Freedom of Information request on the Marketing Authorisation Application for Nifedipine and Famotidine (FOI 22/377)
Published 31 May 2022
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FOI 22/377
14th February 2022
Dear
Thank you for your email.
Nifedipine Capsules 5 mg (PL 20395/0311) was granted by a CoA on 01 November 2018. The original marketing authorisation (MA), PL 13606/0056, was granted via an abridged simple application (HMR 56, formerly Article 10c) on 04 March 1998, showing identicality to Nifedipine Capsules 5 mg (PL 04569/0215). As this was authorised via an abridged simple application, no bioequivalence study was required to grant this MA. As this MA was authorised before it was a requirement for the UK to publish Public Assessment Reports (PARs), no PAR is available for this product.
Regarding PL 13606/0056, please see details above.
Famotidine 40 mg Film Coated Tablets (PL 04569/0423) was granted via an abridged standard application (HMR 51, formerly Article 10.1) on 02 July 2001, showing essential similarity to Pepcid 40mg (PL 00025/0216). As this MA was authorised before it was a requirement for the UK to publish Public Assessment Reports (PARs), no PAR is available for this product.
Famotidine 40mg Tablets (PL 11311/0478) was granted by a CoA on 21 September 2009. The original MA, PL 32019/0034, was granted via an abridged simple application (HMR 56, formerly Article 10c) on 03 July 2009, showing identicality to Famotidine 40mg Tablets (PL 11311/0227). As this was authorised via an abridged simple application, no bioequivalence study was required to grant this MA. A link to the PAR is provided below:
https://mhraproducts4853.blob.core.windows.net/docs/b59864af34c5680496493f1c5c6063cf9a1b79c7
Famotidine 40mg Tablets (PL 00289/0345) was granted by a incoming mutual recognition procedure (MRP) on 04 August 2000 (DE/H/0238/002/MR). The legal basis for the authorisation of this product was HMR 51 (formerly Article 10.1), showing essential similarity to Pepcid 40mg (PL 00025/0216). As this MA was authorised before it was a requirement for the UK to publish Public Assessment Reports (PARs), no PAR is available for this product.
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