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Following a comprehensive scientific safety review of the latest available data on the safety of pholcodine, together with advice from the independent Commission on Human Medicines, it has been concluded that the potential r…
The risk of foetal malformation with oral retinoids is extremely high, even when used at a low dose or for a short time during pregnancy. All oral retinoids have an associated Pregnancy Prevention Programme (PPP), which is s…
Oral lidocaine-containing products for infant teething are only to be available under the supervision of a pharmacist so that parents and caregivers can receive guidance about managing infant teething symptoms. Non-medicinal…
Doses of theophylline, fluvoxamine, caffeine, coumarins including warfarin and the antipsychotics clozapine and olanzapine may have to be altered.
Information for healthcare professionals and the public about COVID-19 Vaccine AstraZeneca.
Breastfed babies might very rarely develop side-effects due to the presence of morphine in breast milk.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (21 May 2024) launched a four-week consultation which will support improved safety for certain high risk in vitro diagnostic (IVD) devices.
A list of PLGB numbers for the grandfathering of CAP MAs.
Guidance on whether or not your product is a medical device.
Information for manufacturers of Software as a Medical Device, detailing events that may cause indirect harm and are therefore reportable.
The Medicines and Healthcare Regulatory Agency (MHRA) has released a statement on CE marking recognition for medical devices and in vitro diagnostics.
Medicines and Healthcare products Regulatory Agency (MHRA) good manufacturing practice (GMP) deficiencies since April 2010.
Latest evidence suggests long-term use of combined oral contraceptives or progestogen-only injectable contraceptives is associated with a small increased risk of cervical cancer.
A large study has shown no safety issues of concern relating to the use of metformin during pregnancy. The licence for metformin now reflects that it can be considered for use during pregnancy and the periconceptional phase …
List of Field Safety Notices (FSNs) from 22 to 26 May 2023
Following the conclusion of a review of post-marketing safety data by the MHRA, all pholcodine-containing medicines are being recalled and withdrawn from the UK as a precaution.
This alert highlights the Adult Renal Association Clinical Practice Guidelines (2020) recommendation on calcium gluconate use to support organisations to update local policies and guidelines for the treatment of severe hyper…
A clinical trial has shown an increased risk of recurrent thrombotic events associated with rivaroxaban compared with warfarin, in patients with antiphospholipid syndrome and a history of thrombosis. Other direct-acting oral…
Approved countries for batch testing and importation of medicines
This guidance sets out how the MHRA is handling centralised applications that were still pending on 1 January 2021.
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