/ml Por oldatos infúzióhoz

20 mg

Pulbere pentru soluție injectabilă

Intravenoasă

Irlanda

MAH:

| Novartis Pharmaceuticals UK, |
| --- |
| Frimley Business Park, |
| Frimley, |
| Camberley, |
| Surrey |
| Gu16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK,

Frimley Business Park,

Frimley,

Camberley,

Surrey

Gu16 7SR

United Kingdom

Mailing address:

| Novartis Ireland Ltd Beech House, Beech Hill Office Campus Clonskeagh |
| --- |
| Dublin 4 |
| Ireland |

Novartis Ireland Ltd Beech House, Beech Hill Office Campus Clonskeagh

Dublin 4

Ireland

Cardioxane

500 mg

Pulbere pentru soluție perfuzabilă

Intravenoasă

Italia

| Novartis Farma spa |
| --- |
| Largo Umberto Boccioni, |
| 121040 Origgio- Varese |
| Italy |

Novartis Farma spa

Largo Umberto Boccioni,

121040 Origgio- Varese

Italy

CARDIOXANE

500 mg

pulbere pentru soluție perfuzabilă

Intravenoasă

Lituania

| Novartis Finland Oy |
| --- |
| Metsänneidonkuja 10 |
| FI-02130 Espoo |
| Finland |

Novartis Finland Oy

Metsänneidonkuja 10

FI-02130 Espoo

Finland

Cardioxane

500 mg

Pulbere pentru soluție perfuzabilă

Intravenoasă

Luxemburg

| NOVARTIS PHARMA GMBH |
| --- |
| 25 ROONSTRASSE |
| 90429 NUERNBERG |
| Germany |

NOVARTIS PHARMA GMBH

25 ROONSTRASSE

90429 NUERNBERG

Germany

CARDIOXANE

500 mg

PULBERE PENTRU SOLUȚIE PERFUZABILĂ

Intravenoasă

Olanda

| Novartis Pharma B.V. |
| --- |
| Raapopseweg 1 |
| 6824 DP ARNHEM |
| The Netherlands |

Novartis Pharma B.V.

Raapopseweg 1

6824 DP ARNHEM

The Netherlands

Cardioxane 500 mg

500 mg

pulbere pentru soluție perfuzabilă

Intravenoasă

Norvegia

| Novartis Norge AS |
| --- |
| Postboks 237 Okern |
| 0510 Oslo |
| Norway |

Novartis Norge AS

Postboks 237 Okern

0510 Oslo

Norway

Cardioxane

500 mg

Pulbere pentru soluție perfuzabilă

injecție

Polonia

| Novartis Pharma GmbH |
| --- |
| Roonstarsse 25 |
| D-90429 Nürnberg |
| Germany |

Novartis Pharma GmbH

Roonstarsse 25

D-90429 Nürnberg

Germany

Cardioxane

500 mg

pulbere pentru soluție perfuzabilă

Intravenoasă

Portugalia

| Novartis Farma - Produtos Farmacêuticos, S.A. |
| --- |
| Rua do Centro Empresarial, |
| Edifício 8, |
| Quinta da Beloura |
| 2710-444 Sintra |
| Portugal |

Novartis Farma - Produtos Farmacêuticos, S.A.

Rua do Centro Empresarial,

Edifício 8,

Quinta da Beloura

2710-444 Sintra

Portugal

Cardioxane

500 mg

pulbere pentru soluție perfuzabilă

Intravenoasă

România

| CYATHUS EXQUIRERE |
| --- |
| Pharmaforschungs GmbH |
| Rudolfsplatz 2/8 |
| 1010 Wien |
| Austria |

CYATHUS EXQUIRERE

Pharmaforschungs GmbH

Rudolfsplatz 2/8

1010 Wien

Austria

CYRDANAX 20 mg/ml

20 mg/ml

pulbere pentru soluție perfuzabilă

Intravenoasă

Slovacia

| Novartis s.r.o. |
| --- |
| GEMINI, budova B |
| Na Pankráci 1724 / 129 |
| CZ-140 00 Praha 4 |
| Czech Republic |

Novartis s.r.o.

GEMINI, budova B

Na Pankráci 1724 / 129

CZ-140 00 Praha 4

Czech Republic

CARDIOXANE

500 mg

pulbere pentru soluție perfuzabilă

Intravenoasă

Marea Britanie

| Novartis Pharmaceuticals UK Limted Frimley Business Park |
| --- |
| Frimley, |
| Camberley |
| Surrey |
| GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Limted Frimley Business Park

Frimley,

Camberley

Surrey

GU16 7SR

United Kingdom

Cardioxane

500 mg

pulbere pentru soluție perfuzabilă

Intravenoasă

---

ANEXA IV

LISTA CU DENUMIRILE COMERCIALE, FORMELE FARMACEUTICE, CONCENTRAȚIILE MEDICAMENTELOR, CĂILE DE ADMINISTRARE, DEȚINĂTORII AUTORIZAȚIEI DE PUNERE PE PIAȚĂ ÎN STATELE MEMBRE

| Statul membru UE/SEE | Deținătorul autorizației de punere pe piață | Numele inventat | Concentrația | Forma farmaceutică | Calea de administrare | Conținutul
  (concentrația) |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Pfizer Corporation Austria Ges.m.b.H. |
| Floridsdorfer Hauptstrasse 1 |
| 1210 Wien |
| Austria |

Statul membru UE/SEE

Deținătorul autorizației de punere pe piață

Numele inventat

Concentrația

Forma farmaceutică

Calea de administrare

Conținutul

(concentrația)

Austria

Pfizer Corporation Austria Ges.m.b.H.

Floridsdorfer Hauptstrasse 1

1210 Wien

Austria

Diflucan 50 mg - Kapseln

50 mg

Capsule

Administrare orală

N/A

Austria

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

Pfizer Corporation Austria Ges.m.b.H.

Floridsdorfer Hauptstrasse 1

1210 Wien

Austria

Diflucan 100 mg - Kapseln

100 mg

Capsule

Administrare orală

N/A

Austria

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

Pfizer Corporation Austria Ges.m.b.H.

Floridsdorfer Hauptstrasse 1

1210 Wien

Austria

Diflucan 150 mg - Kapseln

150 mg

Capsule

Administrare orală

N/A

Austria

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

Pfizer Corporation Austria Ges.m.b.H.

Floridsdorfer Hauptstrasse 1

1210 Wien

Austria

Fungata 150 mg - Kapsel

150 mg

Capsule

Administrare orală

N/A

Austria

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

Pfizer Corporation Austria Ges.m.b.H.

Floridsdorfer Hauptstrasse 1

1210 Wien

Austria

Diflucan 200 mg - Kapseln

200 mg

Capsule

Administrare orală

N/A

Austria

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

Pfizer Corporation Austria Ges.m.b.H.

Floridsdorfer Hauptstrasse 1

1210 Wien

Austria

Diflucan 50 mg/5 ml - Trockensaft

50 mg/5 ml

Pulbere pentru suspensie orală

Administrare orală

10 mg/ml

Austria

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

Pfizer Corporation Austria Ges.m.b.H.

Floridsdorfer Hauptstrasse 1

1210 Wien

Austria

Diflucan 200 mg/5 ml - Trockensaft

200 mg/5 ml

Pulbere pentru suspensie orală

Administrare orală

40 mg/ml

Austria

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

Pfizer Corporation Austria Ges.m.b.H.

Floridsdorfer Hauptstrasse 1

1210 Wien

Austria

Diflucan 100 mg - Infusionsflaschen

100 mg/50 ml

Soluție perfuzabilă

Administrare intravenoasă

2 mg/ml

Austria

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

Pfizer Corporation Austria Ges.m.b.H.

Floridsdorfer Hauptstrasse 1

1210 Wien

Austria

Diflucan 200 mg - Infusionsflaschen

200 mg/100 ml

Soluție perfuzabilă

Administrare intravenoasă

2 mg/ml

Austria

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

Pfizer Corporation Austria Ges.m.b.H.

Floridsdorfer Hauptstrasse 1

1210 Wien

Austria

Diflucan 400 mg - Infusionsflaschen

400 mg/200 ml

Soluție perfuzabilă

Administrare intravenoasă

2 mg/ml

Belgia

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

Pfizer SA

Boulevard de la Plaine 17

1050 Brussels

Belgium

Diflucan

50 mg

Capsule

Administrare orală

N/A

Belgia

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

Pfizer SA

Boulevard de la Plaine 17

1050 Brussels

Belgium

Diflucan

100 mg

Capsule

Administrare orală

N/A

Belgia

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

Pfizer SA

Boulevard de la Plaine 17

1050 Brussels

Belgium

Diflucan

150 mg

Capsule

Administrare orală

N/A

Belgia

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

Pfizer SA

Boulevard de la Plaine 17

1050 Brussels

Belgium

Diflucan

200 mg

Capsule

Administrare orală

N/A

Belgia

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

Pfizer SA

Boulevard de la Plaine 17

1050 Brussels

Belgium

Diflucan

50 mg/5 ml

Pulbere pentru suspensie

Administrare orală

10 mg/ml

Belgia

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

Pfizer SA

Boulevard de la Plaine 17

1050 Brussels

Belgium

Diflucan

200 mg/5 ml

Pulbere pentru suspensie

Administrare orală

40 mg/ml

Belgia

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

Pfizer SA

Boulevard de la Plaine 17

1050 Brussels

Belgium

Diflucan

200 mg/100 ml

Soluție perfuzabilă

Administrare intravenoasă

2 mg/ml

Belgia

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

Pfizer SA

Boulevard de la Plaine 17

1050 Brussels

Belgium

Diflucan

400 mg/200 ml

Soluție perfuzabilă

Administrare intravenoasă

2 mg/ml

Bulgaria

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

Pfizer Europe MA EEIG

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan

50 mg

Capsule

Administrare orală

N/A

Bulgaria

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

Pfizer Europe MA EEIG

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan

150 mg

Capsule

Administrare orală

N/A

Bulgaria

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

Pfizer Europe MA EEIG

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan

2 mg/ml

Soluție perfuzabilă

Administrare intravenoasă

2 mg/ml

Cipru

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

Pfizer Hellas A. E.

243, Messoghion Ave.

154 51 Νeo Psychiko Athens

Greece

Fungustatin

150 mg

Capsule

Administrare orală

N/A

Cipru

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

Pfizer Hellas A. E.

243, Messoghion Ave.

154 51 Νeo Psychiko Athens

Greece

Fungustatin

100 mg/50 ml

Soluție perfuzabilă

Administrare intravenoasă

2 mg/ml

Republica Cehă

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

Pfizer. s r.o.

Stroupežnického 17

150 00 Prague 5

Czech Republic

Diflucan 50 mg

50 mg

Capsule

Administrare orală

N/A

Republica Cehă

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

Pfizer. s r.o.,

Stroupežnického 17

150 00 Prague 5

Czech Republic

Diflucan 100 mg

100 mg

Capsule

Administrare orală

N/A

Republica Cehă

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

Pfizer. s r.o.,

Stroupežnického 17

150 00 Prague 5

Czech Republic

Diflucan 150 mg

150 mg

Capsule

Administrare orală

N/A

Republica Cehă

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

Pfizer. s r.o.,

Stroupežnického 17

150 00 Prague 5

Czech Republic

Diflucan I.V.

