Opella Healthcare UK LTD has informed the MHRA that there is an error on the artwork for the outer carton of Dulcolax Adult 5mg GR Tablets (packsize 20 count). The dose instruction incorrectly states for use in 12 years and older. These general sale packs are intended for use only in adult patients (18 years and over).
Similar Posts
Decision: Parallel import licences granted in 2025
Parallel import licences granted in 2025.
Class 2 Medicines Recall: Inhixa 12,000IU (120mg)/0.8mL solution for injection, Maxearn Limited, EL(25)A/27
Maxearn Limited have informed the MHRA that the carton used to package two imported batches of Inhixa have been released to the market with a typographical error on one side of the carton.
Cutting-edge personalised treatments, made while you wait, will deliver specialised care to patients more quickly
New regulations effective today will make it faster and easier for cutting-edge cancer treatments and personalised gene therapies to be made right where patients are treated.
Paracetamol and pregnancy – reminder that taking paracetamol during pregnancy remains safe
Patients should be reminded and reassured that there is no evidence that taking paracetamol during pregnancy causes autism in children. Paracetamol is recommended as the first-choice pain reliever for pregnant women, used at the lowest dose and for the shortest duration. It also acts as an antipyretic and is therefore used to treat fever.
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
Apply for manufacturer or wholesaler of medicines licences
How to apply for, update and cancel licences for the manufacture, import and wholesale of human and veterinary medicines.