Freedom of Information request on the BP monographs for Benzatropine Mesilate and Bezatropine Tablets (FOI 22/540)
Published 14 June 2022
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FOI 22/540
11th April 2022
Dear
Thank you for your email.
I am pleased to provide you with some of the information requested, see below.
According to our records, the BP monographs for Benzatropine Mesilate and Bezatropine Tablets were published prior to 1987 based on technical input from the manufacturer at the time, May and Baker Pharmaceuticals to the British Pharmacopoeia Commission. The monograph has been updated several times since then to its current form.
According to our records the BP monograph for prochlorperazine mesilate was initially published in BP 1963, based on technical input from the manufacturer at the time, May and Baker Pharmaceuticals to the British Pharmacopoeia Commission. The monograph has been updated several times since then to its current form.
Given the age of these monographs, they pre-date the close links between the BP Commission and the MHRA and it is unlikely they would have undergone review by Licensing Assessors prior to publication.
At the present time there are no UK product licences in our database, nor listed in the BNF (subscription) or the electronic Medicines Compendium (no subscription needed). According to an online search this product “Cogentin” was discontinued in May 2012 (https://www.netdoctor.co.uk/medicines/brain-nervous-system/a6443/cogentin-discontinued-in-the-uk-may-2012/). This product does however appear to be still available in other territories (e.g. the US - https://www.webmd.com/rx/drug-prices/benztropine-mesylate).
Prochlorperazine Mesilate Injection and Oral Solutions are currently licensed in the UK (Stemetil Solution for Injection and Syrup, PL 04425/0590 and 04425/0595, respectively) from Sanofi-Aventis and Prochlorperazine Injection, PL 12762/0599, from Mercury Pharma. The confusion here appears to be because the substance is named as per the BP monograph (prochlorperazine mesilate) so a search for “prochlorperazine dimesilate” would not have returned any results. Apologies for the incorrect information given previously.
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