Imlygic
talimogene laherparepvec
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Imlygic. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Imlygic.
For practical information about using Imlygic, patients should read the package leaflet or contact their doctor or pharmacist.
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List item
Imlygic : EPAR - Summary for the public (PDF/79.69 KB)
First published: 05/02/2016
Last updated: 05/02/2016
EMA/708487/2015 -
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List item
Imlygic : EPAR - Risk-management-plan summary (PDF/125.67 KB)
First published: 05/02/2016
Last updated: 27/11/2020
Authorisation details
Product details | |
---|---|
Name |
Imlygic
|
Agency product number |
EMEA/H/C/002771
|
Active substance |
talimogene laherparepvec
|
International non-proprietary name (INN) or common name |
talimogene laherparepvec
|
Therapeutic area (MeSH) |
Melanoma
|
Anatomical therapeutic chemical (ATC) code |
L01XX51
|
Publication details | |
---|---|
Marketing-authorisation holder |
Amgen Europe B.V.
|
Revision |
13
|
Date of issue of marketing authorisation valid throughout the European Union |
16/12/2015
|
Contact address |
Minervum 7061
4817 ZK Breda Netherlands |
Product information
10/11/2022 Imlygic - EMEA/H/C/002771 - P46-011
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Antineoplastic agents
Therapeutic indication
Imlygic is indicated for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a) with no bone, brain, lung or other visceral disease.