Adakveo
crizanlizumab
Table of contents
Overview
Adakveo is a medicine for preventing painful crises in patients with sickle cell disease aged 16 years and older.
Sickle cell disease is a genetic condition in which the red blood cells become rigid and sticky and change from being disc-shaped to being crescent-shaped (like a sickle). They can block the flow of blood in blood vessels, causing painful crises that affect the chest, abdomen and other parts of the body.
Adakveo can be used as an add-on treatment with hydroxycarbamide (also known as hydroxyurea) or on its own in patients for whom hydroxycarbamide does not work well enough or causes too many side effects. Adakveo contains the active substance crizanlizumab.
Sickle cell disease is rare, and Adakveo was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 9 August 2012.
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Adakveo : EPAR - Medicine overview (PDF/208.21 KB)
First published: 24/11/2020
Last updated: 21/08/2023
EMA/446082/2020 -
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Adakveo : EPAR - Risk-management-plan summary (PDF/340.06 KB)
First published: 24/11/2020
Last updated: 21/08/2023
Authorisation details
Product details | |
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Name |
Adakveo
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Agency product number |
EMEA/H/C/004874
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Active substance |
Crizanlizumab
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International non-proprietary name (INN) or common name |
crizanlizumab
|
Therapeutic area (MeSH) |
Anemia, Sickle Cell
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Anatomical therapeutic chemical (ATC) code |
B06AX01
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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. |
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. |
Publication details | |
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Marketing-authorisation holder |
Novartis Europharm Limited
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Revision |
6
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Date of issue of marketing authorisation valid throughout the European Union |
28/10/2020
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Contact address |
Vista Building |
Product information
03/08/2023 Adakveo - EMEA/H/C/004874 - 004874/A20/0013
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.
Assessment history
News
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26/05/2023
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26/05/2023
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 January 202327/01/2023
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24/07/2020