Freedom of Information request on Konakion MM Ampoules 10 mg/ml solution granted a Change of Authorisation Holder (FOI 21/1052)
Published 17 January 2022
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17th September 2021
FOI 21/1052
Dear
Thank you for your email.
Konakion MM Ampoules 10 mg/ml solution for injection (PL 45043/0040) was granted by a Change of Authorisation Holder (CoA) on 22 October 2020.
The original marketing authorisation was granted to Roche Products Limited (PL 00031/0254) on 17 August 1993, via the equivalent of an Article 10c application (abridged simple).
Kind regards,
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU