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Document 52008XC1031(02)
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 September 2008 to 30 September 2008 (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 September 2008 to 30 September 2008 (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 September 2008 to 30 September 2008 (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 )
SL C 276, 31.10.2008, p. 9–73
(BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
31.10.2008 |
EN |
Official Journal of the European Union |
C 276/9 |
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 September 2008 to 30 September 2008
(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) )
(2008/C 276/03)
— 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 |
|||||
|
3.9.2008 |
Cozaar |
See Annex I |
See Annex I |
8.9.2008 |
|||||
|
3.9.2008 |
Cozaar Comp |
See Annex II |
See Annex II |
8.9.2008 |
|||||
|
9.9.2008 |
Arcoxia |
See Annex III |
See Annex III |
11.9.2008 |
|||||
|
9.9.2008 |
Etoricoxib |
See Annex IV |
See Annex IV |
11.9.2008 |
|||||
|
11.9.2008 |
Activelle |
See Annex V |
See Annex V |
15.9.2008 |
|||||
|
11.9.2008 |
Rapinyl |
See Annex VI |
See Annex VI |
15.9.2008 |
|||||
|
15.9.2008 |
Remeron |
See Annex VII |
See Annex VII |
17.9.2008 |
|||||
|
23.9.2008 |
Gemzar |
See Annex VIII |
See Annex VIII |
24.9.2008 |
|||||
|
26.9.2008 |
Sodium Salicylate |
See Annex IX |
See Annex IX |
29.9.2008 |
|||||
|
26.9.2008 |
Toltrazuril |
See Annex X |
See Annex X |
29.9.2008 |
|||||
|
26.9.2008 |
Aclasta |
|
This Decision is addressed to the Member States |
29.9.2008 |
— 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 |
|
9.9.2008 |
Pulairmax |
See Annex XI |
See Annex XI |
11.9.2008 |
— Lift of 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 |
|
5.9.2008 |
Suramox 15 % LA — Stabox 15 % LA |
See Annex XII |
See Annex XII |
9.9.2008 |
(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 |
Marketing Authorisation Holder |
(Invented) Name Losartan potassium |
Strength |
Pharmaceutical Form |
Route of administration |
||||||
|
Austria |
|
Cosaar 12,5 mg — Filmtabletten |
12,5 mg |
Film-coated tablet |
Oral use |
||||||
|
Austria |
|
Cosaar 50 mg — Filmtabletten |
50 mg |
Film-coated tablet |
Oral use |
||||||
|
Austria |
|
Cosaar 100 mg — Filmtabletten |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Belgium |
|
Cozaar 100 mg |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Belgium |
|
Cozaar 50 MG |
50 mg |
Film-coated tablet |
Oral use |
||||||
|
Belgium |
|
Cozaar 12,5 mg |
12,5 mg |
Film-coated tablet |
Oral use |
||||||
|
Belgium |
|
Cozaar Cardio Start |
21 X 12,5 mg + 14 X 50 mg |
Film-coated tablet |
Oral use |
||||||
|
Belgium |
|
Loortan 100 mg |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Belgium |
|
Loortan 50 mg |
50 mg |
Film-coated tablet |
Oral use |
||||||
|
Belgium |
|
Loortan 12,50 mg |
12,5 mg |
Film-coated tablet |
Oral use |
||||||
|
Belgium |
|
Loortan Cardio Start |
21 X 12,5 mg + 14 X 50 mg |
Film-coated tablet |
Oral use |
||||||
|
Bulgaria |
|
Cozaar |
50 mg |
Film-coated tablet |
Oral use |
||||||
|
Cyprus |
|
Cozaar |
50 mg |
Film-coated tablet |
Oral use |
||||||
|
Cyprus |
|
Cozaar |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Denmark |
|
Cozaar |
12,5 mg |
Film-coated tablet |
Oral use |
||||||
|
Denmark |
|
Cozaar |
50 mg |
Film-coated tablet |
Oral use |
||||||
|
Denmark |
|
Cozaar |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Denmark |
|
Cozaar Startpakke |
12,5 mg + 50 mg |
Film-coated tablet |
Oral use |
||||||
|
Estonia |
|
Cozaar |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Estonia |
|
Cozaar |
50 mg |
Film-coated tablet |
Oral use |
||||||
|
Estonia |
|
Cozaar 12,5 mg |
12,5 mg |
Film-coated tablet |
Oral use |
||||||
|
Finland |
|
Cozaar |
12,5 mg |
Film-coated tablet |
Oral use |
||||||
|
Finland |
|
Cozaar |
12,5 mg and 50 mg (initiation pack) |
Film-coated tablet |
Oral use |
||||||
|
Finland |
|
Cozaar |
50 mg |
Film-coated tablet |
Oral use |
||||||
|
Finland |
|
Cozaar |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
France |
|
Cozaar 100 mg film-coated tablets |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
France |
|
Cozaar 50 mg scored coated tablets |
50 mg |
Scored coated tablet |
Oral use |
||||||
|
Germany |
|
Cardopal Start 12,5 mg Filmtabletten |
12,5 mg |
Film-coated tablet |
Oral use |
||||||
|
Germany |
|
Lorzaar 100 mg Filmtabletten |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Germany |
|
Lorzaar 50 mg Filmtabletten |
50 mg |
Film-coated tablet |
Oral use |
||||||
|
Germany |
|
Lorzaar Protect 100 mg Filmtabletten |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Germany |
|
Lorzaar Protect 50 mg Filmtabletten |
50 mg |
Film-coated tablet |
Oral use |
||||||
|
Germany |
|
Lorzaar Start 12,5 mg Filmtabletten |
12,5 mg |
Film-coated tablet |
Oral use |
||||||
|
Germany |
|
Pinzaar 100 mg Filmtabletten |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Germany |
|
Pinzaar 50 mg Filmtabletten |
50 mg |
Film-coated tablet |
Oral use |
||||||
|
Germany |
|
Lorzaar Varipharmstart 12,5 mg Filmtabletten |
12,5 mg |
Film-coated tablet |
Oral use |
||||||
|
Greece |
|
Cozaar |
12,5 mg |
Film-coated tablet |
Oral use |
||||||
|
Greece |
|
Cozaar |
50 mg |
Film-coated tablet |
Oral use |
||||||
|
Greece |
|
Cozaar |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Hungary |
|
Cozaar |
12,5 mg |
Film-coated tablet |
Oral use |
||||||
|
Hungary |
|
Cozaar |
50 mg |
Film-coated tablet |
Oral use |
||||||
|
Hungary |
|
Cozaar |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Ireland |
|
Cozaar 50 mg Film-coated tablets |
50 mg |
Film-coated tablet |
Oral use |
||||||
|
Ireland |
|
Cozaar 100 mg Film-coated tablets |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Ireland |
|
Cozaar 12,5 mg Film-coated tablets |
12,5 mg |
Film-coated tablet |
Oral use |
||||||
|
Italy |
|
Lortaan 50 mg compresse rivestite con film |
50 mg |
Film-coated tablet |
Oral use |
||||||
|
Italy |
|
Lortaan 12,5 mg compresse rivestite con film |
12,5 mg |
Film-coated tablet |
Oral use |
||||||
|
Italy |
|
Lortaan 100 mg compresse rivestite con film |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Italy |
|
Neo-Lotan 50 mg compresse rivestite con film |
50 mg |
Film-coated tablet |
Oral use |
||||||
|
Italy |
|
Neo-Lotan 12,5 mg compresse rivestite con film |
12,5 mg |
Film-coated tablet |
Oral use |
||||||
|
Italy |
|
Neo-Lotan 100 mg compresse rivestite con film |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Italy |
|
Losaprex 50 mg compresse rivestite con film |
50 mg |
Film-coated tablet |
Oral use |
||||||
|
Italy |
|
Losaprex 12,5 mg compresse rivestite con film |
12.5 mg |
Film-coated tablet |
Oral use |
||||||
|
Italy |
|
Losaprex 100 mg compresse rivestite con film |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Latvia |
|
Cozaar 50 mg film-coated tablets |
50 mg |
Film-coated tablet |
Oral use |
||||||
|
Latvia |
|
Cozaar 100 mg film-coated tablets |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Lithuania |
|
Cozaar (Losartan) |
12,5 mg |
Film-coated tablet |
Oral use |
||||||
|
Lithuania |
|
Cozaar (Losartan) |
50 mg |
Film-coated tablet |
Oral use |
||||||
|
Lithuania |
|
Cozaar (Losartan) |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Luxembourg |
|
Cozaar 100 mg |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Luxembourg |
|
Cozaar 50 MG |
50 mg |
Film-coated tablet |
Oral use |
||||||
|
Luxembourg |
|
Cozaar 12,5 mg |
12,5 mg |
Film-coated tablet |
Oral use |
||||||
|
Luxembourg |
|
Cozaar Cardio Start |
21 X 12,5 mg + 14 X 50 mg |
Film-coated tablet |
Oral use |
||||||
|
Luxembourg |
|
Loortan 100 mg |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Luxembourg |
|
Loortan 50 mg |
50 mg |
Film-coated tablet |
Oral use |
||||||
|
Luxembourg |
|
Loortan 12,50 mg |
12,5 mg |
Film-coated tablet |
Oral use |
||||||
|
Luxembourg |
|
Loortan Cardio Start |
21 X 12,5 mg + 14 X 50 mg |
Film-coated tablet |
Oral use |
||||||
|
Malta |
|
“Cozaar 100 mg” pilloli miksija b'rita |
10 mg |
Film-coated tablet |
Oral use |
||||||
|
Malta |
|
“Cozaar 50 mg” pilloli miksija b'rita |
50 mg |
Film-coated tablet |
Oral use |
||||||
|
The Netherlands |
|
Cozaar 50 |
50 mg |
Film-coated tablet |
Oral use |
||||||
|
The Netherlands |
|
Cozaar 100 |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Poland |
|
Cozaar |
12,5 mg |
Film-coated tablet |
Oral use |
||||||
|
Poland |
|
Cozaar |
50 mg |
Film-coated tablet |
Oral use |
||||||
|
Poland |
|
Cozaar |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Portugal |
|
Cozaar |
50 mg |
Film-coated tablet |
Oral use |
||||||
|
Portugal |
|
