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Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster.
How to submit your periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER)
How a marketing authorisation holder should report a defect with a veterinary medicine.
Viatris has received reports of brown discolouration and blockage in the needle of pre-filled syringes of Arixtra. This quality defect is related to oxidation of the syringe needle.
Baxter Healthcare Corporation have informed the MHRA that the Patient Information Leaflet (PIL) packed in specified batches does not contain up to date information relating to the duration of contraception required for females after stopping taking this medication.
Change to the information provided on adverse events for Profender Modified-release Tablets, Profender Spot-on Solution and Profender Multi-dose Spot-on Solution in the SPC.
Fake medicines are illegally produced products that may contain incorrect ingredients, no active ingredients, or harmful substances.
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