Nemdatine (memantine)
Generic
- Region
- 🇪🇺 EU
- Active substance
- memantine
- Company
- Actavis Group PTC ehf
- Status
- Authorised
- Therapeutic area
- Alzheimer Disease
- CHMP opinion
- Thu 21 Feb 2013
- EU approval
- Mon 22 Apr 2013
- Designations
- Generic
- Application
- EMEA/H/C/002680
- ATC
- N06DX01
- Official record
- www.ema.europa.eu
Indication
Treatment of patients with moderate to severe Alzheimer’s disease.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Memantine Mylan Authorised · Mylan Pharmaceuticals Limited
- 🇪🇺 Ebixa Authorised · H. Lundbeck A/S
- 🇪🇺 Memantine Accord Authorised · Accord Healthcare S.L.U.
- 🇪🇺 Axura Authorised · Merz Pharmaceuticals GmbH
- 🇪🇺 Memantine Merz Authorised · Merz Pharmaceuticals GmbH
- 🇪🇺 Memantine LEK Withdrawn · Pharmathen S.A.
- 🇪🇺 Memantine ratiopharm Authorised · Ratiopharm GmbH
- 🇪🇺 Marixino (previously Maruxa) Authorised · KRKA tovarna zdravil d.d. Novo mesto
- 🇪🇺 Acrescent Refused · H. Lundbeck A/S
- 🇪🇺 Memantine FGK Application withdrawn · FGK Representative Service GmbH
- 🇪🇺 Balaxur Refused · Merz Pharmaceuticals GmbH
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.