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A step-by-step guide on using the MORE Platform for Registrations for Submissions of device related incidents.
Importing investigational medicinal products for use in clinical trials
Information about ensuring blood and blood component safety.
How to join the phase I accreditation scheme.
The authorisation holder for dapagliflozin has withdrawn the indication for type 1 diabetes mellitus. The removal of the type 1 diabetes indication is not due to any new safety concerns and the other indications of dapaglifl…
Submission dates and how the submissions using the EC decision reliance procedure work.
Reporting, investigating and recalling suspected defective medicinal products to the Defective Medicines Report Centre (DMRC).
Forms to make a variation to a manufacturer's licence.
List of Field Safety Notices from 22 to 26 April 2024.
The Medicines and Healthcare products Regulatory Agency (MHRA) is working in partnership with Slimming World as part of the Agency’s wider #FakeMeds Campaign to encourage those wanting to lose weight to turn to safe, legitim…
Patients with severe alopecia areata (patchy hair loss) could access a new medicine to help treat their condition.
A short course (3 to 7 days) may be used with caution in certain patients with an eGFR of 30 to 44 ml/min/1.73m2
Public Assessment Report of review of Finasteride safety data and expert advice on management of risks.
Guidance on how to submit changes to labelling and patient information leaflets to MHRA.
Other effective medicines are available for epilepsy and bipolar disorder and valproate should only be used if these don’t work or aren’t suitable for an individual patient
Different antiepileptic drugs (AEDs) vary considerably in their characteristics, which influences the risk of whether switching between different manufacturers’ products of a particular drug may cause adverse effects or loss…
Manufacturer licences including importer licences, specials, investigational and non orthodox and wholesale distribution licences.
The new safety measures being introduced in UK are for male and female patients
Register as a manufacturer, importer or distributor of active substances.
MHRA has received a small number of reports suggesting lack of efficacy (thromboembolic events) in patients taking 15 mg or 20 mg rivaroxaban on an empty stomach; remind patients to take 15 mg or 20 mg rivaroxaban tablets wi…
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