Freedom of Information request on reference medicinal products during the initial marketing authorisation applications for Nifedipine Capsules 10 mg and Famotidine 20mg Tablets (FOI 22/478)
Published 31 May 2022
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FOI 22/478
25th February 2022
Dear
Thank you for your email.
Nifedipine Capsules 10 mg (PL 20395/0286) was granted by a Change of Authorisation Holder (CoA) on 27-09-2018. The original authorisation was for PL 13606/0057, which was authorised as an abridged simple (Article 10c, informed consent) application on 04 March 1998. As this was granted as an abridged simple application, no reference medicinal product was stated in the application and bioequivalence was not required to be shown. As this application was granted before the legislation requiring regulators to publish Public Assessment Reports (PARs) came into force, no PAR exists for this marketing authorisation.
Famotidine 20mg Tablets (PL 11311/0477) was granted by a Change of Authorisation Holder (CoA) on 21-09-2009. The original authorisation was for PL 32019/0033, which was authorised as an abridged simple (Article 10c, informed consent) application on 03 July 2009. As this was granted as an abridged simple application, no reference medicinal product was stated in the application and bioequivalence was not required to be shown. A link to the PAR for this product is provided below:
https://mhraproducts4853.blob.core.windows.net/docs/b59864af34c5680496493f1c5c6063cf9a1b79c7
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