Singapore - English - HSA (Health Sciences Authority)

otsuka pharmaceuticals (singapore) pte. ltd. - aripiprazole - tablet - 5.0 mg - aripiprazole 5.0 mg

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - aripiprazole monohydrate 416.07mg equivalent to aripiprazole 400 mg;   - injection with diluent - 400 mg - active: aripiprazole monohydrate 416.07mg equivalent to aripiprazole 400 mg   excipient: carmellose sodium mannitol monobasic sodium phosphate monohydrate sodium hydroxide water for injection - for maintenance of clinical improvement in the treatment of schizophrenia

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

otsuka america pharmaceutical, inc. - tolvaptan (unii: 21g72t1950) (tolvaptan - unii:21g72t1950) - tolvaptan 15 mg - samsca® is indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia (serum sodium <125 meq/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). limitations of use patients requiring intervention to raise serum sodium urgently to prevent or to treat serious neurological symptoms should not be treated with samsca. it has not been established that raising serum sodium with samsca provides a symptomatic benefit to patients. samsca is contraindicated in the following conditions: - patients with autosomal dominant polycystic kidney disease (adpkd) outside of fda-approved rems [see warnings and precautions (5.2)] - unable to sense or respond to thirst - hypovolemic hyponatremia - taking strong cyp3a inhibitors [see warnings and precautions (5.5)] - anuria - hypersensitivity (e.g., anaphylactic shock, rash generalized) to tolvaptan or

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

luen wah medical co. sdn. bhd. - glucose anhydrous -

European Union - English - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - aripiprazole - schizophrenia; bipolar disorder - psycholeptics - abilify is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.abilify is indicated for the treatment of moderate to severe manic episodes in bipolar i disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.abilify is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in bipolar i disorder in adolescents aged 13 years and older.

European Union - English - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - aripiprazole - schizophrenia - psycholeptics - maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole.

European Union - English - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - tolvaptan - polycystic kidney, autosomal dominant - diuretics, - jinarc is indicated to slow the progression of cyst development and renal insufficiency of autosomal dominant polycystic kidney disease (adpkd) in adults with ckd stage 1 to 3 at initiation of treatment with evidence of rapidly progressing disease.

European Union - English - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - tolvaptan - inappropriate adh syndrome - diuretics, - treatment of adult patients with hyponatraemia secondary to syndrome of inappropriate antidiuretic-hormone secretion (siadh).,

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - aripiprazole monohydrate 312.05mg equivalent to aripiprazole 300 mg;   - injection with diluent - 300 mg - excipient: water for injection active: aripiprazole monohydrate 312.05mg equivalent to aripiprazole 300 mg   excipient: carmellose sodium mannitol monobasic sodium phosphate monohydrate sodium hydroxide - for maintenance of clinical improvement in the treatment of schizophrenia

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).