EUR-Lex Access to European Union law
This document is an excerpt from the EUR-Lex website
Document 52007XC0928(02)
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 )
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 )
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 )
OJ C 228, 28.9.2007, p. 11–12
(BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
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 |
Holder(s) of the marketing authorization |
Member State concerned |
Date of notification |
|||||
|
3.8.2007 |
INCRELEX |
|
This Decision is addressed to the Member States |
6.8.2007 |
|||||
|
22.8.2007 |
Cefuroximaxetil |
See Annex |
See Annex |
23.8.2007 |
|||||
|
28.8.2007 |
Abseamed |
|
This Decision is addressed to the Member States |
31.8.2007 |
|||||
|
28.8.2007 |
Binocrit |
|
This Decision is addressed to the Member States |
31.8.2007 |
|||||
|
28.8.2007 |
Epoetin alfa hexal |
|
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.
ANNEX
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER/APPLICANTS IN THE MEMBER STATES
|
Member State |
Marketing Authorisation Holder |
Applicant |
Invented name |
Strength |
Pharmaceutical Form |
Route of administration |
||||
|
The Netherlands |
|
|
Cefuroximaxetil 125, omhulde tabletten 125 mg |
125 mg |
Coated tablets |
Oral use |
||||
|
Cefuroximaxetil 250, omhulde tabletten 250 mg |
250 mg |
|||||||||
|
Cefuroximaxetil 500, omhulde tabletten 500 mg |
500 mg |
|||||||||
|
Estonia |
|
|
Cefuroxim 1A Pharma 125 mg |
125 mg |
Coated tablets |
Oral use |
||||
|
Cefuroxim 1A Pharma 250 mg |
250 mg |
|||||||||
|
Cefuroxim 1A Pharma 500 mg |
500 mg |
|||||||||
|
Greece |
|
|
Cefuroxime axetil Sandoz 250 mg |
250 mg |
Coated tablets |
Oral use |
||||
|
Cefuroxime axetil Sandoz 500 mg |
500 mg |
|||||||||
|
Portugal |
|
|
Cefuroxima Sandoz 250 mg comprimidos |
250 mg |
Coated tablets |
Oral use |
||||
|
Cefuroxima Sandoz 500 mg comprimidos |
500 mg |
|||||||||
|
Spain |
|
|
Cefuroxima Sandoz 125 mg comprimidos recubiertos con película EFG |
125 mg |
Coated tablets |
Oral use |
||||
|
Cefuroxima Sandoz 250 mg comprimidos recubiertos con película EFG |
250 mg |
|||||||||
|
Cefuroxima Sandoz 500 mg comprimidos recubiertos con película EF |
500 mg |