ATC codes: N05AX13
Schizophrenia or other primary psychotic disorders ICD11 code: 6A4Z
Medicine type
Chemical agent
List type
Parenteral > General injections > IM: 25 mg in pre-filled syringe (as palmitate) ; 50 mg in pre-filled syringe (as palmitate) ; 75 mg in pre-filled syringe (as palmitate) ; 100 mg in pre-filled syringe (as palmitate) ; 150 mg in pre-filled syringe (as palmitate)
EML status history
First added in 2021 (TRS 1035)
Changed in 2023 (TRS 1049)
Adolescents and adults
Therapeutic alternatives
risperidone (ATC codes: N05AX08)
Parenteral > General injections > IM:
Patent information
Patents have expired in most jurisdictions
Summary of evidence and Expert Committee recommendations
The Expert Committee did not recommend inclusion of paliperidone palmitate 3-month long-acting injection on the EML for maintenance treatment of schizophrenia. The Committee noted that compared to the 1-month formulation, the 3-month formulation has evidence of similar clinical efficacy and safety and may offer advantages to patients in terms of fewer injections. However, the Committee noted that it is not recommended to initiate treatment with the 3-month formulation, rather it is used in patients who demonstrate benefit and tolerance to the 1-month formulation over at least 4 months. In addition, the 3-month formulation is more highly priced, not yet available as generic, and currently has limited availability in low- and middle-income countries.