EMA — authorised 18 October 2012
- Application: EMEA/H/C/002424
- Marketing authorisation holder: H. Lundbeck A/S
- Local brand name: Acrescent
- Indication: Treatment of Alzheimers disease
- Status: rejected
🇪🇺 MEMANTINE HYDROCHLORIDE in European Union
EMA authorised MEMANTINE HYDROCHLORIDE on 18 October 2012
Marketing authorisations
EMA — authorised 18 October 2012
- Application: EMEA/H/C/002708
- Marketing authorisation holder: Merz Pharmaceuticals GmbH
- Local brand name: Balaxur
- Status: rejected
EMA — authorised 22 November 2012
- Application: EMEA/H/C/002711
- Marketing authorisation holder: Merz Pharmaceuticals GmbH
- Local brand name: Memantine Merz
- Indication: Treatment of patients with moderate to severe Alzheimer’s disease.
- Status: approved
MEMANTINE HYDROCHLORIDE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is MEMANTINE HYDROCHLORIDE approved in European Union?
Yes. EMA authorised it on 18 October 2012; EMA authorised it on 18 October 2012; EMA authorised it on 22 November 2012.
Who is the marketing authorisation holder for MEMANTINE HYDROCHLORIDE in European Union?
H. Lundbeck A/S holds the EU marketing authorisation.