Ireland - English - HPRA (Health Products Regulatory Authority)

wockhardt uk limited - aripiprazole - tablet - 5 milligram(s) - other antipsychotics; aripiprazole - other antipsychotics - aripiprazole is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. aripiprazole 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

Ireland - English - HPRA (Health Products Regulatory Authority)

wockhardt uk limited - aripiprazole - tablet - 10 milligram(s) - other antipsychotics; aripiprazole - other antipsychotics - aripiprazole is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. aripiprazole 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

Ireland - English - HPRA (Health Products Regulatory Authority)

wockhardt uk limited - aripiprazole - tablet - 15 milligram(s) - other antipsychotics; aripiprazole - other antipsychotics - aripiprazole is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. aripiprazole 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

Ireland - English - HPRA (Health Products Regulatory Authority)

wockhardt uk limited - aripiprazole - tablet - 30 milligram(s) - other antipsychotics; aripiprazole - other antipsychotics - aripiprazole is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. aripiprazole 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

European Union - English - EMA (European Medicines Agency)

accord healthcare s.l.u. - aripiprazole - schizophrenia; bipolar disorder - psycholeptics - aripiprazole accord is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. aripiprazole accord 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. aripiprazole accord 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)

mylan pharmaceuticals limited - aripiprazole - schizophrenia; bipolar disorder - psycholeptics - aripiprazole mylan pharma is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.aripiprazole mylan pharma 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.aripiprazole mylan pharma 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)

sandoz gmbh - aripiprazole - schizophrenia; bipolar disorder - psycholeptics - aripiprazole sandoz is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. aripiprazole sandoz 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. aripiprazole sandoz 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)

zentiva, k.s. - aripiprazole - schizophrenia; bipolar disorder - psycholeptics - aripiprazole zentiva is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.aripiprazole zentiva 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.aripiprazole zentiva 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.

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

remedyrepack inc. - aripiprazole (unii: 82vfr53i78) (aripiprazole - unii:82vfr53i78) - aripiprazole 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) ]. 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 (including aripiprazole) d

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

remedyrepack inc. - aripiprazole (unii: 82vfr53i78) (aripiprazole - unii:82vfr53i78) - aripiprazole oral 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 tablets are 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