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Pharmaceuticals - Community Register

  

List of referrals for human medicinal products

Modafinil containing medicinal products

Product name: Modafinil containing medicinal products
Also marketed in the EU under the name(s): Modafinil, Modafinil Generis, Modafinil LAFON, Modafinil TEVA, Modafinilo TEVA, Modasomil, Modiodal, Modiodal, Provigil, Vigil
INN: modafinil
Indication: Treatent of sleepiness associated with narcolepsy
Marketing Authorisation Holder: Not applicable

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
31/01/2011 Referral EMEA/H/A-31/1186 (2011)578 final COR of 27/01/2011
20/12/2012 Corrigendum (2012)9861 of 18/12/2012