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As with any medicine, the MHRA will keep the safety of gepotidacin under close review.
Information on applying for New Active Substance Work Sharing Initiative (NASWSI) and Biosimilar Work Sharing Initiative (BSWSI) assessments and list of approved products.
Reported problems with the supply of an animal medicine and the date when the issue is expected to be resolved.
Summary of the latest safety advice for medicines and medical device users
The MHRA’s Interim Executive Director of Science and Research writes in The British Medical Journal on the approval of the UK’s first new UTI antibiotic in nearly 30 years, and the wider challenge of tackling antibiotic resistance.
Hikma Farmacêutica (Portugal) S.A has informed the MHRA that the Patient Information Leaflet (PIL) contained within batch CB0033 of Gemcitabine 2g/52.6ml concentrate for solution for infusion does not contain the side effects of serious skin reactions.
For manufacturers and distributors of intermediate and final feedingstuffs containing a medicinal premix or specified feed additives.
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