Canada - English - Health Canada

ipsen biopharmaceuticals canada inc - palovarotene - capsule - 1mg - palovarotene 1mg

Canada - English - Health Canada

ipsen biopharmaceuticals canada inc - palovarotene - capsule - 1.5mg - palovarotene 1.5mg

Canada - English - Health Canada

ipsen biopharmaceuticals canada inc - palovarotene - capsule - 2.5mg - palovarotene 2.5mg

Canada - English - Health Canada

ipsen biopharmaceuticals canada inc - palovarotene - capsule - 5mg - palovarotene 5mg

Canada - English - Health Canada

ipsen biopharmaceuticals canada inc - palovarotene - capsule - 10mg - palovarotene 10mg

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

ipsen biopharmaceuticals, inc. - palovarotene (unii: 28k6i5m16g) (palovarotene - unii:28k6i5m16g) - sohonos is indicated for the reduction in volume of new heterotopic ossification in adults and pediatric patients aged 8 years and older for females and 10 years and older for males with fibrodysplasia ossificans progressiva (fop). sohonos is contraindicated in the following patients: - during pregnancy [see warnings and precautions (5.1) and use in specific populations (8.1)] . - a history of allergy or hypersensitivity to retinoids, or to any component of sohonos. anaphylaxis and other allergic reactions have occurred with other retinoids. [see description (11)]. risk summary sohonos is contraindicated during pregnancy. based on the findings in animal studies and class effects of retinoids, sohonos can cause fetal harm when administered during pregnancy [see warnings and precautions (5.1) and use in specific populations (8.3)] . in animal reproduction studies, oral administration of palovarotene to pregnant rats during the period of organogenesis resulted in multiple fetal malformations typical of retinoids

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

ipsen pty ltd - palovarotene, quantity: 1 mg - capsule, hard - excipient ingredients: croscarmellose sodium; sodium lauryl sulfate; lactose monohydrate; microcrystalline cellulose; povidone; magnesium stearate; titanium dioxide; potable water; gelatin; propylene glycol; butan-1-ol; purified water; isopropyl alcohol; shellac; ethanol absolute; iron oxide black; ammonia; potassium hydroxide - sohonos is indicated to reduce the formation of heterotopic ossification in adults and children aged 8 years and above for females and 10 years and above for males with fibrodysplasia ossificans progressiva (fop).

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

ipsen pty ltd - palovarotene, quantity: 1.5 mg - capsule, hard - excipient ingredients: lactose monohydrate; croscarmellose sodium; magnesium stearate; microcrystalline cellulose; povidone; sodium lauryl sulfate; titanium dioxide; potable water; gelatin; propylene glycol; butan-1-ol; purified water; isopropyl alcohol; shellac; ethanol absolute; iron oxide black; ammonia; potassium hydroxide - sohonos is indicated to reduce the formation of heterotopic ossification in adults and children aged 8 years and above for females and 10 years and above for males with fibrodysplasia ossificans progressiva (fop).

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

ipsen pty ltd - palovarotene, quantity: 10 mg - capsule, hard - excipient ingredients: povidone; magnesium stearate; lactose monohydrate; microcrystalline cellulose; sodium lauryl sulfate; croscarmellose sodium; titanium dioxide; potable water; gelatin; propylene glycol; butan-1-ol; purified water; isopropyl alcohol; shellac; ethanol absolute; iron oxide black; ammonia; potassium hydroxide - sohonos is indicated to reduce the formation of heterotopic ossification in adults and children aged 8 years and above for females and 10 years and above for males with fibrodysplasia ossificans progressiva (fop).

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

ipsen pty ltd - palovarotene, quantity: 2.5 mg - capsule, hard - excipient ingredients: croscarmellose sodium; lactose monohydrate; povidone; magnesium stearate; microcrystalline cellulose; sodium lauryl sulfate; titanium dioxide; potable water; gelatin; propylene glycol; butan-1-ol; purified water; isopropyl alcohol; shellac; ethanol absolute; iron oxide black; ammonia; potassium hydroxide - sohonos is indicated to reduce the formation of heterotopic ossification in adults and children aged 8 years and above for females and 10 years and above for males with fibrodysplasia ossificans progressiva (fop).