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You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.
Addition of a polyethylene glycol (PEG)-based laxative to a liquid that has been thickened with a starch-based thickener may counteract the thickening action, placing patients with dysphagia at a greater risk of aspiration.
This guidance sets out the legal framework for patient information leaflets as described in EU and national legislation and best practice in the area of information design.
List of Field Safety Notices from 29 April to 3 May 2024.
Do not use codeine in children under 12 as it is associated with a risk of respiratory side effects. Codeine is not recommended for adolescents (12 to 18) who have problems with breathing.
How to license a medicine for sale in the UK, including national and international routes, and information on fees.
Information on the implementation of labelling and packaging requirements for medicinal products for human use under the Windsor Framework.
Advice on writing clear notices and maximising replies to your FSNs.
The MHRA has made further changes to the way we issue safety messaging to healthcare providers.
Onsenal▼ (celecoxib) is no longer approved in Europe for the reduction of intestinal polyps in familial adenomatous polyposis (FAP).
Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
May cause skin irritation, particularly in children with eczema, possibly due to sodium lauryl sulfate content.
No one should stop taking valproate without advice from their healthcare professional
How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines.
This guidance identifies common issues with validation and assessment of clinical trial applications and how to avoid them.
Information for healthcare professionals on how pulse oximeters are regulated, home use and issues to look out for when using the devices
Cases of serotonin syndrome have been identified in associated with bupropion, especially in overdose or when bupropion is administered with other drugs with a serotonergic effect.
The actions to take for sourcing medicines in different circumstances.
Concerns over recent years about the use of antipsychotics to treat the behavioural and psychological symptoms of dementia (BPSD).
In view of data showing ongoing exposure to valproate in pregnancy, this article reminds healthcare professionals of the risks in pregnancy and the current Pregnancy Prevention Programme requirements, and provides informatio…
Don’t include personal or financial information like your National Insurance number or credit card details.
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