Overview
The marketing authorisation for Adakveo has been revoked by the European Commission.
Adakveo : EPAR - Medicine overview
Adakveo : EPAR - Risk-management-plan summary
Product information
Adakveo : EPAR - Product information
Latest procedure affecting product information: 004874/A20/0013
03/08/2023
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Adakveo : EPAR - All authorised presentations
Product details
- Name of medicine
- Adakveo
- Active substance
- Crizanlizumab
- International non-proprietary name (INN) or common name
- crizanlizumab
- Therapeutic area (MeSH)
- Anemia, Sickle Cell
- Anatomical therapeutic chemical (ATC) code
- B06AX01
Pharmacotherapeutic group
Other hematological agentsTherapeutic 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.
Assessment history
Adakveo Article-20 procedure - Annex - Scientific conclusions
Adakveo Article-20 procedure - Assessment report
Adakveo : EPAR - Procedural steps taken and scientific information after authorisation
Adakveo-H-C-PSUSA-00010888-202011 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation