Pharmaceuticals - Community Register

  

Community register of orphan medicinal products


GRANTED  

Product information

Nintedanib

EU orphan designation number: EU/3/13/1123   
Active ingredient: Nintedanib
Indication: Treatment of idiopathic pulmonary fibrosis
Sponsor: Boehringer Ingelheim International GmbH
Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Ofev on 15/01/2015 with the number EU/1/14/979

   Public summary of scientific opinion     EPAR

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
30/04/2013 Orphan designation EMA/OD/186/12 (2013)2560 of 26/04/2013