Cozaar 100 mg |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Portugal |
|
Cozaar IC |
12,5 mg |
Film-coated tablet |
Oral use |
||||||
|
Portugal |
|
Cozaar IC — Titulação |
12,5 mg + 50 mg |
Film-coated tablet |
Oral use |
||||||
|
Portugal |
|
Lortaan IC |
12,5 mg |
Film-coated tablet |
Oral use |
||||||
|
Portugal |
|
Lortaan IC — Titulação |
12,5 mg + 50 mg |
Film-coated tablet |
Oral use |
||||||
|
Portugal |
|
Lortaan |
50 mg |
Film-coated tablet |
Oral use |
||||||
|
Portugal |
|
Lortaan 100 mg |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Romania |
|
Cozaar, comprimate filmate, 50 mg |
50 mg |
Film-coated tablet |
Oral use |
||||||
|
Slovenia |
|
Cozaar 12,5 mg filmsko obložene tablete |
12,5 mg |
Film-coated tablet |
Oral use |
||||||
|
Slovenia |
|
Cozaar 50 mg filmsko obložene tablete |
50 mg |
Film-coated tablet |
Oral use |
||||||
|
Slovenia |
|
Cozaar 100 mg filmsko obložene tablete |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Spain |
|
Cozaar 12,5 mg Inicio |
12,5 mg |
Film-coated tablet |
Oral use |
||||||
|
Spain |
|
Cozaar 50 mg |
50 mg |
Film-coated tablet |
Oral use |
||||||
|
Spain |
|
Cozaar 100 mg |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Sweden |
|
Cozaar 12,5 mg filmdragerade tabletter |
12,5 mg |
Film-coated tablet |
Oral use |
||||||
|
Sweden |
|
Cozaar 12,5 mg + 50 mg filmdragerade tabletter |
12,5 + 50 mg |
Film-coated tablet |
Oral use |
||||||
|
Sweden |
|
Cozaar 50 mg filmdragerade tabletter |
50 mg |
Film-coated tablet |
Oral use |
||||||
|
Sweden |
|
Cozaar 100 mg filmdragerade tabletter |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
United Kingdom |
|
Cozaar 50 mg Film-coated tablets |
50 mg |
Film-coated tablet |
Oral use |
||||||
|
United Kingdom |
|
Cozaar 25 mg Film-coated tablets |
25 mg |
Film-coated tablet |
Oral use |
||||||
|
United Kingdom |
|
Cozaar 100 mg Film-coated tablets |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Iceland |
|
Cozaar |
12,5 mg |
Film-coated tablet |
Oral use |
||||||
|
Iceland |
|
Cozaar |
50 mg |
Film-coated tablet |
Oral use |
||||||
|
Iceland |
|
Cozaar |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Norway |
|
Cozaar |
12,5 mg |
Film-coated tablet |
Oral use |
||||||
|
Norway |
|
Cozaar |
50 mg |
Film-coated tablet |
Oral use |
||||||
|
Norway |
|
Cozaar |
100 mg |
Film-coated tablet |
Oral use |
ANNEX II
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
|
Member State |
Marketing Authorisation Holder |
(Invented) Name Losartan potassium and hydrochlorothiazide |
Strength |
Pharmaceutical Form |
Route of administration |
|||||||
|
Austria |
|
Cosaar Plus — Filmtabletten |
50 mg losartan potassium — 12,5 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Austria |
|
Fortzaar-Filmtabletten |
100 mg losartan potassium — 25 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Belgium |
|
Cozaar Plus Forte 100 mg/25 mg |
100 mg losartan potassium — 25 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Belgium |
|
Cozaar Plus 50 mg/12,5 mg |
50 mg losartan potassium — 12,5 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Belgium |
|
Loortan Plus Forte 100 mg/25 mg |
100 mg losartan potassium — 25 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Belgium |
|
Loortan Plus 50 mg/12,5 mg |
50 mg losartan potassium — 12,5 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Bulgaria |
|
Hyzaar |
50 mg losartan potassium — 12,5 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Cyprus |
|
Fortzaar |
100 mg losartan potassium — 25 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Cyprus |
|
Hyzaar |
50 mg losartan potassium — 12,5 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Denmark |
|
Cozaar Comp. |
50 mg losartan potassium — 12,5 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Denmark |
|
Cozaar Comp. Forte |
100 mg losartan potassium — 25 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Denmark |
|
Cozaar Comp. 100 mg/12,5 mg |
100 mg losartan potassium — 12,5 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Denmark |
|
Fortzaar |
100 mg losartan potassium — 25 mg hydrochlorothiazide |
Film-coated tablets |
Oral use |
|||||||
|
Estonia |
|
Hyzaar |
50 mg losartan potassium — 12,5 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Estonia |
|
Fortzaar |
100 mg losartan potassium — 25 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Finland |
|
Cozaar Comp |
50 mg losartan potassium — 12,5 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Finland |
|
Cozaar Comp |
100 mg losartan potassium — 12,5 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Finland |
|
Cozaar Comp Forte |
100 mg losartan potassium — 25 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
France |
|
Fortzaar 100 mg/25 mg comprimé pelliculé |
100 mg losartan potassium — 25 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
France |
|
Hyzaar 100 mg/25 mg comprimé pelliculé |
100 mg losartan potassium — 25 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
France |
|
Fortzaar 50 mg/12,5 mg comprimé pelliculé |
50 mg losartan potassium — 12,5 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
France |
|
Hyzaar 50 mg/12,5 mg comprimé pelliculé |
50 mg losartan potassium — 12,5 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
France |
|
Fortzaar 100 mg/12,5 mg comprimé pelliculé |
100 mg losartan potassium — 12,5 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Germany |
|
Lorzaar Plus 50/12,5 mg Filmtabletten |
50 mg losartan potassium — 12,5 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Germany |
|
Cardopal Plus 50/12,5 mg Filmtabletten |
50 mg losartan potassium — 12,5 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Germany |
|
Lorzaar Varipharm Plus 50/12,5 mg Filmtabletten |
50 mg losartan potassium — 12,5 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Germany |
|
Fortzaar 100/25 mg Filmtabletten |
100 mg losartan potassium — 25 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Germany |
|
Fortzaar Varipharm 100/25 mg Filmtabletten |
100 mg losartan potassium — 25 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Germany |
|
Lorzaar Plus Forte 100/12,5 mg Filmtabletten |
100 mg losartan potassium — 12,5 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Greece |
|
Hyzaar |
50 mg losartan potassium — 12,5 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Greece |
|
Hyzaar 100/25 |
100 mg losartan potassium — 25 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Hungary |
|
Hyzaar 50/12,5 mg |
50 mg losartan potassium — 12,5 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Hungary |
|
Hyzaar Forte 100/25 mg |
100 mg losartan potassium — 25 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Iceland |
|
Cozaar' Comp 50 mg/12,5 mg film-coated tablets |
50 mg losartan potassium — 12,5 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Iceland |
|
Cozaar' Comp 100 mg/25 mg film-coated tablets |
100 mg losartan potassium — 25 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Iceland |
|
Hizaar 50 mg + 12,5 mg compresse rivestite con film |
50 mg losartan potassium — 12,5 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Ireland |
|
Hizaar 100 mg + 25 mg compresse rivestite con film |
100 mg losartan potassium — 25 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Ireland |
|
Forzaar 100 mg + 25 mg compresse rivestite con film |
100 mg losartan potassium — 25 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Italy |
|
Neo-Lotan Plus 50 mg + 12,5 mg compresse rivestite con film |
50 mg losartan potassium — 12,5 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Italy |
|
Neo-Lotan Plus 100 mg + 25 mg compresse rivestite con film |
100 mg losartan potassium — 25 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Italy |
|
Losazid 50 mg + 12,5 mg compresse rivestite con film |
50 mg losartan potassium — 12,5 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Italy |
|
Losazid 100 mg + 25 mg compresse rivestite con film |
100 mg losartan potassium — 25 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Italy |
|
Hyzaar 50 mg/12,5 mg |
50 mg losartan potassium — 12,5 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Italy |
|
Fortzaar 100 mg/25 mg |
100 mg losartan potassium — 25 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Italy |
|
Fortzaar (Losartan/Hydrochlorothiazide) |
100 mg losartan potassium — 25 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Latvia |
|
Hyzaar (Losartan/Hydrochlorothiazide) |
50 mg losartan potassium — 12,5 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Latvia |
|
Cozaar Plus Forte 100 mg/25 mg |
100 mg losartan potassium — 25 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Lithuania |
|
Cozaar Plus 50 mg/12,5 mg |
50 mg losartan potassium — 12,5 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Lithuania |
