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Guidance for Marketing Authorisation Holders and holders of other types of authorisations on their responsibilities for veterinary pharmacovigilance and how to report suspected Adverse Events.
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...
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
Employment Appeal Tribunal Judgment of Judge Shanks on 22 February 2024.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
Explainer for the pharmaceutical industry on Pharmacovigilance requirements mitigations to bridge the gap between the implementation of the EU Regulation on veterinary medicines and the revised Veterinary Medicines Regulations as they have an effect in Great Britain (GB VMR).
Information for public health professionals on immunisation.
A report covering adverse reactions to approved COVID-19 vaccines
Urgent safety updates arising from pharmacovigilance data, including reported adverse events, for veterinary medicines authorised in the UK.
Further measures to be introduced to ensure patients who are prescribed montelukast for the treatment of asthma are informed of the risk of neuropsychiatric reactions
Who you should contact if a pet or other animal or human has an unexpected reaction to a veterinary medicine or a problem with a microchip
Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
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