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Chemidex Pharma Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in their topical steroid products does not contain all the required safety information. Cartons for the products/batches listed are missing side effect information related to Visual Disturbances....
Sun Pharmaceutical Industries Europe B.V. is recalling those product batches listed in this notification as a precautionary measure due to out of specification results reported for the Particulate Matter Test (PMT) during stability testing.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved eplontersen (Wainzua) to treat adults with polyneuropathy associated with hereditary transthyretin amyloidosis (ATTRv), which is a rare progressive condition that runs in families caused by a protein called transthyretin (TTR).
Information on comparator products used in studies supporting abridged marketing authorisation application.
Blumont Pharma Limited has informed the MHRA of an error with the European Article Number (EAN) barcode on the cartons of the batch of Chloramphenicol 1% w/w Eye Ointment (POM version only) in the below table.
Applications received to amend the specification of a patent under sections 27 and 75 before the court and the Office.
Prescribing or supplying veterinary medicines including requirements for registration and inspection of premises.
Information on taking, submitting and processing samples which potentially contain MPXV.
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