ATC codes: N05AH04
Bipolar or related disorders ICD11 code: 6A8Z
Medicine type
Chemical agent
List type
Oral > Solid > tablet: 25 mg (immediate-release) ; 100 mg (immediate-release) ; 150 mg (immediate-release) ; 200 mg (immediate-release) ; 300 mg (immediate-release) ; 50 mg (modified-release) ; 150 mg (modified-release) ; 200 mg (modified-release) ; 300 mg (modified-release) ; 400 mg (modified-release)
EML status history
First added in 2023 (TRS 1049)
Adolescents and adults
Therapeutic alternatives
Patent information
Patents have expired in most jurisdictions
Summary of evidence and Expert Committee recommendations
The Expert Committee recommended the inclusion of quetiapine, with a square box indicating aripiprazole, olanzapine, paliperidone as specified therapeutic alternatives, on the core list of the EML for treatment of bipolar disorders. The Committee considered that the evidence presented in the application demonstrated the effectiveness of the proposed second-generation antipsychotics in the acute treatment and long-term prevention of mania/hypomania and/or depression in bipolar disorders was similar to that of classic mood stabilizers currently included on the EML (carbamazepine, lithium carbonate and valproic acid). All proposed medicines were shown to be either superior or non-inferior to placebo for acceptability (determined by all-cause discontinuations). The Committee agreed that second-generation antipsychotics have an important role in bipolar disorders in patients who do not adequately respond to or experience adverse events from mood stabilizers. Moreover, the Committee noted that the two classes of medicines may be used in combination in selected patients in clinical practice.