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

sun pharmaceutical industries, inc. - tildrakizumab (unii: dew6x41bek) (tildrakizumab - unii:dew6x41bek) - ilumya® is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. ilumya is contraindicated in patients with a previous serious hypersensitivity reaction to tildrakizumab or to any of the excipients [see warnings and precautions (5.1) ]. risk summary limited available data with ilumya use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. human igg is known to cross the placental barrier; therefore, ilumya may be transferred from the mother to the fetus. an embryofetal developmental study conducted with tildrakizumab in pregnant monkeys revealed no treatment-related effects to the developing fetus when tildrakizumab was administered subcutaneously during organogenesis to near parturition at doses up to 159 times the maximum recommended human dose (mrhd). when dosing was continued until parturition, a small increase in neonatal death was observed at 59 times the mrhd [ see data

European Union - English - EMA (European Medicines Agency)

almirall s.a - tildrakizumab - psoriasis - immunosuppressants, interleukin inhibitors, - ilumetri is indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.

Israel - English - Ministry of Health

taro international ltd, israel - tildrakizumab - solution for injection - tildrakizumab 100 mg/ml - tildrakizumab - treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy

Canada - English - Health Canada

sun pharmaceutical industries limited - tildrakizumab - solution - 100mg - tildrakizumab 100mg - misc. skin and mucous membrane agents

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

sun pharma anz pty ltd - tildrakizumab, quantity: 100 mg/ml - injection, solution - excipient ingredients: histidine; sucrose; water for injections; polysorbate 80; histidine hydrochloride monohydrate - ilumya is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.

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

almirall ltd - tildrakizumab - solution for injection - 100mg/1ml

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

jazeera pharmaceutical industries (jpi), saudi arabia - tildrakizumab - solution for injection in pre-filled syringe - 100 mg/ml

Jordan - English - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

شركة أدوية الحكمة - hikma pharmaceuticals - tildrakizumab 100 mg/1 ml syr - 100 mg/1 ml syr

Philippines - English - FDA (Food And Drug Administration)

sun pharma philippines, inc.; distributor: sun pharma philippines, inc. - tildrakizumab - solution for injection (s.c.) - 100 mg/ml

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

sun pharma japan limited - tildrakizumab(genetical recombination) - injection