Medicines Healthcare Products Regulatory Agency
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.