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Pharmaceuticals - Community Register


Community list of not active orphan medicinal products


Product information

5-aminolevulinic acid hydrochloride

EU orphan designation number: EU/3/02/121
Active ingredient: 5-aminolevulinic acid hydrochloride
Indication: Intra-operative photodynamic diagnosis of residual glioma
Sponsor: medac Gesellschaft für klinische Spezialpräparate mbH
Theaterstraße 6, 22880 Wedel, Deutschland
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Gliolan on 07/09/2007 with the number EU/1/07/413

   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
18/11/2002 Orphan designation EMEA/OD/039/02 (2002)4513 of 13/11/2002
24/08/2016 Change of name and/or address of sponsor
12/09/2017 Removal of orphan designation from Community Register