Pharmaceuticals - Community Register


List of refusals for human medicinal products


Product name: Balaxur
Active substance: memantine hydrochloride / donepezil hydrochloride
Indication: Treatment of patients with moderate to moderately severe Alzheimer’s disease who are already on a stable daily dose of 20 mg memantine and 10 mg donepezil.
Marketing Authorisation Holder: Merz Pharmaceuticals GmbH

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
22/02/2013 Centralised - Refusal of marketing authorisation EMEA/H/C/2708 (2013)1101 of 20/02/2013
2/04/2013 Corrigendum (2013)1970 of 27/03/2013