Hemlibra

emicizumab

Opinion

On 31 January 2019, 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 Hemlibra. The marketing authorisation holder for this medicinal product is Roche Registration GmbH.

The CHMP adopted an extension to the existing indication as follows:1

“Hemlibra is proposed for the treatment for routine prophylaxis of bleeding episodes in patients with:

  • haemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors.
  • severe haemophilia A (congenital factor VIII deficiency, FVIII<1 %) without FVIII inhibitors.

Hemlibra can be used in all age groups.”

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.


1 New text in bold.

Key facts

Name
Hemlibra
Agency product number
EMEA/H/C/004406
International non-proprietary name (INN) or common name
  • emicizumab
Active substance
  • Emicizumab
Therapeutic area
Hemophilia A
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.

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.

Date opinion adopted
31/01/2019
Company name
Roche Registration Limited
Status
Positive
Application type
Post-authorisation

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