The Pharmaceutical Journal
Vol 269 No 7215 p349
14 September 2002

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Medicines Control Agency (www.mca.gov.uk)

Beconase to be a GSL medicine

GLAXOSMITHKLINE has asked the Medicines Control Agency to make Beconase Hayfever nasal spray a general sale list medicine.

In discussion with the MCA, GSK has agreed to change the product's name to Beconase Hayfever Relief for Adults and to restrict indications for the reclassified product to the treatment of seasonal allergic rhinitis in adults aged 18 years and over. In addition, pack sizes will be restricted to 100 puffs, and users will be told to seek medical advice if their symptoms have not improved after seven days use and not to use the product for more than a month without medical advice. A warning will also be included in the patient information leaflet that the product could stunt growth if used by children.

In consultation letter ARM5 (Microsoft Word document), the MCA says that Beconase Hayfever nasal spray has been available as a prescription product since 1983 with a well established safety profile which was not significantly changed by its availability as a pharmacy medicine since 1993. The MCA says that the product meets the criteria necessary to become a GSL medicine.