FOI release

Freedom of Information Request – Module 2.4 and 2.5 Overviews for Specified Products

This request was refused in part, so we didn't provide some of the information the requester asked for. This may include information where we can neither confirm nor deny that we hold it.

Case reference FOI2025/01173

Received 8 November 2025

Published 12 December 2025

Request

I am writing to request information under the Freedom of Information Act 2000. Specifically, I would like to obtain copies of the Module 2.4 (Non-clinical Overview) and Module 2.5 (Clinical Overview) sections submitted as part of the marketing authorisation dossiers for the following medicinal products: 1. Vitamins B + C Intravenous High Potency Concentrate for Solution for Infusion 2. Marketing Authorisation Holder: Demo Pharma UK Limited 3. PL 55035/0019 The requested documents are sought for regulatory and scientific reference purposes. Please provide electronic copies (PDF) of the M 2.4 and M 2.5 overviews, or if full copies cannot be released, any redacted versions available under MHRA disclosure policy.

Response

See attached

Documents

• FOI2025_01173 (redacted).pdf (1.1 MB)
• FOI2025_01173_Clinical (M 2.5) overview_redacted_Vitamins B + C Intravenous High Potency Conc for Soln for Inf PL 55035_0019.pdf (3.2 MB)
• FOI2025_01173_Non-clinical (M 2.4) overview_redacted_Vitamins B + C Intravenous High Potency Conc for Soln for Inf PL 55035_0019.pdf (11.6 MB)

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