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Pharmaceuticals - Community Register

  

Community register of orphan medicinal products


GRANTED  

Product information

Recombinant human α-Mannosidase

EU orphan designation number: EU/3/04/260   
Active ingredient: Recombinant human α-Mannosidase
Indication: Treatment of α-Mannosidosis
Sponsor: Chiesi Farmaceutici S.p.A.
Via Palermo 26/A, 43122 Parma, Italia
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Lamzede on 23/03/2018 with the number EU/1/17/1258

   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
28/01/2005 Orphan designation EMEA/OD/074/04 (2005)242 of 26/01/2005
04/02/2005 Change of name and/or address of sponsor
26/01/2015 Transfer of orphan designation EMA/OD/074/04/T/01 (2015)392 of 22/01/2015