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Healthcare professionals prescribing montelukast should be alert to the risk of neuropsychiatric reactions in all patients including children and adolescents. Reported neuropsychiatric reactions include sleep disorders, hallucinations, anxiety and depression, as well as changes in behaviour and mood. Healthcare professionals...
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
The MHRA has approved the combined antibiotic cefepime/enmetazobactam (Exblifep 2 g/0.5 g powder for concentrate for solution for infusion)
A summary of recent letters and notifications sent to healthcare professionals about medicines.
Risk minimisation materials are available to support the safe use of new paediatric formulations of rivaroxaban (Xarelto) and dabigatran etexilate (Pradaxa). In addition, we ask healthcare professionals to consult the current advice to ensure that all patients with renal impairment...
Details of certificates issued under the Special Import System for the top ten veterinary medicines that were imported 1 Oct - 31 Dec 2023.
The MHRA has conducted a thorough assessment of technical and biological safety information provided by NSO and is satisfied that the modified MAGEC X system can now be used in the UK.
Information for healthcare professionals on pertussis (whooping cough).
Information for healthcare professionals and the public about the Pfizer/BioNTech vaccine.
Information for healthcare professionals and the public about the Pfizer/BioNTech's bivalent vaccines
The information in this leaflet is intended to give guidance for parents/carers whose children have been issued oseltamivir oral solution 15mg in 1ml, which has been specially made for children under 1 year old to treat seasonal flu.
Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by Marketing Authorisation Holders (MAHs)
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Details of certificates issued under the Special Import System for the top ten imported veterinary medicines 1 April - 30 June 2023.
Information for those who have been prescribed Paxlovid.
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