Research and analysis

Public Assessment Report of the reclassification of Sudafed Plus Blocked Nose 1mg/50mg/ml Nasal Spray Solution

This PAR covers the assessment of the proposal to make Sudafed Plus Blocked Nose 1mg/50mg/ml nasal spray solution, containing xylometazoline hydrochloride 1mg/ml (0.1% w/v) and dexpanthenol 50mg/ml (5% w/v), available through pharmacies.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 3 August 2022

Documents

Sudafed Plus Blocked Nose 1mg/50mg/ml Nasal Spray Solution - Public Assessment Report (PAR)

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Sudafed Plus Blocked Nose 1mg/50mg/ml Nasal Spray Solution - Public Assessment Report (PAR)

PDF, 138 KB, 6 pages

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Details

Sudafed Plus Blocked Nose 1mg/50mg/ml nasal spray solution can be used for the symptomatic relief of nasal congestion associated with the common cold, influenza, sinusitis, allergic and non-allergic rhinitis (vasomotor rhinitis), other upper respiratory tract allergies in adults and children aged 12 years and over.

Sudafed Plus Blocked Nose 1mg/50mg/ml nasal spray solution contains xylometazoline hydrochloride 1mg/ml (0.1% w/v) and dexpanthenol 50mg/ml (5% w/v).

The marketing authorisation holder, McNeil Products Limited, applied to change the legal status of this product from Prescription Only Medicine (POM) to a Pharmacy (P) medicine.

The Medicines and Healthcare Products Regulatory Agency (MHRA) considers this product sufficiently safe to be sold as a pharmacy medicine. This report outlines the evidence that the MHRA reviewed and which led to the decision to approve the application.

Published 3 August 2022