Balaxur

RSS

memantine hydrochloride / donepezil hydrochloride

Refused
This medicine was refused authorisation for use in the European Union.

Overview

On 18 October 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Balaxur, intended for the treatment of moderate to moderately severe Alzheimer’s disease in patients who are already taking memantine and donepezil.

The company that applied for authorisation is Merz Pharmaceuticals GmbH, Germany.

This EPAR was last updated on 11/03/2013

Application details

Product details
Name
Balaxur
Active substance
  • memantine hydrochloride
  • donepezil hydrochloride
International non-proprietary name (INN) or common name
memantine hydrochloride / donepezil hydrochloride
Therapeutic area (MeSH)
Alzheimer Disease
Anatomical therapeutic chemical (ATC) code
N06DA52
Application details
Marketing-authorisation applicant
Merz Pharmaceuticals GmbH
Date of opinion
18/10/2012
Date of refusal of marketing authorisation
20/02/2013

Assessment history

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