Pharmaceuticals - Community Register

  

Community register of orphan medicinal products


GRANTED  

Product information

Melatonin

EU orphan designation number: EU/3/12/978   
Active ingredient: Melatonin
Indication: Treatment of perinatal asphyxia
Sponsor: Chiesi Farmaceutici S.P.A.
Via Palermo 26/A, 43122 Parma, Italia

   Public summary of scientific opinion    

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
04/04/2012 Orphan Designation EMA/OD/133/11 (2012)2348 of 02/04/2012
30/07/2015 Transfer of orphan designation EMA/OD/133/11/T/01 (2015)5442 of 28/07/2015