Public Assessment Report of the Reclassification of Nasacort Allergy Relief for Adults 55 micrograms/dose, nasal spray, suspension
This PAR covers the assessment of an application to reclassify Nasacort Allergy Relief for Adults 55 micrograms/dose, nasal spray, suspension from Pharmacy (P) medicine to General Sales List.
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Nasacort Allergy Relief for Adults 55 micrograms/dose, nasal spray, suspension (hereafter referred to as Nasacort Allergy) can be used for the relief of symptoms associated with seasonal allergic rhinitis (SAR) in adults aged 18 years and over. These symptoms include sneezing, itchy and runny nose, itchy, red or watery eyes, nasal congestion or associated sinus discomfort.
Allergic rhinitis is inflammation of the inside of the nose caused by an allergen. An allergen is a substance that causes an allergic response. ‘Seasonal’ allergic rhinitis is when symptoms occur at the same time each year in response to a seasonal allergen, for example grass and tree pollen allergens. It is also known as hay fever.
Each spray contains 55 micrograms of triamcinolone acetonide.
The licence holder, Aventis Pharma Limited, applied to change the legal status of this product from a Pharmacy (P) medicine to a General Sales List (GSL) medicine (see Background for definition).
The Medicines and Healthcare Products Regulatory Agency (MHRA) considers this product sufficiently safe to be sold on general sale. This report outlines the evidence that the MHRA reviewed and which led to the decision to approve the application.