2 mg/ml

Soluție perfuzabilă

Administrare intravenoasă

2 mg/ml

Danemarca

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

Pfizer ApS,

Lautrupvang 8

2750 Ballerup

Denmark

Diflucan

50 mg

Capsule

Administrare orală

N/A

Danemarca

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

Pfizer ApS,

Lautrupvang 8

2750 Ballerup

Denmark

Diflucan

150 mg

Capsule

Administrare orală

N/A

Danemarca

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

Pfizer ApS

Lautrupvang 8

2750 Ballerup

Denmark

Diflucan

200 mg

Capsule

Administrare orală

N/A

Danemarca

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

Pfizer ApS

Lautrupvang 8

2750 Ballerup

Denmark

Diflucan

10 mg/ml

Pulbere pentru suspensie

Administrare orală

10 mg/ml

Danemarca

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

Pfizer ApS

Lautrupvang 8

2750 Ballerup

Denmark

Diflucan

2 mg/ml

Soluție perfuzabilă

Administrare intravenoasă

2 mg/ml

Estonia

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

Pfizer Europe MA EEIG

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan 150 mg

150 mg

Capsule

Administrare orală

N/A

Estonia

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

Pfizer Europe MA EEIG

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan 2 mg/ml

2 mg/ml

Soluție perfuzabilă

Administrare intravenoasă

2 mg/ml

Finlanda

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

Pfizer Oy

Tietokuja 4

00330 Helsinki

Finland

Diflucan

50 mg

Capsule

Administrare orală

N/A

Finlanda

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

Pfizer Oy

Tietokuja 4

00330 Helsinki

Finland

Diflucan

100 mg

Capsule

Administrare orală

N/A

Finlanda

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

Pfizer Oy

Tietokuja 4

00330 Helsinki

Finland

Diflucan

150 mg

Capsule

Administrare orală

N/A

Finlanda

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

Pfizer Oy

Tietokuja 4

00330 Helsinki

Finland

Diflucan

10 mg/ml

Pulbere pentru suspensie orală

Administrare orală

10 mg/ml

Finlanda

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

Pfizer Oy

Tietokuja 4

00330 Helsinki,

Finland

Diflucan

40 mg/ml

Pulbere pentru suspensie orală

Administrare orală

40 mg/ml

Finlanda

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

Pfizer Oy,

Tietokuja 4

00330 Helsinki

Finland

Diflucan

2 mg/ml

Soluție perfuzabilă

Administrare intravenoasă

2 mg/ml

Franța

| Pfizer Holding France |
| --- |
| 23-25 Avenue du Docteur Lannelongue |
| 75014 Paris |
| France |

Pfizer Holding France

23-25 Avenue du Docteur Lannelongue

75014 Paris

France

Fluconazole Pfizer

50 mg

Capsule

Administrare orală

N/A

Franța

| Pfizer Holding France |
| --- |
| 23-25 Avenue du Docteur Lannelongue |
| 75014 Paris |
| France |

Pfizer Holding France

23-25 Avenue du Docteur Lannelongue

75014 Paris

France

Triflucan

50 mg

Capsule

Administrare orală

N/A

Franța

| Pfizer Holding France |
| --- |
| 23-25 Avenue du Docteur Lannelongue |
| 75014 Paris |
| France |

Pfizer Holding France

23-25 Avenue du Docteur Lannelongue

75014 Paris

France

Fluconazole Pfizer

100 mg

Capsule

Administrare orală

N/A

Franța

| Pfizer Holding France |
| --- |
| 23-25 Avenue du Docteur Lannelongue |
| 75014 Paris |
| France |

Pfizer Holding France

23-25 Avenue du Docteur Lannelongue

75014 Paris

France

Triflucan

100 mg

Capsule

Administrare orală

N/A

Franța

| Pfizer Holding France |
| --- |
| 23-25 Avenue du Docteur Lannelongue |
| 75014 Paris |
| France |

Pfizer Holding France

23-25 Avenue du Docteur Lannelongue

75014 Paris

France

Fluconazole Pfizer

150 mg

Capsule

Administrare orală

N/A

Franța

| Pfizer Holding France |
| --- |
| 23-25 Avenue du Docteur Lannelongue |
| 75014 Paris |
| France |

Pfizer Holding France

23-25 Avenue du Docteur Lannelongue

75014 Paris

France

Fluconazole Pfizer

200 mg

Capsule

Administrare orală

N/A

Franța

| Pfizer Holding France |
| --- |
| 23-25 Avenue du Docteur Lannelongue |
| 75014 Paris |
| France |

Pfizer Holding France

23-25 Avenue du Docteur Lannelongue

75014 Paris

France

Triflucan

200 mg

Capsule

Administrare orală

N/A

Franța

| Pfizer Holding France |
| --- |
| 23-25 Avenue du Docteur Lannelongue |
| 75014 Paris |
| France |

Pfizer Holding France

23-25 Avenue du Docteur Lannelongue

75014 Paris

France

Fluconazole Pfizer

50 mg/5 ml

Pulbere pentru suspensie orală

Administrare orală

10 mg/ml

Franța

| Pfizer Holding France |
| --- |
| 23-25 Avenue du Docteur Lannelongue |
| 75014 Paris |
| France |

Pfizer Holding France

23-25 Avenue du Docteur Lannelongue

75014 Paris

France

Triflucan

50 mg/5 ml

Pulbere pentru suspensie orală

Administrare orală

10 mg/ml

Franța

| Pfizer Holding France |
| --- |
| 23-25 Avenue du Docteur Lannelongue |
| 75014 Paris |
| France |

Pfizer Holding France

23-25 Avenue du Docteur Lannelongue

75014 Paris

France

Triflucan

200 mg/5 ml

Pulbere pentru suspensie orală

Administrare orală

40 mg/ml

Franța

| Pfizer Holding France |
| --- |
| 23-25 Avenue du Docteur Lannelongue |
| 75014 Paris |
| France |

Pfizer Holding France

23-25 Avenue du Docteur Lannelongue

75014 Paris

France

Triflucan

2 mg/ml

Soluție perfuzabilă

Administrare intravenoasă

2 mg/ml

Germania

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

Pfizer Pharma GmbH

Linkstraße 10

10785 Berlin

Germany

Diflucan

50 mg

Capsule

Administrare orală

N/A

Germania

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

Pfizer Pharma GmbH

Linkstraße 10

10785 Berlin

Germany

Diflucan Derm

50 mg

Capsule

Administrare orală

N/A

Germania

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

Pfizer Pharma GmbH

Linkstraße 10

10785 Berlin

Germany

Diflucan

100 mg

Capsule

Administrare orală

N/A

Germania

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

Pfizer Pharma GmbH

Linkstraße 10

10785 Berlin

Germany

Diflucan

200 mg

Capsule

Administrare orală

N/A

Germania

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

Pfizer Pharma GmbH

Linkstraße 10

10785 Berlin

Germany

Fungata

150 mg

Capsule

Administrare orală

N/A

Germania

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

Pfizer Pharma GmbH

Linkstraße 10

10785 Berlin

Germany

Diflucan Trockensaft

50 mg/5 ml

Pulbere pentru suspensie

Administrare orală

10 mg/ml

Germania

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

Pfizer Pharma GmbH,

Linkstraße 10

10785 Berlin

Germany

Diflucan i.v.-100 mg

100 mg/50 ml

Soluție perfuzabilă

Administrare intravenoasă

2 mg/ml

Germania

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

Pfizer Pharma GmbH

Linkstraße 10

10785 Berlin

Germany

Diflucan i.v.-200 mg

200 mg/100 ml

Soluție perfuzabilă

Administrare intravenoasă

2 mg/ml

Germania

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

Pfizer Pharma GmbH

Linkstraße 10

10785 Berlin

Germany

Diflucan i.v.-400 mg

400 mg/200 ml

Soluție perfuzabilă

Administrare intravenoasă

2 mg/ml

Germania

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

Pfizer Pharma GmbH

Linkstraße 10

10785 Berlin

Germany

Diflucan Derm Saft

5 mg/ml

Sirop

Administrare orală

5 mg/ml

Germania

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

Pfizer Pharma GmbH

Linkstraße 10

10785 Berlin

Germany

Diflucan Saft

5 mg/ml

Sirop

Administrare orală

5 mg/ml

Grecia

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

Pfizer Hellas A. E.

