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

otsuka america pharmaceutical, inc. - aripiprazole (unii: 82vfr53i78) (aripiprazole - unii:82vfr53i78) - aripiprazole 2 mg - abilify (aripiprazole) oral tablets, orally-disintegrating tablets, and oral solution are indicated for the treatment of: - schizophrenia - acute treatment of manic and mixed episodes associated with bipolar i disorder - adjunctive treatment of major depressive disorder - irritability associated with autistic disorder - treatment of tourette's disorder abilify injection is indicated for the treatment of: - agitation associated with schizophrenia or bipolar mania abilify 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)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including abilify, during pregnancy. healthcare providers are encouraged to register patients by contacting the national pregnancy registry for atypical antipsychotics at 1-866-961-2388 or visit http://womensmentalhea

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.

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

otsuka australia pharmaceutical pty ltd - aripiprazole, quantity: 5 mg - tablet, uncoated - excipient ingredients: magnesium stearate; maize starch; hyprolose; lactose monohydrate; microcrystalline cellulose; indigo carmine aluminium lake - - 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.

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

otsuka america pharmaceutical, inc. - tolvaptan (unii: 21g72t1950) (tolvaptan - unii:21g72t1950) - jynarque is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (adpkd). jynarque is contraindicated in patients: - with a history, signs or symptoms of significant liver impairment or injury. this contraindication does not apply to uncomplicated polycystic liver disease [see warnings and precautions (5.1)] - taking strong cyp 3a inhibitors - with uncorrected abnormal blood sodium concentrations [see warnings and precautions (5.3)] - unable to sense or respond to thirst [see warnings and precautions (5.3)] - hypovolemia [see warnings and precautions (5.3)] - hypersensitivity (e.g., anaphylaxis, rash) to tolvaptan or any component of the product [see adverse reactions (6)] - uncorrected urinary outflow obstruction - anuria risk summary available data with jynarque use in pregnant women are insufficient to determine if there is a drug associated risk of adverse developmental outcomes. in embryo-fetal development studies, pregnant rats a

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

luen wah medical co. sdn. bhd. - sodium chloride (salt) -

Singapore - English - HSA (Health Sciences Authority)

nagase singapore (pte) ltd. - microbiology - an in vitro diagnostic device to measure changes in 13co2 content in breath co2 gas by infrared spectroscopic analysis. intended for use in conjunction with commercially available 13c-urea breath tests for the detection of helicobacter pylori (h. pylori) infection. suitable for use in both point of care and clinical laboratory settings.

Singapore - English - HSA (Health Sciences Authority)

nagase singapore (pte) ltd. - microbiology - the poconeplus infrared spectrophotometer is an in vitro diagnostic medical device designed to measure changes in the 13co2 content in breath co2 gas by infrared spectroscopic analysis.

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

otsuka pharmaceuticals (malaysia) sdn. bhd. - tolvaptan -

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

otsuka australia pharmaceutical pty ltd - decitabine, quantity: 35 mg; cedazuridine, quantity: 100 mg - tablet, film coated - excipient ingredients: lactose monohydrate; colloidal anhydrous silica; magnesium stearate; croscarmellose sodium; hypromellose; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350 - inqovi 35/100 is indicated for the treatment of adult patients with myelodysplastic syndromes (mds) intermediate-1, intermediate-2, and high-risk international prognostic scoring system groups, and patients with chronic myelomonocytic leukaemia (cmml).

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

otsuka australia pharmaceutical pty ltd - decitabine, quantity: 35 mg; cedazuridine, quantity: 100 mg - tablet, film coated - excipient ingredients: lactose monohydrate; colloidal anhydrous silica; magnesium stearate; croscarmellose sodium; hypromellose; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350 - inqovi 35/100 is indicated for the treatment of adult patients with myelodysplastic syndromes (mds) intermediate-1, intermediate-2, and high-risk international prognostic scoring system groups, and patients with chronic myelomonocytic leukaemia (cmml).