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

organon pharma pty ltd - asenapine maleate, quantity: 7.03 mg (equivalent: asenapine, qty 5 mg) - wafer - excipient ingredients: gelatin; mannitol - saphris is indicated in the: = treatment of schizophrenia in adults = treatment of acute manic or mixed episodes associated with bipolar 1 disorder in adults as monotherapy or in combination with lithium or sodium valproate = prevention of relapse of manic or mixed episodes in bipolar 1 disorder in adults as monotherapy or in combination with lithium or sodium valproate.

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

organon pharma pty ltd - asenapine maleate, quantity: 14.06 mg (equivalent: asenapine, qty 10 mg) - wafer - excipient ingredients: mannitol; gelatin - saphris is indicated in the: = treatment of schizophrenia in adults = treatment of acute manic or mixed episodes associated with bipolar 1 disorder in adults as monotherapy or in combination with lithium or sodium valproate = prevention of relapse of manic or mixed episodes in bipolar 1 disorder in adults as monotherapy or in combination with lithium or sodium valproate.

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

greenstone llc - asenapine maleate (unii: cu9463u2e2) (asenapine - unii:jkz19v908o) - asenapine sublingual tablets are indicated for: • schizophrenia in adults [see clinical studies ( 14.1 )]   • bipolar i disorder [see clinical studies ( 14.2 )] • acute monotherapy of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of age • adjunctive treatment to lithium or valproate in adults • maintenance monotherapy treatment in adults asenapine is contraindicated in patients with: • severe hepatic impairment (child-pugh c) [see specific populations ( 8.7 ), clinical pharmacology ( 12.3 )] . • a history of hypersensitivity reactions to asenapine. reactions have included anaphylaxis, angioedema, hypotension, tachycardia, swollen tongue, dyspnea, wheezing and rash [see warnings and precautions ( 5.6 ), adverse reactions ( 6 )]. pregnancy exposure registry       there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to asenapine during pregnancy. for more information contact the national pregnancy registry for atypical antipsychotics at 1-866-961-23

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

msn laboratories private limited - asenapine maleate (unii: cu9463u2e2) (asenapine - unii:jkz19v908o) - asenapine sublingual tablets are indicated for: - schizophrenia in adults [see clinical studies (14.1)] - bipolar i disorder [see clinical studies (14.2)] acute monotherapy of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of age adjunctive treatment to lithium or valproate in adults maintenance monotherapy treatment in adults - acute monotherapy of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of age - adjunctive treatment to lithium or valproate in adults - maintenance monotherapy treatment in adults asenapine sublingual tablets are contraindicated in patients with: - severe hepatic impairment (child-pugh c) [see specific populations (8.7), clinical pharmacology (12.3)]. - a history of hypersensitivity reactions to asenapine. reactions have included anaphylaxis, angioedema, hypotension, tachycardia, swollen tongue, dyspnea, wheezing and rash [see warnings and precautions (5.6), adverse reactions (6)]. pregnancy exposure registry there is a pregnancy

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

breckenridge pharmaceutical, inc. - asenapine maleate (unii: cu9463u2e2) (asenapine - unii:jkz19v908o) - asenapine sublingual tablets are indicated for: - schizophrenia in adults [see clinical studies (14.1)] - bipolar i disorder [see clinical studies (14.2)] acute monotherapy of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of age adjunctive treatment to lithium or valproate in adults maintenance monotherapy treatment in adults - acute monotherapy of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of age - adjunctive treatment to lithium or valproate in adults - maintenance monotherapy treatment in adults asenapine sublingual tablets are contraindicated in patients with: - severe hepatic impairment (child-pugh c) [see specific populations (8.7), clinical pharmacology (12.3)]. - a history of hypersensitivity reactions to asenapine. reactions have included anaphylaxis, angioedema, hypotension, tachycardia, swollen tongue, dyspnea, wheezing and rash [see warnings and precautions (5.6), adverse reactions (6)]. pregnancy exposure registry there is a pregnancy

