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Risk of meningioma with cyproterone acetate increases with increasing cumulative dose. Use of cyproterone is contraindicated in patients with previous or current meningioma (for all indications) and should only be considered for control of libido in severe hypersexuality or paraphilias...
Patients with existing meningioma or a history of meningioma must not be prescribed high-dose (≥25 mg per day) cyproterone acetate.
Updated prescribing advice provided.
Government response to the ACMD's review of the evidence on the use and harms of Cumyl-PeGaClone.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (9 April 2024) approved the medicine fosdenopterin (Nulibry) to treat the genetic disease Molybdenum Cofactor Deficiency (MoCD) Type A
Product Safety Report for PTS Packers and Providers Pvt Surfaz-SN Triple Action Cream presenting a serious chemical risk.
The MHRA has authorised cabotegravir as 30 mg tablets and as a 600 mg long-acting injection administered every two months
Protein C (PrC) regulates inflammation and cell death and has known predictive/therapeutic roles in sepsis
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
Systematic reviews and meta-analyses of randomised controlled trials have highlighted a dose-dependent increased risk of atrial fibrillation in patients with established cardiovascular diseases or cardiovascular risk factors treated with omega-3-acid ethyl ester medicines compared to placebo.
Product Safety Report for Esapharma Movate Steroid Cream presenting a serious chemical risk.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
Product Safety Report for Front Pharmaceutical Tydineal Steroid Cream presenting a serious chemical risk.
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
Reported problems with the supply of an animal medicine and the date when the issue is expected to be resolved.
This guidance provides information on comparator products used in studies supporting abridged marketing authorisation applications
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