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Blenrep | European Medicines Agency (EMA)

Europe Markets

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Overview

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

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Deutsch (DE)
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ελληνικά (EL)
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français (FR)
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hrvatski (HR)
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italiano (IT)
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latviešu valoda (LV)
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magyar (HU)
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Malti (MT)
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Nederlands (NL)
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polski (PL)
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português (PT)
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română (RO)
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slovenčina (SK)
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slovenščina (SL)
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Suomi (FI)
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Product information

English (EN)
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български (BG)
(1.97 MB – PDF)

First published: 17/09/2020Last updated: 13/03/2024

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español (ES)
(1.54 MB – PDF)

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čeština (CS)
(1.74 MB – PDF)

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dansk (DA)
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Deutsch (DE)
(1.62 MB – PDF)

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eesti keel (ET)
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français (FR)
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hrvatski (HR)
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íslenska (IS)
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italiano (IT)
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latviešu valoda (LV)
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lietuvių kalba (LT)
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magyar (HU)
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Malti (MT)
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Nederlands (NL)
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norsk (NO)
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polski (PL)
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português (PT)
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română (RO)
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slovenčina (SK)
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slovenščina (SL)
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Suomi (FI)
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svenska (SV)
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Latest procedure affecting product information:
R/017

23/02/2024

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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).

English (EN)
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български (BG)
(76.86 KB – PDF)

First published: 17/09/2020Last updated: 13/03/2024

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español (ES)
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čeština (CS)
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dansk (DA)
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Deutsch (DE)
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eesti keel (ET)
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ελληνικά (EL)
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français (FR)
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hrvatski (HR)
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íslenska (IS)
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italiano (IT)
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latviešu valoda (LV)
(73.96 KB – PDF)

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lietuvių kalba (LT)
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magyar (HU)
(93.53 KB – PDF)

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Malti (MT)
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Nederlands (NL)
(67.27 KB – PDF)

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norsk (NO)
(77.86 KB – PDF)

First published: 17/09/2020Last updated: 13/03/2024

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polski (PL)
(75.04 KB – PDF)

First published: 17/09/2020Last updated: 13/03/2024

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português (PT)
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First published: 17/09/2020Last updated: 13/03/2024

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română (RO)
(77.97 KB – PDF)

First published: 17/09/2020Last updated: 13/03/2024

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slovenčina (SK)
(80.92 KB – PDF)

First published: 17/09/2020Last updated: 13/03/2024

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slovenščina (SL)
(76.87 KB – PDF)

First published: 17/09/2020Last updated: 13/03/2024

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Suomi (FI)
(72.89 KB – PDF)

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svenska (SV)
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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.

More information on Blenrep

English (EN)
(117.24 KB – PDF)

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