|
Loortan Plus Forte 100 mg/25 mg |
100 mg losartan potassium — 25 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Luxembourg |
|
Loortan Plus 50 mg/12,5 mg |
50 mg losartan potassium — 12,5 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Luxembourg |
|
“Cozaar Comp” 50/12,5 mg pilloli miksija b'rita |
50 mg losartan potassium — 12,5 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Luxembourg |
|
“Cozaar Comp” 100/25 mg pilloli miksija b'rita |
100 mg losartan potassium — 25 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Luxembourg |
|
“Cozaar Comp” 100/12,5 mg pilloli miksija b'rita |
100 mg losartan potassium — 12,5 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Malta |
|
Cozaar Plus 100/12,5 |
100 mg losartan potassium — 12,5 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Malta |
|
Fortzaar 100/25 |
100 mg losartan potassium — 25 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Malta |
|
Hyzaar 50/12,5 |
50 mg losartan potassium — 12,5 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
The Netherlands |
|
Hyzaar |
50 mg losartan potassium — 12,5 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
The Netherlands |
|
Hyzaar Forte |
100 mg losartan potassium — 25 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
The Netherlands |
|
Cozaar Plus |
50 mg losartan potassium — 12,5 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Norway |
|
Cozaar Plus |
100 mg losartan potassium — 12,5 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Norway |
|
Fortzaar |
100 mg losartan potassium — 25 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Norway |
|
Siaara |
100 mg losartan potassium — 25 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Poland |
|
Lortaan Plus |
50 mg losartan potassium — 12,5 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Poland |
|
Lortaan Plus |
100 mg losartan potassium — 12,5 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Portugal |
|
Losartan + Hidroclorotiazida Frosst |
100 mg losartan potassium — 12,5 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Portugal |
|
Hyzaar® 50 mg/12,5 mg comprimate filmate |
50 mg losartan potassium — 12,5 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Portugal |
|
Fortzaar® 100/25 mg comprimate filmate |
100 mg losartan potassium — 25 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Portugal |
|
Hyzaar |
50 mg losartan potassium — 12,5 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Portugal |
|
Hyzaar |
100 mg losartan potassium — 12,5 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Portugal |
|
Fortzaar |
100 mg losartan potassium — 25 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Portugal |
|
Cozaar Plus |
50 mg losartan potassium — 12,5 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Romania |
|
Fortzaar |
100 mg losartan potassium — 25 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Romania |
|
Cozaar Comp 50 mg/12,5 mg filmdragerade tabletter |
50 mg losartan potassium — 12,5 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Slovenia |
|
Cozaar Comp 100 mg/12,5 mg filmdragerade tabletter |
100 mg losartan potassium — 12,5 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Slovenia |
|
Cozaar Comp Forte 100 mg/25 mg filmdragerade tabletter |
100 mg losartan potassium — 25 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Slovenia |
|
Cozaar-Comp 50/12,5 mg film-coated tablets |
50 mg losartan potassium — 12,5 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Spain |
|
Cozaar-Comp 100/25 mg film-coated tablets |
100 mg losartan potassium — 25 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Spain |
|
Cozaar-Comp 100 mg/12,5 mg film-coated tablets |
100 mg losartan potassium — 12,5 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Sweden |
|
Cozaar-Comp 50/12,5 mg |
50 mg losartan potassium — 12,5 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Sweden |
|
Cozaar-Comp Forte |
100 mg losartan potassium — 25 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
Sweden |
|
Cozaar-Comp 100/12,5 mg |
100 mg losartan potassium — 12,5 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
United Kingdom |
|
Cozaar Comp |
50 mg losartan potassium — 12,5 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
United Kingdom |
|
Cozaar Comp |
100 mg losartan potassium — 12,5 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
|||||||
|
United Kingdom |
|
Cozaar Comp Forte |
100 mg losartan potassium — 25 mg hydrochlorothiazide |
Film-coated tablet |
Oral use |
ANNEX III
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS/MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
|
Member State |
Marketing Authorisation Holder |
(Invented) Name |
Strength |
Pharmaceutical Form |
Route of adminitration |
||||||
|
Austria |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
||||||
|
Belgium |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
||||||
|
Czech Republic |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
||||||
|
Cyprus |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
||||||
|
Denmark |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
||||||
|
Estonia |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
||||||
|
Finland |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
||||||
|
France |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
||||||
|
Germany |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
||||||
|
Greece |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
||||||
|
Hungary |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
||||||
|
Iceland |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
||||||
|
Ireland |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
||||||
|
Italy |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
||||||
|
Latvia |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
||||||
|
Lithuania |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
||||||
|
Luxembourg |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
||||||
|
Malta |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
||||||
|
The Netherlands |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
||||||
|
Norway |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
||||||
|
Poland |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
||||||
|
Portugal |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
||||||
|
Slovakia |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
||||||
|
Slovenia |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
||||||
|
Spain |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
||||||
|
Sweden |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
||||||
|
United Kingdom |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
ANNEX IV
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS/MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
|
Member State |
Marketing Authorisation Holder |
(Invented) Name |
Strength |
Pharmaceutical Form |
Route of administration |
|||||||
|
Austria |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
|||||||
|
Auxib |
90 mg |
Film-coated tablets |
Oral use |
|||||||||
|
Belgium |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
|||||||
|
Ranacox |
90 mg |
Film-coated tablets |
Oral use |
|||||||||
|
Bulgaria |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
|||||||
|
Czech Republic |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
|||||||
|
Cyprus |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
|||||||
|
Denmark |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
|||||||
|
Estonia |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
|||||||
|
Finland |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
|||||||
|
Turox |
90 mg |
Film-coated tablets |
Oral use |
|||||||||
|
France |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
|||||||
|
Germany |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
|||||||
|
Greece |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
|||||||
|
Hungary |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
|||||||
|
Iceland |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
|||||||
|
Ireland |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
|||||||
|
Italy |
|
Arcoxia |
90 mg |
Film-coated tablet |
Oral use |
|||||||
|
Italy |
|
Algix |
90 mg |
Film-coated tablet |
Oral use |
|||||||
|
Italy |
|
Recoxib |
90 mg |
Film-coated tablets |
Oral use |
|||||||
|
Italy |
|
Tauxib |
90 mg |
Film-coated tablets |
Oral use |
|||||||
|
Latvia |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
|||||||
|
Lithuania |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
|||||||
|
Luxembourg |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
|||||||
|
Ranacox |
