FOI release

Freedom of Information request on the marketing authorisation for Micralax Micro Enema (FOI 21-528)

Published 13 August 2021

8th June 2021 FOI 21/528

Dear

Thank you for your email of 20 May 2021.

The marketing authorisation for Micralax Micro Enema (PL 36301/0019) was granted by a Change of Authorisation Holder (CoA) on 05 July 2010. The original marketing authorisation was granted as an abridged simple (Article 10c) application on 28 June 1991 (PL 00039/0368). As the grant of the original product licence pre-dates the legal requirement for MHRA to publish Public Assessment Reports (PARs) for newly granted marketing authorisations, no PAR has been produced or will be published for this product.

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Yours sincerely

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