243, Messoghion Ave.,

154 51 Νeo Psychiko Athens

Greece

Fungustatin

50 mg

Capsule

Administrare orală

N/A

Grecia

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

Pfizer Hellas A. E.

243, Messoghion Ave.,

154 51 Νeo Psychiko Athens

Greece

Fungustatin

100 mg

Capsule

Administrare orală

N/A

Grecia

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

Pfizer Hellas A. E.

243, Messoghion Ave.

154 51 Νeo Psychiko, Athens

Greece

Fungustatin

150 mg

Capsule

Administrare orală

N/A

Grecia

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

Pfizer Hellas A. E.

243, Messoghion Ave.

154 51 Νeo Psychiko Athens

Greece

Fungustatin

200 mg

Capsule

Administrare orală

N/A

Greece

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

Pfizer Hellas A. E.

243, Messoghion Ave.

154 51 Νeo Psychiko Athens

Greece

Fungustatin

50 mg/5 ml

Pulbere pentru suspensie

Administrare orală

10 mg/ml

Grecia

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

Pfizer Hellas A. E.

243, Messoghion Ave.

154 51 Νeo Psychiko Athens

Greece

Fungustatin

200 mg/5 ml

Pulbere pentru suspensie

Administrare orală

40 mg/ml

Grecia

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

Pfizer Hellas A. E.

243, Messoghion Ave.

154 51 Νeo Psychiko Athens

Greece

Fungustatin

100 mg/50 ml

Soluție perfuzabilă

Administrare intravenoasă

2 mg/ml

Grecia

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

Pfizer Hellas A. E.

243, Messoghion Ave.

154 51 Νeo Psychiko Athens

Greece

Fungustatin

200 mg/100 ml

Soluție perfuzabilă

Administrare intravenoasă

2 mg/ml

Grecia

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

Pfizer Hellas A. E.

243, Messoghion Ave.

154 51 Νeo Psychiko Athens

Greece

Fungustatin

50 mg/25 ml

Soluție perfuzabilă

Administrare intravenoasă

2 mg/ml

Ungaria

| Pfizer KFT |
| --- |
| 1123 |
| Budapest |
| Alkotás u. 53. |
| Hungary |

Pfizer KFT

1123

Budapest

Alkotás u. 53.

Hungary

Diflucan 50 mg kemény kapszula

50 mg

Capsule

Administrare orală

N/A

Ungaria

| Pfizer KFT |
| --- |
| 1123 |
| Budapest |
| Alkotás u. 53. |
| Hungary |

Pfizer KFT

1123

Budapest

Alkotás u. 53.

Hungary

Diflucan 100 mg kemény kapszula

100 mg

Capsule

Administrare orală

N/A

Ungaria

| Pfizer KFT |
| --- |
| 1123 |
| Budapest |
| Alkotás u. 53 |
| Hungary |

Pfizer KFT

1123

Budapest

Alkotás u. 53

Hungary

Diflucan 150 mg kemény kapszula

150 mg

Capsule

Administrare orală

N/A

Ungaria

| Pfizer KFT |
| --- |
| 1123 |
| Budapest |
| Alkotás u. 53. |
| Hungary |

Pfizer KFT

1123

Budapest

Alkotás u. 53.

Hungary

Diflucan 200 mg kemény kapszula

200 mg

Capsule

Administrare orală

N/A

Ungaria

| Pfizer KFT |
| --- |
| 1123 |
| Budapest |
| Alkotás u. 53. |
| Hungary |

Pfizer KFT

1123

Budapest

Alkotás u. 53.

Hungary

Diflucan 10 mg/ml por belsőleges szuszpenzióhoz

50 mg/5 ml

Pulbere pentru suspensie orală

Administrare orală

10 mg/ml

Ungaria

| Pfizer KFT |
| --- |
| 1123 |
| Budapest |
| Alkotás u. 53. |
| Hungary |

Pfizer KFT

1123

Budapest

Alkotás u. 53.

Hungary

Diflucan 40 mg/ml por belsőleges szuszpenzióhoz

200 mg/5 ml

Pulbere pentru suspensie orală

Administrare orală

40 mg/ml

Ungaria

| Pfizer KFT |
| --- |
| 1123 |
| Budapest, |
| Alkotás u. 53. |
| Hungary |

Pfizer KFT

1123

Budapest,

Alkotás u. 53.

