United States - English - NLM (National Library of Medicine)

amgen inc - talimogene laherparepvec (unii: 07730v90l6) (talimogene laherparepvec - unii:07730v90l6) - talimogene laherparepvec 1000000 [pfu] in 1 ml - imlygic is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery. limitations of use : imlygic has not been shown to improve overall survival or have an effect on visceral metastases. imlygic is a live, attenuated herpes simplex virus and may cause life-threatening disseminated herpetic infection in patients who are immunocompromised. do not administer imlygic to immunocompromised patients, including those with a history of primary or acquired immunodeficient states, leukemia, lymphoma, aids or other clinical manifestations of infection with human immunodeficiency viruses, and those on immunosuppressive therapy [see nonclinical toxicology ( 13.2 )] . do not administer imlygic to pregnant patients. risk summary adequate and well-controlled studies with imlygic have not been conducted in pregnant women. no effects on embryo-fetal development have been observed in a stu

Australia - English - Department of Health (Therapeutic Goods Administration)

amgen australia pty ltd - talimogene laherparepvec -

Australia - English - Department of Health (Therapeutic Goods Administration)

amgen australia pty ltd - talimogene laherparepvec -

Israel - English - Ministry of Health

amgen europe b.v. - talimogene laherparepvec - solution for injection - talimogene laherparepvec 10^8 pfu / 1 ml - talimogene laherparepvec - 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.

Israel - English - Ministry of Health

amgen europe b.v. - talimogene laherparepvec - solution for injection - talimogene laherparepvec 10^6 pfu / 1 ml - talimogene laherparepvec - 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.

European Union - English - EMA (European Medicines Agency)

amgen europe b.v. - talimogene laherparepvec - melanoma - antineoplastic agents - 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.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

amgen ltd - talimogene laherparepvec - solution for injection - 100mega u/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

amgen ltd - talimogene laherparepvec - solution for injection - 1mega u/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

amgen ltd - talimogene laherparepvec - solution for injection - 100mega u/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

amgen ltd - talimogene laherparepvec - solution for injection - 1mega u/1ml