Israel - English - Ministry of Health

merck sharp & dohme (israel - 1996) company ltd, israel - asenapine as maleate - tablets sublingual - asenapine as maleate 5 mg - asenapine - asenapine - schizophrenia saphris is indicated for the treatment of schizophrenia in adults. the efficacy of saphris was established in two 6-week trials and one maintenance trial in adults bipolar disorder monotherapy: saphris is indicated for the acute treatment of manic or mixed episodes associated with bipolar i disorder. efficacy was established in two 3-week monotherapy trials in adults adjunctive therapy: saphris is indicated as adjunctive therapy with either lithium or valproate for the acute treatment of manic or mixed episodes associated with bipolar i disorder. efficacy was established in one 3-week adjunctive trial in adults.

Israel - English - Ministry of Health

merck sharp & dohme (israel - 1996) company ltd, israel - asenapine as maleate - tablets sublingual - asenapine as maleate 10 mg - asenapine - asenapine - schizophrenia saphris is indicated for the treatment of schizophrenia in adults. the efficacy of saphris was established in two 6-week trials and one maintenance trial in adults bipolar disorder monotherapy: saphris is indicated for the acute treatment of manic or mixed episodes associated with bipolar i disorder. efficacy was established in two 3-week monotherapy trials in adults adjunctive therapy: saphris is indicated as adjunctive therapy with either lithium or valproate for the acute treatment of manic or mixed episodes associated with bipolar i disorder. efficacy was established in one 3-week adjunctive trial in adults.

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

alembic pharmaceuticals inc. - asenapine (unii: jkz19v908o) (asenapine - unii:jkz19v908o) - asenapine is indicated for: • bipolar i disorder [see clinical studies (14.2)] • acute monotherapy of manic or mixed episodes, in pediatric patients 10 to 17 years of age • adjunctive treatment to lithium or valproate in adults asenapine is contraindicated in patients with: - severe hepatic impairment (child-pugh c) [see specific populations (8.7), clinical pharmacology (12.3)] . - a history of hypersensitivity reactions to asenapine. reactions have included anaphylaxis, angioedema, hypotension, tachycardia, swollen tongue, dyspnea, wheezing and rash [see warnings and precautions (5.6), adverse reactions (6)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to asenapine 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 a

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

alembic pharmaceuticals limited - asenapine (unii: jkz19v908o) (asenapine - unii:jkz19v908o) - asenapine is indicated for: • bipolar i disorder [see clinical studies (14.2)] • acute monotherapy of manic or mixed episodes, in pediatric patients 10 to 17 years of age • adjunctive treatment to lithium or valproate in adults asenapine is contraindicated in patients with: - severe hepatic impairment (child-pugh c) [see specific populations (8.7), clinical pharmacology (12.3)] . - a history of hypersensitivity reactions to asenapine. reactions have included anaphylaxis, angioedema, hypotension, tachycardia, swollen tongue, dyspnea, wheezing and rash [see warnings and precautions (5.6), adverse reactions (6)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to asenapine 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 a

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

sigmapharm laboratories, llc - asenapine (unii: jkz19v908o) (asenapine - unii:jkz19v908o) - asenapine sublingual tablet(s) is indicated for: - bipolar i disorder  [see clinical studies ( 14.2)] adjunctive treatment to lithium or valproate in adults - adjunctive treatment to lithium or valproate in adults asenapine is contraindicated in patients with: - severe hepatic impairment (child-pugh c) [see specific populations ( 8.7), clinical pharmacology ( 12.3)]. severe hepatic impairment (child-pugh c) [see specific populations ( 8.7), clinical pharmacology ( 12.3)]. - a history of hypersensitivity reactions to asenapine. reactions have included anaphylaxis, angioedema, hypotension, tachycardia, swollen tongue, dyspnea, wheezing and ra