Hungary

Diflucan 2 mg/ml oldatos infúzió

2 mg/ml

Soluție perfuzabilă

Administrare intravenoasă

2 mg/ml

Islanda

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

Pfizer ApS

Lautrupvang 8

2750 Ballerup

Denmark

Diflucan

50 mg

Capsule

Administrare orală

N/A

Islanda

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

Pfizer ApS

Lautrupvang 8

2750 Ballerup

Denmark

Diflucan

150 mg

Capsule

Administrare orală

N/A

Islanda

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

Pfizer ApS

Lautrupvang 8

2750 Ballerup

Denmark

Diflucan

200 mg

Capsule

Administrare orală

N/A

Islanda

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

Pfizer ApS

Lautrupvang 8

2750 Ballerup

Denmark

Diflucan

10 mg/ml

Pulbere pentru suspensie

Administrare orală

10 mg/ml

Islanda

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

Pfizer ApS

Lautrupvang 8

2750 Ballerup

Denmark

Diflucan

2 mg/ml

Soluție perfuzabilă

Administrare intravenoasă

2 mg/ml

Irlanda

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

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan

50 mg

Capsule

Administrare orală

N/A

Irlanda

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

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan

150 mg

Capsule

Administrare orală

N/A

Irlanda

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

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan

200 mg

Capsule

Administrare orală

N/A

Irlanda

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

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan

50 mg/5 ml

Pulbere pentru suspensie

Administrare orală

10 mg/ml

Irlanda

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

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan

200 mg/5 ml

Pulbere pentru suspensie

Administrare orală

40 mg/ml

Irlanda

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

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan

200 mg/100 ml

Soluție perfuzabilă

Administrare intravenoasă

2 mg/ml

Irlanda

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

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan

50 mg/25 ml

Soluție perfuzabilă

Administrare intravenoasă

2 mg/ml

Italia

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

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina

Italy

Diflucan

50 mg

Capsule

Administrare orală

N/A

Italia

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

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina

Italy

Diflucan

100 mg

Capsule

Administrare orală

N/A

Italia

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

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina

Italy

Diflucan

150 mg

Capsule

Administrare orală

N/A

Italia

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

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina

Italy

Diflucan

200 mg

Capsule

Administrare orală

N/A

Italia

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

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina

Italy

Diflucan

50 mg/5 ml

Pulbere pentru suspensie

Administrare orală

10 mg/ml

Italia

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

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina

Italy

Diflucan

2 mg/ml

Soluție perfuzabilă

Administrare intravenoasă

2 mg/ml

Letonia

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

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan 50 mg kapsulas

50 mg

Capsule

Administrare orală

N/A

Letonia

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

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan 150 mg kapsulas

150 mg

Capsule

Administrare orală

N/A

Letonia

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

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan 2 mg/ml šķīdums infūzijām

2 mg/ml

Soluție perfuzabilă

Administrare intravenoasă

2 mg/ml

Lituania

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

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan

50 mg

Capsule

Administrare orală

N/A

Lituania

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

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan

100 mg

Capsule

Administrare orală

N/A

Lituania

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

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan

150 mg

Capsule

Administrare orală

N/A

Lituania

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

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan

2 mg/ml

Soluție perfuzabilă

Administrare intravenoasă

2 mg/ml

Luxemburg

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

Pfizer SA

Boulevard de la Plaine 17

1050 Brussels

Belgium

Diflucan

50 mg

Capsule

Administrare orală

N/A

Luxemburg

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

Pfizer SA

Boulevard de la Plaine 17

1050 Brussels

Belgium

Diflucan

100 mg

Capsule

Administrare orală

N/A

Luxemburg

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

Pfizer SA

Boulevard de la Plaine 17

1050 Brussels

Belgium

Diflucan

150 mg

Capsule

Administrare orală

N/A

Luxemburg

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

Pfizer SA

Boulevard de la Plaine 17

1050 Brussels

Belgium

Diflucan

200 mg

Capsule

Administrare orală

N/A

Luxemburg

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

Pfizer SA

Boulevard de la Plaine 17

1050 Brussels

Belgium

Diflucan

50 mg/5 ml

Pulbere pentru suspensie

Administrare orală

10 mg/ml

Luxemburg

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

Pfizer SA

Boulevard de la Plaine 17

1050 Brussels

Belgium

Diflucan

200 mg/5 ml

Pulbere pentru suspensie

Administrare orală

40 mg/ml

Luxemburg

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

Pfizer SA

Boulevard de la Plaine 17

1050 Brussels

Belgium

Diflucan

200 mg/100 ml

Soluție perfuzabilă

Administrare intravenoasă

2 mg/ml

Luxemburg

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

Pfizer SA

Boulevard de la Plaine 17

1050 Brussels

Belgium

Diflucan

400 mg/200 ml

Soluție perfuzabilă

Administrare intravenoasă

2 mg/ml

Malta

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

Pfizer Hellas S.A.

243, Messoghion Ave.

154 51 Νeo Psychiko Athens

Greece

Diflucan

50 mg/25 ml

Soluție perfuzabilă

Administrare intravenoasă

2 mg/ml

Malta

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

Pfizer Hellas S.A.

243, Messoghion Ave.

154 51 Νeo Psychiko Athens

Greece

Diflucan

200 mg/100 ml

Soluție perfuzabilă

Administrare intravenoasă

2 mg/ml

Olanda

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

Pfizer bv

Rivium Westlaan 142

2909 LD Capelle a/d IJssel

The Netherlands

Diflucan 50

50 mg

Capsule

Administrare orală

N/A

Olanda

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

Pfizer bv

Rivium Westlaan 142

2909 LD Capelle a/d IJssel

The Netherlands

Diflucan 100

100 mg

Capsule

Administrare orală

N/A

Olanda

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

Pfizer bv

Rivium Westlaan 142

2909 LD Capelle a/d IJssel

The Netherlands

Diflucan 150

150 mg

Capsule

Administrare orală

N/A

Olanda

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

Pfizer bv

Rivium Westlaan 142

2909 LD Capelle a/d IJssel

The Netherlands

Diflucan 200

200 mg

Capsule

Administrare orală

N/A

Olanda

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

Pfizer bv

Rivium Westlaan 142

2909 LD Capelle a/d IJssel

The Netherlands

Diflucan suspensie 50

50 mg/5 ml

Pulbere pentru suspensie

Administrare orală

10 mg/ml

Olanda

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

Pfizer bv

Rivium Westlaan 142

2909 LD Capelle a/d IJssel

The Netherlands

Diflucan suspensie 200

200 mg/5 ml

Pulbere pentru suspensie

Administrare orală

40 mg/ml

Olanda

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

Pfizer bv

Rivium Westlaan 142

2909 LD Capelle a/d IJssel

The Netherlands

Diflucan I.V.

