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Official Journal of the European Union, C 383, 30 December 2011

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		ISSN 1977-091X doi:10.3000/1977091X.C_2011.383.eng
Official Journal of the European Union		C 383

English edition	Information and Notices	Volume 54 30 December 2011

Notice No	Contents	page
	IV Notices
	NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES
	European Commission
2011/C 383/01	Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2011 to 31 October 2011(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)	1

2011/C 383/02	Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2011 to 31 October 2011(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)	17

IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

30.12.2011

Official Journal of the European Union

C 383/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2011 to 31 October 2011

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1) )

2011/C 383/01

— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

2.9.2011

Vibativ

telavancin

Astellas Pharma Europe B.V.

Elisabethhof 19,

NL-2353 EW Leiderdorp,

Nederland

EU/1/11/705/001-002

powder for concentrate for solution for infusion

J01XA03

6.9.2011

2.9.2011

Votubia

Everolimus

Novartis Europharm Limited

Wimblehurst Road, Horsham,

West Sussex,

RH12 5AB,

United Kingdom

EU/1/11/710/001-007

Tablet

L01XE10

6.9.2011

5.9.2011

Zytiga

abiraterone

Janssen-Cilag International NV

Turnhoutseweg 30,

B-2340 Beerse,

België

EU/1/11/714/001

Tablet

L02BX03

7.9.2011

16.9.2011

Dexdor

dexmedetomidine

Orion Corporation

Orionintie 1,

FI-02200 Espoo,

Suomi

EU/1/11/718/001-006

Concentrate for solution for infusion

N05CM18

21.9.2011

19.9.2011

Incivo

telaprevir

Janssen-Cilag International NV

Turnhoutseweg 30,

B-2340 Beerse,

België

EU/1/11/720/001

Film-coated tablet

Pending

22.9.2011

30.9.2011

Pramipexole Accord

pramipexole

Accord Healthcare Limited

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

London

NW3 5JJ,

United Kingdom

EU/1/11/728/001-010

Tablet

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

EU/1/11/712/001-028

Film-coated tablet

N03AX14

5.1.2011

3.10.2011

Levetiracetam Actavis

levetiracetam

Actavis Group PTC ehf.

Reykjavikurvegur 76-78,

220 Hafnarfjordur,

Iceland

EU/1/11/713/001-040

Film-coated tablet

N03AX14

5.10.2011

3.10.2011

Matever

levetiracetam

Pharmathen S.A.

6 Dervenakion,

15351 Pallini Attiki,

Ελλάδα

EU/1/11/711/001-030

Concentrate for solution for infusion

Film-coated tablet

N03AX14

6.10.2011

3.10.2011

Telmisartan Teva Pharma

telmisartan

Teva Pharma B.V.

Computerweg 10,

3542 DR Utrecht,

Nederland

EU/1/11/719/001-060

Tablet

C09CA07

5.10.2011

27.10.2011

Eurartesim

dihydroartemisinin/piperaquine tetraphosphate

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A

Viale Shakespeare 47,

00144 Rome,

Italia

EU/1/11/716/001-005

Film-coated tablet

P01BF05

2.11.2011

— Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

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

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

EU/1/07/424/001

6.9.2011

5.9.2011

Advagraf

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

EU/1/10/658/001-002

7.9.2011

5.9.2011

Apidra

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

EU/1/09/543/001-002

7.9.2011

5.9.2011

Insuman

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

EU/1/05/323/001-013

7.9.2011

5.9.2011

Removab

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

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

EU/1/97/054/001

EU/1/97/054/004-005

7.9.2011

CANCIDAS

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

EU/1/07/392/003

13.9.2011

7.9.2011

Irbesartan HCT Winthrop

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

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

EU/1/06/361/001-002

15.9.2011

13.9.2011

Raloxifene Teva

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

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

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

EU/1/08/479/001-003

16.9.2011

Aerius

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

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

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

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

EU/1/09/564/001-003

20.9.2011

16.9.2011

Myclausen

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

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

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

EU/1/08/452/001

21.9.2011

16.9.2011

Resolor

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

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

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

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

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

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

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

EU/1/04/307/001-021

22.9.2011

Clopidogrel DURA

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

EU/1/08/501/001-002

26.9.2011

22.9.2011

Leflunomide ratiopharm

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

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

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

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

EU/1/07/399/001-006

4.10.2011

3.10.2011

Elaprase

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

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

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

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

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

EU/1/05/320/001

10.10.2011

6.10.2011

Sildenafil Actavis

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

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

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

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

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

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

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

EU/1/09/582/001

14.10.2011

12.10.2011

Stelara

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

EU/1/11/669/001-004

14.1.2011

12.10.2011

Xeplion

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

EU/1/08/486/001-011

14.10.2011

17.10.2011

Docetaxel Teva

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

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

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

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

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

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

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

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

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

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

EU/1/98/086/001-034

26.10.2011

24.10.2011

Daxas

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

EU/1/07/384/001-005

26.10.2011

24.10.2011

Ebixa

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

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

EU/1/03/262/001-008

27.10.2011

24.10.2011

Erbitux

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

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

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

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

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

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

EU/1/04/298/001-003

26.10.2011

24.10.2011

Levemir

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

EU/1/04/279/001-044

26.10.2011

24.10.2011

Nexavar

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

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

EU/1/09/590/001-006

26.10.2011

24.10.2011

Revatio

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

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

EU/1/01/174/001-021

26.10.2011

24.10.2011

Sycrest

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

EU/1/07/386/001-018

26.10.2011

24.10.2011

Votrient

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

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

EU/1/07/387/001-026

4.11.2011

27.10.2011

Axura

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

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

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

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

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

EU/1/08/485/001-011

4.11.2011

27.10.2011

Leflunomide Winthrop

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

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,

EU/1/10/643/001

4.11.2011

27.10.2011

Rasilamlo

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

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

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

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

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

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

EU/1/06/336/001

4.11.2011

27.10.2011

Xiliarx

Novartis Europharm Ltd

Wimblehurst Road, Horsham,

West Sussex

RH12 5AB,

United Kingdom

EU/1/08/486/001-011

4.11.2011

— Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

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

EU/1/05/313/001-009

19.10.2011

— Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (2) ): Accepted

Date of the Décision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

7.9.2011

Nobivac Myxo-RHD

Live myxoma vectored RHD virus strain 009

Intervet International B.V.

Wim de Körverstraat 35,

5831 AN Boxmeer,

Nederland

EU/2/11/132/001-004

Lyophilisate and solvent for suspension for injection

QI08AD

9.9.2011

13.9.2011

Recocam

Meloxicam

CF Pharma Limited

Unit 622, Northern Extension,

Waterford,

Ireland

EU/2/11/133/001-003

Solution for injection

QM01AC06

15.9.2011

6.10.2011

Recuvyra

Fentanyl

Nexcyon Pharmaceuticals Ltd.

Bank Barn, How Mill,

Brampton,

Cumbria

CA8 9JY,

UNITED KINGDOM

EU/2/11/127/001

Transdermal solution

QN02AB03

11.10.2011

— Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

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

EU/2/06/069/001

15.9.2011

16.9.2011

Loxicom

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

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

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

EU/2/07/072/003-004

24.10.2011

Meloxoral

Le Vet B.V.

Wilgenweg 7,

3421 TV

Oudewater,

Nederland

EU/2/10/111/001-007

26.10.2011

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

The European Medicines Agency

7, Westferry Circus,

Canary Wharf

UK - LONDON E14 4H

(1) OJ L 136, 30.4.2004, p. 1.

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

30.12.2011

Official Journal of the European Union

C 383/17

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2011 to 31 October 2011

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2) )

2011/C 383/02

— Issuing, maintenance or modification of a national marketing authorization

Date of the decision	Name(s) of the medicinal product	Holder(s) of the marketing authorization	Member State concerned	Date of notification
7.10.2011	Norvasc and associated names	See Annex I	See Annex I	10.10.2011
20.10.2011	Synulox Lactating Cow Art 34	See Annex II	See Annex II	21.10.2011
13.9.2011	Dexrazoxane - Art 31	See Annex III	See Annex III	15.9.2011
2.9.2011	Diflucan and associated names - Art 30	See Annex IV	See Annex IV	5.9.2011
24.10.2011	Dexamethasone Alapis - Art 29	See Annex V	See Annex V	25.10.2011

— Refusal of a national marketing authorization

Date of the decision	Name(s) of the medicinal product	Holder(s) of the marketing authorization	Member State concerned	Date of notification
22.9.2011	Canazole Clotrimazole Cream 1 % w/w - Art. 29	See Annex VI	See Annex VI	23.9.2011

— Suspension of a national marketing authorization

Date of the decision	Name(s) of the medicinal product	Holder(s) of the marketing authorization	Member State concerned	Date of notification
22.9.2011	Canazole Clotrimazole Cream 1 % w/w - Art. 29	See Annex VI	See Annex VI	23.9.2011
16.9.2011	Goserelin cell pharm 3,6 mg Implantat and associated names	See Annex VII	See Annex VII	20.9.2011
16.9.2011	Novimp 3,6 mg Implantat and associated names - Ref. Art.36	See Annex VIII	See Annex VIII	19.9.2011
16.9.2011	Novosis Goserelin 3,6 mg Implantat and associated names	See Annex IX	See Annex IX	19.9.2011

(1) OJ L 311, 28.11.2001, p. 67.

