Maviret - opinion on variation to marketing authorisation

Opinion

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

glecaprevir / pibrentasvir

Opinion

On 21 May 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 Maviret. The marketing authorisation holder for this medicinal product is Abbvie Deutschland GmbH & Co. KG.

The CHMP adopted an extension to the existing indication as follows:

Maviret is indicated for the treatment of acute and chronic hepatitis C virus (HCV) infection in adults and children aged 3 years and older (see sections 4.2, 4.4. and 5.1).

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.

CHMP post-authorisation summary of positive opinion for Maviret (VR/0000316551)

Adopted Reference Number: EMADOC-1700519818-3140849

Key facts

• Name of medicine:
  Maviret
• EMA product number:
  EMEA/H/C/004430
• Active substance:
  • glecaprevir
  • pibrentasvir
• International non-proprietary name (INN) or common name:
  • glecaprevir
  • pibrentasvir
• Therapeutic area (MeSH):
  Hepatitis C, Chronic
• Anatomical therapeutical chemical (ATC) code:
  J05AP57
• Accelerated assessment:

  This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment.

• Marketing authorisation holder:
  AbbVie Deutschland GmbH & Co. KG
• Date of opinion:
  21/05/2026
• Status:
  Positive