Freedom of Information request on the clinical study report for Amitriptyline 25 mg Film-coated Tablets (PL 13606/0251) (FOI 21/746).
Published 29 December 2021
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20th July 2021
FOI 21/746
Dear
Thank you for your communication, dated 29 June 2021, in which you requested the clinical study report for Amitriptyline 25 mg Film-coated Tablets (PL 13606/0251).
Please note that a bioequivalence study was not required for the approval of the marketing authorisation application for Amitriptyline 25 mg Film-coated Tablets (PL 13606/0251). A biowaiver was accepted according to the criteria for BCS-based biowaivers, as outlined in the CHMP Guideline on the investigation of bioequivalence (CPMP/EWP/QWP/1401/98 Rev. 1/ Corr **).
For further information, please see the link below to the Public Assessment Report for Amitriptyline 10 mg, 25 mg and 50 mg Film-coated Tablets (PL 13606/0250-0252).
https://mhraproducts4853.blob.core.windows.net/docs/5f89e66128de5d40db7502215109cb2c234a0288
I now consider this request closed. If you require any further information, please respond to the FOI Licensing Team at [email protected].
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Yours sincerely,
The FOI Licensing Team