FOI release
Confirmation of qualitative composition of Largactil Tablets (25 mg, 50 mg, 100 mg)
Case reference FOI2025/01266
Received 4 December 2025
Published 29 January 2026
Request
Under the Freedom of Information Act 2000, we seek the following information regarding medicinal products previously and currently approved in the UK. We seek the below information on a medicinal product previously approved in the UK, Largactil 25/50/100 mg Tablets which were licensed by Aventis Pharma for use in the UK until 2008: · Confirmation of the qualitative composition of these medicinal products, specifically if the product strengths were based on the Chlorpromazine as Hydrochloride salt or the chlorpromazine base. · Additionally please share copies of the Summary of Product Characteristics (SmPC) and Patient Information Leaflets (PIL) for Largactil Tablets (25 mg, 50 mg, 100 mg). We are also seeking the below information on the currently approved product CHLORACTIL/Chlorpromazine HCl - 25 mg, 50 mg, 100mg originally approved in 1988 according to the SmPC published by the MHRA: · Whether Largactil and Chloractil were considered interchangeable (therapeutically equivalent) by MHRA or its predecessor agencies prior to the withdrawal of Largactil from the UK market in 2008. · Any guidance, regulatory decisions, or communications issued by MHRA (or its predecessor) on prescribing or substituting these products (Largactil and Chloractil) during the period of 1988 until 2008. · If available, the reason for Largactil’s withdrawal from the UK market. Please provide the requested information in electronic format via email. If any of the requested documents or information is already publicly available, kindly direct us to the relevant source.
Response
See attached
Documents
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