European Union - English - EMA (European Medicines Agency)

n.v. organon - asenapine (as maleate)  - bipolar disorder - psycholeptics - sycrest is indicated for the treatment of moderate to severe manic episodes associated with bipolar i disorder in adults.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

lundbeck ltd - asenapine maleate - sublingual tablet - 10mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

lundbeck ltd - asenapine maleate - sublingual tablet - 5mg

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.

Singapore - English - HSA (Health Sciences Authority)

msd pharma (singapore) pte. ltd. - asenapine maleate 14.06mg eqv asenapine - tablet, orally disintegrating - 10mg

Singapore - English - HSA (Health Sciences Authority)

msd pharma (singapore) pte. ltd. - asenapine maleate 7.03mg eqv asenapine - tablet, orally disintegrating - 5mg

Canada - English - Health Canada

organon canada inc. - asenapine (asenapine maleate) - tablet - 5mg - asenapine (asenapine maleate) 5mg - atypical antipsychotics

Canada - English - Health Canada

organon canada inc. - asenapine (asenapine maleate) - tablet - 10mg - asenapine (asenapine maleate) 10mg - atypical antipsychotics

Canada - English - Health Canada

mint pharmaceuticals inc - olanzapine - tablet (orally disintegrating) - 5mg - olanzapine 5mg - atypical antipsychotics