Jivi - opinion on variation to marketing authorisation

Opinion

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

damoctocog alfa pegol

Opinion

On 25 April 2025, 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 Jivi. The marketing authorisation holder for this medicinal product is Bayer AG.

The CHMP adopted an extension to the existing indication to include treatment of children from 7 years of age, as follows:¹

Treatment and prophylaxis of bleeding in previously treated patients ≥ 12 7 years of age with haemophilia A (congenital factor VIII deficiency).

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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¹ New text in bold, removed text as strikethrough

CHMP post-authorisation summary of positive opinion for Jivi (II-34)

AdoptedReference Number: EMA/CHMP/123587/2025

Key facts

• Name of medicine:
  Jivi
• EMA product number:
  EMEA/H/C/004054
• Active substance:
  Damoctocog alfa pegol
• International non-proprietary name (INN) or common name:
  damoctocog alfa pegol
• Therapeutic area (MeSH):
  Hemophilia A
• Anatomical therapeutical chemical (ATC) code:
  B02BD02
• Marketing authorisation holder:
  Bayer AG
• Date of opinion:
  25/04/2025
• Status:
  Positive