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

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

arrotex pharmaceuticals pty ltd - anagrelide hydrochloride, quantity: 0.61 mg (equivalent: anagrelide, qty 0.5 mg) - capsule, hard - excipient ingredients: lactose; povidone; crospovidone; microcrystalline cellulose; lactose monohydrate; titanium dioxide; gelatin; magnesium stearate - anagrelide apotex capsules are indicated for the treatment of essential thrombocythaemia.

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

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

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

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)

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

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: lactose monohydrate; magnesium stearate; croscarmellose sodium; gelatin; microcrystalline cellulose; titanium dioxide; povidone; lactose - anagrelide rmb capsules are indicated for the treatment of essential thrombocythaemia