FOI release

Freedom of Information request on the marketing authorisations for Antepsin (FOI 21/1065)

Published 25 February 2022

24th September 2021

FOI 21/1065

Dear

Thank you for your email.

The reason for the cancellation of each of the marketing authorisations for Antepsin is provided below:

PL 12185/0010 ANTEPSIN 1G/5ML – This was cancelled at the request of the MAH on 27 September 2019

PL 12185/0009 ANTEPSIN 500MG - This was cancelled at the request of the MAH on 29 December 2005

PL 12185/0008 ANTEPSIN 1G – This licence was cancelled because of Sunset Clause provisions on 30 May 2019.

PL 00607/0045 ANTEPSIN TABLETS – This licence was cancelled but we have no further records on when or why this occurred.

PL 00011/0176 ANTEPSIN TABLETS 1G - Change of Authorisation Holder (CoA) to PL 12185/0008, granted 01 December 1998

PL 00011/0175 ANTEPSIN TABLETS 500MG – Change of Authorisation Holder (CoA) to PL 12185/0009, granted 01 December 1998

PL 00011/0160 ANTEPSIN SUSPENSION 1 GRAM/5ML – Change of Authorisation Holder (CoA) to PL 12185/0010, granted 01 December 1998

Kind regards,

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU