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MHRA omeprazole

This article was originally published in The Tan Sheet

Executive Summary

UK medicines agency seeks comments by June 27 on reclassification of Gastro-resistant Tablets (omeprazole 10 mg) from "prescription only medicine" to "pharmacy status," according to May 16 1MHRA consultation document. Galpharm Healthcare's reclassification proposal "restricts omeprazole sale to 10 mg x 28 tablets (14-28 days treatment) and advises against long-term use without reference to the pharmacist," agency notes. Proposed P status "and pack size will also limit the indirect danger posed by the masking of serious underlying disease, which is in line with the approved dosage regimens for nonprescription omeprazole in Sweden and the USA," MHRA states. FDA has deemed AstraZeneca/P&G's Prilosec approvable for OTC use pending label revisions (2"The Tan Sheet" Aug. 26, 2002, In Brief)...

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