(2) OJ L 311, 28.11.2001, p. 1.

ANNEX I

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

Member State EU/EEA

Marketing authorisation holder

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Austria

Pfizer Corporation Austria Ges.m.b.H.

Floridsdorfer Hauptstrasse 1

A - 1210 Wien

Austria

Norvasc 5 mg - Tabletten

5 mg

Tablet

Oral use

Austria

Pfizer Corporation Austria Ges.m.b.H.

Floridsdorfer Hauptstrasse 1

A - 1210 Wien

Austria

Norvasc 10 mg - Tabletten

10 mg

Tablet

Oral use

Belgium

Pfizer SA

Boulevard de la Plaine 17,

B-1050 Brussels

Belgium

Amlor

5 mg

Capsule, Hard

Oral use

Belgium

Pfizer SA

Boulevard de la Plaine 17,

B-1050 Brussels

Belgium

Amlor

10 mg

Capsule, Hard

Oral use

Bulgaria

Pfizer Europe MA EEIG,

Ramsgate Road,

Sandwich,

Kent,

CT13 9NJ,

United Kingdom

Norvasc

5 mg

Tablet

Oral use

Bulgaria

Pfizer Europe MA EEIG,

Ramsgate Road,

Sandwich,

Kent,

CT13 9NJ,

United Kingdom

Norvasc

10 mg

Tablet

Oral use

Cyprus

Pfizer Hellas A. E.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens,

Greece

Norvasc

5 mg

Capsule, Hard

Oral use

Cyprus

Pfizer Hellas A. E.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens,

Greece

Norvasc

Capsule, Hard

Oral use

Denmark

Pfizer ApS,

Lautrupvang 8,

2750 Ballerup,

Denmark

Norvasc

5 mg

Tablet

Oral use

Denmark

Pfizer ApS,

Lautrupvang 8,

2750 Ballerup,

Denmark

Norvasc

10 mg

Tablet

Oral use

Denmark

Pfizer ApS,

Lautrupvang 8,

2750 Ballerup,

Denmark

Amlodipine Pfizer

5 mg

Tablet

Oral use

Denmark

Pfizer ApS,

Lautrupvang 8,

2750 Ballerup,

Denmark

Amlodipine Pfizer

10 mg

Tablet

Oral use

Estonia

Pfizer Europe MA EEIG,

Ramsgate Road,

Sandwich,

Kent,

CT13 9NJ,

United Kingdom

Norvasc

5 mg

Tablet

Oral use

Estonia

Pfizer Europe MA EEIG,

Ramsgate Road,

Sandwich,

Kent,

CT13 9NJ,

United Kingdom

Norvasc

10 mg

Tablet

Oral use

Finland

Pfizer Oy,

Tietokuja 4,

00330 Helsinki,

Finland

Norvasc

5 mg

Tablet

Oral use

Finland

Pfizer Oy,

Tietokuja 4,

00330 Helsinki,

Finland

Norvasc

10 mg

Tablet

Oral use

France

Pfizer Holding France

23-25 Avenue du Docteur Lannelongue

75014 Paris

France

Amlor

5 mg

Capsule, Hard

Oral use

France

Pfizer Holding France

23-25 Avenue du Docteur Lannelongue

75014 Paris

France

Amlor

10 mg

Capsule, Hard

Oral use

Germany

Pfizer Pharma GmbH,

Linkstraße 10

10785 Berlin,

Germany

Norvasc 5 mg

5 mg

Tablet

Oral use

Germany

Pfizer Pharma GmbH,

Linkstraße 10

10785 Berlin,

Germany

Norvasc 10 mg

10 mg

Tablet

Oral use

Greece

Pfizer Hellas A. E.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens,

Greece

Norvasc

5 mg

Capsule, Hard

Oral use

Greece

Pfizer Hellas A. E.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens,

Greece

Norvasc

10 mg

Capsule, Hard

Oral use

Hungary

Pfizer KFT,

Budapest,

Alkotás u. 53

1123

Hungary

Norvasc

5 mg

Tablet

Oral use

Hungary

Pfizer KFT,

Budapest,

Alkotás u. 53

1123

Hungary

Norvasc

10 mg

Tablet

Oral use

Iceland

Pfizer ApS,

Lautrupvang 8,

2750 Ballerup,

Denmark

Norvasc

5 mg

Tablet

Oral use

Iceland

Pfizer ApS,

Lautrupvang 8,

2750 Ballerup,

Denmark

Norvasc

10 mg

Tablet

Oral use

Ireland

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Istin

5 mg

Tablet

Oral use

Ireland

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Istin

10 mg

Tablet

Oral use

Ireland

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Amlodipine besilate 5 mg tablets

5 mg

Tablet

Oral use

Ireland

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Amlodipine besilate 10 mg tablets

