CRED NPM

05/11/2024

Internal

Rationale for the switch

● SAR: well-established non-prescription/ GSL category, with well-recognised symptoms. Suitable for self-selection and treatment

● Most of the other 2 nd generation antihistamines were classified as non-prescription/ GSL drugs

● WW legal status overview: fexofenadine has been approved for over 20 years in over 110 countries; the experience of its use without a prescription shows a similar profile to that observed in the clinical trials and post-marketing experience

● Very good safety profile of fexofenadine: ➢ The most commonly reported AEs are minor and can be resolved on discontinuation of treatment ➢ Unlike some other antihistamines, fexofenadine is non-sedating and a once daily treatment

The Organisation for Professionals in Regulatory Affairs

5

Internal

Benefits of reclassification

✓ The increase in choice of antihistamines for SAR is a benefit to the public

✓ Easier and quicker access to effective and safe medicine, allowing people more autonomy and choice

✓ It enables self-care

✓ It reduces pressure on our healthcare system

✓ It strengthens the wider economy

Fexofenadine a justifiable candidate for an approvable reclassification

The Organisation for Professionals in Regulatory Affairs

6

3