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MHRA approves Nasacort nasal spray for general sale

The UK Ministry of Healthcare Products Regulatory Agency (MHRA) announced that it has approved an application from Aventis Pharma (Sanofi) to reclassify Nasacort Allergy Relief triamcinolone acetonide nasal spray for the treatment of allergic rhinitis in patients aged 18 and over from a pharmacy (P) medicine to a general sales list (GSL) product. Nasacort was approved as a P medicine in 2001 and has been available from pharmacies in the UK since 2009; the reclassification will allow it to be sold in grocery stores and other retail outlets.

In the US, the FDA approved over-the-counter sales of Nasacort Allergy 24HR for ages 2 and over in 2013. The dosage level of both Nasacort Allergy Relief and Nasacort Allergy 24HR is 55 mcg/dose.

According to the MHRA’s Public Assessment Report, “There has been a low reporting rate of adverse events since Nasacort Allergy has been available as a P medicine, in particular, there have been 45 adverse events reported, some of which are common amongst other nasal steroid sprays.”

Read the MHRA Public Assessment Report.

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published on May 28, 2021

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