FOI release

Freedom of Information request on the authorisation of Repevax ( FOI 21/1196)

Published 26 May 2022

FOI 21/1196

19th November 2021

Dear,

Thank you for your email.

According to our records, Repevax is authorised in the UK to Sanofi Pasteur Europe (PL 46602/0005). It was authorised on 30-11-2016 by a Change of Authorisation Holder from PL 06745/0121. PL 06745/0121 was granted by an incoming mutual recognition procedure on 19-11-2002 (DE/H/0215/001/MR). Our records also state that Repevax is not currently marketed. We would advise that you contact Sanofi Pasteur Europe for further information as to why this is.

Kind Regards

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU

Telephone 020 3080 6000