Adakveo (crizanlizumab)
ConditionalAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- crizanlizumab
- Company
- Novartis Europharm Limited
- Status
- Revoked
- Therapeutic area
- Anemia, Sickle Cell
- CHMP opinion
- Thu 23 Jul 2020
- EU approval
- Wed 28 Oct 2020
- Designations
- Conditional, Additional monitoring
- Application
- EMEA/H/C/004874
- ATC
- B06AX01
- Official record
- www.ema.europa.eu
Indication
Adakveo is indicated for the prevention of recurrent vaso occlusive crises (VOCs) in sickle cell disease patients aged 16 years and older. It can be given as an add on therapy to hydroxyurea/hydroxycarbamide (HU/HC) or as monotherapy in patients for whom HU/HC is inappropriate or inadequate.
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.