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Document 52009XC0227(03)
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 January 2009 to 31 January 2009 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC )
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 January 2009 to 31 January 2009 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC )
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 January 2009 to 31 January 2009 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC )
OJ C 48, 27.2.2009, p. 12–24
(BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
27.2.2009 |
EN |
Official Journal of the European Union |
C 48/12 |
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 January 2009 to 31 January 2009
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2) )
(2009/C 48/05)
— 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 |
|||||
16.1.2009 |
STELARA |
|
This Decision is addressed to the Member States |
20.1.2009 |
|||||
16.1.2009 |
RoActemra |
|
This Decision is addressed to the Member States |
20.1.2009 |
|||||
22.1.2009 |
Cozaar |
Voir annexe I |
See Annex I |
26.1.2009 |
|||||
30.1.2009 |
Thalidomide Celgene |
|
This Decision is addressed to the Member States |
3.2.2009 |
(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 FORM(S), STRENGTH(S), ROUTE(S) OF ADMINISTRATION OF THE MEDICINAL PRODUCT(S), MARKETING AUTHORIZATION HOLDER(S) IN THE MEMBER STATES
Member State |
Marketing Authorization Holder |
Invented name Losartan potassium |
Strength |
Pharmaceutical Form |
Route of administration |
Content (concentration) |
||||||
Austria |
|
Cosaar 12,5 mg — Filmtabletten |
12,5 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Austria |
|
Cosaar 50 mg — Filmtabletten |
50 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Austria |
|
Cosaar 100 mg — Filmtabletten |
100 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Belgium |
|
Cozaar 100 mg |
100 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Belgium |
|
Cozaar 50 mg |
50 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Belgium |
|
Cozaar 12,5 mg |
12,5 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Belgium |
|
Cozaar Cardio Start |
21 × 12,5 mg + 14 × 50 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Belgium |
|
Loortan 100 mg |
100 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Belgium |
|
Loortan 50 mg |
50 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Belgium |
|
Loortan 12,50 mg |
12,5 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Belgium |
|
Loortan Cardio Start |
21 × 12,5 mg + 14 × 50 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Bulgaria |
|
Cozaar |
50 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Cyprus |
|
Cozaar |
50 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Cyprus |
|
Cozaar |
100 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Czech Republic |
|
Cozaar 12,5 mg |
12,5 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Czech Republic |
|
Cozaar 50 mg |
50 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Czech Republic |
|
Cozaar 100 mg |
100 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Denmark |
|
Cozaar |
12,5 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Denmark |
|
Cozaar |
50 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Denmark |
|
Cozaar |
100 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Denmark |
|
Cozaar Startpakke |
12,5 mg + 50 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Estonia |
|
Cozaar |
100 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Estonia |
|
Cozaar |
50 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Estonia |
|
Cozaar 12,5 mg |
12,5 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Finland |
|
Cozaar |
12,5 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Finland |
|
Cozaar |
12,5 mg and 50 mg (initiation pack) |
Film-coated tablet |
Oral use |
N/A |
||||||
Finland |
|
Cozaar |
50 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Finland |
|
Cozaar |
100 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
France |
|
Cozaar 100 mg film-coated tablets |
100 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
France |
|
Cozaar 50 mg scored coated tablets |
50 mg |
Scored coated tablet |
Oral use |
N/A |
||||||
Germany |
|
Cardopal Start 12,5 mg Filmtabletten |
12,5 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Germany |
|
Lorzaar 100 mg Filmtabletten |
100 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Germany |
|
Lorzaar 50 mg Filmtabletten |
50 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Germany |
|
Lorzaar Protect 100 mg Filmtabletten |
100 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Germany |
|
Lorzaar Protect 50 mg Filmtabletten |
50 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Germany |
|
Lorzaar Start 12,5 mg Filmtabletten |
12,5 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Germany |
|
Pinzaar 100 mg Filmtabletten |
100 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Germany |
|
Pinzaar 50 mg Filmtabletten |
50 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Germany |
|
Lorzaar Varipharmstart 12,5 mg Filmtabletten |
12,5 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Greece |
|
Cozaar |
12,5 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Greece |
|
Cozaar |
50 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Greece |
|
Cozaar |
100 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Hungary |
|
Cozaar |
12,5 mg |
Tablets, film-coated |
Oral use |
N/A |
||||||
Hungary |
|
Cozaar |
50 mg |
Tablets, film-coated |
Oral use |
N/A |
||||||
Hungary |
|
Cozaar |
100 mg |
Tablets, film-coated |
Oral use |
N/A |
||||||
Ireland |
|
Cozaar 50 mg Film-coated tablets |
50 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Ireland |
|
Cozaar 100 mg Film-coated tablets |
100 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Ireland |
