Cablivi
caplacizumab
Table of contents
Overview
Cablivi is a medicine for use in adults and children from 12 years of age weighing at least 40 kg and who have an episode of acquired thrombotic thrombocytopenic purpura (aTTP), a blood clotting disorder. During an episode of aTTP, blood clots form in small blood vessels and the patient has a low count of platelets (components that help the blood to clot).
Cablivi is used together with plasma exchange (a procedure that removes certain antibodies from the blood) and treatments to reduce the activity of the immune system (the body’s defences).
Cablivi contains the active substance caplacizumab.
aTTP is rare, and Cablivi was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 30 April 2009. Further information on the orphan designation:EU/3/09/629.
-
List item
Cablivi : EPAR - Medicine overview (PDF/123.77 KB)
First published: 10/09/2018
Last updated: 22/06/2020
EMA/244353/2020 -
-
List item
Cablivi : EPAR - Risk-management-plan summary (PDF/25.32 KB)
First published: 10/09/2018
Last updated: 10/09/2018
Authorisation details
Product details | |
---|---|
Name |
Cablivi
|
Agency product number |
EMEA/H/C/004426
|
Active substance |
Caplacizumab
|
International non-proprietary name (INN) or common name |
caplacizumab
|
Therapeutic area (MeSH) |
Purpura, Thrombotic Thrombocytopenic
|
Anatomical therapeutic chemical (ATC) code |
B01A
|
Orphan |
This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation. |
Publication details | |
---|---|
Marketing-authorisation holder |
Ablynx NV
|
Revision |
8
|
Date of issue of marketing authorisation valid throughout the European Union |
30/08/2018
|
Contact address |
Technologiepark 21
9052 Zwijnaarde Belgium |
Product information
17/04/2023 Cablivi - EMEA/H/C/004426 - R/0042
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
Antithrombotic agents
Therapeutic indication
Cablivi is indicated for the treatment of adults experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP), in conjunction with plasma exchange and immunosuppression.