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

alembic pharmaceuticals limited - aripiprazole (unii: 82vfr53i78) (aripiprazole - unii:82vfr53i78) - aripiprazole 2 mg - aripiprazole is indicated for the treatment of: •schizophrenia [see clinical studies (14.1)] additional pediatric use information is approved for otsuka america pharmaceutical, inc.’s abilify® (aripiprazole) product. however, due to otsuka america pharmaceutical, inc.’s marketing exclusivity rights, this drug product is not labeled with that information. aripiprazole is contraindicated in patients with a history of a hypersensitivity reaction to aripiprazole. reactions have ranged from pruritus/urticaria to anaphylaxis [see adverse reactions (6.2)]. teratogenic effects pregnancy category c: pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aripiprazole during pregnancy. for more information contact the national pregnancy registry for atypical antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/. risk summary neonates exposed to antipsychotic drugs (includi

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

alembic pharmaceuticals limited - aripiprazole (unii: 82vfr53i78) (aripiprazole - unii:82vfr53i78) - aripiprazole 10 mg - aripiprazole orally disintegrating tablets are indicated for the treatment of: •schizophrenia [see clinical studies (14.1)] additional pediatric use information is approved for otsuka america pharmaceutical, inc.’s abilify® (aripiprazole) product. however, due to otsuka america pharmaceutical, inc.’s marketing exclusivity rights, this drug product is not labeled with that information.  aripiprazole is contraindicated in patients with a history of a hypersensitivity reaction to aripiprazole. reactions have ranged from pruritus/urticaria to anaphylaxis [see adverse reactions (6.2)]. teratogenic effects pregnancy category c: pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aripiprazole during pregnancy. for more information contact the national pregnancy registry for atypical antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/ . risk summary   neonates exposed to an

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

otsuka australia pharmaceutical pty ltd - tolvaptan, quantity: 30 mg - tablet - excipient ingredients: magnesium stearate; indigo carmine aluminium lake; maize starch; hyprolose; microcrystalline cellulose; lactose monohydrate - samsca is indicated for the treatment of clinically significant hypervolemic or euvolemic hyponatremia (serum sodium less than 125 mmol/l, or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction) including patients with heart failure and syndrome of inappropriate antidiuretic hormone (siadh).

Philippines - English - FDA (Food And Drug Administration)

otsuka (phils.) pharmaceutical, inc.; distributor: zyre pharmaceuticals corporation - amino acids - intavenous injection - 80mg/ml (8% w/v)

Philippines - English - FDA (Food And Drug Administration)

otsuka (phils.) pharmaceutical, inc.; distributor: macropharma corporation - amino acids - intavenous injection - 70mg/ml (7% w/v)

Philippines - English - FDA (Food And Drug Administration)

otsuka (phils.) pharmaceutical, inc.; distributor: macropharma corporation - hydroxyethyl starch (200/0.5) 6% w/v isotonic with sodium chloride - intravenous infusion - 60mg/ml (6% w/v)

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

otsuka australia pharmaceutical pty ltd - aripiprazole, quantity: 30 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; iron oxide red; maize starch; microcrystalline cellulose; magnesium stearate; hyprolose - - abilify is indicated for the treatment of schizophrenia including maintenance of clinical improvement during continuation therapy. - acute treatment of manic or mixed episodes associated with bipolar i disorder in adults as monotherapy and in combination with lithium or valproate; - maintenance treatment of manic or mixed episodes in bipolar i disorder in adults as monotherapy.

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

otsuka australia pharmaceutical pty ltd - aripiprazole, quantity: 20 mg - tablet, uncoated - excipient ingredients: hyprolose; maize starch; microcrystalline cellulose; magnesium stearate; lactose monohydrate - - abilify is indicated for the treatment of schizophrenia including maintenance of clinical improvement during continuation therapy. - acute treatment of manic or mixed episodes associated with bipolar i disorder in adults as monotherapy and in combination with lithium or valproate; - maintenance treatment of manic or mixed episodes in bipolar i disorder in adults as monotherapy.

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

otsuka australia pharmaceutical pty ltd - aripiprazole, quantity: 15 mg - tablet, uncoated - excipient ingredients: magnesium stearate; hyprolose; iron oxide yellow; maize starch; microcrystalline cellulose; lactose monohydrate - - abilify is indicated for the treatment of schizophrenia including maintenance of clinical improvement during continuation therapy. - acute treatment of manic or mixed episodes associated with bipolar i disorder in adults as monotherapy and in combination with lithium or valproate; - maintenance treatment of manic or mixed episodes in bipolar i disorder in adults as monotherapy.

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

otsuka australia pharmaceutical pty ltd - aripiprazole, quantity: 10 mg - tablet, uncoated - excipient ingredients: iron oxide red; maize starch; microcrystalline cellulose; lactose monohydrate; hyprolose; magnesium stearate - - abilify is indicated for the treatment of schizophrenia including maintenance of clinical improvement during continuation therapy. - acute treatment of manic or mixed episodes associated with bipolar i disorder in adults as monotherapy and in combination with lithium or valproate; - maintenance treatment of manic or mixed episodes in bipolar i disorder in adults as monotherapy.