Freedom of Information request (FOI 22/848)
Published 17 January 2024
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FOI 22/848
22nd August 2022
Dear
Thank you for your information request, dated 18 July 2022, where you asked for the information below:
“We were hoping to get hold of the trial data that supports the original licence and dose for menadiol (PL 16853/0110)
https://www.medicines.org.uk/emc/product/1349/smpc
Alliance Pharmaceuticals acquired Cambridge labs and they don’t have information regarding this.
Do you have any information that was originally submitted to the MHRA to gain the licence?”
This was granted by a CoA on 10 August 2010. The original marketing authorisation (PL 12070/0007) was authorised via an abridged simple on 30 April 1992. As this was an abridged simple application, no clinical trial data would have been submitted for this application, as they would have referred directly to the reference product, Synkavit Tablets (PL 00031/5115R), which was authorised as a reviewed licence on 28 March 1988.
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MHRA Customer Experience Centre