Freedom of Information request on the first Summary of Product Characteristics (SmPC) for Flomaxtra XL (FOI 21-520)
Published 13 August 2021
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14th June 2021 FOI 21/520
Dear
Many thanks for your email.
Regarding your request for the first Summary of Product Characteristics (SmPC) for Flomaxtra XL, 400 micrograms, film-coated prolonged-release tablet (PL 00166/ 0199), we have searched our electronic records and the earliest SmPC that we hold dates from 10 October 2006 (please see attached). Unfortunately, because of the current restrictions with lockdown because of the Covid-19 pandemic, we are unable to access any records we hold for this product licence in our paper archive.
Regarding your request for the Public Assessment Report (PAR) for this product, as the legal requirement for the UK to publish PARs for new marketing authorisations only came into force on 31 October 2005, no PAR was published for this product.
Best regards
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU