Overview

The conditional marketing authorisation for Blenrep has not been renewed by the European Commission.

Blenrep : EPAR - Medicine overview

български (BG) (234.39 KB - PDF)
español (ES) (205.5 KB - PDF)
čeština (CS) (247.94 KB - PDF)
dansk (DA) (200.3 KB - PDF)
Deutsch (DE) (212.35 KB - PDF)
eesti keel (ET) (183.71 KB - PDF)
ελληνικά (EL) (283.85 KB - PDF)
français (FR) (207.67 KB - PDF)
hrvatski (HR) (239.75 KB - PDF)
italiano (IT) (203.37 KB - PDF)
latviešu valoda (LV) (259.49 KB - PDF)
lietuvių kalba (LT) (248.05 KB - PDF)
magyar (HU) (241.88 KB - PDF)
Malti (MT) (258.79 KB - PDF)
Nederlands (NL) (207.71 KB - PDF)
polski (PL) (247.35 KB - PDF)
português (PT) (206.8 KB - PDF)
română (RO) (250.38 KB - PDF)
slovenčina (SK) (249.5 KB - PDF)
slovenščina (SL) (240.87 KB - PDF)
Suomi (FI) (198.98 KB - PDF)
svenska (SV) (202.28 KB - PDF)

Blenrep : EPAR - Risk Management Plan

Product information

Blenrep : EPAR - Product information

български (BG) (1.97 MB - PDF)
español (ES) (1.54 MB - PDF)
čeština (CS) (1.74 MB - PDF)
dansk (DA) (1.5 MB - PDF)
Deutsch (DE) (1.62 MB - PDF)
eesti keel (ET) (1.62 MB - PDF)
ελληνικά (EL) (2.61 MB - PDF)
français (FR) (1.76 MB - PDF)
hrvatski (HR) (1.75 MB - PDF)
íslenska (IS) (1.46 MB - PDF)
italiano (IT) (1.69 MB - PDF)
latviešu valoda (LV) (1.78 MB - PDF)
lietuvių kalba (LT) (1.8 MB - PDF)
magyar (HU) (1.9 MB - PDF)
Malti (MT) (2.03 MB - PDF)
Nederlands (NL) (1.73 MB - PDF)
norsk (NO) (1.51 MB - PDF)
polski (PL) (1.85 MB - PDF)
português (PT) (1.51 MB - PDF)
română (RO) (1.91 MB - PDF)
slovenčina (SK) (1.95 MB - PDF)
slovenščina (SL) (1.74 MB - PDF)
Suomi (FI) (1.53 MB - PDF)
svenska (SV) (1.56 MB - PDF)

Latest procedure affecting product information: R/017

23/02/2024

Globe icon

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

български (BG) (76.86 KB - PDF)
español (ES) (89.85 KB - PDF)
čeština (CS) (59.22 KB - PDF)
dansk (DA) (51.08 KB - PDF)
Deutsch (DE) (51.01 KB - PDF)
eesti keel (ET) (42.62 KB - PDF)
ελληνικά (EL) (72.08 KB - PDF)
français (FR) (72.85 KB - PDF)
hrvatski (HR) (73.47 KB - PDF)
íslenska (IS) (92.79 KB - PDF)
italiano (IT) (66.89 KB - PDF)
latviešu valoda (LV) (73.96 KB - PDF)
lietuvių kalba (LT) (76.51 KB - PDF)
magyar (HU) (93.53 KB - PDF)
Malti (MT) (81.16 KB - PDF)
Nederlands (NL) (67.27 KB - PDF)
norsk (NO) (77.86 KB - PDF)
polski (PL) (75.04 KB - PDF)
português (PT) (77.12 KB - PDF)
română (RO) (77.97 KB - PDF)
slovenčina (SK) (80.92 KB - PDF)
slovenščina (SL) (76.87 KB - PDF)
Suomi (FI) (72.89 KB - PDF)
svenska (SV) (75.04 KB - PDF)

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 agents

Therapeutic 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.

Authorisation details

EMA product number
EMEA/H/C/004935

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.

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.

Marketing authorisation holder
GlaxoSmithKline (Ireland) Limited

12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland

Opinion adopted
23/07/2020
Marketing authorisation issued
25/08/2020
Revision
8

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

Blenrep : Orphan maintenance assessment report (initial authorisation)

Blenrep : EPAR - Public assessment report

CHMP summary of positive opinion for Blenrep

Topics

This page was last updated on

How useful do you find this page?