Norgine Limited is recalling one batch of product as a precautionary measure due to some units containing low amounts of active ingredients.
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Class 2 Medicines Recall: Zaditen 0.25 mg/ml, eye drops, solution, Laboratoires Théa EL(25)A/34
Laboratoires Théa trading as Thea Pharmaceuticals Limited have notified the MHRA of an out of specification event related to environmental monitoring during manufacturing, which may increase the risk of microbial contamination of the medicinal product.
Guidance: Pharmacovigilance following agreement of the Windsor Framework
Information on the implementation of changes to pharmacovigilance for medicines authorised in the UK following the agreement of the Windsor Framework.
Valproate (Belvo, Convulex, Depakote, Dyzantil, Epilim, Epilim Chrono or Chronosphere, Episenta, Epival, and Syonell▼): updated safety and educational materials to support patient discussion on reproductive risks
Updated safety and educational materials are now available to support the implementation of the regulatory measures announced in the November 2023 National Patient Safety Alert and the September 2024 Drug Safety Update. They also include previous updates to product information on the risk of low birth weight in children exposed to valproate during pregnancy.
MHRA statement on the PATHWAYS puberty blocker trial
With all complex clinical trials, MHRA’s top priority is the safety and wellbeing of the trial participants
Public advised to stop using certain non-sterile alcohol-free wipes
Due to risk of infection, non-sterile alcohol-free wipes are not appropriate for the treatment of injuries, wounds or on broken skin, nor for cleaning of intravenous lines.
Statutory guidance: MHRA fees
Fees payable to the MHRA from 2025.