2 mg/ml

Soluție perfuzabilă

Administrare intravenoasă

2 mg/ml

Norvegia

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

Pfizer AS

Pb. 3

1324 Lysaker

Norway

Diflucan

50 mg

Capsule

Administrare orală

N/A

Norvegia

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

Pfizer AS

Pb. 3

1324 Lysaker

Norway

Diflucan

100 mg

Capsule

Administrare orală

N/A

Norvegia

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

Pfizer AS

Pb. 3

1324 Lysaker

Norway

Diflucan

150 mg

Capsule

Administrare orală

N/A

Norvegia

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

Pfizer AS

Pb. 3

1324 Lysaker

Norway

Diflucan

200 mg

Capsule

Administrare orală

N/A

Norvegia

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

Pfizer AS

Pb. 3

1324 Lysaker

Norway

Diflucan

50 mg/5 ml

Pulbere pentru suspensie

Administrare orală

10 mg/ml

Norvegia

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

Pfizer AS

Pb. 3

1324 Lysaker

Norway

Diflucan

200 mg/5 ml

Pulbere pentru suspensie

Administrare orală

40 mg/ml

Norvegia

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

Pfizer AS

Pb. 3

1324 Lysaker

Norway

Diflucan

2 mg/ml

Soluție perfuzabilă

Administrare intravenoasă

2 mg/ml

Polonia

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

Pfizer Europe MA EEIG

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan

50 mg

Capsule

Administrare orală

N/A

Polonia

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

Pfizer Europe MA EEIG

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan

150 mg

Capsule

Administrare orală

N/A

Polonia

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

Pfizer Europe MA EEIG

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan

2 mg/ml

Soluție perfuzabilă

Administrare intravenoasă

2 mg/ml

Portugalia

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

Laboratorios Pfizer,

Lda. Lagoas Park

Edifício 10

2740-271 Porto Salvo

Portugal

Diflucan

50 mg

Capsule

Administrare orală

N/A

Portugalia

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

Laboratorios Pfizer,

Lda. Lagoas Park

Edifício 10

2740-271 Porto Salvo

Portugal

Diflucan

100 mg

Capsule

Administrare orală

N/A

Portugalia

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

Laboratorios Pfizer,

Lda. Lagoas Park

Edifício 10

2740-271 Porto Salvo

Portugal

Diflucan

150 mg

Capsule

Administrare orală

N/A

Portugalia

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

Laboratorios Pfizer,

Lda., Lagoas Park

Edifício 10

2740-271 Porto Salvo

Portugal

Diflucan

200 mg

Capsule

Administrare orală

N/A

Portugalia

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

Laboratorios Pfizer,

Lda. Lagoas Park

Edifício 10

2740-271 Porto Salvo

Portugal

Diflucan

10 mg/ml

Pulbere pentru suspensie orală

Administrare orală

10 mg/ml

Portugalia

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

Laboratorios Pfizer,

Lda. Lagoas Park

Edifício 10

2740-271 Porto Salvo

Portugal

Diflucan

40 mg/ml

Pulbere pentru suspensie orală

Administrare orală

40 mg/ml

Portugalia

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

Laboratorios Pfizer,

Lda. Lagoas Park

Edifício 10

2740-271 Porto Salvo

Portugal

Diflucan

2 mg/ml

Soluție perfuzabilă

Administrare intravenoasă

2 mg/ml

România

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

Pfizer Europe MA EEIG

Ramsgate Road

Sandwich

Kent

CT13 9NJ,

United Kingdom

Diflucan 50 mg

50 mg

Capsule

Administrare orală

N/A

România

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

Pfizer Europe MA EEIG

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan 150 mg

150 mg

Capsule

Administrare orală

N/A

România

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

Pfizer Europe MA EEIG

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan 50 mg/5 ml

50 mg/5 ml

Pulbere pentru suspensie orală

Administrare orală

10 mg/ml

România

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

Pfizer Europe MA EEIG

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan 2 mg/ml

2 mg/ml

Soluție perfuzabilă

Administrare intravenoasă

2 mg/ml

Republica Slovacă

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

Pfizer Europe MA EEIG

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan 50 mg

50 mg

Capsule

Administrare orală

N/A

Republica Slovacă

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

Pfizer Europe MA EEIG

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan 100 mg

100 mg

Capsule

Administrare orală

N/A

Republica Slovacă

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

Pfizer Europe MA EEIG

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan 150 mg

150 mg

Capsule

Administrare orală

N/A

Republica Slovacă

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

Pfizer Europe MA EEIG

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan P.O.S. 50 mg/5 ml

50 mg/5 ml

Pulbere pentru suspensie orală

Administrare orală

10 mg/ml

Republica Slovacă

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

Pfizer Europe MA EEIG

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan P.O.S. 200 mg/5 ml

200 mg/5 ml

Pulbere pentru suspensie orală

Administrare orală

40 mg/ml

Republica Slovacă

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

Pfizer Europe MA EEIG

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan IV 2 mg/ml

2 mg/ml

Soluție perfuzabilă intravenoasă

Administrare intravenoasă

2 mg/ml

Slovenia

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

Pfizer Luxembourg SARL

51, Avenue J. F. Kennedy

L-1855 Luxembourg,

Luxembourg

Diflucan 50 mg trde kapsule

50 mg

Capsule

Administrare orală

N/A

Slovenia

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

Pfizer Luxembourg SARL

51, Avenue J. F. Kennedy

L-1855 Luxembourg,

Luxembourg

Diflucan 100 mg trde kapsule

100 mg

Capsule

Administrare orală

N/A

Slovenia

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

Pfizer Luxembourg SARL

51, Avenue J. F. Kennedy

L-1855 Luxembourg,

Luxembourg

Diflucan 150 mg trde kapsule

150 mg

Capsule

Administrare orală

N/A

Slovenia

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

Pfizer Luxembourg SARL

51, Avenue J. F. Kennedy

L-1855 Luxembourg,

Luxembourg

Diflucan 10 mg/ ml prašek za peroralno suspenzijo

10 mg/ml

Pulbere pentru suspensie

Administrare orală

10 mg/ml

Slovenia

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

Pfizer Luxembourg SARL

51, Avenue J. F. Kennedy

L-1855 Luxembourg,

Luxembourg

Diflucan 40 mg/ml prašek za peroralno suspenzijo

40 mg/ml

Pulbere pentru suspensie

Administrare orală

40 mg/ml

Slovenia

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

Pfizer Luxembourg SARL

51, Avenue J. F. Kennedy

L-1855 Luxembourg,

Luxembourg

Diflucan 2 mg/ml raztopina za infundiranje

2 mg/ml

Soluție perfuzabilă

Administrare intravenoasă

2 mg/ml

Spania

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

Vinci Farma, S.A. (Grupo Pfizer)

Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Diflucan 50 mg cápsulas duras

50 mg

Capsule

Administrare orală

N/A

Spania

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

Vinci Farma, S.A. (Grupo Pfizer)

Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Diflucan 100 mg cápsulas duras

100 mg

Capsule

Administrare orală

N/A

Spania

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

Vinci Farma, S.A. (Grupo Pfizer)

Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Diflucan 150 mg cápsulas duras

150 mg

Capsule

Administrare orală

N/A

Spania

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

Vinci Farma, S.A. (Grupo Pfizer)

Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Diflucan 200 mg cápsulas duras

200 mg

Capsule

Administrare orală

N/A

Spania

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

Vinci Farma, S.A. (Grupo Pfizer)

Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Diflucan 50 mg/5 ml polvo para suspensión oral

50 mg/5 ml

Pulbere pentru suspensie

Administrare orală

10 mg/ml

Spania

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

Vinci Farma, S.A. (Grupo Pfizer)

Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Diflucan 200 mg/5 ml polvo para suspensión oral

