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Novartis's pain drug among latest MHRA reclassifications

This article was originally published in Scrip

Executive Summary

Novartis's 12.5mg immediate-release tablets of diclofenac potassium, Voltarol Pain-Eze, are now available without a prescription after the UK medicines regulator, theMHRA, reclassified them to over-the-counter pharmacy status. Novartis proposed the change in November 2007 (Scrip No 3315, p 3) when it said that the product was already marketed in more than 50 countries as an OTC drug. In its round-up of reclassifications over the past 12 months, the MHRA reports that it has reclassified naproxen 250mg tablets from prescription-only to pharmacy status. It has also moved diclofenac diethylammonium from pharmacy-only status to the general sales list (GSL), and increased its maximum pack size from 30g to 50g. Cetirizine is also now available on general sale and its maximum pack size has been increased from seven to 14 tablets. The MHRA says that the Commission on Human Medicines has advised against the reclassification of fluconazole 150mg capsules from pharmacy to GSL status, following concerns raised during the public consultation exercise.

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