90 mg |
Film-coated tablets |
Oral use |
|||||||||
|
Malta |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
|||||||
|
The Netherlands |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
|||||||
|
Auxib |
90 mg |
Film-coated tablets |
Oral use |
|||||||||
|
Norway |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
|||||||
|
Poland |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
|||||||
|
Portugal |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
|||||||
|
Portugal |
|
Exxiv |
90 mg |
Film-coated tablets |
Oral use |
|||||||
|
Portugal |
|
Turox |
90 mg |
Film-coated tablets |
Oral use |
|||||||
|
Romania |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
|||||||
|
Slovakia |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
|||||||
|
Slovenia |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
|||||||
|
Spain |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
|||||||
|
Spain |
|
Exxiv |
90 mg |
Film-coated tablets |
Oral use |
|||||||
|
Sweden |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
|||||||
|
Turox |
90 mg |
Film-coated tablets |
Oral use |
|||||||||
|
United Kingdom |
|
Arcoxia |
90 mg |
Film-coated tablets |
Oral use |
|||||||
|
Auxib 90 |
90 mg |
Film-coated tablets |
Oral use |
|||||||||
|
Exxiv 90 |
90 mg |
Film-coated tablets |
Oral use |
|||||||||
|
Turox 90 |
90 mg |
Film-coated tablets |
Oral use |
ANNEX V
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS/MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
|
Member State |
Marketing Authorisation Holder |
Applicant |
(Invented) Name |
Strength |
Pharmaceutical Form |
Route of administration |
|||||
|
Austria |
|
|
Noviana 0,5 mg/0,1 mg Filmtabletten |
Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg |
Film-coated tablets |
Oral use |
|||||
|
Belgium |
|
|
Activelle minor comprimés pelliculés |
Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg |
Film-coated tablets |
Oral use |
|||||
|
Bulgaria |
|
|
Eviana филмирани таблетки |
Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg |
Film-coated tablets |
Oral use |
|||||
|
Czech Republic |
|
|
Noviana potahované tablety |
Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg |
Film-coated tablets |
Oral use |
|||||
|
Denmark |
|
|
Activelle low filmovertrukne tabletter |
Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg |
Film-coated tablets |
Oral use |
|||||
|
Estonia |
|
|
Activelle |
Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg |
Film-coated tablets |
Oral use |
|||||
|
Finland |
|
|
Activelle 0,5 mg/0,1 mg tabl. |
Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg |
Film-coated tablets |
Oral use |
|||||
|
France |
|
|
Activelle 0,5 mg/0,1 mg, comprimé pelliculé |
Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg |
Film-coated tablets |
Oral use |
|||||
|
Germany |
|
|
Noviana |
Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg |
Film-coated tablets |
Oral use |
|||||
|
Hungary |
|
|
Noviana filmtabletta |
Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg |
Film-coated tablets |
Oral use |
|||||
|
Iceland |
|
|
Activelle low 0,5 mg/0,1 mg tablets filmuhúðaðar töflur |
Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg |
Film-coated tablets |
Oral use |
|||||
|
Ireland |
|
|
Activelle Tablets |
Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg |
Film-coated tablets |
Oral use |
|||||
|
Italy |
|
|
Activelle 0,5 mg/0,1 mg compresse film-rivestite |
Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg |
Film-coated tablets |
Oral use |
|||||
|
Latvia |
|
|
Noviana 0,5 mg/0,1 mg apvalkotās tabletes |
Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg |
Film-coated tablets |
Oral use |
|||||
|
Lithuania |
|
|
Activelle |
Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg |
Film-coated tablets |
Oral use |
|||||
|
Luxembourg |
|
|
Activelle comprimés pelliculés |
Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg |
Film-coated tablets |
Oral use |
|||||
|
The Netherlands |
|
|
Activelle filmomhulde tabletten |
Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg |
Film-coated tablets |
Oral use |
|||||
|
Norway |
|
|
Noviana 0,5 mg/0,1 mg tablett filmdrasjert |
Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg |
Film-coated tablets |
Oral use |
|||||
|
Portugal |
|
|
Activelle |
Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg |
Film-coated tablets |
Oral use |
|||||
|
Romania |
|
|
Noviana comprimate filmate |
Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg |
Film-coated tablets |
Oral use |
|||||
|
Slovak Republic |
|
|
Noviana |
Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg |
Film-coated tablets |
Oral use |
|||||
|
Slovenia |
|
|
Noviana filmsko obložene tablete |
Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg |
Film-coated tablets |
Oral use |
|||||
|
Spain |
|
|
Activelle 0,5 mg/ 0,1 mg comprimidos recubiertos de película |
Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg |
Film-coated tablets |
Oral use |
|||||
|
Sweden |
|
|
Activelle |
Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg |
Film-coated tablets |
Oral use |
|||||
|
United Kingdom |
|
|
Noviana film-coated tablets |
Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg |
Film-coated tablets |
Oral use |
ANNEX VI
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS AND MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
|
Member State |
Marketing Authorisation Holder |
Applicant |
(Invented) Name |
Strength |
Pharmaceutical Form |
Route of administration |
||||
|
Austria |
|
|
Rapinyl |
50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg |
Sublingual tablet |
Sublingual use |
||||
|
Belgium |
|
|
Rapinyl |
50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg |
Sublingual tablet |
Sublingual use |
||||
|
Cyprus |
|
|
Rapinyl (1) |
50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg |
Sublingual tablet |
Sublingual use |
||||
|
Czech Republic |
|
|
Rapinyl |
50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg |
Sublingual tablet |
Sublingual use |
||||
|
Denmark |
|
|
Rapinyl |
50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg |
Sublingual tablet |
Sublingual use |
||||
|
Estonia |
|
|
Rapinyl |
50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg |
Sublingual tablet |
Sublingual use |
||||
|
Finland |
|
|
Rapinyl (1) |
50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg |
Sublingual tablet |
Sublingual use |
||||
|
France |
|
|
Rapinyl |
50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg |
Sublingual tablet |
Sublingual use |
||||
|
Germany |
|
|
Rapinyl |
50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg |
Sublingual tablet |
Sublingual use |
||||
|
Greece |
|
|
Rapinyl |
50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg |
Sublingual tablet |
Sublingual use |
||||
|
Hungary |
|
|
Rapinyl |
50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg |
Sublingual tablet |
Sublingual use |
||||
|
Iceland |
|
|
Rapinyl |
50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg |
Sublingual tablet |
Sublingual use |
||||
|
Ireland |
|
|
Rapinyl |
50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg |
Sublingual tablet |
Sublingual use |
||||
|
Italy |
|
|
Rapinyl (1) |
50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg |
Sublingual tablet |
Sublingual use |
||||
|
Latvia |
|
|
Rapinyl |
50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg |
Sublingual tablet |
Sublingual use |
||||
|
Lithuania |
|
|
Rapinyl |
50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg |
Sublingual tablet |
Sublingual use |
||||
|
Luxembourg |
|
|
Rapinyl |
50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg |
Sublingual tablet |
Sublingual use |
||||
|
Norway |
|
|
Rapinyl |
50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg |
Sublingual tablet |
Sublingual use |
||||
|
Poland |
|
|
Rapinyl |
50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg |
Sublingual tablet |
Sublingual use |
||||
|
Portugal |
|
|
Rapinyl |
50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg |
Sublingual tablet |
Sublingual use |
||||
|
Slovak Republic |
|
|
Rapinyl |
50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg |
Sublingual tablet |
Sublingual use |
||||
|
Slovenia |
|
|
Rapinyl |
50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg |
Sublingual tablet |
Sublingual use |
||||
|
Spain |
|
|
Rapinyl (1) |
50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg |
Sublingual tablet |
Sublingual use |
||||
|
Sweden |
|
|
Abstral |
50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg |
Sublingual tablet |
Sublingual use |
||||
|
United Kingdom |
|
|
Rapinyl |
50 μg 100 μg 200 μg 300 μg 400 μg 600 μg 800 μg |
Sublingual tablet |
Sublingual use |
(1) Name approval pending.
