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The approach the MHRA intends to take for products approved or pending in decentralised procedure (DCP) or mutual recognition procedures (MRP).
Risk of accidental overdose, particularly in infants and neonates.
The Medicines and Healthcare products Regulatory Agency (MHRA) has reinforced its safety guidance on the steps to take in anaphylaxis, after new figures obtained by the MHRA show more than 25,000 admissions to English hospit…
Download MHRA's Request for Further Information (RFI) response template, with guidance on how to complete it.
Guidance for importers of unlicensed human medicines on meeting the requirements of the TSE (Transmissible Spongiform Encephalopathies) guidelines.
Cipla (EU) Limited, UK and Pharmathen S.A. have informed the MHRA that the outer carton (box) of the product batches mentioned in this notification are missing the medicines legal classification for a Prescription Only Medic…
Neon Healthcare Ltd is recalling the specific batch mentioned in this notification as a precautionary measure.
Updated contraindications and maximum dose recommendations when taken with a number of other medicines.
The MHRA has approved the combined antibiotic cefepime/enmetazobactam (Exblifep 2 g/0.5 g powder for concentrate for solution for infusion)
Healthcare professionals should consider measuring magnesium levels before starting PPI treatment and repeat measurements periodically during prolonged treatment.
The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
These reports outline the MHRA’s Corporate and Business Plans, detailing the agency's strategic direction over the next three years.
An interpretation of the good manufacturing practice (GMP) requirements for specials manufacturers.
Launched in January 2024, IRP aims to further help bring life-saving new medicines to UK patients without delay
Dame June Raine, MHRA's Chief Executive, will be stepping down in the Autumn following five years in the role
Guidance for marketing authorisation holders on drafting direct healthcare professional communications (DHPCs)
Updated advice on use of nicorandil as second-line treatment for stable angina - some ulcers may progress to complications unless treatment is stopped.
MHRA is updating advice provided in MDA/2012/036, to assist the early detection of soft tissue reactions in patients implanted with metal-on-metal (MoM) hip replacements (MDA/2017/018)
Exeltis UK Limited has informed the MHRA regarding an inconsistency in the Patient Information Leaflet (PIL) packaged in cartons of the specified batches of Gepretix 100mg capsules.
Reminder on risk of serious and fatal toxicity in overdose.
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