- 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The marketing authorisation for Tremelimumab AstraZeneca has been withdrawn at the request of the marketing-authorisation holder.
Tremelimumab AstraZeneca : EPAR - Medicine Overview
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slovenščina (SL) (234.1 KB - PDF)
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svenska (SV) (195.71 KB - PDF)
Tremelimumab AstraZeneca : EPAR - Risk Management Plan
English (EN) (2.52 MB - PDF)
Product information
Tremelimumab AstraZeneca : EPAR - Product Information
English (EN) (1.11 MB - PDF)
български (BG) (1.13 MB - PDF)
español (ES) (1.13 MB - PDF)
čeština (CS) (1.06 MB - PDF)
dansk (DA) (1.09 MB - PDF)
Deutsch (DE) (1.33 MB - PDF)
eesti keel (ET) (1.1 MB - PDF)
ελληνικά (EL) (1.24 MB - PDF)
français (FR) (1.16 MB - PDF)
hrvatski (HR) (1.08 MB - PDF)
íslenska (IS) (1.1 MB - PDF)
italiano (IT) (1.09 MB - PDF)
latviešu valoda (LV) (1.08 MB - PDF)
lietuvių kalba (LT) (1.21 MB - PDF)
magyar (HU) (1.21 MB - PDF)
Malti (MT) (1.3 MB - PDF)
Nederlands (NL) (1.15 MB - PDF)
norsk (NO) (1.1 MB - PDF)
polski (PL) (1.23 MB - PDF)
português (PT) (1.16 MB - PDF)
română (RO) (1.22 MB - PDF)
slovenčina (SK) (1.35 MB - PDF)
slovenščina (SL) (1.05 MB - PDF)
Suomi (FI) (1.12 MB - PDF)
svenska (SV) (1.06 MB - PDF)
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).
Tremelimumab AstraZeneca : EPAR - All authorised presentations
English (EN) (58.05 KB - PDF)
български (BG) (59.93 KB - PDF)
español (ES) (53.28 KB - PDF)
čeština (CS) (59.01 KB - PDF)
dansk (DA) (60.09 KB - PDF)
Deutsch (DE) (55.98 KB - PDF)
eesti keel (ET) (53.27 KB - PDF)
ελληνικά (EL) (66.29 KB - PDF)
français (FR) (56.2 KB - PDF)
hrvatski (HR) (60.65 KB - PDF)
íslenska (IS) (55.46 KB - PDF)
italiano (IT) (58.33 KB - PDF)
latviešu valoda (LV) (58.17 KB - PDF)
lietuvių kalba (LT) (56.54 KB - PDF)
magyar (HU) (54.08 KB - PDF)
Malti (MT) (63.46 KB - PDF)
Nederlands (NL) (55.09 KB - PDF)
norsk (NO) (53.09 KB - PDF)
polski (PL) (55.18 KB - PDF)
português (PT) (55.18 KB - PDF)
română (RO) (53.8 KB - PDF)
slovenčina (SK) (57.06 KB - PDF)
slovenščina (SL) (53.23 KB - PDF)
Suomi (FI) (57.15 KB - PDF)
svenska (SV) (57.5 KB - PDF)
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 agentsTherapeutic 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
Tremelimumab AstraZeneca : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (306.54 KB - PDF)
Tremelimumab AstraZeneca : EPAR - Public Assessment Report
English (EN) (12.83 MB - PDF)
CHMP summary of positive opinion for Tremelimumab AstraZeneca
English (EN) (176.39 KB - PDF)
News on Tremelimumab AstraZeneca
More information on Tremelimumab AstraZeneca
Public statement on Tremelimumab AstraZeneca : Withdrawal of the marketing authorisation in the European Union
English (EN) (106.17 KB - PDF)