Laboratoires Théa trading as Thea Pharmaceuticals Limited have notified the MHRA of an out of specification event related to environmental monitoring during manufacturing, which may increase the risk of microbial contamination of the medicinal product.
Similar Posts
Guidance: Medical devices: legal requirements for specific medical products
Information for manufacturers on the regulations that apply to prosthetic, orthotic and ophthalmic devices.
Field Safety Notices: 14 to 18 July 2025
List of Field Safety Notices from 14 to 18 July 2025.
MHRA approves zuranolone to treat postnatal depression in adults following childbirth
As with any medicine, the MHRA will keep the safety of zuranolone under close review.
MHRA seeks input on AI regulation at ‘pivotal moment’ for healthcare
National Commission is seeking evidence to shape regulation of AI in healthcare and support the UK’s ambition for a world-leading, AI-enabled NHS
MHRA crackdown on illegal ‘Botox’ after victims left seriously ill
More than 40 people hospitalised following suspected use of unlicensed botulinum toxin products.
Cancel a medicine’s marketing authorisation or other licence
Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission.