Namuscla (Mexiletine)
Orphan
- Region
- 🇪🇺 EU
- Active substance
- Mexiletine
- Company
- Lupin Europe GmbH
- Status
- Authorised
- Therapeutic area
- Myotonic Disorders
- CHMP opinion
- Thu 18 Oct 2018
- EU approval
- Tue 18 Dec 2018
- Designations
- Orphan
- Application
- EMEA/H/C/004584
- ATC
- C01BB02
- Official record
- www.ema.europa.eu
Indication
Namuscla is indicated for the symptomatic treatment of myotonia in adult patients with non-dystrophic myotonic disorders.
Regulatory milestones
No milestones recorded in the last year.
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