Access to European Union law
<a href="https://eur-lex.europa.eu/content/help/eurlex-content/experimental-features.html" target="_blank">More about the experimental features corner</a>
Choose the experimental features you want to try
EUR-Lex
Access to European Union law

This document is an excerpt from the EUR-Lex website

You are here
Use quotation marks to search for an "exact phrase". Append an asterisk (*) to a search term to find variations of it (transp*, 32019R*). Use a question mark (?) instead of a single character in your search term to find variations of it (ca?e finds case, cane, care).
Search tips
Need more search options? Use the Advanced search

Document C:2011:383:FULL

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


    Display all documents published in this Official Journal
     

    ISSN 1977-091X

    doi:10.3000/1977091X.C_2011.383.eng

    Official Journal

    of the European Union

    C 383
    European flag  

    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

    EN

     

    IV Notices

    NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

    European Commission

    30.12.2011   

    EN

    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

    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

    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

    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,

    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

    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

    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   

    EN

    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

    10

    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

    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: 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

    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: 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
    Top