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 09/07/2018

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
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Amgen Europe B.V.
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
16/12/2015
Contact address
Minervum 7061
4817 ZK Breda
Netherlands

Product information

04/06/2018 Imlygic - EMEA/H/C/002771 - IG/0946

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.

Assessment history

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