10 mg

Tablet

Oral use

Italy

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina –

Italy

Norvasc

5 mg

Tablet

Oral use

Italy

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina,

Italy

Norvasc

10 mg

Tablet

Oral use

Italy

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina,

Italy

Monopina

5 mg

Tablet

Oral use

Italy

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina –

Italy

Monopina

10 mg

Tablet

Oral use

Latvia

Pfizer Limited,

Ramsgate Road,

Sandwich,

Kent

CT13 9NJ,

United Kingdom

Norvasc 5 mg tabletes

5 mg

Tablet

Oral use

Latvia

Pfizer Limited,

Ramsgate Road,

Sandwich,

Kent

CT13 9NJ,

United Kingdom

Norvasc 10 mg tabletes

10 mg

Tablet

Oral use

Lithuania

Pfizer Europe MA EEIG,

Ramsgate Road,

Sandwich,

Kent,

CT13 9NJ,

United Kingdom

Norvasc

5 mg

Tablet

Oral use

Lithuania

Pfizer Europe MA EEIG,

Ramsgate Road,

Sandwich,

Kent,

CT13 9NJ,

United Kingdom

Norvasc

10 mg

Tablet

Oral use

Lithuania

Pfizer Europe MA EEIG,

Ramsgate Road,

Sandwich,

Kent,

CT13 9NJ,

United Kingdom

Norvasc

5 mg

Capsule, Hard

Oral use

Lithuania

Pfizer Europe MA EEIG,

Ramsgate Road,

Sandwich,

Kent,

CT13 9NJ,

United Kingdom

Norvasc

10 mg

Capsule, Hard

Oral use

Luxembourg

Pfizer SA

Boulevard de la Plaine 17

B-1050 Brussels,

Belgium

Amlor

5 mg

Capsule, Hard

Oral use

Luxembourg

Pfizer SA

Boulevard de la Plaine 17

B-1050 Brussels,

Belgium

Amlor

10 mg

Capsule, Hard

Oral use

Malta

Pfizer Hellas S.A.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens,

Greece

Istin

5 mg

Tablet

Oral use

Malta

Pfizer Hellas S.A.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens,

Greece

Istin

10 mg

Tablet

Oral use

Netherlands

Pfizer bv

Rivium Westlaan 142

2909 LD Capelle a/d IJssel

The Netherlands

Norvasc 5

5 mg

Tablet

Oral use

Netherlands

Pfizer bv

Rivium Westlaan 142

2909 LD Capelle a/d IJssel

The Netherlands

Norvasc 10

10 mg

Tablet

Oral use

Norway

Pfizer AS

Pb. 3

1324 Lysaker

Norway

Norvasc

5 mg

Tablet

Oral use

Norway

Pfizer AS

Pb. 3

1324 Lysaker

Norway

Norvasc

10 mg

Tablet

Oral use

Poland

Pfizer Europe MA EEIG,

Ramsgate Road,

Sandwich,

Kent,

CT13 9NJ,

United Kingdom

Norvasc

5 mg

Tablet

Oral use

Poland

Pfizer Europe MA EEIG,

Ramsgate Road,

Sandwich,

Kent,

CT13 9NJ,

United Kingdom

Norvasc

10 mg

Tablet

Oral use

Portugal

Laboratorios Pfizer, Lda.,

Lagoas Park, Edifício 10,

2740-271 Porto Salvo,

Portugal

Norvasc

5 mg

Tablet

Oral use

Portugal

Laboratorios Pfizer, Lda.,

Lagoas Park, Edifício 10,

2740-271 Porto Salvo,

Portugal

Norvasc

10 mg

Tablet

Oral use

Romania

Pfizer Europe MA EEIG,

Ramsgate Road,

Sandwich,

Kent,

CT13 9NJ,

United Kingdom

Norvasc 5 mg capsule

5 mg

Capsule, Hard

Oral use

Romania

Pfizer Europe MA EEIG,

Ramsgate Road,

Sandwich,

Kent,

CT13 9NJ,

United Kingdom

Norvasc 10 mg capsule

10 mg

Capsule, Hard

Oral use

Romania

Pfizer Europe MA EEIG,

Ramsgate Road,

Sandwich,

Kent,

CT13 9NJ,

United Kingdom

Norvasc 5 mg

5 mg

Tablet

Oral use

Romania

Pfizer Europe MA EEIG,

Ramsgate Road,

Sandwich,

Kent,

CT13 9NJ,

United Kingdom

Norvasc 10 mg

10 mg

Tablet

Oral use

Slovak Republic

Pfizer Europe MA EEIG,

Ramsgate Road,

Sandwich,

Kent,

CT13 9NJ,

United Kingdom

Norvasc

5 mg

Tablet

Oral use

Slovak Republic

Pfizer Europe MA EEIG,

Ramsgate Road,

Sandwich,

Kent,

CT13 9NJ,

United Kingdom

Norvasc

10 mg

Tablet

Oral use

Slovenia

Pfizer Luxembourg SARL,

51, Avenue J. F. Kennedy,

L-1855 Luxembourg

Norvasc 5 mg tablete

5 mg

Tablet

Oral use

Slovenia

Pfizer Luxembourg SARL,

51, Avenue J. F. Kennedy,

L-1855 Luxembourg

Norvasc 10 mg tablete

10 mg

Tablet

Oral use

Spain

PFIZER, S.A.

Av. De Europa, 20-B

Parque Empresarial “La Moraleja”

28108 ALCOBENDAS Madrid,

Spain

Norvas 5 mg comprimidos

5 mg

Tablet

Oral use

Spain

PFIZER, S.A.

Av. De Europa, 20-B

Parque Empresarial “La Moraleja”

28108 ALCOBENDAS Madrid,

Spain

Norvas 10 mg comprimidos

10 mg

Tablet

Oral use

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

Tablet

Oral use

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

Tablet

Oral use

Sweden

Pfizer AB

19190 Sollentuna

Sweden

Norvasc

5 mg

Tablet

Oral use

Sweden

Pfizer AB

191 90 Sollentuna

Sweden

Norvasc

10 mg

Tablet

Oral use

United Kingdom

Pfizer Limited,

Ramsgate Road,

Sandwich,

United Kingdom

Istin

5 mg

Tablet

Oral use

United Kingdom

Pfizer Limited,

Ramsgate Road,

Sandwich,

Kent,

CT13 9NJ,

United Kingdom

Istin

10 mg

Tablet

Oral use

ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, WITHDRAWAL PERIOD, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

Member State EU/EEA

Marketing Authorisation Holder

Name

INN

Strengths

Pharmaceutical form

Animal species

Withdrawal period

(meat and milk)

Austria

Pfizer Corporation Austria GmbH

Floridsdorfer Hauptstraße 1

1210 Wien

Austria

Synulox comp - Injektoren für Kühe

Amoxicillin (as amoxicillin trihydrate)

200 mg

Intramammary suspension

Cattle

Meat and offal: 4 days,

milk: 3 days

Clavulanic acid (as potassium clavulanate)

50 mg

Prednisolone

10 mg

Bulgaria

Pfizer Animal Health MA EEIG

Ramstage Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Synulox Lactating Cow

Amoxicillin (as amoxicillin trihydrate)

200 mg

Intramammary suspension

Cattle

Meat: 7 days

Milk: 60 hours

In combination with SYNULOX RTU:

Meat: 42 days.

Milk: 60 hours.

Clavulanic acid (as potassium clavulanate)

50 mg

Prednisolone

10 mg

Cyprus

PFIZER HELLAS AE

Mesogeion Ave. 243

154 51 Neo Psichiko

Athens

Greece

SYNULOX LC

Amoxicillin (as amoxicillin trihydrate)

200 mg

Intramammary suspension

Cattle

Edible tissues: 4 days

Milk: 72 Hours

Clavulanic acid (as potassium clavulanate)

50 mg

Prednisolone

10 mg

Czech Republic

Pfizer, spol. s r.o.

Veterinární divize – Anumal Health

Stroupežnického 17

150 00 Praha 5

Czech Republic

SYNULOX LC 260 mg intramam. suspension for cattle

Amoxicillin (as amoxicillin trihydrate)

200 mg

Intramammary suspension

Cattle

Meat: 7 days

Milk 84 hours (7 milkings)

Clavulanic acid (as potassium clavulanate)

50 mg

Prednisolone

10 mg

France

PFIZER

23/25 Avenue Du Docteur Lannelongue

75014 Paris

France

SYNULOX INTRAMAMMAIRE

Amoxicillin (as amoxicillin trihydrate)

200 mg

Intramammary suspension

Cattle

Meat: 7 days

Milk: 2 days

Clavulanic acid (as potassium clavulanate)

50 mg

Prednisolone

10 mg

Greece

PFIZER HELLAS A.E

Mesogion Av 242

154 51 N. Psichiko

Greece

SYNULOX LC

Amoxicillin (as amoxicillin trihydrate)

200 mg

Intramammary suspension

Cattle

Meat: 3 days

Milk: 72 hours

Clavulanic acid (as potassium clavulanate)

10 mg

Prednisolone

50 mg

Hungary

Pfizer Kft.

Budapest

Alkotás u. 53.

1123

Hungary

SYNULOX LC tőgyinfúzió

Amoxicillin (as amoxicillin trihydrate)

200 mg

Intramammary suspension

Cattle

Edible tissues: 4 days

Milk: 60 hours

Clavulanic acid (as potassium clavulanate)

50 mg

Prednisolone

10 mg

Ireland

Pfizer Healthcare Ireland, Trading as Pfizer Animal Health

Ringaskiddy

County Cork

Ireland

Synulox Lactating Cow Intramammary suspension.

Amoxicillin (as amoxicillin trihydrate)

200 mg

Intramammary suspension

Cattle

Meat and offal: 7 Days

Milk: 60 Hours

Meat: 7 days

Milk (cows milked twice daily): 60 hours (i.e. at the 5th milking) after the last treatment. When any other milking routine is followed milk may be taken for human consumption only after the same period from the last treatment (e.g. with 3 times a day milking, milk for human consumption may only be taken at the 8th milking).

In combination with SYNULOX RTU:

Meat: 42 days.

Milk: 80 hours.

Clavulanic acid (as potassium clavulanate)

50 mg

Prednisolone

10 mg

Italy

PFIZER ITALIA

Via Valbiondone 113

00188 Roma

Italy

SYNULOX ENDOMAMMARIO

Amoxicillin (as amoxicillin trihydrate)

200 mg

Intramammary suspension

Cattle

Meat: 4 days

Milk: 108 hours

Clavulanic acid (as potassium clavulanate)

50 mg

Prednisolone

10 mg

Latvia

Pfizer Animal Health MA EEIG

Ramsgate Road

Sandwich,

Kent

CT13 9NJ

United Kingdom

Synulox LC Suspensija ievadīšanai tesmenī laktējošām govīm

Amoxicillin (as amoxicillin trihydrate)

200 mg

Intramammary suspension

Cattle

Meat: 7 days

In combination with SYNULOX RTU:

Meat: 42 days.

Milk: 60 hours.

Clavulanic acid (as potassium clavulanate)

50 mg

Prednisolone

10 mg

Lithuania

Pfizer Animal Health MA EEIG

Ramstage Road

Sandwich

Kent

CT13 9NJ

United Kingdom

SYNULOX LC, intramaminė suspensija

Amoxicillin (as amoxicillin trihydrate)

200 mg

Intramammary suspension

Cattle

Meat: 7 days

Milk: 60 hours

In combination with SYNULOX RTU:

Meat: 42 days.

Milk: 60 hours.

Clavulanic acid (as potassium clavulanate)

50 mg

Prednisolone

10 mg

Norway

Pfizer Oy

Animal Health

Tietokuja 4

00330 Helsinki

Finland

Synulox comp. vet

Amoxicillin (as amoxicillin trihydrate)

200 mg

Intramammary emulsion

Cattle

Meat: 6 days

Milk: 5 days

Clavulanic acid (as potassium clavulanate)

50 mg

Prednisolone

10 mg

Poland

Pfizer Trading Polska Sp. z o. o.

ul. Rzymowskiego 34

02-697 Warszawa

Poland

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

Amoxicillin (as amoxicillin trihydrate)

200 mg

Intramammary suspension

Cattle

Meat and offal: 4 days

Milk: 60 hours

Clavulanic acid (as potassium clavulanate)

50 mg

Prednisolone

10 mg

Portugal

Laboratórios Pfizer, Lda

Lagoas Park -Edifício 10

Porto Salvo

2470 Oeiras

Portugal

SYNULOX LC suspensão intramamária para bovinos em lactação

Amoxicillin (as amoxicillin trihydrate)

200 mg

Intramammary suspension

Cattle

Meat and offal: 14 days

Milk: 2 days

Clavulanic acid (as potassium clavulanate)

50 mg

Prednisolone

10 mg

Romania

Pfizer Animal Health MA EEIG

Ramstage Road

Sandwich

Kent

CT13 9NJ

United Kingdom

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

Amoxicillin (as amoxicillin trihydrate)

200 mg

Intramammary suspension

Cattle

Meat and offal: 7 days

Milk: 60 hours

In combination with SYNULOX RTU:

Meat: 42 days.

Milk: 14 days.

Clavulanic acid (as potassium clavulanate)

50 mg

Prednisolone

10 mg

Slovak Republic

Pfizer Luxembourg

SARL, o.z.

Pfizer AH

Pribinova 25

811 09 Bratislava

Slovak Republic

Synulox LC 260 mg intramammary suspension

Amoxicillin (as amoxicillin trihydrate)

200 mg

Intramammary suspension

Cattle

Meat: 7 days

Milk: 84 hours (7 milkings)

Clavulanic acid (as potassium clavulanate)

50 mg

Prednisolone

10 mg

Slovenia

PFIZER Luxembourg SARL

51,Avenue

J.F.Kennedy

1855 Luxembourg

SYNULOX LC intramamarna suspenzija za krave v laktaciji

Amoxicillin (as amoxicillin trihydrate)

200 mg

Intramammary suspension

Cattle

Meat and offal: 7 days

Milk: 60 hours

Clavulanic acid (as potassium clavulanate)

50 mg

Prednisolone

10 mg

Spain

PFIZER, S.A.

Avd. Europa 20-B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Spain

SYNULOX LC

Amoxicillin (as amoxicillin trihydrate)

200 mg

Intramammary suspension

Cattle

Meat: 7 days

Milk: 60 hours or 5 milking

Clavulanic acid (as potassium clavulanate)

50 mg

Prednisolone

10 mg

The Netherlands

Pfizer

Rivium Westlaan 142

2909 LD Capelle a/d

Ijssel

The Netherlands

Avuloxil

Amoxicillin (as amoxicillin trihydrate)

200 mg

Intramammary suspension

Cattle

Meat: 7 days

Milk: 4 days

Clavulanic acid (as potassium clavulanate)

50 mg

Prednisolone

10 mg

United Kingdom

Pfizer Ltd

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Synulox Lactating Cow Intramammary Suspension

Amoxicillin (as amoxicillin trihydrate)

200 mg

Intramammary suspension

Cattle

Meat: 7 days

In combination with SYNULOX RTU:

Meat: 42 days.

Milk: 60 hours.

Clavulanic acid (as potassium clavulanate)

50 mg

Prednisolone

10 mg

ANNEX III

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, APPLICANTS, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

Member State EU/EEA

Marketing authorisation holder

Product name

Strength

Pharmaceutical form

Route of administration

Austria

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17 A

1020 Wien

Austria

Cardioxane 500 mg - Pulver zur Herstellung einer Infusionslösung

500 mg

Powder for solution for infusion

Intravenous use

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

Powder for solution for infusion

Intravenous use

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

Powder for solution for infusion

Intravenous use

Czech Republic

Novartis s.r.o.

GEMINI, budova B

Na Pankráci 1724 / 129

CZ-140 00 Praha 4

Czech Republic

Cardioxane

500 mg

Powder for solution for injection

Intravenous use

Czech Republic

CYATHUS EXQUIRERE

Pharmaforschungs GmbH

Rudolfsplatz 2/8

1010 Wien

Austria

Cyrdanax 20 mg/ml prášek pro přípravu infuzního roztoku

20 mg

Powder for solution for injection

Intravenous use

Germany

Novartis Pharma GmbH

Roonstr. 25

D-90429 Nürnberg

Germany

CARDIOXANE 500 mg, Pulver zur Herstellung einer Infusionslösung

500 mg

Powder for solution for infusion

Intravenous (not otherwise specified)

Germany

CYATHUS EXQUIRERE

Pharmaforschungs GmbH

Rudolfsplatz 2/8

1010 Wien

Austria

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

20 mg

Powder for solution for injection

Intravenous use

Germany

CYATHUS EXQUIRERE

Pharmaforschungs GmbH

Rudolfsplatz 2/8

1010 Wien

Austria

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

20 mg

Powder for solution for injection

Intravenous use

Denmark

Novartis Healthcare A/S,

Lyngbyvej 172

DK-2100 Copenhagen Ø

Denmark

Cardioxane

500 mg

Powder for solution for infusion

Intravenous use

Greece

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

12 km National Highway No 1

Metamorfosi Attikis 14451

Greece

CARDIOXANE

500 mg/vial

Powder for solution for infusion

Intravenous use

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

Powder for solution for infusion

Intravenous use

Finland

Novartis Finland Oy,

Metsänneidonkuja 10

02130 Espoo

Finland

Cardioxane

500 mg

powder for solution for infusion

Intravenous use

France

NOVARTIS PHARMA SAS

2-4, rue Lionel Terray

92500 Rueil-Malmaison

FRANCE

CARDIOXANE 500 mg, poudre pour solution pour perfusion

500 mg

powder for solution for infusion

Intravenous use

France

CYATHUS EXQUIRERE

Pharmaforschungs GmbH

Rudolfsplatz 2/8

1010 Wien

Austria

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

20 mg

Powder for solution for injection

Intravenous use

Hungary

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47.

(Bartók-Ház, V. em.)

1114

Budapest

Hungary

CARDIOXANE

500 mg

Powder for solution for infusion

Intravenous use

Hungary

CYATHUS EXQUIRERE

Pharmaforschungs GmbH

Rudolfsplatz 2/8

1010 Wien

Austria

Procard 20 mg/ml Por oldatos infúzióhoz

20 mg

Powder for solution for injection

Intravenous use

Ireland

MAH:

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

Cardioxane

500 mg

Powder for solution for infusion

Intravenous use

Italy

Novartis Farma spa

Largo Umberto Boccioni,

121040 Origgio- Varese

Italy

CARDIOXANE

500 mg

powder for solution for infusion

Intravenous use

Lithuania

Novartis Finland Oy

Metsänneidonkuja 10

FI-02130 Espoo

Finland

Cardioxane

500 mg

Powder for solution for infusion

Intravenous use

Luxembourg

NOVARTIS PHARMA GMBH

25 ROONSTRASSE

90429 NUERNBERG

Germany

CARDIOXANE

500 mg

POWDER FOR SOLUTION FOR INFUSION

Intravenous use

Netherlands

Novartis Pharma B.V.

Raapopseweg 1

6824 DP ARNHEM

The Netherlands

Cardioxane 500 mg

500 mg

powder for solution for infusion

Intravenous use

Norway

Novartis Norge AS

Postboks 237 Okern

0510 Oslo

Norway

Cardioxane

500 mg

Powder for solution for infusion

injection

Poland

Novartis Pharma GmbH

Roonstarsse 25

D-90429 Nürnberg

Germany

Cardioxane

500 mg

powder for solution for infusion

Intravenous use

Portugal

Novartis Farma - Produtos Farmacêuticos, S.A.

Rua do Centro Empresarial,

Edifício 8,

Quinta da Beloura

2710-444 Sintra

Portugal

Cardioxane

500 mg

powder for solution for infusion

Intravenous use

Romania

CYATHUS EXQUIRERE

Pharmaforschungs GmbH

Rudolfsplatz 2/8

1010 Wien

Austria

CYRDANAX 20 mg/ml

20 mg/ml

powder for solution for infusion

Intravenous use

Slovakia

Novartis s.r.o.