200 mg/5 ml

Pulbere pentru suspensie

Administrare orală

40 mg/ml

Spania

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

Vinci Farma, S.A. (Grupo Pfizer)

Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Diflucan 2 mg/ml solución para perfusión

2 mg/ml

Soluție perfuzabilă

Administrare intravenoasă

2 mg/ml

Suedia

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

Pfizer AB

191 90 Sollentuna

Sweden

Diflucan

50 mg

Capsule

Administrare orală

N/A

Suedia

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

Pfizer AB

191 90 Sollentuna

Sweden

Diflucan

100 mg

Capsule

Administrare orală

N/A

Suedia

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

Pfizer AB

191 90 Sollentuna

Sweden

Diflucan

150 mg

Capsule

Administrare orală

N/A

Suedia

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

Pfizer AB

191 90 Sollentuna

Sweden

Diflucan

200 mg

Capsule

Administrare orală

N/A

Suedia

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

Pfizer AB

191 90 Sollentuna

Sweden

Diflucan

10 mg/ml

Pulbere pentru suspensie

Administrare orală

10 mg/ml

Suedia

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

Pfizer AB

191 90 Sollentuna

Sweden

Diflucan

40 mg/ml

Pulbere pentru suspensie

Administrare orală

40 mg/ml

Suedia

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

Pfizer AB

191 90 Sollentuna

Sweden

Diflucan

2 mg/ml

Soluție perfuzabilă

Administrare intravenoasă

2 mg/ml

Marea Britanie

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

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan

50 mg

Capsule

Administrare orală

N/A

Marea Britanie

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

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan

150 mg

Capsule

Administrare orală

N/A

Marea Britanie

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

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan

200 mg

Capsule

Administrare orală

N/A

Marea Britanie

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

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan

50 mg/5 ml

Pulbere pentru suspensie

Oral use

10 mg/ml

Marea Britanie

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

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan

200 mg/5 ml

Pulbere pentru suspensie

Oral use

40 mg/ml

Marea Britanie

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

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan

2 mg/ml

Soluție perfuzabilă

Administrare intravenoasă

2 mg/ml

---

ANEXA V

LISTA CU DENUMIRILE COMERCIALE, FORMA(ELE) FARMACEUTICĂ(E), CONCENTRAȚIA(IILE), CALEA(CĂILE) DE ADMINISTRARE A(ALE) MEDICAMENTULUI (ELOR), SOLICITANTUL (ȚII), DEȚINĂTORUL(II) AUTORIZAȚIEI DE PUNERE PE PIAȚĂ ÎN STATELE MEMBRE

| Statul Membru UE/SEE | Solicitantul | Numele inventat Numele | Concentrația | Forma farmaceutică | Calea de administrare | Conținutul
  (concentrația) |
| --- | --- | --- | --- | --- | --- | --- |
| Belgia | Alapis S.A., |
| 2 Aftokratoros |
| Nikolaou street, |
| 17671 Athens, |
| Greece |

Statul Membru UE/SEE

Solicitantul

Numele inventat Numele

Concentrația

Forma farmaceutică

Calea de administrare

Conținutul

(concentrația)

Belgia

Alapis S.A.,

2 Aftokratoros

Nikolaou street,

17671 Athens,

Greece

Dexamethasone Alapis

0,4 mg/ml

Soluție orală

Orală

1 flacon × 150 ml

Bulgaria

| Alapis Bulgaria Ltd., |
| --- |
| 29, Atanas Dukov |
| Str. 1407, |
| Sofia, |
| Bulgaria |

Alapis Bulgaria Ltd.,

29, Atanas Dukov

Str. 1407,

Sofia,

Bulgaria

Dexamethasone Alapis

0,4 mg/ml

Soluție orală

Orală

1 flacon × 150 ml

Cipru

| Alapis S.A., |
| --- |
| 2 Aftokratoros |
| Nikolaou street, |
| 17671 Athens, |
| Greece |

Alapis S.A.,

2 Aftokratoros

Nikolaou street,

17671 Athens,

Greece

Dexamethasone Alapis

0,4 mg/ml

Soluție orală

Orală

1 flacon × 150 ml

Germania

| Alapis S.A., |
| --- |
| 2 Aftokratoros |
| Nikolaou street, |
| 17671 Athens, |
| Greece |

Alapis S.A.,

2 Aftokratoros

Nikolaou street,

17671 Athens,

Greece

Dexamethasone Alapis

0,4 mg/ml

Soluție orală

Orală

1 flacon × 150 ml

Grecia

| Alapis S.A., |
| --- |
| 2 Aftokratoros |
| Nikolaou street, |
| 17671 Athens, |
| Greece |

Alapis S.A.,

2 Aftokratoros

Nikolaou street,

17671 Athens,

Greece

Dexamethasone Alapis

0,4 mg/ml

Soluție orală

Orală

1 flacon × 150 ml

Malta

| Alapis S.A., |
| --- |
| 2 Aftokratoros |
| Nikolaou street, |
| 17671 Athens, |
| Greece |

Alapis S.A.,

2 Aftokratoros

Nikolaou street,

17671 Athens,

Greece

Dexamethasone Alapis

0,4 mg/ml

Soluție orală

Orală

1 flacon × 150 ml

Portugalia

| Alapis S.A., |
| --- |
| 2 Aftokratoros |
| Nikolaou street, |
| 17671 Athens, |
| Greece |

Alapis S.A.,

2 Aftokratoros

Nikolaou street,

17671 Athens,

Greece

Dexamethasone Alapis

0,4 mg/ml

Soluție orală

Orală

1 flacon × 150 ml

România

| Alapis Romania s.r.l. |
| --- |
| Strada Leordeni nr. 13, Bragadiru, |
| Jud.IIfov, 077025, |
| Romania |

Alapis Romania s.r.l.

