Blenrep
Withdrawn
This medicine's authorisation has been withdrawn
belantamab mafodotin
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
The conditional marketing authorisation for Blenrep has not been renewed by the European Commission.
Blenrep : EPAR - Medicine overview
Reference Number: EMA/407643/2020
English (EN) (206.74 KB - PDF)
First published: Last updated:
български (BG) (234.39 KB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
español (ES) (205.5 KB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
čeština (CS) (247.94 KB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
dansk (DA) (200.3 KB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
Deutsch (DE) (212.35 KB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
eesti keel (ET) (183.71 KB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
ελληνικά (EL) (283.85 KB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
français (FR) (207.67 KB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
hrvatski (HR) (239.75 KB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
italiano (IT) (203.37 KB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
latviešu valoda (LV) (259.49 KB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
lietuvių kalba (LT) (248.05 KB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
magyar (HU) (241.88 KB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
Malti (MT) (258.79 KB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
Nederlands (NL) (207.71 KB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
polski (PL) (247.35 KB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
português (PT) (206.8 KB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
română (RO) (250.38 KB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
slovenčina (SK) (249.5 KB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
slovenščina (SL) (240.87 KB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
Suomi (FI) (198.98 KB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
svenska (SV) (202.28 KB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
Blenrep : EPAR - Risk Management Plan
English (EN) (50 MB - PDF)
First published: Last updated:
Product information
Blenrep : EPAR - Product information
English (EN) (1.6 MB - PDF)
First published: Last updated:
български (BG) (1.97 MB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
español (ES) (1.54 MB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
čeština (CS) (1.74 MB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
dansk (DA) (1.5 MB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
Deutsch (DE) (1.62 MB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
eesti keel (ET) (1.62 MB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
ελληνικά (EL) (2.61 MB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
français (FR) (1.76 MB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
hrvatski (HR) (1.75 MB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
íslenska (IS) (1.46 MB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
italiano (IT) (1.69 MB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
latviešu valoda (LV) (1.78 MB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
lietuvių kalba (LT) (1.8 MB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
magyar (HU) (1.9 MB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
Malti (MT) (2.03 MB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
Nederlands (NL) (1.73 MB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
norsk (NO) (1.51 MB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
polski (PL) (1.85 MB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
português (PT) (1.51 MB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
română (RO) (1.91 MB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
slovenčina (SK) (1.95 MB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
slovenščina (SL) (1.74 MB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
Suomi (FI) (1.53 MB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
svenska (SV) (1.56 MB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
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
English (EN) (42.5 KB - PDF)
First published: Last updated:
български (BG) (76.86 KB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
español (ES) (89.85 KB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
čeština (CS) (59.22 KB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
dansk (DA) (51.08 KB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
Deutsch (DE) (51.01 KB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
eesti keel (ET) (42.62 KB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
ελληνικά (EL) (72.08 KB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
français (FR) (72.85 KB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
hrvatski (HR) (73.47 KB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
íslenska (IS) (92.79 KB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
italiano (IT) (66.89 KB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
latviešu valoda (LV) (73.96 KB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
lietuvių kalba (LT) (76.51 KB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
magyar (HU) (93.53 KB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
Malti (MT) (81.16 KB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
Nederlands (NL) (67.27 KB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
norsk (NO) (77.86 KB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
polski (PL) (75.04 KB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
português (PT) (77.12 KB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
română (RO) (77.97 KB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
slovenčina (SK) (80.92 KB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
slovenščina (SL) (76.87 KB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
Suomi (FI) (72.89 KB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
svenska (SV) (75.04 KB - PDF)
First published: 17/09/2020Last updated: 13/03/2024
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.
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.
PRIME: priority medicine
This medicine was granted entry to the EMA Priority Medicines (PRIME) scheme during its development. PRIME is a scheme launched by EMA to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach patients earlier. For more information, see PRIME: priority medicines.
- 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
English (EN) (395.71 KB - PDF)
First published: Last updated:
Blenrep-H-C-004935-R-0017 : EPAR - Assessment Report - Renewal
Reference Number: EMA/72045/2024
English (EN) (7.03 MB - PDF)
First published: Last updated:
Blenrep-H-C-PSUSA-00010869-202208 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
Reference Number: EMA/264790/2023
English (EN) (171.09 KB - PDF)
First published: Last updated:
Blenrep : Orphan maintenance assessment report (initial authorisation)
AdoptedReference Number: EMADOC-1700519818-499024
English (EN) (650.47 KB - PDF)
First published: Last updated:
Blenrep : EPAR - Public assessment report
AdoptedReference Number: EMA/CHMP/414341/2020 Corr.
English (EN) (8.78 MB - PDF)
First published: Last updated:
CHMP summary of positive opinion for Blenrep
AdoptedReference Number: EMA/383350/2020
English (EN) (168.98 KB - PDF)
First published:
News on Blenrep
More information on Blenrep
Public statement on Blenrep (belantamab mafodotin): Non-renewal of the conditional marketing authorisation in the European Union
Reference Number: EMA/108999/2024
English (EN) (117.24 KB - PDF)
First published:
More information on Blenrep
This page was last updated on