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Document 52003XC0603(04)

Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 April 2003 to 15 May 2003 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

OJ C 129, 3.6.2003, p. 22–35 (ES, DA, DE, EL, EN, FR, IT, NL, PT, FI, SV)

52003XC0603(04)

Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 April 2003 to 15 May 2003 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

Official Journal C 129 , 03/06/2003 P. 0022 - 0035


Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 April 2003 to 15 May 2003

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

(2003/C 129/06)

- Issuing, maintenance or modification of a national marketing authorisation

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- Suspension of a national marketing authorisation

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(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, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS, PACKAGING AND PACKAGE SIZES OF THE MEDICINAL PRODUCT IN THE MEMBER STATES

FLUOXETINE-CONTAINING MEDICINAL PRODUCTS - ELI LILLY MARKETING AUTHORISATIONS IN THE EUROPEAN UNION

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ANNEX II

LIST OF THE PHARMACEUTICAL FORMS, STRENGTHS, ROUTES OF ADMINISTRATION, PACKAGING AND PACKAGE SIZES OF THE VETERINARY MEDICINAL PRODUCT IN THE MEMBER STATES

Marketing Authorisation Holder (Name and address):

Reference Member State:

UNITED KINGDOM

Schering-Plough Ltd Schering-Plough House

Shire Park

Welwyn Garden City Herts AL7 1TW United Kingdom

Concerned Member States:

AUSTRIA

Essex Tierarznei Ndl. der Essex Pharma GmbH Thomas-Dehler-Str. 27 D - 81737 München

BELGIUM

Schering-Plough NV/SA Rue de Stallesstraat 73 B - 1180 Brussels

DENMARK

Schering-Plough A/S Hvedemarken 12 DK - 3520 Farum

FINLAND

Schering-Plough A/S Hvedemarken 12 DK - 3520 Farum

FRANCE

Schering-Plough Veterinaire 92, rue Baudin F - 92300 Levallois-Perret

GERMANY

Essex Tierarznei Ndl. der Essex Pharma GmbH Thomas-Dehler-Str. 27 D - 81737 München

GREECE

Schering-Plough SA 63, Agiou Dimitriou Str. G - 17455 Alimos

Athens

IRELAND

Schering-Plough Ltd Schering-Plough House

Shire Park

Welwyn Garden City Herts AL7 1TW United Kingdom

LUXEMBOURG

Schering-Plough NV/SA Rue de Stallesstraat 73 B - 1180 Brussels

PORTUGAL

Schering-Plough II-Veterinaria, Lda Casal Colaride, Agualva P - 2735 Cacem

SPAIN

Schering-Plough SA Km 36, Carretera Nacional I E - 28750 San Agustin de Guadalix

Madrid

SWEDEN

Schering-Plough A/S Hvedemarken 12 DK - 3520 Farum

THE NETHERLANDS

Schering-Plough NV/SA Rue de Stallesstraat 73 B - 1180 Brussels

Presentations:

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ANNEX III

LIST OF NAMES OF THE VETERINARY MEDICINAL PRODUCTS BASED ON BENZATHINE PENICILLIN FOR FOOD PRODUCING ANIMALS AND MARKETING AUTHORISATION HOLDERS IN EU MEMBER STATES, ICELAND AND NORWAY

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