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 |
8
|
Date of issue of marketing authorisation valid throughout the European Union |
16/12/2015
|
Contact address |
Minervum 7061
4817 ZK Breda Netherlands |
Product information
18/11/2020 Imlygic - EMEA/H/C/002771 - IB/0039
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
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.