Update: Phenylephrine – Lack of Effectiveness of Oral Preparations as Nasal Decongestant

Update: Phenylephrine – Lack of Effectiveness of Oral Preparations as Nasal Decongestant

This document is intended to communicate with the Holders of Certificates of Registration (HCRs) of orally administered phenylephrine-containing medicines.

 

Following the communication issued to stakeholders on 30 July 2024 regarding the ineffectiveness of oral phenylephrine preparations as nasal decongestants, HCRs for orally administered phenylephrine-containing medicines were given 90 days to respond, as outlined in the communication.

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Document Number: CLINPR03-2024/25
Version: 1
Date Updated: 28/01/2025
File Type: pdf
Category: Communication to industry
Unit: Clinical Evaluations Management, General ECTD & human medicines