Strada Leordeni nr. 13, Bragadiru,

Jud.IIfov, 077025,

Romania

Dexamethasone Alapis

0,4 mg/ml

Soluție orală

Orală

1 flacon × 150 ml

Regatul Unit

| Alapis S.A., |
| --- |
| 2 Aftokratoros |
| Nikolaou street, |
| 17671 Athens, |
| Greece |

Alapis S.A.,

2 Aftokratoros

Nikolaou street,

17671 Athens,

Greece

Dexamethasone Alapis

0,4 mg/ml

Soluție orală

Orală

1 flacon × 150 ml

---

ANEXA VI

LISTA CU DENUMIREA COMMERCIALĂ, FORMA FARMACEUTICĂ, CONCENTRAȚIA MEDICINAMENTULUI, MODUL DE ADMINISTRARE, SOLICITANTUL, DEȚINĂTORUL AUTORIZAȚIEI DE PUNETE PE PIAȚĂ DIN STATELE MEMBRE

| Statele Membre UE/AEE | Deținătorul autorizației de punere pe piață | Solicitantul | Denumire comercială | Concentrația | Forma farmaceutică | Mod de administrare | Conținutul
  (concentrația) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Irlanda | Pinewood Laboratories Limited, Ballmacarbry, Clonmel, Co. Tipperary, |
| Ireland |

Statele Membre UE/AEE

Deținătorul autorizației de punere pe piață

Solicitantul

Denumire comercială

Concentrația

Forma farmaceutică

Mod de administrare

Conținutul

(concentrația)

Irlanda

Pinewood Laboratories Limited, Ballmacarbry, Clonmel, Co. Tipperary,

Ireland

Canazole Clotrimazole Cream 1 % w/w

1 % w/w

Cremă

Cutanată

1 %w/w

Marea Britanie

| Pinewood Laboratories Limited, Ballymacarbry, Clonmel, Co. Tipperary, |
| --- |
| Ireland |

Pinewood Laboratories Limited, Ballymacarbry, Clonmel, Co. Tipperary,

Ireland

Canazole Clotrimazole Cream 1 % w/w

1 % w/w

Cremă

Cutanată

1 %w/w

---

ANEXA VII

LISTA CU DENUMIRILE COMERCIALE, FORMELE FARMACEUTICE, CONCENTRAȚIA, CALEA DE ADMINISTRARE A MEDICAMENTULUI, SOLICITANTII, DEȚINĂTORII AUTORIZAȚIEI DE PUNERE PE PIAȚĂ ÎN STATELE MEMBRE

| Statul Membru UE/SEE | Deținătorul autorizației de punere pe piață | Numele inventat | Concentrația | Forma farmaceutică | Calea de administrare |
| --- | --- | --- | --- | --- | --- |
| Austria | STADA Arzneimittel GmbH, |
| Muthgasse 36, |
| A-1190 Wien |
| Austria |

Statul Membru UE/SEE

Deținătorul autorizației de punere pe piață

Numele inventat

Concentrația

Forma farmaceutică

Calea de administrare

Austria

STADA Arzneimittel GmbH,

Muthgasse 36,

A-1190 Wien

Austria

Novogos 3,6 mg Implantat

3,6 mg

Implant

Subcutanată

Germania

| cell pharm GmbH |
| --- |
| Theodor-Heuss-Str. 52 |
| 61118 Bad Vilbel |
| Germany |

cell pharm GmbH

Theodor-Heuss-Str. 52

61118 Bad Vilbel

Germany

Goserelin cell pharm 3,6 mg Implantat

3,6 mg

Implant, Seringă preumplută

Subcutanată

Marea Britanie

| Genus Pharmaceuticals, |
| --- |
| Park View House, |
| 65 London Road, |
| Newbury, Berkshire |
| RG14 1 JN |
| United Kingdom |

Genus Pharmaceuticals,

Park View House,

65 London Road,

Newbury, Berkshire

RG14 1 JN

United Kingdom

Novgos 3,6 mg Implant

3,6 mg

Implant

Subcutanată

---

ANEXA VIII

LISTA CU DENUMIRILE COMERCIALE, FORMELE FARMACEUTICE, CONCENTRAȚIA, CALEA DE ADMINISTRARE A MEDICAMENTULUI, SOLICITANTUL, DEȚINĂTORUL AUTORIZAȚIEI DE PUNERE PE PIAȚĂ ÎN STATELE MEMBRE

| Statul Membru UE/SEE | Deținătorul autorizației de punere pe piață | Numele inventat | Concentrația | Forma farmaceutică | Calea de administrare |
| --- | --- | --- | --- | --- | --- |
| Austria | Acino AG |
| Am Windfeld 35 |
| 83714 Miesbach |
| Germany |

Statul Membru UE/SEE

Deținătorul autorizației de punere pe piață

Numele inventat

Concentrația

Forma farmaceutică

Calea de administrare

Austria

Acino AG

Am Windfeld 35

83714 Miesbach

Germany

Novimp 3,6 mg Implantat

3,6 mg

implant, seringă preumplută

subcutanată

Germania

| Acino AG |
| --- |
| Am Windfeld 35 |
| 83714 Miesbach |
| Germany |

Acino AG

Am Windfeld 35

83714 Miesbach

Germany

Novimp 3,6 mg Implantat

3,6 mg

implant

subcutanată

Marea Britanie

| Acino AG |
| --- |
| Am Windfeld 35 |
| 83714 Miesbach |
| Germany |

Acino AG

Am Windfeld 35

83714 Miesbach

Germany

Novimp 3,6 mg Implant

3,6 mg

implant

subcutanată

---

ANEXA IX

LISTA CU DENUMIRILE COMERCIALE, FORMELE FARMACEUTICE, CONCENTRAȚIA, CALEA DE ADMINISTRARE A MEDICAMENTULUI, SOLICITANTUL, DEȚINĂTORUL AUTORIZAȚIEI DE PUNERE PE PIAȚĂ ÎN STATELE MEMBRE

| Statul Membru UE/SEE | Deținătorul autorizației de punere pe piață | Numele inventat | Concentrația | Forma farmaceutică | Calea de administrare |
| --- | --- | --- | --- | --- | --- |
| Austria | Acino AG |
| Am Windfeld 35 |
| 83714 Miesbach |
| Germany |

Statul Membru UE/SEE

Deținătorul autorizației de punere pe piață

Numele inventat

Concentrația

Forma farmaceutică

Calea de administrare

Austria

Acino AG

Am Windfeld 35

83714 Miesbach

Germany

Goserelin Novosis 3,6 mg Implantat

3,6 mg

implant, seringă preumplută

subcutanată

Germania

| Acino AG |
| --- |
| Am Windfeld 35 |
| 83714 Miesbach |
| Germany |

Acino AG

Am Windfeld 35

83714 Miesbach

Germany

Novosis Goserelin 3,6 mg Implantat

3,6 mg

implant

subcutanată

Marea Britanie

| Acino AG |
| --- |
| Am Windfeld 35 |
| 83714 Miesbach |
| Germany |

Acino AG

Am Windfeld 35

83714 Miesbach

Germany

Gosacin 3,6 mg Implant

3,6 mg

implant

subcutanată

---