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Rosemont Pharmaceuticals Limited is recalling a single batch of Urospir 50mg/5ml Oral Solution (spironolactone) as a precautionary measure. The recall is due to errors in some of the dose calculation in millilitres being stated incorrectly in the SmPC and PIL....
Safety leaflet on topical corticosteroids and withdrawal reactions to help patients and their carers to use these medicines safely.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
How to get information including patient information leaflets (PILs), details on how the medicine can be used (SmPCs) and scientific reports (PARs).
Guidance on the collection, verification, and reporting of safety events in clinical trials of an investigational medicinal product.
A form of IP that extends the protection of patented active ingredients present in pharmaceutical or plant protection products.
Guidance on the process for ending a clinical trial.
Information about the reproductive risks of taking valproate medicines and the measures in place to reduce potential harm.
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