CRED NPM

05/11/2024

Internal Regulatory Background

1996: Fexofenadine was first approved in the UK 1997: Fexofenadine approved in FR

2000: First attempt at reclassification in the UK in 2000 → refused by CHM. 2012: First attempt at reclassification in FR -> Rejection from ANSM

The change of legal status from prescription medicine only to non-prescription medicine has been approved in numerous countries (Finland: first country to switch in 2008).

2019: SAM with MHRA December 2021: GSL approval

2022: New switch attempt in FR October 2023: Switch approval

The Organisation for Professionals in Regulatory Affairs

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Internal

ALLEVIA direct switch from POM to GSL in the UK

The Organisation for Professionals in Regulatory Affairs

The Organisation for Professionals i Regulatory Affairs

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