Canada - English - Health Canada

serb sas - telotristat ethyl (telotristat etiprate) - tablet - 250mg - telotristat ethyl (telotristat etiprate) 250mg - antidiarrhea agents

Israel - English - Ministry of Health

medison pharma ltd - telotristat ethyl as etiprate - film coated tablets - telotristat ethyl as etiprate 250 mg - xermelo is indicated for the treatment of carcinoid syndrome diarrhoea in combination with somatostatin analogue (ssa) therapy in adults inadequately controlled by ssa therapy.

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

lexicon pharmaceuticals, inc. - telotristat ethyl (unii: 8g388563m7) (telotristat - unii:381v4fcv2z) - telotristat ethyl 250 mg - xermelo is indicated for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (ssa) therapy in adults inadequately controlled by ssa therapy. none. risk summary there are no human data with xermelo use in pregnant women to inform a drug-associated risk. in animal reproduction studies, no effects on embryo-fetal development were observed with the administration of oral telotristat ethyl to rats during organogenesis at doses up to 750 mg/kg/day (approximately 9 times the exposure at the rhd [recommended human dose]). treatment of pregnant rabbits with oral telotristat ethyl during organogenesis produced maternal toxicity and post-implantation loss at doses of 250 mg/kg/day or higher (approximately 15 times the exposure at the rhd), and reduced fetal weight at 500 mg/kg/day (approximately 33 times the exposure at the rhd). in a pre-/postnatal development study, an increased incidence of mortality in rat offspring was observed during postnatal days 0 to 4 at the maternal oral do

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

clinect pty ltd - telotristat etiprate, quantity: 327.9 mg (equivalent: telotristat ethyl, qty 250 mg) - tablet, film coated - excipient ingredients: hyprolose; colloidal anhydrous silica; lactose; magnesium stearate; croscarmellose sodium; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350 - xermelo is indicated for the treatment of carcinoid syndrome diarrhoea in combination with somatostatin analog (ssa) therapy in adults inadequately controlled by ssa therapy.

European Union - English - EMA (European Medicines Agency)

serb sas - telotristat etiprate - carcinoid tumor; neuroendocrine tumors - other alimentary tract and metabolism products - xermelo is indicated for the treatment of carcinoid syndrome diarrhoea in combination with somatostatin analogue (ssa) therapy in adults inadequately controlled by ssa therapy.

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

lexicon pharmaceuticals, inc. - telotristat ethyl (unii: 8g388563m7) (telotristat - unii:381v4fcv2z) - xermelo is indicated for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (ssa) therapy in adults inadequately controlled by ssa therapy. none. risk summary there are no human data with xermelo use in pregnant women to inform a drug-associated risk. in animal reproduction studies, no effects on embryo-fetal development were observed with the administration of oral telotristat ethyl to rats during organogenesis at doses up to 750 mg/kg/day (approximately 9 times the exposure at the rhd [recommended human dose]). treatment of pregnant rabbits with oral telotristat ethyl during organogenesis produced maternal toxicity and post-implantation loss at doses of 250 mg/kg/day or higher (approximately 15 times the exposure at the rhd), and reduced fetal weight at 500 mg/kg/day (approximately 33 times the exposure at the rhd). in a pre-/postnatal development study, an increased incidence of mortality in rat offspring was observed during postnatal days 0 to 4 at the maternal oral do

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

tersera therapeutics llc - telotristat ethyl (unii: 8g388563m7) (telotristat - unii:381v4fcv2z) - xermelo is indicated for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (ssa) therapy in adults inadequately controlled by ssa therapy. xermelo is contraindicated in patients with a history of a hypersensitivity reaction to telotristat. reactions have included angioedema, rash and pruritis. risk summary there are no human data with xermelo use in pregnant women to inform a drug-associated risk. in animal reproduction studies, no effects on embryo-fetal development were observed with the administration of oral telotristat ethyl to rats during organogenesis at doses up to 750 mg/kg/day (approximately 9 times the exposure at the rhd [recommended human dose]). treatment of pregnant rabbits with oral telotristat ethyl during organogenesis produced maternal toxicity and post-implantation loss at doses of 250 mg/kg/day or higher (approximately 15 times the exposure at the rhd), and reduced fetal weight at 500 mg/kg/day (approximately 33 times the exposure at the rhd). in a pr

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

ipsen ltd - telotristat ethyl - tablet - 250mg

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

ipsen pharma, france - telotristat ethyl - film-coated tablet - 250 mg

European Union - English - EMA (European Medicines Agency)

merck sharp & dohme b.v. - doravirine, lamivudine, tenofovir disoproxil fumarate - hiv infections - antivirals for treatment of hiv infections, combinations - delstrigo is indicated for the treatment of adults infected with hiv 1 without past or present evidence of resistance to the nnrti class, lamivudine, or tenofovir.delstrigo is also indicated for the treatment of adolescents aged 12 years and older weighing at least 35 kg who are infected with hiv-1 without past or present evidence of resistance to the nnrti class, lamivudine, or tenofovir and who have experienced toxicities which preclude the use of other regimens that do not contain tenofovir disoproxil.