Pharmaceuticals - Union Register

  

Union Register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Cablivi   
Auth. number : EU/1/18/1305
Active substance : caplacizumab
Orphan market exclusivity for "Treatment of thrombotic thrombocytopenic purpura" (based on designation EU/3/09/629) started on 4/09/2018
   10 years of market exclusivity
   This orphan market exclusivity will expire on 4/09/2028
ATC: Anatomical main group: B - Blood and blood forming organs
Therapeutic subgroup: B01 - Antithrombotic agents
Pharmacological subgroup: B01A - Antithrombotic agents
Chemical subgroup: B01AX - Other antithrombotic agents
Chemical substance: B01AX07 - caplacizumab
(See WHO ATC Index)
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.
Marketing Authorisation Holder: Ablynx N.V.
Technologiepark 21, 9052 Zwijnaarde, België

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Union Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
4/09/2018 Centralised - Authorisation EMEA/H/C/4426 (2018)5867 of 31/08/2018
22/10/2018 Centralised - Variation EMEA/H/C/4426/IB/1
12/02/2019 Centralised - Variation EMEA/H/C/4426/IAIN/03