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

taro pharmaceuticals u.s.a., inc. - calcipotriene (unii: 143nq3779b) (calcipotriene - unii:143nq3779b), betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - calcipotriene and betamethasone dipropionate topical suspension is indicated for the topical treatment of plaque psoriasis of the scalp in patients 12 years and older and plaque psoriasis of the scalp and body in patients 18 years and older. additional pediatric use information is approved for leo pharma a/s's taclonex® (calcipotriene and betamethasone dipropionate) topical suspension. however, due to leo pharma a/s's marketing exclusivity rights, this drug product is not labeled with that information. none. risk summary available data with calcipotriene and betamethasone dipropionate topical suspension are not sufficient to evaluate a drug-associated risk for major birth defects, miscarriages, or adverse maternal or fetal outcomes. although there are no available data on use of the calcipotriene component in pregnant women, systemic exposure to calcipotriene after topical administration of calcipotriene and betamethasone dipropionate topical suspension is likely to be low [see clinical pharmacology (12.3)].

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

trifluent pharma llc - calcipotriene (unii: 143nq3779b) (calcipotriene - unii:143nq3779b) - calcipotriene foam should not be used by patients with known hypercalcemia. calcipotriene foam is indicated for the topical treatment of plaque psoriasis of the scalp and body in adults and pediatric patients 4 years of age and older. risk summary although there are no available data on the drug- associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes in pregnant women exposed to calcipotriene foam, systemic exposure to calcipotriene is likely to be low [see clinical pharmacology ( 12.2, 12.3)] . in animal reproduction studies, oral administration of calcipotriene to pregnant rats and rabbits during the period of organogenesis resulted in an increased incidence of minor skeletal abnormalities, including enlarged fontanelles and extra ribs in rats and an increased incidence of minor skeletal abnormalities, including incomplete ossification of pubic bones and forelimb phalanges in rabbits (see data) . the available data do not allow the calculation of rel

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

padagis israel pharmaceuticals ltd - calcipotriene monohydrate (unii: s7499tyy6g) (calcipotriene - unii:143nq3779b), betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - calcipotriene and betamethasone dipropionate topical suspension is indicated for the topical treatment of plaque psoriasis of the scalp in patients 12 years and older and plaque psoriasis of the scalp and body in patients 18 years and older. additional pediatric use information is approved for leo pharma a/s’s taclonex® (calcipotriene and betamethasone dipropionate) topical suspension. however, due to leo pharma a/s’s marketing exclusivity rights, this drug product is not labeled with that information. none. risk summary available data with calcipotriene and betamethasone dipropionate topical suspension are not sufficient to evaluate a drug-associated risk for major birth defects, miscarriages, or adverse maternal or fetal outcomes. although there are no available data on use of the calcipotriene component in pregnant women, systemic exposure to calcipotriene after topical administration of calcipotriene and betamethasone dipropionate topical suspension is likely to be low [see clinical pharmacology (12.3)]

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

bryant ranch prepack - calcipotriene hydrate (unii: s7499tyy6g) (calcipotriene - unii:143nq3779b), betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - calcipotriene and betamethasone dipropionate topical suspension is indicated for the topical treatment of plaque psoriasis of the scalp in patients 12 years and older and plaque psoriasis of the scalp and body in patients 18 years and older. additional pediatric use information is approved for leo pharma a/s’s taclonex® (calcipotriene and betamethasone dipropionate) topical suspension. however, due to leo pharma a/s’s marketing exclusivity rights, this drug product is not labeled with that information. none. risk summary available data with calcipotriene and betamethasone dipropionate topical suspension are not sufficient to evaluate a drug-associated risk for major birth defects, miscarriages, or adverse maternal or fetal outcomes. although there are no available data on use of the calcipotriene component in pregnant women, systemic exposure to calcipotriene after topical administration of calcipotriene and betamethasone dipropionate topical suspension is likely to be low [see clinical pharmacology (12.3

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

bryant ranch prepack - calcipotriene hydrate (unii: s7499tyy6g) (calcipotriene - unii:143nq3779b), betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - calcipotriene and betamethasone dipropionate topical suspension is indicated for the topical treatment of plaque psoriasis of the scalp in patients 12 years and older and plaque psoriasis of the scalp and body in patients 18 years and older. additional pediatric use information is approved for leo pharma a/s’s taclonex® (calcipotriene and betamethasone dipropionate) topical suspension. however, due to leo pharma a/s’s marketing exclusivity rights, this drug product is not labeled with that information. none. risk summary available data with calcipotriene and betamethasone dipropionate topical suspension are not sufficient to evaluate a drug-associated risk for major birth defects, miscarriages, or adverse maternal or fetal outcomes. although there are no available data on use of the calcipotriene component in pregnant women, systemic exposure to calcipotriene after topical administration of calcipotriene and betamethasone dipropionate topical suspension is likely to be low [see clinical pharmacology (12.3

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

golden state medical supply, inc. - calcipotriene (unii: 143nq3779b) (calcipotriene - unii:143nq3779b) - calcipotriene ointment, 0.005%, is indicated for the treatment of plaque psoriasis in adults. the safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established. calcipotriene is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. it should not be used by patients with demonstrated hypercalcemia or evidence of vitamin d toxicity. calcipotriene should not be used on the face.

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

golden state medical supply, inc. - calcipotriene (unii: 143nq3779b) (calcipotriene - unii:143nq3779b) - calcipotriene cream, 0.005%, is indicated for the treatment of plaque psoriasis. the safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established. calcipotriene cream is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. it should not be used by patients with demonstrated hypercalcemia or evidence of vitamin d toxicity. calcipotriene cream should not be used on the face.

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

bryant ranch prepack - calcipotriene (unii: 143nq3779b) (calcipotriene - unii:143nq3779b) - calcipotriene cream, 0.005%, is indicated for the treatment of plaque psoriasis. the safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established. calcipotriene cream, 0.005% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. it should not be used by patients with demonstrated hypercalcemia or evidence of vitamin d toxicity. calcipotriene cream, 0.005% should not be used on the face.

Malta - English - Medicines Authority

central procurement & supplies unit ub002 industrial estate, san gwann sgn 3000, malta - calcipotriol - ointment - calcipotriol 50 µg/g - antipsoriatics

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

leo pharma pty ltd - calcipotriol, quantity: 50 microgram/g; betamethasone dipropionate (equivalent: betamethasone, qty 500 microgram/g) - gel - excipient ingredients: nitrogen; hydrogenated castor oil; polyoxypropylene-11 stearyl ether; butylated hydroxytoluene; liquid paraffin; dl-alpha-tocopherol - topical treatment of scalp psoriasis. topical treatment of mild to moderate plaque psoriasis on the body in adults.