|
Cozaar 12,5 mg Film-coated tablets |
12,5 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Italy |
|
Lortaan 50 mg compresse rivestite con film |
50 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Italy |
|
Lortaan 12,5 mg compresse rivestite con film |
12,5 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Italy |
|
Lortaan 100 mg compresse rivestite con film |
100 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Italy |
|
Neo-Lotan 50 mg compresse rivestite con film |
50 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Italy |
|
Neo-Lotan 12,5 mg compresse rivestite con film |
12,5 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Italy |
|
Neo-Lotan 100 mg compresse rivestite con film |
100 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Italy |
|
Losaprex 50 mg compresse rivestite con film |
50 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Italy |
|
Losaprex 12,5 mg compresse rivestite con film |
12,5 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Italy |
|
Losaprex 100 mg compresse rivestite con film |
100 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Latvia |
|
Cozaar 50 mg film-coated tablets |
50 mg |
Film-coated tablets |
Oral use |
N/A |
||||||
Latvia |
|
Cozaar 100 mg film-coated tablets |
100 mg |
Film-coated tablets |
Oral use |
N/A |
||||||
Lithuania |
|
Cozaar (Losartan) |
12,5 mg |
film-coated tablet |
oral use |
N/A |
||||||
Lithuania |
|
Cozaar (Losartan) |
50 mg |
film-coated tablet |
oral use |
N/A |
||||||
Lithuania |
|
Cozaar (Losartan) |
100 mg |
film-coated tablet |
oral use |
N/A |
||||||
Luxembourg |
|
Cozaar 100 mg |
100 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Luxembourg |
|
Cozaar 50 mg |
50 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Luxembourg |
|
Cozaar 12,5 mg |
12,5 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Luxembourg |
|
Cozaar Cardio Start |
21 × 12,5 mg + 14 × 50 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Luxembourg |
|
Loortan 100 mg |
100 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Luxembourg |
|
Loortan 50 mg |
50 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Luxembourg |
|
Loortan 12,50 mg |
12,5 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Luxembourg |
|
Loortan Cardio Start |
21 × 12,5 mg + 14 × 50 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Malta |
|
‘Cozaar 100 mg’ pilloli miksija b'rita |
100 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Malta |
|
‘Cozaar 50 mg’ pilloli miksija b'rita |
50 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Netherlands |
|
Cozaar 50 |
50 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Netherlands |
|
Cozaar 100 |
100 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Poland |
|
Cozaar |
12,5 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Poland |
|
Cozaar |
50 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Poland |
|
Cozaar |
100 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Portugal |
|
Cozaar |
50 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Portugal |
|
Cozaar 100 mg |
100 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Portugal |
|
Cozaar IC |
12,5 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Portugal |
|
Cozaar IC — Titulação |
12,5 mg + 50 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Portugal |
|
Lortaan IC |
12,5 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Portugal |
|
Lortaan IC — Titulação |
12,5 mg + 50 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Portugal |
|
Lortaan |
50 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Portugal |
|
Lortaan 100 mg |
100 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Romania |
|
Cozaar, comprimate filmate, 50 mg |
50 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Slovakia |
|
Cozaar 12,5 mg |
12,5 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Slovakia |
|
Cozaar 50 mg |
50 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Slovakia |
|
Cozaar 100 mg |
100 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Slovenia |
|
Cozaar 12,5 mg filmsko obložene tablete |
12,5 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Slovenia |
|
Cozaar 50 mg filmsko obložene tablete |
50 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Slovenia |
|
Cozaar 100 mg filmsko obložene tablete |
100 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Spain |
|
Cozaar 12,5 mg Inicio |
12,5 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Spain |
|
Cozaar 50 mg |
50 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Spain |
|
Cozaar 100 mg |
100 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Sweden |
|
Cozaar 12,5 mg filmdragerade tabletter |
12,5 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Sweden |
|
Cozaar 12,5 mg + 50 mg filmdragerade tabletter |
12,5 + 50 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Sweden |
|
Cozaar 50 mg filmdragerade tabletter |
50 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Sweden |
|
Cozaar 100 mg filmdragerade tabletter |
100 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
United Kingdom |
|
Cozaar 25 mg Film-coated tablets |
25 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
United Kingdom |
|
Cozaar 50 mg Film-coated tablets |
50 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
United Kingdom |
|
Cozaar 100 mg Film-coated tablets |
100 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Iceland |
|
Cozaar |
12,5 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Iceland |
|
Cozaar |
50 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Iceland |
|
Cozaar |
100 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Norway |
|
Cozaar |
12,5 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Norway |
|
Cozaar |
50 mg |
Film-coated tablet |
Oral use |
N/A |
||||||
Norway |
|
Cozaar |
100 mg |
Film-coated tablet |
Oral use |
N/A |