Public Assessment Report of the Reclassification of Benacort Hayfever Relief for Adults 64 micrograms, nasal spray from POM to GSL
This PAR covers the assessment of an application to reclassify Benacort Hayfever Relief for Adults 64 micrograms, nasal spray from Prescription Only Medicine (POM) to General Sales (GSL).
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Benacort Hayfever Relief for Adults 64 micrograms, nasal spray is a medicine sprayed inside the nose for the treatment of seasonal allergic rhinitis (hayfever) in adults and adolescents aged 18 years and over.
The full name of the medicine is Benacort Hayfever Relief for Adults 64 micrograms, nasal spray. Each spray of the product contains 64 micrograms of budenoside.
It is manufactured by McNEIL PRODUCTS LIMITED.
PL 15513/0409
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.