We use some essential cookies to make this website work.
We’d like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services.
We also use cookies set by other sites to help us deliver content from their services.
You have accepted additional cookies. You can change your cookie settings at any time.
You have rejected additional cookies. You can change your cookie settings at any time.
Departments, agencies and public bodies
News stories, speeches, letters and notices
Detailed guidance, regulations and rules
Reports, analysis and official statistics
Consultations and strategy
Data, Freedom of Information releases and corporate reports
GlaxoSmithKline UK Ltd have informed the MHRA that an incorrect version of the Summary of Product Characteristics section 4.2 and the Patient Information Leaflet is inside the sealed pack, and contains unapproved text.
A patient alert card is being introduced for men taking finasteride to help raise awareness of the risk of psychiatric side effects and sexual dysfunction, including the potential for sexual dysfunction to persist after treatment has stopped. Healthcare professionals are...
Travel and clinical advice on Cyclospora including characteristics, symptoms, diagnosis and epidemiology.
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
Healthcare professionals prescribing montelukast should be alert to the risk of neuropsychiatric reactions in all patients including children and adolescents. Reported neuropsychiatric reactions include sleep disorders, hallucinations, anxiety and depression, as well as changes in behaviour and mood. Healthcare professionals...
AVU provides services for genotypic antiviral resistance testing of HIV and HCV, investigation of HIV transmission events and HSV antiviral resistance testing by phenotyping.
Information for British nationals who are victims of rape and sexual assault in the Federated States of Micronesia.
Information for patients who have been prescribed Paxlovid (nirmatrelvir 150mg and ritonavir 100mg) film-coated tablets COVID-19 antiviral medication.
Examples of viral haemorrhagic fevers (VHFs) include Lassa fever, Crimean-Congo haemorrhagic fever, Marburg and Ebola virus diseases.
Safety leaflet on topical corticosteroids and withdrawal reactions to help patients and their carers to use these medicines safely.
Check the tariff classification for surface-active preparation for washing the skin and the hair (gel 2-in-1).
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Search for information about medicines including patient information leaflets (PILs), details on how the medicine can be used (SmPCs) and scientific reports (PARs).
Collection of information and guidance for patients and for healthcare professionals on the reproductive risks of valproate and new safety measures introduced to reduce these risks.
GlaxoSmithKline UK are recalling multiple batches of 125ml bottles of the above product. This is due to incorrect dosing instructions on the patient information leaflet advising patients to take half the recommended dose - class 2 action within 48 hours....
An overview of the process including submitting or fast tracking an application, naming your medicine and paying fees.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
Advice and guidance on the health needs of migrant patients from Uruguay for healthcare practitioners.
Don’t include personal or financial information like your National Insurance number or credit card details.
To help us improve GOV.UK, we’d like to know more about your visit today. We’ll send you a link to a feedback form. It will take only 2 minutes to fill in. Don’t worry we won’t send you spam or share your email address with anyone.