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Pharmaceuticals - Union Register


Register of orphan medicinal products


Product information

Ambroxol hydrochloride

EU orphan designation number: EU/3/18/2017   
Active ingredient: Ambroxol hydrochloride
Indication: Treatment of amyotrophic lateral sclerosis
Sponsor: Spedding Research Solutions SAS
6 rue Ampère, 78110 Le Vésinet, France


European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
29/05/2018 Orphan designation EMA/OD/236/17 (2018)3384 of 25/05/2018