Imlygic

RSS

talimogene laherparepvec

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 21/04/2022

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
11
Date of issue of marketing authorisation valid throughout the European Union
16/12/2015
Contact address
Minervum 7061
4817 ZK Breda
Netherlands

Product information

24/03/2022 Imlygic - EMEA/H/C/002771 - II/0048

Product information documents contain:

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.

Assessment history

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