ATC codes: N05AD01
Schizophrenia or other primary psychotic disorders ICD11 code: 6A4Z
Medicine type
Chemical agent
List type
Additional notes
The square box applies only to oral dose forms of haloperidol and chlorpromazine
Parenteral > General injections > IM: 5 mg per mL in ampoule
Oral > Solid: 2 mg ; 5 mg
EML status history
First added in 1977 (TRS 615)
Changed in 1979 (TRS 641)
Changed in 1987 (TRS 770)
Changed in 2007 (TRS 950)
Changed in 2009 (TRS 958)
Changed in 2013 (TRS 985)
Changed in 2021 (TRS 1035)
Changed in 2023 (TRS 1049)
Adolescents and adults
Therapeutic alternatives
chlorpromazine (ATC codes: N05AA01)
Oral > Liquid: 25 mg per 5 mL (hydrochloride)
Oral > Solid: 100 mg (hydrochloride)
Patent information
Patents have expired in most jurisdictions
Summary of evidence and Expert Committee recommendations
The Expert Committee recalled the request made by the 2021 Committee that therapeutic alternatives for the square box listings for chlorpromazine, fluphenazine and haloperidol in this section of the EML be reviewed. The Expert Committee accepted the rationale applied by the WHO Department of Mental Health and Substance Use in identifying suitable therapeutic alternatives, and made the following recommendations: - Chlorpromazine (oral formulations only) be included as a therapeutic alternative to oral haloperidol. (This recommendation, coupled with the recommendation above to remove chlorpromazine injection, effectively removes the independent listing for chlorpromazine from the EML). - Haloperidol decanoate and zuclopenthixol decanoate be included as therapeutic alternatives to fluphenazine (decanoate/enantate). The Expert Committee recommended the deletion of chlorpromazine and haloperidol (all dosage forms) from the complementary list of the EMLc. The Committee noted that schizophrenia and other chronic psychotic disorders are rare in children younger than 12 years. The Committee agreed that the available evidence for these medicines in the treatment of psychoses in children was inconclusive and insufficient to support their ongoing inclusion on the EMLc.