ANNEX VII
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
|
Member State |
Marketing Authorisation Holder |
INN |
(Invented) Name |
Strength |
Pharmaceutical Form |
Route of administration |
Content (concentration) |
|||||||
|
Austria |
|
Mirtazapine |
Remeron SolTab Schmelztabletten |
15 mg |
Orodispersible tablets |
Oral use |
|
|||||||
|
Mirtazapine |
Remeron SolTab Schmelztabletten |
30 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron SolTab Schmelztabletten |
45 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Belgium |
Delegation of power:
|
Mirtazapine |
Remergon |
15 mg |
Film-coated tablets |
Oral use |
|
|||||||
|
Mirtazapine |
Remergon |
30 mg |
Film-coated tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remergon |
45 mg |
Film-coated tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remergon SolTab |
15 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remergon SolTab |
30 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remergon SolTab |
45 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remergon |
15 mg/ml |
Oral solution |
Oral use |
990 mg/66 ml |
|||||||||
|
Cyprus |
|
Mirtazapine |
Remeron |
30 mg |
Film-coated tablets |
Oral use |
|
|||||||
|
Czech Republic |
|
Mirtazapine |
REMERON 15 MG |
15 mg |
Film-coated tablets |
Oral use |
|
|||||||
|
Mirtazapine |
REMERON 30 MG |
30 mg |
Film-coated tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
REMERON 45 MG |
45 mg |
Film-coated tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
REMERON SOLTAB 15 MG |
15 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
REMERON SOLTAB 30 MG |
30 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
REMERON SOLTAB 45 MG |
45 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Denmark |
|
Mirtazapine |
Mitazon Smelt |
15 mg |
Orodispersible tablets |
Oral use |
|
|||||||
|
Mirtazapine |
Mitazon Smelt |
30 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Mitazon Smelt |
45 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Mitazon |
30 mg |
Film-coated tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron Smelt |
15 mg |
Orodispersible tablets |
Oral use |
|
||||||||
|
Mirtazapine |
Remeron Smelt |
30 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron Smelt |
45 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron Oral, opløsning |
15 mg/ml |
Oral solution |
Oral use |
990 mg/66 ml |
|||||||||
|
Estonia |
|
Mirtazapine |
Remeron |
15 mg |
Film-coated tablets |
Oral use |
|
|||||||
|
Mirtazapine |
Remeron |
30 mg |
Film-coated tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron |
45 mg |
Film-coated tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron SolTab |
15 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron SolTab |
30 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron SolTab |
45 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Finland |
|
Mirtazapine |
Remeron Soltab |
15 mg |
Orodispersible tablets |
Oral use |
|
|||||||
|
Mirtazapine |
Remeron Soltab |
30 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron Soltab |
45 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron |
15 mg |
Film-coated tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron |
30 mg |
Film-coated tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron |
45 mg |
Film-coated tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron |
15 mg/ml |
Oral solution |
Oral use |
990 mg/66 ml |
|||||||||
|
Mirtazapine |
Mirtazon |
30 mg |
Film-coated tablets |
Oral use |
|
||||||||
|
Mirtazapine |
Mirtazon Smelt |
15 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Mirtazon Smelt |
30 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Mirtazon Smelt |
45 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
France |
|
Mirtazapine |
Norset |
15 mg |
Film-coated tablets |
Oral use |
|
|||||||
|
Mirtazapine |
Norset |
30 mg |
Film-coated tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Norset |
15 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Norset |
30 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Norset |
45 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Norset |
15 mg/ml |
Oral solution |
Oral use |
990 mg/66 ml |
|||||||||
|
Germany |
|
Mirtazapine |
Remergil |
15 mg |
Film-coated tablets |
Oral use |
|
|||||||
|
Mirtazapine |
Remergil |
30 mg |
Film-coated tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remergil |
45 mg |
Film-coated tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remergil SolTab |
15 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remergil SolTab |
30 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remergil SolTab |
45 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remergil |
15 mg/ml |
Oral solution |
Oral use |
990 mg/66 ml |
|||||||||
|
Mirtazapine |
Mirtazapin STADA |
15 mg |
Orodispersible tablets |
Oral use |
|
||||||||
|
Mirtazapine |
Mirtazapin STADA |
30 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Mirtazapin STADA |
45 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Greece |
|
Mirtazapine |
Remeron |
15 mg |
Film-coated tablets |
Oral use |
|
|||||||
|
Mirtazapine |
Remeron |
30 mg |
Film-coated tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron |
45 mg |
Film-coated tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron SolTab |
15 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron SolTab |
30 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron SolTab |
45 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron |
15 mg/ml |
Oral solution |
Oral use |
990 mg/66 ml |
|||||||||
|
Hungary |
|
Mirtazapine |
Remeron |
30 mg |
Film-coated tablets |
Oral use |
|
|||||||
|
Mirtazapine |
Remeron |
45 mg |
Film-coated tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron SolTab |
30 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron SolTab |
45 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Iceland |
|
Mirtazapine |
Remeron |
15 mg |
Film-coated tablets |
Oral use |
|
|||||||
|
Mirtazapine |
Remeron |
30 mg |
Film-coated tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron |
45 mg |
Film-coated tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron Smelt |
15 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron Smelt |
30 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron Smelt |
45 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron 15 mg/ml |
15 mg/ml |
Oral solution |
Oral use |
990 mg/66 ml |
|||||||||
|
Ireland |
|
Mirtazapine |
Zispin® film-coated tablets |
15 mg |
Film-coated tablets |
Oral use |
|
|||||||
|
Mirtazapine |
Zispin® film-coated tablets |
30 mg |
Film-coated tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Zispin® film-coated tablets |
45 mg |
Film-coated tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Zispin® Soltab® orodispersible tablets |
15 mg |
Orodispersible tablets |
Oral use |
|
||||||||
|
Mirtazapine |
Zispin® Soltab® orodispersible tablets |
30 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Zispin® Soltab® orodispersible tablets |
45 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Zispin® oral solution |
15 mg/ml |
Oral solution |
Oral use |
990 mg/66 ml |
|||||||||
|
Italy |
|
mirtazapine |
Remeron |
15 mg |
Film-coated tablets |
Oral use |
|
|||||||
|
mirtazapine |
Remeron |
30 mg |
Film-coated tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron |
45 mg |
Film-coated tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron |
15 mg/ml |
Oral solution |
Oral use |
990 mg/66 ml |
|||||||||
|
Mirtazapine |
Remeron |
15 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron |
30 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron |
45 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Mirtazapina Organon |
15 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Mirtazapina Organon |
30 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Mirtazapina Organon |
45 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Latvia |
|
Mirtazapine |
Remeron |
30 mg |
Film-coated tablets |
Oral use |
|
|||||||
|
Mirtazapine |
Remeron SolTab |
15 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron SolTab |
30 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron SolTab |
45 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Lithuania |
|
Mirtazapine |
Remeron |
30 mg |
Film-coated tablets |
Oral use |
|
|||||||
|
Mirtazapine |
Remeron Sol Tab |
15 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron Sol Tab |
30 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron Sol Tab |
45 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Luxembourg |
Delegation of power:
|
Mirtazapine |
Remergon |
15 mg |
Film-coated tablets |
Oral use |
|
|||||||
|
Mirtazapine |
Remergon |
