Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 July 2009 to 31 July 2009 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council )
Date: 2009-09-25
Institutions: European Commission
Subjects: EU Member State, market approval, marketing, marketing standard, medicinal product, pharmaceutical legislation, withdrawal from the market








C_2009231EN.01001801.xml










25.9.2009   


EN


Official Journal of the European Union


C 231/18





Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 July 2009 to 31 July 2009

(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)
)

2009/C 231/04
—   Issuing, maintenance or modification of a national marketing authorisation










Date of the decision


Name(s) of the medicinal product


Holder(s) of the marketing authorisation


Member State concerned


Date of notification




2.7.2009


Nymusa







Chiesi Farmaceutici SpA




Via Palermo 26/A




43100 Parma PR




ITALIA






This Decision is addressed to the Member States


3.7.2009




20.7.2009


Instanyl







Nycomed Danmark ApS




Langebjerg 1




4000 Roskilde




DANMARK






This Decision is addressed to the Member States


22.7.2009




—   Suspension of a national marketing authorisation










Date of the decision


Name(s) of the medicinal product


Holder(s) of the marketing authorisation


Member State concerned


Date of notification




14.7.2009


Prokanazol


See Annex I


See Annex I


15.7.2009






(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) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, APPLICANT(S)/MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES












Member State EU/EEA


Marketing Authorisation Holder


Applicant


(Invented) Name


Strength


Pharmaceutical form


Route of administration




Czech Republic







PRO.MED.CS Praha a.s.




Telčská 1




140 00 Prague 4




CZECH REPUBLIC






 


Prokanazol


100 mg


Hard capsules


Oral use




Latvia


 







PRO.MED.CS Praha a.s.




Telčská 1




140 00 Prague 4




CZECH REPUBLIC






Prokanaz 100 mg cietās kapsulas


100 mg


Hard capsules


Oral use




Lithuania


 







PRO.MED.CS Praha a.s.




Telčská 1




140 00 Prague 4




CZECH REPUBLIC






Prokanaz


100 mg


Hard capsules


Oral use




Poland


 







PRO.MED.CS Praha a.s.




Telčská 1




140 00 Prague 4




CZECH REPUBLIC






Prokanazol


100 mg


Hard capsules


Oral use




Slovak Republic


 







PRO.MED.CS Praha a.s.




Telčská 1




140 00 Prague 4




CZECH REPUBLIC






Prokanazol


100 mg


Hard capsules


Oral use




Slovenia


 







PRO.MED.CS Praha a.s.




Telčská 1




140 00 Prague 4




CZECH REPUBLIC






Prokanazol 100 mg trde kapsule


100 mg


Hard capsules


Oral use