Imlygic (talimogene laherparepvec)
ATMP
- Region
- 🇪🇺 EU
- Active substance
- talimogene laherparepvec
- Company
- Amgen Europe B.V.
- Status
- Authorised
- Therapeutic area
- Melanoma
- CHMP opinion
- Thu 23 Jul 2015
- EU approval
- Wed 16 Dec 2015
- Designations
- ATMP
- Application
- EMEA/H/C/002771
- ATC
- L01XX51
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.