Hemlibra (emicizumab)
Accelerated assessment
- Region
- 🇪🇺 EU
- Active substance
- emicizumab
- Company
- Roche Registration Limited
- Status
- Authorised
- Therapeutic area
- Hemophilia A
- CHMP opinion
- Thu 25 Jan 2018
- EU approval
- Fri 23 Feb 2018
- Designations
- Accelerated assessment
- Application
- EMEA/H/C/004406
- ATC
- B02BX06
- Official record
- www.ema.europa.eu
Indication
Hemlibra is indicated for routine prophylaxis of bleeding episodes in patients with haemophilia A (congenital factor VIII deficiency): with factor VIII inhibitors without factor VIII inhibitors who have: severe disease (FVIII < 1%) moderate disease (FVIII ? 1% and ? 5%) with severe bleeding phenotype. Hemlibra can be used in all age groups.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.