Namuscla - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation

mexiletine hcl

Opinion

On 26 March 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Namuscla. The marketing authorisation holder for this medicinal product is Lupin Europe GmbH.

The CHMP adopted two new strengths, 62 mg and 83 mg hard capsules, in addition to the already authorised 167 mg strength. The CHMP also adopted changes to the existing indication as follows:

Namuscla is indicated for the symptomatic treatment of myotonia in children aged 6 to 11 years weighing at least 20 kg, adolescents aged 12 to 17 years and adult patients ≥ 18 years with non-dystrophic myotonic disorders.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

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Notes: New text in bold

CHMP post-authorisation summary of positive opinion for Namuscla (X/0000258210)

Adopted Reference Number: EMADOC-1700519818-3015439

Key facts

• Name of medicine:
  Namuscla
• EMA product number:
  EMEA/H/C/004584
• Active substance:
  Mexiletine hydrochloride
• International non-proprietary name (INN) or common name:
  mexiletine hcl
• Therapeutic area (MeSH):
  Myotonic Disorders
• Anatomical therapeutical chemical (ATC) code:
  C01BB02
• Orphan:

  This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

• Marketing authorisation holder:
  Lupin Europe GmbH
• Date of opinion:
  26/03/2026
• Status:
  Positive