Overview
The conditional marketing authorisation for Blenrep has not been renewed by the European Commission.
Blenrep : EPAR - Medicine overview
Blenrep : EPAR - Risk Management Plan
Product information
Blenrep : EPAR - Product information
Latest procedure affecting product information: R/017
23/02/2024
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).
Blenrep : EPAR - All authorised presentations
Product details
- Name of medicine
- Blenrep
- Active substance
- belantamab mafodotin
- International non-proprietary name (INN) or common name
- belantamab mafodotin
- Therapeutic area (MeSH)
- Multiple Myeloma
- Anatomical therapeutic chemical (ATC) code
- L01XC39
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
Blenrep is indicated as monotherapy for the treatment of multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.
Assessment history
Blenrep : EPAR - Procedural steps taken and scientific information after the authorisation
Blenrep-H-C-004935-R-0017 : EPAR - Assessment Report - Renewal
Blenrep-H-C-PSUSA-00010869-202208 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation