Canada - English - Health Canada

pharmascience inc - anagrelide (anagrelide hydrochloride monohydrate) - capsule - 0.5mg - anagrelide (anagrelide hydrochloride monohydrate) 0.5mg - platelet-reducing agents

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

physicians total care, inc. - anagrelide hydrochloride (unii: vns4435g39) (anagrelide - unii:k9x45x0051) - anagrelide 0.5 mg - anagrelide hydrochloride capsules are indicated for the treatment of patients with thrombocythemia, secondary to myeloproliferative disorders, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events (see clinical studies , dosage and administration ). anagrelide is contraindicated in patients with severe hepatic impairment. exposure to anagrelide is increased 8 fold in patients with moderate hepatic impairment (see clinical pharmacology ). use of anagrelide in patients with severe hepatic impairment has not been studied (see also warnings, hepatic ).

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

teva pharmaceuticals usa, inc. - anagrelide hydrochloride (unii: ytm763y5c8) (anagrelide - unii:k9x45x0051) - anagrelide 0.5 mg - anagrelide capsules are indicated for the treatment of patients with thrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events. none. risk summary available data from case reports with anagrelide use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal embryo-fetal studies, delayed fetal development (delayed skeletal ossification and reduced body weight) was observed in rats administered anagrelide hydrochloride during organogenesis at doses approximately 97 times the maximum clinical dose (10 mg/day) based on body surface area (see data) . there are adverse effects on maternal and fetal outcomes associated with thrombocythemia in pregnancy (see clinical considerations). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown

Canada - English - Health Canada

pharmel inc - anagrelide (anagrelide hydrochloride monohydrate) - capsule - 0.5mg - anagrelide (anagrelide hydrochloride monohydrate) 0.5mg - platelet-reducing agents

Canada - English - Health Canada

dominion pharmacal - anagrelide (anagrelide hydrochloride monohydrate) - capsule - 0.5mg - anagrelide (anagrelide hydrochloride monohydrate) 0.5mg - platelet-reducing agents

Canada - English - Health Canada

mylan pharmaceuticals ulc - anagrelide (anagrelide hydrochloride) - capsule - 0.5mg - anagrelide (anagrelide hydrochloride) 0.5mg - platelet-reducing agents

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

carilion materials management - anagrelide hydrochloride (unii: vns4435g39) (anagrelide - unii:k9x45x0051) - anagrelide 0.5 mg - anagrelide capsules usp are indicated for the treatment of patients with thrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events [see clinical studies (14), dosage and administration (2)] . none. teratogenic effects pregnancy category c risk summary there are no adequate and well-controlled studies with anagrelide in pregnant women. in animal embryo-fetal studies, delayed development (delayed skeletal ossification and reduced body weight) was observed in rats administered anagrelide hydrochloride during organogenesis at doses substantially higher than the maximum clinical dose of 10 mg/day. anagrelide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. animal data anagrelide hydrochloride was administered orally to pregnant rats and rabbits during the period of organogenesis at doses up to 900 mg/kg/day in rats and

European Union - English - EMA (European Medicines Agency)

mylan pharmaceuticals limited - anagrelide hydrochloride - thrombocythemia, essential - antineoplastic agents - anagrelide is indicated for the reduction of elevated platelet counts in at risk essential thrombocythaemia (et) patients who are intolerant to their current therapy or whose elevated platelet counts are not reduced to an acceptable level by their current therapy.an at-risk patientan at-risk essential thrombocythaemia patient is defined by one or more of the following features:>60 years of age ora platelet count >1,000 x 10⁹/l ora history of thrombo-haemorrhagic events. 

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

southern cross pharma pty ltd - anagrelide hydrochloride, quantity: 0.57 mg (equivalent: anagrelide, qty 0.5 mg) - capsule, hard - excipient ingredients: povidone; magnesium stearate; gelatin; lactose monohydrate; croscarmellose sodium; titanium dioxide; microcrystalline cellulose; lactose - anagrelide lupin capsules are indicated for the treatment of essential thrombocythaemia

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

torrent pharmaceuticals limited - anagrelide hydrochloride anhydrous (unii: vns4435g39) (anagrelide - unii:k9x45x0051) - anagrelide 0.5 mg - anagrelide capsules are indicated for the treatment of patients with thrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events . none. risk summary available data from case reports with anagrelide use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal embryo-fetal studies, delayed fetal development (delayed skeletal ossification and reduced body weight) was observed in rats administered anagrelide hydrochloride during organogenesis at doses approximately 97 times the maximum clinical dose (10 mg/day) based on body surface area ( see data ). there are adverse effects on maternal and fetal outcomes associated with thrombocythemia in pregnancy ( see clinical considerations ). the estimated background risk of major birth defects and misca