30 mg |
Film-coated tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remergon |
45 mg |
Film-coated tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remergon SolTab |
15 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remergon SolTab |
30 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remergon SolTab |
45 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remergon |
15 mg/ml |
Oral solution |
Oral use |
990 mg/66 ml |
|||||||||
|
The Netherlands |
|
Mirtazapine |
Remeron |
15 mg |
Film-coated tablets |
Oral use |
|
|||||||
|
Mirtazapine |
Remeron |
30 mg |
Film-coated tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron |
45 mg |
Film-coated tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron drank |
15 mg/ml |
Oral solution |
Oral use |
990 mg/66 ml |
|||||||||
|
Mirtazapine |
Remeron SolTab |
15 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron SolTab |
30 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron SolTab |
45 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Mirtazapine orodispergeerbare tabletten |
15 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Mirtazapine orodispergeerbare tabletten |
30 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Mirtazapine orodispergeerbare tabletten |
45 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Norway |
|
Mirtazapine |
Remeron |
30 mg |
Film-coated tablets |
Oral use |
|
|||||||
|
Mirtazapine |
Remeron |
45 mg |
Film-coated tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron-S smeltetabletter |
15 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron-S smeltetabletter |
30 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron-S smeltetabletter |
45 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron mikstur, oppløsning |
15 mg/ml |
Oral solution |
Oral use |
990 mg/66 ml |
|||||||||
|
Poland |
|
Mirtazapine |
Remeron |
30 mg |
Film-coated tablets |
Oral use |
|
|||||||
|
Portugal |
|
Mirtazapine |
Mirtazapina Organon |
15 mg |
Film-coated tablets |
Oral use |
|
|||||||
|
Mirtazapine |
Mirtazapina Organon |
30 mg |
Film-coated tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron |
45 mg |
Film-coated tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron SolTab |
15 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron SolTab |
30 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron SolTab |
45 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron |
15 mg/ml |
Oral solution |
Oral use |
990 mg/66 ml |
|||||||||
|
Mirtazapine |
Mirtazon |
15 mg |
Orodispersible tablets |
Oral use |
|
||||||||
|
Mirtazapine |
Mirtazon |
30 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Mirtazon |
45 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Romania |
|
Mirtazapine |
Remeron SolTab 15 mg |
15 mg |
Orodispersible tablets |
Oral use |
|
|||||||
|
Mirtazapine |
Remeron SolTab 30 mg |
30 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron SolTab 45 mg |
45 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Slovak Republic |
|
Mirtazapine |
REMERON 15 mg |
15 mg |
Film-coated tablets |
Oral use |
|
|||||||
|
Mirtazapine |
REMERON 30 mg |
30 mg |
Film-coated tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
REMERON 45 mg |
45 mg |
Film-coated tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
REMERON Soltab 15 mg |
15 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
REMERON Soltab 30 mg |
30 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
REMERON Soltab 45 mg |
45 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Spain |
|
Mirtazapine |
Rexer |
15 mg |
Film-coated tablets |
Oral use |
|
|||||||
|
Mirtazapine |
Rexer |
30 mg |
Film-coated tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Rexer |
45 mg |
Film-coated tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Rexer Flas |
15 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Rexer Flas |
30 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Rexer Flas |
45 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Rexer |
15 mg/ml |
Oral solution |
Oral use |
990 mg/66 ml |
|||||||||
|
Mirtazapine |
Mirtazapina Organon |
15 mg |
Orodispersible tablets |
Oral use |
|
||||||||
|
Mirtazapine |
Mirtazapina Organon |
30 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Mirtazapina Organon |
45 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Sweden |
|
Mirtazapine |
Remeron |
15 mg |
Film-coated tablets |
Oral use |
|
|||||||
|
Mirtazapine |
Remeron |
30 mg |
Film-coated tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron |
45 mg |
Film-coated tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron |
15 mg/ml |
Oral solution |
Oral use |
990 mg/66 ml |
|||||||||
|
Mirtazapine |
Remeron-S |
15 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron-S |
30 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Remeron-S |
45 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Mirtazapin IP |
15 mg |
Film-coated tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Mirtazapin IP |
30 mg |
Film-coated tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Mirtazapin IP |
45 mg |
Film-coated tablets |
Oral use |
|
|||||||||
|
United Kingdom |
|
Mirtazapine |
Mirtazapine 15 mg tablets |
15 mg |
Film-coated tablets |
Oral use |
|
|||||||
|
Mirtazapine |
Mirtazapine 30 mg tablets |
30 mg |
Film-coated tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Mirtazapine 45 mg tablets |
45 mg |
Film-coated tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Mirtazapine 15 mg/ml oral solution |
15 mg/ml |
Oral solution |
Oral use |
990 mg/66 ml |
|||||||||
|
Mirtazapine |
Zispin SolTab 15 mg orodispersible tablet |
15 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Zispin SolTab 30 mg orodispersible tablet |
30 mg |
Orodispersible tablets |
Oral use |
|
|||||||||
|
Mirtazapine |
Zispin SolTab 45 mg orodispersible tablet |
45 mg |
Orodispersible tablets |
Oral use |
|
ANNEX VIII
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
|
Member State |
Marketing Authorisation Holder |
(Invented) Name |
Strength |
Pharmaceutical Form |
Route of administration |
||||||
|
Austria |
|
Gemzar 200 mg — Trockensubstanz zur Infusionsbereitung |
200 mg |
Powder for solution for infusion |
Intravenous use |
||||||
|
Austria |
|
Gemzar 1 g — Trockensubstanz zur Infusionsbereitung |
1 000 mg |
Powder for solution for infusion |
Intravenous use |
||||||
|
Belgium |
|
Gemzar 1000 |
1 000 mg |
Powder for solution for infusion |
Intravenous use |
||||||
|
Belgium |
|
Gemzar 200 |
200 mg |
Powder for solution for infusion |
Intravenous use |
||||||
|
Bulgaria |
|
Gemzar |
200 mg |
Powder for solution for infusion |
Intravenous use |
||||||
|
Bulgaria |
|
Gemzar |
1 g |
Powder for solution for infusion |
Intravenous use |
||||||
|
Czech Republic |
|
Gemzar 1 g |
1 g |
Powder for solution for infusion |
Intravenous use |
||||||
|
Czech Republic |
|
Gemzar 200 mg |
200 mg |
Powder for solution for infusion |
Intravenous use |
||||||
|
Cyprus |
|
Gemzar |
200 mg |
Powder for solution for infusion |
Intravenous use |
||||||
|
Cyprus |
|
Gemzar |
1 g |
Powder for solution for infusion |
Intravenous use |
||||||
|
Denmark |
|
Gemzar |
200 mg |
Powder for solution for infusion |
Intravenous use |
||||||
|
Denmark |
|
Gemzar |
1 g |
Powder for solution for infusion |
Intravenous use |
||||||
|
Estonia |
|
Gemzar 200 mg powder for solution for infusion |
200 mg |
Powder for solution for infusion |
Intravenous use |
||||||
|
Estonia |
|
Gemzar 1 g powder for solution for infusion |
1 g |
Powder for solution for infusion |
Intravenous use |
||||||
|
Finland |
|
Gemzar 200 mg powder for solution for infusion |
200 mg |
Powder for solution for infusion |
Intravenous use |
||||||
|
Finland |
|
Gemzar 1 g powder for solution for infusion |
1 g |
Powder for solution for infusion |
Intravenous use |
||||||
|
France |
|
Gemzar 1 000 mg, poudre pour solution pour perfusion |
1 000 mg |
Powder for solution for infusion |
Intravenous use |
||||||
|
France |
|
Gemzar 200 mg, poudre pour solution pour perfusion |
200 mg |
Powder for solution for infusion |
Intravenous use |
||||||
|
Germany |
|
Gemzar 200 mg Pulver zur Herstellung einer Infusionslösung |
200 mg |
Powder for solution for infusion |
Intravenous use |
||||||
|
Germany |
|
Gemzar 1 g Pulver zur Herstellung einer Infusionslösung |
1 000 mg |
Powder for solution for infusion |
Intravenous use |
||||||
|
Greece |
|
ΓΚΕΜΖΑΡ |
200 mg |
Powder for solution for infusion |
Intravenous use |
||||||
|
Greece |
|
ΓΚΕΜΖΑΡ |
1 000 mg |
Powder for solution for infusion |
Intravenous use |
||||||
|
Hungary |
|
Gemzar 1 g powder for injection |
1 g |
Powder for injection |
Intravenous use |
||||||
|
Hungary |
|
Gemzar 200 mg powder for injection |
