Aquipta - opinion on variation to marketing authorisation

Opinion

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

atogepant

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 Aquipta. The marketing authorisation holder for this medicinal product is AbbVie Deutschland GmbH & Co. KG.

The CHMP adopted a new indication as follows:

Aquipta is indicated for:

• Acute treatment of migraine with or without aura in adults
• Pprophylaxis of migraine in adults who have at least 4 migraine days per month.

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 Aquipta (VR-0000310717)

Adopted Reference Number: EMADOC-1700519818-3082414

Key facts

• Name of medicine:
  Aquipta
• EMA product number:
  EMEA/H/C/005871
• Active substance:
  atogepant
• International non-proprietary name (INN) or common name:
  atogepant
• Therapeutic area (MeSH):
  Migraine Disorders
• Anatomical therapeutical chemical (ATC) code:
  N02CD07
• 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.

• Marketing authorisation holder:
  AbbVie Deutschland GmbH & Co. KG
• Date of opinion:
  23/04/2026
• Status:
  Positive