Tremelimumab AstraZeneca

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Withdrawn

This medicine's authorisation has been withdrawn

tremelimumab
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

The marketing authorisation for Tremelimumab AstraZeneca has been withdrawn at the request of the marketing-authorisation holder.

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Product information

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Latest procedure affecting product information: IG1659
04/09/2023
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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).

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slovenščina (SL) (53.23 KB - PDF)

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Suomi (FI) (57.15 KB - PDF)

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svenska (SV) (57.5 KB - PDF)

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Product details

Name of medicine
Tremelimumab AstraZeneca
Active substance
Tremelimumab
International non-proprietary name (INN) or common name
tremelimumab
Therapeutic area (MeSH)
Carcinoma, Non-Small-Cell Lung
Anatomical therapeutic chemical (ATC) code
L01FX20

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Tremelimumab AstraZeneca in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (NSCLC) with no sensitising EGFR mutations or ALK positive mutations.

Authorisation details

EMA product number
EMEA/H/C/004650
Marketing authorisation holder
AstraZeneca AB

151 85 Sodertalje
Sweden

Opinion adopted
15/12/2022
Marketing authorisation issued
20/02/2023
Revision
1

Assessment history

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