GEMINI, budova B

Na Pankráci 1724 / 129

CZ-140 00 Praha 4

Czech Republic

CARDIOXANE

500 mg

powder for solution for infusion

Intravenous use

United Kingdom

Novartis Pharmaceuticals UK Limted Frimley Business Park

Frimley,

Camberley

Surrey

GU16 7SR

United Kingdom

Cardioxane

500 mg

powder for solution for infusion

Intravenous use

ANNEX IV

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

Member State EU/EEA

Marketing authorisation holder

Invented Name

Strength

Pharmaceutical form

Route of administration

Content

(concentration)

Austria

Pfizer Corporation Austria Ges.m.b.H.

Floridsdorfer Hauptstrasse 1

1210 Wien

Austria

Diflucan 50 mg - Kapseln

50 mg

Capsule, Hard

Oral use

N/A

Austria

Pfizer Corporation Austria Ges.m.b.H.

Floridsdorfer Hauptstrasse 1

1210 Wien

Austria

Diflucan 100 mg - Kapseln

100 mg

Capsule, Hard

Oral use

N/A

Austria

Pfizer Corporation Austria Ges.m.b.H.

Floridsdorfer Hauptstrasse 1

1210 Wien

Austria

Diflucan 150 mg - Kapseln

150 mg

Capsule, Hard

Oral use

N/A

Austria

Pfizer Corporation Austria Ges.m.b.H.

Floridsdorfer Hauptstrasse 1

1210 Wien

Austria

Fungata 150 mg - Kapsel

150 mg

Capsule, Hard

Oral use

N/A

Austria

Pfizer Corporation Austria Ges.m.b.H.

Floridsdorfer Hauptstrasse 1

1210 Wien

Austria

Diflucan 200 mg - Kapseln

200 mg

Capsule, Hard

Oral use

N/A

Austria

Pfizer Corporation Austria Ges.m.b.H.

Floridsdorfer Hauptstrasse 1

1210 Wien

Austria

Diflucan 50 mg/5 ml - Trockensaft

50 mg/5 ml

Powder for oral Suspension

Oral use

10 mg/ml

Austria

Pfizer Corporation Austria Ges.m.b.H.

Floridsdorfer Hauptstrasse 1

1210 Wien

Austria

Diflucan 200 mg/5 ml - Trockensaft

200 mg/5 ml

Powder for oral Suspension

Oral use

40 mg/ml

Austria

Pfizer Corporation Austria Ges.m.b.H.

Floridsdorfer Hauptstrasse 1

1210 Wien

Austria

Diflucan 100 mg - Infusionsflaschen

100 mg/50 ml

Solution for Infusion

Intravenous use

2 mg/ml

Austria

Pfizer Corporation Austria Ges.m.b.H.

Floridsdorfer Hauptstrasse 1

1210 Wien

Austria

Diflucan 200 mg - Infusionsflaschen

200 mg/100 ml

Solution for Infusion

Intravenous use

2 mg/ml

Austria

Pfizer Corporation Austria Ges.m.b.H.

Floridsdorfer Hauptstrasse 1

1210 Wien

Austria

Diflucan 400 mg - Infusionsflaschen

400 mg/200 ml

Solution for Infusion

Intravenous use

2 mg/ml

Belgium

Pfizer SA

Boulevard de la Plaine 17

1050 Brussels

Belgium

Diflucan

50 mg

Capsule, Hard

Oral use

N/A

Belgium

Pfizer SA

Boulevard de la Plaine 17

1050 Brussels

Belgium

Diflucan

100 mg

Capsule, Hard

Oral use

N/A

Belgium

Pfizer SA

Boulevard de la Plaine 17

1050 Brussels

Belgium

Diflucan

150 mg

Capsule, Hard

Oral use

N/A

Belgium

Pfizer SA

Boulevard de la Plaine 17

1050 Brussels

Belgium

Diflucan

200 mg

Capsule, Hard

Oral use

N/A

Belgium

Pfizer SA

Boulevard de la Plaine 17

1050 Brussels

Belgium

Diflucan

50 mg/5 ml

Powder for Suspension

Oral use

10 mg/ml

Belgium

Pfizer SA

Boulevard de la Plaine 17

1050 Brussels

Belgium

Diflucan

200 mg/5 ml

Powder for Suspension

Oral use

40 mg/ml

Belgium

Pfizer SA

Boulevard de la Plaine 17

1050 Brussels

Belgium

Diflucan

200 mg/100 ml

Solution for Infusion

Intravenous use

2 mg/ml

Belgium

Pfizer SA

Boulevard de la Plaine 17

1050 Brussels

Belgium

Diflucan

400 mg/200 ml

Solution for Infusion

Intravenous use

2 mg/ml

Bulgaria

Pfizer Europe MA EEIG

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan

50 mg

Capsule, Hard

Oral use

N/A

Bulgaria

Pfizer Europe MA EEIG

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan

150 mg

Capsule, Hard

Oral use

N/A

Bulgaria

Pfizer Europe MA EEIG

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan

2 mg/ml

Solution for Infusion

Intravenous use

2 mg/ml

Cyprus

Pfizer Hellas A. E.

243, Messoghion Ave.

154 51 Νeo Psychiko Athens

Greece

Fungustatin

150 mg

Capsule, Hard

Oral use

N/A

Cyprus

Pfizer Hellas A. E.

243, Messoghion Ave.

154 51 Νeo Psychiko Athens

Greece

Fungustatin

100 mg/50 ml

Solution for Infusion

Intravenous use

2 mg/ml

Czech Republic

Pfizer. s r.o.

Stroupežnického 17

150 00 Prague 5

Czech Republic

Diflucan 50 mg

50 mg

Capsule, Hard

Oral use

N/A

Czech Republic

Pfizer. s r.o.,

Stroupežnického 17

150 00 Prague 5

Czech Republic

Diflucan 100 mg

100 mg

Capsule, Hard

Oral use

N/A

Czech Republic

Pfizer. s r.o.,

Stroupežnického 17

150 00 Prague 5

Czech Republic

Diflucan 150 mg

150 mg

Capsule, Hard

Oral use

N/A

Czech Republic

Pfizer. s r.o.,

Stroupežnického 17

150 00 Prague 5

Czech Republic

Diflucan I.V.

2 mg/ml

Solution for Infusion

Intravenous use

2 mg/ml

Denmark

Pfizer ApS,

Lautrupvang 8

2750 Ballerup

Denmark

Diflucan

50 mg

Capsule, Hard

Oral use

N/A

Denmark

Pfizer ApS,

Lautrupvang 8

2750 Ballerup

Denmark

Diflucan

150 mg

Capsule, Hard

Oral use

N/A

Denmark

Pfizer ApS

Lautrupvang 8

2750 Ballerup

Denmark

Diflucan

200 mg

Capsule, Hard

Oral use

N/A

Denmark

Pfizer ApS

Lautrupvang 8

2750 Ballerup

Denmark

Diflucan

10 mg/ml

Powder for Suspension

Oral use

10 mg/ml

Denmark

Pfizer ApS

Lautrupvang 8

2750 Ballerup

Denmark

Diflucan

2 mg/ml

Solution for Infusion

Intravenous use

2 mg/ml

Estonia

Pfizer Europe MA EEIG

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan 150 mg

150 mg

Capsule, Hard

Oral use

N/A

Estonia

Pfizer Europe MA EEIG

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan 2 mg/ml

2 mg/ml

Solution for Infusion

Intravenous use

2 mg/ml

Finland

Pfizer Oy

Tietokuja 4

00330 Helsinki

Finland

Diflucan

50 mg

Capsule, Hard

Oral use

N/A

Finland

Pfizer Oy

Tietokuja 4

00330 Helsinki

Finland

Diflucan

100 mg

Capsule, Hard

Oral use

N/A

Finland

Pfizer Oy

Tietokuja 4

00330 Helsinki

Finland

Diflucan

150 mg

Capsule, Hard

Oral use

N/A

Finland

Pfizer Oy

Tietokuja 4

00330 Helsinki

Finland

Diflucan

10 mg/ml

Powder for Oral Suspension

Oral use

10 mg/ml

Finland

Pfizer Oy

Tietokuja 4

00330 Helsinki,

Finland

Diflucan

40 mg/ml

Powder for Oral Suspension

Oral use

40 mg/ml

Finland

Pfizer Oy,

Tietokuja 4

00330 Helsinki

Finland

Diflucan

2 mg/ml

Solution for Infusion

Intravenous use

2 mg/ml

France

Pfizer Holding France

23-25 Avenue du Docteur Lannelongue

75014 Paris

France

Fluconazole Pfizer

50 mg

Capsule, Hard

Oral use

N/A

France

Pfizer Holding France

23-25 Avenue du Docteur Lannelongue

75014 Paris

France

Triflucan

50 mg

Capsule, Hard

Oral use

N/A

France

Pfizer Holding France

23-25 Avenue du Docteur Lannelongue

75014 Paris

France

Fluconazole Pfizer

100 mg

Capsule, Hard

Oral use

N/A

France

Pfizer Holding France

23-25 Avenue du Docteur Lannelongue

75014 Paris

France

Triflucan

100 mg

Capsule, Hard

Oral use

N/A

France

Pfizer Holding France

23-25 Avenue du Docteur Lannelongue

75014 Paris

France

Fluconazole Pfizer

150 mg

Capsule, Hard

Oral use

N/A

France

Pfizer Holding France

23-25 Avenue du Docteur Lannelongue

75014 Paris

France

Fluconazole Pfizer

200 mg

Capsule, Hard

Oral use

N/A

France

Pfizer Holding France

23-25 Avenue du Docteur Lannelongue

75014 Paris

France

Triflucan

200 mg

Capsule, Hard

Oral use

N/A

France

Pfizer Holding France

23-25 Avenue du Docteur Lannelongue

75014 Paris

France

Fluconazole Pfizer

50 mg/5 ml

Powder for Oral Suspension

Oral use

10 mg/ml

France

Pfizer Holding France

23-25 Avenue du Docteur Lannelongue

75014 Paris

France

Triflucan

50 mg/5 ml

Powder for Oral Suspension

Oral use

10 mg/ml

France

Pfizer Holding France

23-25 Avenue du Docteur Lannelongue

75014 Paris

France

Triflucan

200 mg/5 ml

Powder for Oral Suspension

Oral use

40 mg/ml

France

Pfizer Holding France

23-25 Avenue du Docteur Lannelongue

75014 Paris

France

Triflucan

2 mg/ml

Solution for Infusion

Intravenous use

2 mg/ml

Germany

Pfizer Pharma GmbH

Linkstraße 10

10785 Berlin

Germany

Diflucan

50 mg

Capsule, Hard

Oral use

N/A

Germany

Pfizer Pharma GmbH

Linkstraße 10

10785 Berlin

Germany

Diflucan Derm

50 mg

Capsule, Hard

Oral use

N/A

Germany

Pfizer Pharma GmbH

Linkstraße 10

10785 Berlin

Germany

Diflucan

100 mg

Capsule, Hard

Oral use

N/A

Germany

Pfizer Pharma GmbH

Linkstraße 10

10785 Berlin

Germany

Diflucan

200 mg

Capsule, Hard

Oral use

N/A

Germany

Pfizer Pharma GmbH

Linkstraße 10

10785 Berlin

Germany

Fungata

150 mg

Capsule, Hard

Oral use

N/A

Germany

Pfizer Pharma GmbH

Linkstraße 10

10785 Berlin

Germany

Diflucan Trockensaft

50 mg/5 ml

Powder for Suspension

Oral use

10 mg/ml

Germany

Pfizer Pharma GmbH,

Linkstraße 10

10785 Berlin

Germany

Diflucan i.v.-100 mg

100 mg/50 ml

Solution for Infusion

Intravenous use

2 mg/ml

Germany

Pfizer Pharma GmbH

Linkstraße 10

10785 Berlin

Germany

Diflucan i.v.-200 mg

200 mg/100 ml

Solution for Infusion

Intravenous use

2 mg/ml

Germany

Pfizer Pharma GmbH

Linkstraße 10

10785 Berlin

Germany

Diflucan i.v.-400 mg

400 mg/200 ml

Solution for Infusion

Intravenous use

2 mg/ml

Germany

Pfizer Pharma GmbH

Linkstraße 10

10785 Berlin

Germany

Diflucan Derm Saft

5 mg/ml

Syrup

Oral use

5 mg/ml

Germany

Pfizer Pharma GmbH

Linkstraße 10

10785 Berlin

Germany

Diflucan Saft

5 mg/ml

Syrup

Oral use

5 mg/ml

Greece

Pfizer Hellas A. E.

243, Messoghion Ave.,

154 51 Νeo Psychiko Athens

Greece

Fungustatin

50 mg

Capsule, Hard

Oral use

N/A

Greece

Pfizer Hellas A. E.

243, Messoghion Ave.,

154 51 Νeo Psychiko Athens

Greece

Fungustatin

100 mg

Capsule, Hard

Oral use

N/A

Greece

Pfizer Hellas A. E.

243, Messoghion Ave.

154 51 Νeo Psychiko, Athens

Greece

Fungustatin

150 mg

Capsule, Hard

Oral use

N/A

Greece

Pfizer Hellas A. E.

243, Messoghion Ave.

154 51 Νeo Psychiko Athens

Greece

Fungustatin

200 mg

Capsule, Hard

Oral use

N/A

Greece

Pfizer Hellas A. E.

243, Messoghion Ave.

154 51 Νeo Psychiko Athens

Greece

Fungustatin

50 mg/5 ml

Powder for Suspension

Oral use

10 mg/ml

Greece

Pfizer Hellas A. E.

243, Messoghion Ave.

154 51 Νeo Psychiko Athens

Greece

Fungustatin

200 mg/5 ml

Powder for Suspension

Oral use

40 mg/ml

Greece

Pfizer Hellas A. E.

243, Messoghion Ave.

154 51 Νeo Psychiko Athens

Greece

Fungustatin

100 mg/50 ml

Solution for Infusion

Intravenous use

2 mg/ml

Greece

Pfizer Hellas A. E.

243, Messoghion Ave.

154 51 Νeo Psychiko Athens

Greece

Fungustatin

200 mg/100 ml

Solution for Infusion

Intravenous use

2 mg/ml

Greece

Pfizer Hellas A. E.

243, Messoghion Ave.

154 51 Νeo Psychiko Athens

Greece

Fungustatin

50 mg/25 ml

Solution for Infusion

Intravenous use

2 mg/ml

Hungary

Pfizer KFT

1123

Budapest

Alkotás u. 53.

Hungary

Diflucan 50 mg kemény kapszula

50 mg

Capsule, Hard

Oral use

N/A

Hungary

Pfizer KFT

1123

Budapest

Alkotás u. 53.

Hungary

Diflucan 100 mg kemény kapszula

100 mg

Capsule, Hard

Oral use

N/A

Hungary

Pfizer KFT

1123

Budapest

Alkotás u. 53

Hungary

Diflucan 150 mg kemény kapszula

150 mg

Capsule, Hard

Oral use

N/A

Hungary

Pfizer KFT

1123

Budapest

Alkotás u. 53.

Hungary

Diflucan 200 mg kemény kapszula

200 mg

Capsule, Hard

Oral use

N/A

Hungary

Pfizer KFT

1123

Budapest

Alkotás u. 53.

Hungary

Diflucan 10 mg/ml por belsőleges szuszpenzióhoz

50 mg/5 ml

Powder for Oral suspension

Oral use

10 mg/ml

Hungary

Pfizer KFT

1123

Budapest

Alkotás u. 53.

Hungary

Diflucan 40 mg/ml por belsőleges szuszpenzióhoz

200 mg/5 ml

Powder for Oral Suspension

Oral use

40 mg/ml

Hungary

Pfizer KFT

1123

Budapest,

Alkotás u. 53.

Hungary

Diflucan 2 mg/ml oldatos infúzió

2 mg/ml

Solution for Infusion

Intravenous use

2 mg/ml

Iceland

Pfizer ApS

Lautrupvang 8

2750 Ballerup

Denmark

Diflucan

50 mg

Capsule, Hard

Oral use

N/A

Iceland

Pfizer ApS

Lautrupvang 8

2750 Ballerup

Denmark

Diflucan

150 mg

Capsule, Hard

Oral use

N/A

Iceland

Pfizer ApS

Lautrupvang 8

2750 Ballerup

Denmark

Diflucan

200 mg

Capsule, Hard

Oral use

N/A

Iceland

Pfizer ApS

Lautrupvang 8

2750 Ballerup

Denmark

Diflucan

10 mg/ml

Powder for Suspension

Oral use

10 mg/ml

Iceland

Pfizer ApS

Lautrupvang 8

2750 Ballerup

Denmark

Diflucan

2 mg/ml

Solution for Infusion

Intravenous use

2 mg/ml

Ireland

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan

50 mg

Capsule, Hard

Oral use

N/A

Ireland

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan

150 mg

Capsule, Hard

Oral use

N/A

Ireland

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan

200 mg

Capsule, Hard

Oral use

N/A

Ireland

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan

50 mg/5 ml

Powder for Suspension

Oral use

10 mg/ml

Ireland

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan

200 mg/5 ml

Powder for Suspension

Oral use

40 mg/ml

Ireland

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan

200 mg/100 ml

Solution for Infusion

Intravenous use

2 mg/ml

Ireland

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan

50 mg/25 ml

Solution for Infusion

Intravenous use

2 mg/ml

Italy

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina

Italy

Diflucan

50 mg

Capsule, Hard

Oral use

N/A

Italy

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina

Italy

Diflucan

100 mg

Capsule, Hard

Oral use

N/A

Italy

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina

Italy

Diflucan

150 mg

Capsule, Hard

Oral use

N/A

Italy

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina

Italy

Diflucan

200 mg

Capsule, Hard

Oral use

N/A

Italy

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina

Italy

Diflucan

50 mg/5 ml

Powder for Suspension

Oral use

10 mg/ml

Italy

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina

Italy

Diflucan

2 mg/ml

Solution for Infusion

Intravenous use

2 mg/ml

Latvia

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan 50 mg kapsulas

50 mg

Capsule, Hard

Oral use

N/A

Latvia

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan 150 mg kapsulas

150 mg

Capsule, Hard

Oral use

N/A

Latvia

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan 2 mg/ml šķīdums infūzijām

2 mg/ml

Solution for Infusion

Intravenous use

2 mg/ml

Lithuania

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan

50 mg

Capsule, Hard

Oral use

N/A

Lithuania

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan

100 mg

Capsule, Hard

Oral use

N/A

Lithuania

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan

150 mg

Capsule, Hard

Oral use

N/A

Lithuania

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan

2 mg/ml

Solution for Infusion

Intravenous use

2 mg/ml

Luxembourg

Pfizer SA

Boulevard de la Plaine 17

1050 Brussels

Belgium

Diflucan

50 mg

Capsule, Hard

Oral use

N/A

Luxembourg

Pfizer SA

Boulevard de la Plaine 17

1050 Brussels

Belgium

Diflucan

100 mg

Capsule, Hard

Oral use

N/A

Luxembourg

Pfizer SA

Boulevard de la Plaine 17

1050 Brussels

Belgium

Diflucan

150 mg

Capsule, Hard

Oral use

N/A

Luxembourg

Pfizer SA

Boulevard de la Plaine 17

1050 Brussels

Belgium

Diflucan

200 mg

Capsule, Hard

Oral use

N/A

Luxembourg

Pfizer SA

Boulevard de la Plaine 17

1050 Brussels

Belgium

Diflucan

50 mg/5 ml

Powder for Suspension

Oral use

10 mg/ml

Luxembourg

Pfizer SA

Boulevard de la Plaine 17

1050 Brussels

Belgium

Diflucan

200 mg/5 ml

Powder for Suspension

Oral use

40 mg/ml

Luxembourg

Pfizer SA

Boulevard de la Plaine 17

1050 Brussels

Belgium

Diflucan

200 mg/100 ml

Solution for Infusion

Intravenous use

2 mg/ml

Luxembourg

Pfizer SA

Boulevard de la Plaine 17

1050 Brussels

Belgium

Diflucan

400 mg/200 ml

Solution for Infusion

Intravenous use

2 mg/ml

Malta

Pfizer Hellas S.A.

243, Messoghion Ave.

154 51 Νeo Psychiko Athens

Greece

Diflucan

50 mg/25 ml

Solution for Infusion

Intravenous use

2 mg/ml

Malta

Pfizer Hellas S.A.

243, Messoghion Ave.

154 51 Νeo Psychiko Athens

Greece

Diflucan

200 mg/100 ml

Solution for Infusion

Intravenous use

2 mg/ml

Netherlands

Pfizer bv

Rivium Westlaan 142

2909 LD Capelle a/d IJssel

The Netherlands

Diflucan 50

50 mg

Capsule

Oral use

N/A

Netherlands

Pfizer bv

Rivium Westlaan 142

2909 LD Capelle a/d IJssel

The Netherlands

Diflucan 100

100 mg

Capsule

Oral use

N/A

Netherlands

Pfizer bv

Rivium Westlaan 142

2909 LD Capelle a/d IJssel

The Netherlands

Diflucan 150

150 mg

Capsule

Oral use

N/A

Netherlands

Pfizer bv

Rivium Westlaan 142

2909 LD Capelle a/d IJssel

The Netherlands

Diflucan 200

200 mg

Capsule

Oral use

N/A

Netherlands

Pfizer bv

Rivium Westlaan 142

2909 LD Capelle a/d IJssel

The Netherlands

Diflucan suspensie 50

50 mg/5 ml

Powder for Suspension

Oral use

10 mg/ml

Netherlands

Pfizer bv

Rivium Westlaan 142

2909 LD Capelle a/d IJssel

The Netherlands

Diflucan suspensie 200

200 mg/5 ml

Powder for Suspension

Oral use

40 mg/ml

Netherlands

Pfizer bv

Rivium Westlaan 142

2909 LD Capelle a/d IJssel

The Netherlands

Diflucan I.V.

