Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 August 2007 to 31 August 2007 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council )
Date: 2007-09-28
Institutions: European Commission
Subjects: EU Member State, market approval, marketing standard, medicinal product, pharmaceutical legislation

28.9.2007

EN

Official Journal of the European Union

C 228/11

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 1 August 2007 to 31 August 2007

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council (1)
or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council (2))

(2007/C 228/03)

— Issuing, maintenance or modification of a national marketing authorisation

Date of the
decision

Name(s) of the
medicinal product

3.8.2007

INCRELEX

Holder(s) of the marketing authorization

Member State concerned

Tercica Europe Limited
2 Harbourmaster Place
International Financial Services Centre
Dublin 1
Ireland

This Decision is addressed
to the Member States

22.8.2007

Cefuroximaxetil

See Annex

See Annex

28.8.2007

Abseamed

Medice Arzneimittel Pütter GmbH &
Co KG
Kuhloweg 37
D-58638 Iserlohn

This Decision is addressed
to the Member States

Date of
notification

6.8.2007

23.8.2007

31.8.2007

28.8.2007

Binocrit

Sandoz GmbH
Biochemiestraße 10
A-6250 Kundl

This Decision is addressed
to the Member States

31.8.2007

28.8.2007

Epoetin alfa hexal

HEXAL Biotech Forschungs GmbH
Industriestraße 25
D-83607 Holzkirchen

This Decision is addressed
to the Member States

3.9.2007

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

Member State

Marketing Authorisation
Holder

The
Netherlands

Sandoz B.V.
Veluwezoom 22
1327 Almere
Nederland

Estonia

Greece

Portugal

Spain

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE
OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER/APPLICANTS IN THE MEMBER STATES

ANNEX

Applicant

Invented name

Strength

Pharmaceutical Form

Route of
administration

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

Sandoz GmbH
Biochemiestraße 10
A-6250 Kundl

Sandoz Farmacêutica Lda.
Alameda da Quinta da Beloura
Edifício 1-Esc. 15
P-2710-693 Sintra

Sandoz Farmacéutica, S.A.
Gran Vía de les Corts Catalanes, 764
E-08013 Barcelona

Cefuroximaxetil 125, omhulde tabletten 125 mg

Cefuroximaxetil 250, omhulde tabletten 250 mg

Cefuroximaxetil 500, omhulde tabletten 500 mg

Cefuroxim 1A Pharma 125 mg

Cefuroxim 1A Pharma 250 mg

Cefuroxim 1A Pharma 500 mg

Cefuroxime axetil Sandoz 250 mg

Cefuroxime axetil Sandoz 500 mg

Cefuroxima Sandoz 250 mg comprimidos

Cefuroxima Sandoz 500 mg comprimidos

Cefuroxima Sandoz 125 mg comprimidos recubiertos con
película EFG

Cefuroxima Sandoz 250 mg comprimidos recubiertos con
película EFG

Cefuroxima Sandoz 500 mg comprimidos recubiertos con
película EF

125 mg

250 mg

500 mg

125 mg

250 mg

500 mg

250 mg

500 mg

250 mg

500 mg

Coated tablets

Oral use

Coated tablets

Oral use

Coated tablets

Oral use

Coated tablets

Oral use

125 mg

Coated tablets

Oral use

250 mg

500 mg

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