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How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
Safety leaflet on topical corticosteroids and withdrawal reactions to help patients and their carers to use these medicines safely.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
Guidance for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion.
How a product complies with EU safety, health and environmental requirements, and how to place a CE marking on your product.
Details of the system for reporting adverse drug reactions from medicines or adverse incidents with medical devices in the UK.
Guidance for people with symptoms of a respiratory infection including COVID-19, or a positive test result for COVID-19.
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
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