Cablivi

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caplacizumab

Authorised
This medicine is authorised for use in the European Union.

Overview

Cablivi is a medicine used for treating adults 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 (in which certain antibodies are removed 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.

This EPAR was last updated on 14/03/2019

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
Additional monitoringAdditional 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.

OrphanOrphan

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
2
Date of issue of marketing authorisation valid throughout the European Union
30/08/2018
Contact address
Technologiepark 21
9052 Zwijnaarde
Belgium

Product information

12/02/2019 Cablivi - EMEA/H/C/004426 - IAIN/0003

Contents

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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.

Assessment history

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