Public Assessment Report of the Reclassification of Allevia 120mg Tablets
This PAR covers the assessment of an application to reclassify Allevia 120mg tablets from Prescription Only Medicine (POM) to General Sales List (GSL).
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Allevia 120mg Tablets can be used for the relief of symptoms associated with seasonal allergic rhinitis (SAR) in adults and children aged 12 years and over. 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 tablet contains 120 milligrams of fexofenadine hydrochloride.
It is manufactured by Aventis Pharma Limited.
PL 04425/0667 - 0042
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.