Agamree - opinion on variation to marketing authorisation

Opinion

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

vamorolone

Opinion

On 23 April 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 Agamree. The marketing authorisation holder for this medicinal product is Santhera Pharmaceuticals (Deutschland) GmbH.

The CHMP adopted a change to the existing indication as follows:

Agamree is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients aged 4 2 years and older.

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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Note: New text in bold, removed text as strikethrough.

CHMP post-authorisation summary of positive opinion for Agamree (VR-0000293535)

Adopted Reference Number: EMADOC-1700519818-3082428

Key facts

• Name of medicine:
  Agamree
• EMA product number:
  EMEA/H/C/005679
• Active substance:
  vamorolone
• International non-proprietary name (INN) or common name:
  vamorolone
• Therapeutic area (MeSH):
  Muscular Dystrophy, Duchenne
• Anatomical therapeutical chemical (ATC) code:
  H02AB18
• Additional monitoring:

  This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

• 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:
  Santhera Pharmaceuticals (Deutschland) GmbH
• Date of opinion:
  23/04/2026
• Státusz:
  Positive