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ATC codes: N05AA01
EMLc
Indication
Schizophrenia or other primary psychotic disorders ICD11 code: 6A4Z
INN
Chlorpromazine
Medicine type
Chemical agent
List type
Core (EML)
Complementary (EMLc)
Formulations
Oral > Liquid: 25 mg per 5 mL (hydrochloride)
Oral > Solid: 100 mg (hydrochloride) ; 10 mg (hydrochloride) (EMLc) ; 25 mg (hydrochloride) (EMLc) ; 50 mg (hydrochloride) (EMLc)
Parenteral > General injections > unspecified: 25 mg per mL in 2 mL ampoule (hydrochloride)
EML status history
First added in 1977 (TRS 615)
Changed in 1979 (TRS 641)
Changed in 2007 (TRS 950)
Changed in 2009 (TRS 958)
Changed in 2013 (TRS 985)
Changed in 2021 (TRS 1035)
Removed in 2023 (TRS 1049)
Sex
All
Age
Also recommended for children
Therapeutic alternatives
Medicines within the same pharmacological class can be used
Therapeutic alternatives limitations
Therapeutic alternatives to be reviewed (2023)
Therapeutic alternatives limitations for EMLc
The square box does not apply for the listing of chlorpromazine on the EMLc
Patent information
Patents have expired in most jurisdictions
Summary of evidence and Expert Committee recommendations
The Expert Committee recommended the removal of chlorpromazine immediate-release injection from the core list of the EML for the treatment of schizophrenia and related psychoses because of a lack of high-quality evidence of benefit versus either placebo, or the alternative EML-listed haloperidol immediate-release injection, with a likely increased risk of adverse effects. 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).