2 mg/ml

Solution for Infusion

Intravenous use

2 mg/ml

Norway

Pfizer AS

Pb. 3

1324 Lysaker

Norway

Diflucan

50 mg

Capsule, Hard

Oral use

N/A

Norway

Pfizer AS

Pb. 3

1324 Lysaker

Norway

Diflucan

100 mg

Capsule, Hard

Oral use

N/A

Norway

Pfizer AS

Pb. 3

1324 Lysaker

Norway

Diflucan

150 mg

Capsule, Hard

Oral use

N/A

Norway

Pfizer AS

Pb. 3

1324 Lysaker

Norway

Diflucan

200 mg

Capsule, Hard

Oral use

N/A

Norway

Pfizer AS

Pb. 3

1324 Lysaker

Norway

Diflucan

50 mg/5 ml

Powder for Oral Suspension

Oral use

10 mg/ml

Norway

Pfizer AS

Pb. 3

1324 Lysaker

Norway

Diflucan

200 mg/5 ml

Powder for Oral Suspension

Oral use

40 mg/ml

Norway

Pfizer AS

Pb. 3

1324 Lysaker

Norway

Diflucan

2 mg/ml

Solution for Infusion

Intravenous use

2 mg/ml

Poland

Pfizer Europe MA EEIG

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan

50 mg

Capsule,

Oral use

N/A

Poland

Pfizer Europe MA EEIG

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan

150 mg

Capsule,

Oral use

N/A

Poland

Pfizer Europe MA EEIG

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan

2 mg/ml

Solution for Infusion

Intravenous use

2 mg/ml

Portugal

Laboratorios Pfizer,

Lda. Lagoas Park

Edifício 10

2740-271 Porto Salvo

Portugal

Diflucan

50 mg

Capsule, Hard

Oral use

N/A

Portugal

Laboratorios Pfizer,

Lda. Lagoas Park

Edifício 10

2740-271 Porto Salvo

Portugal

Diflucan

100 mg

Capsule, Hard

Oral use

N/A

Portugal

Laboratorios Pfizer,

Lda. Lagoas Park

Edifício 10

2740-271 Porto Salvo

Portugal

Diflucan

150 mg

Capsule, Hard

Oral use

N/A

Portugal

Laboratorios Pfizer,

Lda., Lagoas Park

Edifício 10

2740-271 Porto Salvo

Portugal

Diflucan

200 mg

Capsule, Hard

Oral use

N/A

Portugal

Laboratorios Pfizer,

Lda. Lagoas Park

Edifício 10

2740-271 Porto Salvo

Portugal

Diflucan

10 mg/ml

Powder for oral Suspension

Oral use

10 mg/ml

Portugal

Laboratorios Pfizer,

Lda. Lagoas Park

Edifício 10

2740-271 Porto Salvo

Portugal

Diflucan

40 mg/ml

Powder for oral Suspension

Oral use

40 mg/ml

Portugal

Laboratorios Pfizer,

Lda. Lagoas Park

Edifício 10

2740-271 Porto Salvo

Portugal

Diflucan

2 mg/ml

Solution for Infusion

Intravenous use

2 mg/ml

Romania

Pfizer Europe MA EEIG

Ramsgate Road

Sandwich

Kent

CT13 9NJ,

United Kingdom

Diflucan 50 mg

50 mg

Capsule, Hard

Oral use

N/A

Romania

Pfizer Europe MA EEIG

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan 150 mg

150 mg

Capsule, Hard

Oral use

N/A

Romania

Pfizer Europe MA EEIG

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan 50 mg/5 ml

50 mg/5 ml

Powder for oral Suspension

Oral use

10 mg/ml

Romania

Pfizer Europe MA EEIG

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan 2 mg/ml

2 mg/ml

Solution for Infusion

Intravenous use

2 mg/ml

Slovak Republic

Pfizer Europe MA EEIG

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan 50 mg

50 mg

Capsule

Oral use

N/A

Slovak Republic

Pfizer Europe MA EEIG

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan 100 mg

100 mg

Capsule

Oral use

N/A

Slovak Republic

Pfizer Europe MA EEIG

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan 150 mg

150 mg

Capsule

Oral use

N/A

Slovak Republic

Pfizer Europe MA EEIG

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

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

50 mg/5 ml

Powder for Oral Suspension

Oral use

10 mg/ml

Slovak Republic

Pfizer Europe MA EEIG

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

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

200 mg/5 ml

Powder for Oral Suspension

Oral use

40 mg/ml

Slovak Republic

Pfizer Europe MA EEIG

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan IV 2 mg/ml

2 mg/ml

Solution for Intravenous Infusion

Intravenous use

2 mg/ml

Slovenia

Pfizer Luxembourg SARL

51, Avenue J. F. Kennedy

L-1855 Luxembourg,

Luxembourg

Diflucan 50 mg trde kapsule

50 mg

Capsule, Hard

Oral use

N/A

Slovenia

Pfizer Luxembourg SARL

51, Avenue J. F. Kennedy

L-1855 Luxembourg,

Luxembourg

Diflucan 100 mg trde kapsule

100 mg

Capsule, Hard

Oral use

N/A

Slovenia

Pfizer Luxembourg SARL

51, Avenue J. F. Kennedy

L-1855 Luxembourg,

Luxembourg

Diflucan 150 mg trde kapsule

150 mg

Capsule, Hard

Oral use

N/A

Slovenia

Pfizer Luxembourg SARL

51, Avenue J. F. Kennedy

L-1855 Luxembourg,

Luxembourg

Diflucan 10 mg/ ml prašek za peroralno suspenzijo

10 mg/ml

Powder for Suspension

Oral use

10 mg/ml

Slovenia

Pfizer Luxembourg SARL

51, Avenue J. F. Kennedy

L-1855 Luxembourg,

Luxembourg

Diflucan 40 mg/ml prašek za peroralno suspenzijo

40 mg/ml

Powder for Suspension

Oral use

40 mg/ml

Slovenia

Pfizer Luxembourg SARL

51, Avenue J. F. Kennedy

L-1855 Luxembourg,

Luxembourg

Diflucan 2 mg/ml raztopina za infundiranje

2 mg/ml

Solution for Infusion

Intravenous use

2 mg/ml

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, Hard

Oral use

N/A

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, Hard

Oral use

N/A

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, Hard

Oral use

N/A

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, Hard

Oral use

N/A

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

Powder for Suspension

Oral use

10 mg/ml

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

Powder for Suspension

Oral use

40 mg/ml

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

Solution for Infusion

Intravenous use

2 mg/ml

Sweden

Pfizer AB

191 90 Sollentuna

Sweden

Diflucan

50 mg

Capsule, Hard

Oral use

N/A

Sweden

Pfizer AB

191 90 Sollentuna

Sweden

Diflucan

100 mg

Capsule, Hard

Oral use

N/A

Sweden

Pfizer AB

191 90 Sollentuna

Sweden

Diflucan

150 mg

Capsule, Hard

Oral use

N/A

Sweden

Pfizer AB

191 90 Sollentuna

Sweden

Diflucan

200 mg

Capsule, Hard

Oral use

N/A

Sweden

Pfizer AB

191 90 Sollentuna

Sweden

Diflucan

10 mg/ml

Powder for Suspension

Oral use

10 mg/ml

Sweden

Pfizer AB

191 90 Sollentuna

Sweden

Diflucan

40 mg/ml

Powder for Suspension

Oral use

40 mg/ml

Sweden

Pfizer AB

191 90 Sollentuna

Sweden

Diflucan

2 mg/ml

Solution for Infusion

Intravenous use

2 mg/ml

United Kingdom

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan

50 mg

Capsule, Hard

Oral use

N/A

United Kingdom

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan

150 mg

Capsule, Hard

Oral use

N/A

United Kingdom

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan

200 mg

Capsule, Hard

Oral use

N/A

United Kingdom

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan

50 mg/5 ml

Powder for Suspension

Oral use

10 mg/ml

United Kingdom

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan

200 mg/5 ml

Powder for Suspension

Oral use

40 mg/ml

United Kingdom

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Diflucan

2 mg/ml

Solution for Infusion

Intravenous use

2 mg/ml

ANNEX V

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATIONS, APPLICANTS IN THE MEMBER STATES

Member State EU/EEA

Applicant

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Content

(concentration)

Belgium

Alapis S.A.,

2 Aftokratoros

Nikolaou street,

17671 Athens,

Greece

Dexamethasone Alapis

0,4 mg/ml

Oral solution

Oral use

1 Bottle × 150 ml

Bulgaria

Alapis Bulgaria Ltd.,

29, Atanas Dukov

Str. 1407,

Sofia,

Bulgaria

Dexamethasone Alapis

0,4 mg/ml

Oral solution

Oral use

1 Bottle × 150 ml

Cyprus

Alapis S.A.,

2 Aftokratoros

Nikolaou street,

17671 Athens,

Greece

Dexamethasone Alapis

0,4 mg/ml

Oral solution

Oral use

1 Bottle × 150 ml

Germany

Alapis S.A.,

2 Aftokratoros

Nikolaou street,

17671 Athens,

Greece

Dexamethasone Alapis

0,4 mg/ml

Oral solution

Oral use

1 Bottle × 150 ml

Greece

Alapis S.A.,

2 Aftokratoros

Nikolaou street,

17671 Athens,

Greece

Dexamethasone Alapis

0,4 mg/ml

Oral solution

Oral use

1 Bottle × 150 ml

Malta

Alapis S.A.,

2 Aftokratoros

Nikolaou street,

17671 Athens,

Greece

Dexamethasone Alapis

0,4 mg/ml

Oral solution

Oral use

1 Bottle × 150 ml

Portugal

Alapis S.A.,

2 Aftokratoros

Nikolaou street,

17671 Athens,

Greece

Dexamethasone Alapis

0,4 mg/ml

Oral solution

Oral use

1 Bottle × 150 ml

Romania

Alapis Romania s.r.l.

Strada Leordeni nr. 13, Bragadiru,

Jud.IIfov, 077025,

Romania

Dexamethasone Alapis

0,4 mg/ml

Oral solution

Oral use

1 Bottle × 150 ml

United Kingdom

Alapis S.A.,

2 Aftokratoros

Nikolaou street,

17671 Athens,

Greece

Dexamethasone Alapis

0,4 mg/ml

Oral solution

Oral use

1 Bottle × 150 ml

ANNEX VI

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANT / MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES

Member State EU/EEA

Marketing authorisation holder

Applicant

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Content

(concentration)

Ireland

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

Ireland

Canazole Clotrimazole Cream 1 % w/w

1 % w/w

Cream

Cutaneous Use

100 mg/ml

United Kingdom

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

Ireland

Canazole Clotrimazole Cream 1 % w/w

1 % w/w

Cream

Cutaneous Use

100 mg/ml

ANNEX VII

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

Member State EU/EEA

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

Austria

STADA Arzneimittel GmbH,

Muthgasse 36,

A-1190 Wien

Austria

Novogos 3,6 mg Implantat

3,6 mg

implant, pre-filled syringe

subcutaneous use

Germany

Cell Pharm GmbH

Theodor-Heuss-Str. 52

61118 Bad Vilbel

Germany

Goserelin cell pharm 3,6 mg Implantat

3,6 mg

implant

subcutaneous use

United Kingdom

Genus Pharmaceuticals,

Park View House,

65 London Road,

Newbury, Berkshire

RG14 1JN

United Kingdom

Novgos 3,6 mg Implant

3,6 mg

implant

subcutaneous use

ANNEX VIII

LIST OF THE NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES

Member State EU/EEA

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

Austria

Acino AG

Am Windfeld 35

83714 Miesbach

Germany

Novimp 3,6 mg Implantat

3,6 mg

implant, pre-filled syringe

subcutaneous use

Germany

Acino AG

Am Windfeld 35

83714 Miesbach

Germany

Novimp 3,6 mg Implantat

3,6 mg

implant

subcutaneous use

United Kingdom

Acino AG

Am Windfeld 35

83714 Miesbach

Germany

Novimp 3,6 mg Implant

3,6 mg

implant

subcutaneous use

ANNEX IX

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES

Member State EU/EEA

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

Austria

Acino AG

Am Windfeld 35

83714 Miesbach

Germany

Goserelin Novosis 3,6 mg Implantat

3,6 mg

implant, pre-filled syringe

subcutaneous use

Germany

Acino AG

Am Windfeld 35

83714 Miesbach

Germany

Novosis Goserelin 3,6 mg Implantat

3,6 mg

implant

subcutaneous use

United Kingdom

Acino AG

Am Windfeld 35

83714 Miesbach

Germany

Gosacin 3,6 mg Implant

3,6 mg

implant

subcutaneous use

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