|
31.5.2013 |
EN |
Official Journal of the European Union |
C 154/8 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 30 April 2013
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2) )
2013/C 154/02
— 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 |
|
10.4.2013 |
Kantos Master and associated names |
See Annex |
See Annex |
11.4.2013 |
(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, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
|
Member State in EU/EEA |
Marketing authorisaton holder |
Product name |
Strength |
Pharmaceutical form |
Route of administration |
||||||
|
Austria |
|
Formodual 100/6 Mikrogramm/Sprühstoß, Druckgasinhalation, Lösung |
100/6 micrograms per actuation |
pressurised inhalation solution |
inhalation use |
||||||
|
Belgium |
|
Inuvair |
100/6 micrograms per actuation |
pressurised inhalation solution |
inhalation use |
||||||
|
Bulgaria |
|
Foster |
100/6 micrograms per actuation |
pressurised inhalation solution |
inhalation use |
||||||
|
Cyprus |
|
Foster |
100/6 micrograms per actuation |
pressurised inhalation solution |
inhalation use |
||||||
|
Denmark |
|
Innovair |
100/6 micrograms per actuation |
pressurised inhalation solution |
inhalation use |
||||||
|
Estonia |
|
Foster |
100/6 micrograms per actuation |
pressurised inhalation solution |
inhalation use |
||||||
|
Finland |
|
Innovair |
100/6 micrograms per actuation |
pressurised inhalation solution |
inhalation use |
||||||
|
France |
|
Formodual |
100/6 micrograms per actuation |
pressurised inhalation solution |
inhalation use |
||||||
|
Germany |
|
Kantos Master |
100/6 micrograms per actuation |
pressurised inhalation solution |
inhalation use |
||||||
|
Greece |
|
Inuvair |
100/6 micrograms per actuation |
pressurised inhalation solution |
inhalation use |
||||||
|
Hungary |
|
Formodual |
100/6 micrograms per actuation |
pressurised inhalation solution |
inhalation use |
||||||
|
Italy |
|
Inuver |
100/6 micrograms per actuation |
pressurised inhalation solution |
inhalation use |
||||||
|
Latvia |
|
Foster |
100/6 micrograms per actuation |
pressurised inhalation solution |
inhalation use |
||||||
|
Lithuania |
|
Foster |
100/6 micrograms per actuation |
pressurised inhalation solution |
inhalation use |
||||||
|
Luxembourg |
|
Inuvair |
100/6 micrograms per actuation |
pressurised inhalation solution |
inhalation use |
||||||
|
Norway |
|
Inuxair |
100/6 micrograms per actuation |
pressurised inhalation solution |
inhalation use |
||||||
|
Poland |
|
Formodual |
100/6 micrograms per actuation |
pressurised inhalation solution |
inhalation use |
||||||
|
Romania |
|
Foster |
100/6 micrograms per actuation |
pressurised inhalation solution |
inhalation use |
||||||
|
Slovenia |
|
Formodual |
100/6 micrograms per actuation |
pressurised inhalation solution |
inhalation use |
||||||
|
Spain |
|
Formodual |
100/6 micrograms per actuation |
pressurised inhalation solution |
inhalation use |
||||||
|
Sweden |
|
Innovair |
100/6 micrograms per actuation |
pressurised inhalation solution |
inhalation use |
||||||
|
The Netherlands |
|
Foster |
100/6 micrograms per actuation |
pressurised inhalation solution |
inhalation use |
||||||
|
United Kingdom |
|
Formodual |
100/6 micrograms per actuation |
pressurised inhalation solution |
inhalation use |