Pharmaceuticals - Community Register

  

Community register of orphan medicinal products


GRANTED  

Product information

Purified bromelain

EU orphan designation number: EU/3/02/107   
Active ingredient: Purified bromelain
Indication: Treatment of partial deep dermal and full thickness burns
Sponsor: MediWound Germany GmbH
Eisenstr. 5, D-65428 Ruesselsheim, Deutschland
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name NexoBrid on 18/12/2012 with the number EU/1/12/803

   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
01/08/2002 Orphan designation EMEA/OD/012/02 (2002)3018 of 30/07/2002
10/06/2010 Transfer of orphan designation EMEA/OD/012/02/T/01 (2010)3721 of 04/06/2010
15/09/2011 Change of name and/or address of sponsor EMEA/OD/012/02
02/08/2013 Transfer of orphan designation EMEA/OD/012/02/T/02 (2013)5098 of 31/07/2013