Adakveo

Withdrawn

This medicine's authorisation has been withdrawn

crizanlizumab

Overview

The marketing authorisation for Adakveo has been revoked by the European Commission.

Adakveo : EPAR - Medicine overview

Reference Number: EMA/446082/2020

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 agents

Therapeutic 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.

Authorisation details

• EMA product number:
  EMEA/H/C/004874
• Conditional approval:

  This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

• Marketing authorisation holder:
  Novartis Europharm Limited

  Vista Building; Elm Park, Merrion Road; Dublin 4; Ireland

• Opinion adopted:
  23/07/2020
• Marketing authorisation issued:
  28/10/2020
• Withdrawal of marketing authorisation:
  03/08/2023
• Revision:
  6

Assessment history

Changes since initial authorisation of medicine

Adakveo Article-20 procedure - Annex - Scientific conclusions

Adakveo Article-20 procedure - Assessment report

Reference Number: EMA/267688/2023

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

Reference Number: EMA/CHMP/378769/2021

Initial marketing authorisation documents

Adakveo : EPAR - Public assessment report

AdoptedReference Number: EMA/427120/2020

Adakveo: Orphan maintenance assessment report (initial authorisation)

AdoptedReference Number: EMADOC-1700519818-516929

CHMP summary of positive opinion for Adakveo

AdoptedReference Number: EMA/373250/2020