200 mg |
Powder for injection |
Intravenous use |
||||||
|
Ireland |
|
Gemzar 200 mg powder for solution for infusion |
200 mg |
Powder for solution for infusion |
Intravenous use |
||||||
|
Ireland |
|
Gemzar 1 g powder for solution for infusion |
1 g |
Powder for solution for infusion |
Intravenous use |
||||||
|
Iceland |
|
Gemzar |
200 mg |
Powder for solution for infusion |
Intravenous use |
||||||
|
Iceland |
|
Gemzar |
1 g |
Powder for solution for infusion |
Intravenous use |
||||||
|
Italy |
|
Gemzar 200 mg powder for solution for infusion and intravesical instillation |
200 mg |
Powder for solution for infusion and intravesical instillation |
Intravenous use and intravesical use |
||||||
|
Italy |
|
Gemzar 1 g powder for solution for infusion and intravesical instillation |
1 g |
Powder for solution for infusion and intravesical instillation |
Intravenous use and intravesical use |
||||||
|
Latvia |
|
Gemzar |
1 g |
Powder for solution for infusion |
Intravenous use |
||||||
|
Latvia |
|
Gemzar |
200 mg |
Powder for solution for infusion |
Intravenous use |
||||||
|
Lithuania |
|
Gemzar |
200 mg |
Powder for solution for infusion |
Intravenous use |
||||||
|
Lithuania |
|
Gemzar |
1 000 mg |
Powder for solution for infusion |
Intravenous use |
||||||
|
Luxembourg |
|
Gemzar |
200 mg |
Powder for solution for infusion |
Intravenous use |
||||||
|
Luxembourg |
|
Gemzar |
1 g |
Powder for solution for infusion |
Intravenous use |
||||||
|
Malta |
|
Gemzar |
200 mg |
Powder for solution for infusion |
Intravenous use |
||||||
|
Malta |
|
Gemzar |
1 g |
Powder for solution for infusion |
Intravenous use |
||||||
|
The Netherlands |
|
Gemzar |
200 mg |
Powder for solution for infusion |
Intravenous use |
||||||
|
The Netherlands |
|
Gemzar |
1 g |
Powder for solution for infusion |
Intravenous use |
||||||
|
Norway |
|
Gemzar |
1 g |
Powder for solution for infusion |
Intravenous use |
||||||
|
Norway |
|
Gemzar |
200 mg |
Powder for solution for infusion |
Intravenous use |
||||||
|
Poland |
|
Gemzar |
200 mg |
Powder for solution for infusion |
Intravenous use |
||||||
|
Poland |
|
Gemzar |
1 g |
Powder for solution for infusion |
Intravenous use |
||||||
|
Portugal |
|
Gemzar |
200 mg |
Powder for solution for infusion |
Intravenous use |
||||||
|
Portugal |
|
Gemzar |
1 000 mg |
Powder for solution for infusion |
Intravenous use |
||||||
|
Romania |
|
Gemzar 1 g |
1 000 mg |
Powder for solution for infusion |
Intravenous use |
||||||
|
Romania |
|
Gemzar 200 mg |
200 mg |
Powder for solution for infusion |
Intravenous use |
||||||
|
Slovakia |
|
Gemzar 1 g |
1 g |
Powder for solution for infusion |
Intravenous use |
||||||
|
Slovakia |
|
Gemzar 200 mg |
200 mg |
Powder for solution for infusion |
Intravenous use |
||||||
|
Slovenia |
|
Gemzar 200 mg prašek za raztopino za infundiranje |
200 mg |
Powder for solution for infusion |
Intravenous use |
||||||
|
Slovenia |
|
Gemzar 1 g prašek za raztopino za infundiranje |
1 g |
Powder for solution for infusion |
Intravenous use |
||||||
|
Spain |
|
Gemzar 1 g powder for solution for injection |
1 g |
Powder for solution for injection |
Intravenous use |
||||||
|
Spain |
|
Gemzar 200 mg powder for solution for injection |
200 mg |
Powder for solution for injection |
Intravenous use |
||||||
|
Sweden |
|
Gemzar |
200 mg |
Powder for solution for infusion |
Intravenous use |
||||||
|
Sweden |
|
Gemzar |
1 g |
Powder for solution for infusion |
Intravenous use |
||||||
|
United Kingdom |
|
Gemzar 200 mg powder for solution for infusion |
200 mg |
Powder for solution for infusion |
Intravenous use |
||||||
|
United Kingdom |
|
Gemzar 1g powder for solution for infusion |
1 g |
Powder for solution for infusion |
Intravenous use |
ANNEX IX
NAME, PHARMACEUTICAL FORMS, STRENGTH OF THE MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDER/APPLICANT
|
Member State/Marketing Authorisation Number |
Marketing Authorisation Holder |
Product invented name |
Pharmaceutical Form |
Strength/Active substance (INN) |
Animal species |
|
Austria (8-00694) |
Chevita Tierarzneimittel Ges.m.b.H. |
Asprimax 850 mg/g |
Powder for oral solution |
Sodium salicylate |
Pigs |
|
The Netherlands (REG NL 8913) |
Dopharma Research B.V. |
NA-SALICYLAAT, 100 %, powder for solution for oral administration |
Powder for oral solution |
Sodium salicylate |
Calves and pigs |
|
The Netherlands (REG NL 10411) |
Dopharma Research B.V. |
NA-SALICYLAAT, 80 % WSP |
Powder for oral solution |
Sodium salicylate |
Calves and pigs |
|
Decentralised procedure subject to an Article 33 Referral (CD 17 April 2008) |
Eurovet Animal Health B.V. |
SOLACYL 100 %, powder for oral solution for calves and pigs |
Powder for oral solution |
|
Calves and pigs |
ANNEX X
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE(S) OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
|
Member State |
Invented name |
Marketing Authorisation Holder Company Name and Address |
Animal species |
Pharmaceutical Form |
Strength |
Indications |
||||||||
|
Austria |
Baycox 25 mg/ml Lösung zum Eingeben für Hühner und Puten |
|
Chickens and turkeys |
Oral solution |
25 mg/ml |
Treatment of coccidiosis |
||||||||
|
Belgium |
Baycox 2,5 % orale oplossing |
|
Chickens and turkeys |
Oral solution |
25 mg/ml |
Treatment of coccidiosis |
||||||||
|
Bulgaria |
Baycox 2,5 % solution |
|
Chickens and turkeys |
Oral solution |
25 mg/ml |
Treatment of coccidiosis |
||||||||
|
Bulgaria |
Cevazuril oral solution |
|
Broilers, breeders, pullets and turkeys |
Oral solution |
25 mg/ml |
Prevention and treatment of coccidiosis |
||||||||
|
Cyprus |
Baycox 2,5 % oral solution |
|
Broilers and turkeys |
Oral solution |
25 mg/ml |
Treatment of coccidiosis |
||||||||
|
Czech Republic |
Baycox 2,5 % sol. ad us. vet. |
|
Chickens and turkeys |
Oral solution |
25 mg/ml |
Treatment of coccidiosis |
||||||||
|
France |
Baycox 2,5 % |
|
Chickens: broilers, pullets and breeders |
Oral solution |
25 mg/ml |
Prevention and treatment of coccidiosis |
||||||||
|
France |
CEVAZURIL |
|
Chickens: broilers, pullets and breeders |
Oral solution |
25 mg/ml |
Prevention and treatment of coccidiosis |
||||||||
|
Germany |
Baycox 2,5 % |
|
Chickens and turkeys |
Oral solution |
25 mg/ml |
Treatment of coccidiosis |
||||||||
|
Greece |
Baycox 2,5 % oral solution |
|
Broilers and turkeys |
Oral solution |
25 mg/ml |
Treatment of coccidiosis |
||||||||
|
Hungary |
Baycox 2,5 % solution A.U.V. |
|
Chickens and turkeys |
Oral solution |
25 mg/ml |
Treatment of coccidiosis |
||||||||
|
Ireland |
Baycox 2,5 % Solution |
|
Chickens |
Oral solution |
25 mg/ml |
Treatment and control of coccidiosis |
||||||||
|
Italy |
Baycox soluzione 2,5 % |
|
Chickens and turkeys |
Oral solution |
25 mg/ml |
Treatment of coccidiosis |
||||||||
|
Italy |
Cevazuril (1) |
|
Chickens and turkeys |
Oral solution |
25 mg/ml |
Treatment of coccidiosis |
||||||||
|
Poland |
Baycox 2,5 % |
|
Broilers, breeders, turkeys and pigeons |
Oral solution |
25 mg/ml |
Chickens and turkeys: treatment of coccidiosis Pigeons: Treatment and prevention of coccidiosis |
||||||||
|
Portugal |
Baycox 2,5 % oral solution |
|
Chickens and turkeys |
Oral solution |
25 mg/ml |
Treatment of coccidiosis |
||||||||
|
Romania |
Cevazuril |
|
Broilers, breeders, pullets and turkeys |
Oral solution |
25 mg/ml |
Treatment of coccidiosis |
||||||||
|
Slovakia |
Baycox 2,5 % sol. a.u.v. |
|
Chickens and turkeys |
Oral solution |
25 mg/ml |
Treatment of coccidiosis |
||||||||
|
Slovenia |
Baycox 2,5 % w/v oral solution |
|
Chickens and turkeys |
Oral solution |
25 mg/ml |
Treatment of coccidiosis |
||||||||
|
The Netherlands |
Baycox 2,5 % |
|
Chickens and turkeys |
Oral solution |
25 mg/ml |
Treatment of coccidiosis |
||||||||
|
The Netherlands |
Baycox oplossing 2,5 % |
|
Chickens and turkeys |
Oral solution |
25 mg/ml |
Treatment of coccidiosis |
||||||||
|
United Kingdom |
Baycox 2,5 % oral solution |
|
Broilers and broiler breeders |
Oral solution |
25 mg/ml |
Treatment of coccidiosis |
(1) The marketing authorisation is suspended on 12 June 2007.
ANNEX XI
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH(S) OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANT, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
|
Member State |
Marketing Authorisation Holder |
Applicant |
(Invented) Name |
Strength |
Pharmaceutical Form |
Route of administration |
Content (concentration) |
||||||
|
Austria |
|
|
Pulairmax 100 μg/Dosis Pulver zur Inhalation |
100 μg |
Inhalation powder |
Inhalation use |
100 micrograms |
||||||
|
Pulairmax 200 μg/Dosis Pulver zur Inhalation |
200 μg |
Inhalation powder |
Inhalation use |
200 micrograms |
|||||||||
|
Pulairmax 400 μg/Dosis Pulver zur Inhalation |
