Is Talimogene laherparepvec authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Talimogene laherparepvec: Imlygic.

Is Talimogene laherparepvec authorised in the United Kingdom?

The MHRA category lists of UK marketing authorisations include 2 products containing Talimogene laherparepvec, including IMLYGIC 1X10E6 PFU/ML SOLUTION FOR INJECTION; IMLYGIC 1X10E8 PFU/ML SOLUTION FOR INJECTION.

Active substance

Talimogene laherparepvec

EMA 1
UK MHRA 2

Open in the medicines table

EMA European Union — centrally authorised medicines

Imlygic Amgen Europe B.V. · Authorised · authorised 16 Dec 2015 · ATC L01XX51

Therapeutic indication (EMA)

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.

UK MHRA United Kingdom — marketing authorisations

Product	Authorisation	Holder	Legal status
IMLYGIC 1X10E6 PFU/ML SOLUTION FOR INJECTION	PLGB 13832/0019	AMGEN LIMITED	POM
IMLYGIC 1X10E8 PFU/ML SOLUTION FOR INJECTION	PLGB 13832/0020	AMGEN LIMITED	POM

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.