Information on Medicines and Healthcare products Regulatory Agency spending over £25,000.
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Nirogacestat hydrobromide approved to treat desmoid tumours
As with any medicine, the MHRA will keep the safety and effectiveness of Nirogacestat hydrobromide under close review.
Class 2 Medicines Recall: Depo-Medrone 80 mg in 2 mL, Maxearn Limited EL(25)A/29
A batch of Depo-Medrone has been released to the market with an error. The vial over label incorrectly states that the total vial content is 40 mg in 1 mL, when the correct total vial content is 80mg in 2 mL (with a concentration of 40mg/ml of methylprednisolone acetate).
Consultation on the Revised International Council for Harmonisation Guideline M4Q(R2)
The MHRA is consulting with UK stakeholders to gather feedback and comments on a revised international guideline, M4Q(R2).
Research: Report of The Commission on Human Medicines Isotretinoin Implementation Advisory Expert Working Group
Report of Isotretinoin Implementation Advisory Expert Working Group regarding recommendations to strengthen the safe use of isotretinoin, the acne medicine commonly known by brand names Roaccutane and Reticutan.
Medicines: apply for a variation to your marketing authorisation
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
Increased risks identified with Profemur cobalt chrome modular neck hip replacements
Patients implanted with affected devices should expect to be contacted directly for a follow-up assessment, if required.