400 μg |
Inhalation powder |
Inhalation use |
400 micrograms |
|||||||||
|
Belgium |
|
|
Pulairmax 100 μg inhalatiepoeder |
100 μg |
Inhalation powder |
Inhalation use |
100 micrograms |
||||||
|
Pulairmax 200 μg inhalatiepoeder |
200 μg |
Inhalation powder |
Inhalation use |
200 micrograms |
|||||||||
|
Pulairmax 400 μg inhalatiepoeder |
400 μg |
Inhalation powder |
Inhalation use |
400 micrograms |
|||||||||
|
Cyprus |
|
|
Pulairmax 100 μg Σκόνη για εισπνοή |
100 μg |
Inhalation powder |
Inhalation use |
100 micrograms |
||||||
|
Pulairmax 200 μg Σκόνη για εισπνοή |
200 μg |
Inhalation powder |
Inhalation use |
200 micrograms |
|||||||||
|
Pulairmax 400 μg Σκόνη για εισπνοή |
400 μg |
Inhalation powder |
Inhalation use |
400 micrograms |
|||||||||
|
Czech Republic |
|
|
Pulmax 100 μg Prášek k inhalaci |
100 μg |
Inhalation powder |
Inhalation use |
100 micrograms |
||||||
|
Pulmax 200 μg Prášek k inhalaci |
200 μg |
Inhalation powder |
Inhalation use |
200 micrograms |
|||||||||
|
Pulmax 400 μg Prášek k inhalaci |
400 μg |
Inhalation powder |
Inhalation use |
400 micrograms |
|||||||||
|
Denmark |
|
|
Pulairmax |
100 μg |
Inhalation powder |
Inhalation use |
100 micrograms |
||||||
|
Pulairmax |
200 μg |
Inhalation powder |
Inhalation use |
200 micrograms |
|||||||||
|
Pulairmax |
400 μg |
Inhalation powder |
Inhalation use |
400 micrograms |
|||||||||
|
Estonia |
|
|
Pulairmax |
100 μg |
Inhalation powder |
Inhalation use |
100 micrograms |
||||||
|
Pulairmax |
200 μg |
Inhalation powder |
Inhalation use |
200 micrograms |
|||||||||
|
Pulairmax |
400 μg |
Inhalation powder |
Inhalation use |
400 micrograms |
|||||||||
|
Finland |
|
|
Pulairmax 100 μg inhalaatiojauhe |
100 μg |
Inhalation powder |
Inhalation use |
100 micrograms |
||||||
|
Pulairmax 200 μg inhalaatiojauhe |
200 μg |
Inhalation powder |
Inhalation use |
200 micrograms |
|||||||||
|
Pulairmax 400 μg inhalaatiojauhe |
400 μg |
Inhalation powder |
Inhalation use |
400 micrograms |
|||||||||
|
Germany |
|
|
Pulairmax 100 Mikrogramm/Dosis Pulver zur Inhalation |
100 μg |
Inhalation powder |
Inhalation use |
100 micrograms |
||||||
|
Pulairmax 200 Mikrogramm/Dosis Pulver zur Inhalation |
200 μg |
Inhalation powder |
Inhalation use |
200 micrograms |
|||||||||
|
Pulairmax 400 Mikrogramm/Dosis Pulver zur Inhalation |
400 μg |
Inhalation powder |
Inhalation use |
400 micrograms |
|||||||||
|
Greece |
|
|
Pulairmax 100 μg Κόνις για εισπνοή |
100 μg |
Inhalation powder |
Inhalation use |
100 micrograms |
||||||
|
Pulairmax 200 μg Κόνις για εισπνοή |
200 μg |
Inhalation powder |
Inhalation use |
200 micrograms |
|||||||||
|
Pulairmax 400 μg Κόνις για εισπνοή |
400 μg |
Inhalation powder |
Inhalation use |
400 micrograms |
|||||||||
|
Ireland |
|
|
Pulairmax 100 μg Inhalation Powder |
100 μg |
Inhalation powder |
Inhalation use |
100 micrograms |
||||||
|
Pulairmax 200 μg Inhalation Powder |
200 μg |
Inhalation powder |
Inhalation use |
200 micrograms |
|||||||||
|
Pulairmax 400 μg Inhalation Powder |
400 μg |
Inhalation powder |
Inhalation use |
400 micrograms |
|||||||||
|
Italy |
|
|
Pulairmax 100 polvere per inalazione |
100 μg |
Inhalation powder |
Inhalation use |
100 micrograms |
||||||
|
Pulairmax 200 mcg polvere per inalazione |
200 μg |
Inhalation powder |
Inhalation use |
200 micrograms |
|||||||||
|
Pulairmax 400 mcg polvere per inalazione |
400 μg |
Inhalation powder |
Inhalation use |
400 micrograms |
|||||||||
|
Latvia |
|
|
Pulairmax |
100 μg |
Inhalation powder |
Inhalation use |
100 micrograms |
||||||
|
Pulairmax |
200 μg |
Inhalation powder |
Inhalation use |
200 micrograms |
|||||||||
|
Pulairmax |
400 μg |
Inhalation powder |
Inhalation use |
400 micrograms |
|||||||||
|
Lithuania |
|
|
Pulairmax |
100 μg |
Inhalation powder |
Inhalation use |
100 micrograms |
||||||
|
Pulairmax |
200 μg |
Inhalation powder |
Inhalation use |
200 micrograms |
|||||||||
|
Pulairmax |
400 μg |
Inhalation powder |
Inhalation use |
400 micrograms |
|||||||||
|
Luxembourg |
|
|
Pulairmax 100 μg poudre pour inhalation |
100 μg |
Inhalation powder |
Inhalation use |
100 micrograms |
||||||
|
Pulairmax 200 μg poudre pour inhalation |
200 μg |
Inhalation powder |
Inhalation use |
200 micrograms |
|||||||||
|
Pulairmax 400 μg poudre pour inhalation |
400 μg |
Inhalation powder |
Inhalation use |
400 micrograms |
|||||||||
|
Malta |
|
|
Pulairmax 100 μg Trab li jittiehed bin-nifs |
100 μg |
Inhalation powder |
Inhalation use |
100 micrograms |
||||||
|
Pulairmax 200 μg Trab li jittiehed bin-nifs |
200 μg |
Inhalation powder |
Inhalation use |
200 micrograms |
|||||||||
|
Pulairmax 400 μg Trab li jittiehed bin-nifs |
400 μg |
Inhalation powder |
Inhalation use |
400 micrograms |
|||||||||
|
The Netherlands |
|
|
Pulmax 100 mg, inhalatiepoeder |
100 μg |
Inhalation powder |
Inhalation use |
100 micrograms |
||||||
|
Pulmax 200 mg, inhalatiepoeder |
200 μg |
Inhalation powder |
Inhalation use |
200 micrograms |
|||||||||
|
Pulmax 400 mg, inhalatiepoeder |
400 μg |
Inhalation powder |
Inhalation use |
400 micrograms |
|||||||||
|
Norway |
|
|
Pulairmax 100 μg inhalasjonspulver |
100 μg |
Inhalation powder |
Inhalation use |
100 micrograms |
||||||
|
Pulairmax 200 μg inhalasjonspulver |
200 μg |
Inhalation powder |
Inhalation use |
200 micrograms |
|||||||||
|
Pulairmax 400 μg inhalasjonspulver |
400 μg |
Inhalation powder |
Inhalation use |
400 micrograms |
|||||||||
|
Poland |
|
|
Pulmax 100 μg proszek do inhalacji |
100 μg |
Inhalation powder |
Inhalation use |
100 micrograms |
||||||
|
Pulmax 200 μg proszek do inhalacji |
200 μg |
Inhalation powder |
Inhalation use |
200 micrograms |
|||||||||
|
Pulmax 400 μg proszek do inhalacji |
400 μg |
Inhalation powder |
Inhalation use |
400 micrograms |
|||||||||
|
Portugal |
|
|
Pulmax, 100 μg pó para inalação |
100 μg |
Inhalation powder |
Inhalation use |
100 micrograms |
||||||
|
Pulmax, 200 μg pó para inalação |
200 μg |
Inhalation powder |
Inhalation use |
200 micrograms |
|||||||||
|
Pulmax, 400 μg pó para inalação |
400 μg |
Inhalation powder |
Inhalation use |
400 micrograms |
|||||||||
|
Slovak Republic |
|
|
Pulmax 100 mcg Inhalačný prášok |
100 μg |
Inhalation powder |
Inhalation use |
100 micrograms |
||||||
|
Pulmax 200 mcg Inhalačný prášok |
200 μg |
Inhalation powder |
Inhalation use |
200 micrograms |
|||||||||
|
Pulmax 400 mcg Inhalačný prášok |
400 μg |
Inhalation powder |
Inhalation use |
400 micrograms |
|||||||||
|
Spain |
|
|
Budesonida TEVA 100 microgramos polvo para inhalación EFG |
100 μg |
Inhalation powder |
Inhalation use |
100 micrograms |
||||||
|
Budesonida TEVA 200 microgramos polvo para inhalación EFG |
200 μg |
Inhalation powder |
Inhalation use |
200 micrograms |
|||||||||
|
Budesonida TEVA 400 microgramos polvo para inhalación EFG |
400 μg |
Inhalation powder |
Inhalation use |
400 micrograms |
|||||||||
|
Sweden |
|
|
Pulairmax |
100 μg |
Inhalation powder |
Inhalation use |
100 micrograms |
||||||
|
Pulairmax |
200 μg |
Inhalation powder |
Inhalation use |
200 micrograms |
|||||||||
|
Pulairmax |
400 μg |
Inhalation powder |
Inhalation use |
400 micrograms |
ANNEX XII
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS, ANIMAL SPECIES, FREQUENCY AND ROUTES OF ADMINISTRATION, RECOMMENDED DOSES, WITHDRAWAL PERIODS AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES CONCERNED BY THE REFERRAL
|
Member State |
Marketing Authorisation Holder |
(Invented) Name |
Pharmaceutical Form |
Strength |
Animal species |
Frequency and route of administration |
Recommended dose |
Withdrawal period (meat and milk) |
||||
|
Czech Republic |
|
Suramox 15 % LA |
Suspension for injection |
150 mg/ml |
Cattle, pigs |
Two intramuscular injections at 48 hours interval |
15 mg amoxicillin/kg bw (equivalent to 1 ml/10 kg) |
Meat and offal: Cattle: 58 days Pigs: 35 days Milk: 2,5 days |
||||
|
Spain (1) |
|
Stabox 15 % LA |
Suspension for injection |
150 mg/ml |
Cattle, pigs |
Two intramuscular injections at 48 hours interval |
15 mg amoxicillin/kg bw (equivalent to 1 ml/10 kg) |
Meat and offal: Cattle: 58 days Pigs: 35 days Milk: 2,5 days |
||||
|
Italy |
|
Stabox 15 % LA |
Suspension for injection |
150 mg/ml |
Cattle, pigs |
Two intramuscular injections at 48 hours interval |
15 mg amoxicillin/kg bw (equivalent to 1 ml/10 kg) |
Meat and offal: Cattle: 58 days Pigs: 35 days Milk: 2,5 days |
||||
|
France (2) |
|
Suramox 15 % LA |
Suspension for injection |
150 mg/ml |
Cattle, pigs |
Two intramuscular injections at 48 hours interval |
15 mg amoxicillin/kg bw (equivalent to 1 ml/10 kg) |
Meat and offal: Cattle: 58 days Pigs: 35 days Milk: 2,5 days |
(1) Marketing Authorisation not granted.
(2) Reference Member State for the Mutual recognition Procedure.