Hympavzi - opinion on variation to marketing authorisation

Opinion

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

marstacimab

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 Hympavzi. The marketing authorisation holder for this medicinal product is Pfizer Europe MA EEIG.

The CHMP adopted changes to the existing indication as follows:

Hympavzi is indicated for routine prophylaxis of bleeding episodes in patients 12 years of age and older, weighing at least 35 kg, with: 

• severe hHaemophilia A (congenital factor VIII deficiency, FVIII < 1%):
• wWithout factor VIII inhibitors who have severe disease (FVIII < 1%), or
• With factor VIII inhibitors
• severe hHaemophilia B (congenital factor IX deficiency, FIX < 1%):
• wWithout factor IX inhibitors who have severe disease (FIX < 1%).
• With factor IX inhibitors

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, removed text as strikethrough

CHMP post-authorisation summary of positive opinion for Hympavzi (VR/0000304590)

Adopted Reference Number: EMADOC-1700519818-2999788

Key facts

• Name of medicine:
  Hympavzi
• EMA product number:
  EMEA/H/C/006240
• Active substance:
  marstacimab
• International non-proprietary name (INN) or common name:
  marstacimab
• Therapeutic area (MeSH):
  • Hemophilia A
  • Hemophilia B
• Anatomical therapeutical chemical (ATC) code:
  B02BX11
• Marketing authorisation holder:
  Pfizer Europe MA EEIG
• Date of opinion:
  26/03/2026
• Status:
  Positive