Freedom of Information request (FOI 22/618)
Published 17 January 2024
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19th October 2022
FOI 22/618
Dear
Thank you for your email and we apologise for delay in response.
On 12th April 2022 we received you request under the Freedom of Information Act “copies of toxicity/teratogenicity study results for the combination of Dicyclomine and Doxylamine (without Pyridoxine) as used in the drug Debendox which you may hold by Merrell Dow Pharmaceuticals and Committee on Safety of Medicines.” This request was also made in October 2020 and we replied on 16th October 2020 (FOI 20/396). In this response we noted that your request might cover information that is held in our paper archives, which are stored externally. Given the ongoing COVID-19 outbreak at that time and agency staff working remotely we were not able to access these materials. We have now consulted the paper archive and can confirm that we have not identified information fulfilling your request in relation to a dual combination product with doxylamine and dicyclomine.
If you disagree with how we have interpreted the Freedom of Information Act 2000 in answering your request, you can ask for an internal review. Please reply to this email, within two months of this reply, specifying that you would like an Internal Review to be carried out.
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Yours sincerely
MHRA Customer Experience Centre