Half of all safety warnings issued to drug manufacturers in India and China The majority of warnings from European and US drug regulators are to drug manufacturing sites in India and China, raising concerns about the fragility of the global supply chain.…
EMA orders medicine name changes for first time to reduce errors For the first time, drug companies across Europe have been told to change the names of medicines containing liposomal in their drug delivery systems following reports of medication errors that have led to patient deaths.…
Cannabis-derived medicine for treatment of two rare forms of epilepsy approved by EMA committee A European Medicines Agency committee has given a positive opinion for what could be the first plant-derived cannabis-based medicine to be approved in Europe for the treatment of any form of epilepsy.…
EMA makes recommendations to reduce methotrexate dosing errors Only doctors with expertise in using methotrexate-containing medicines should be able to prescribe them, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee has recommended.…
EU task force guidance on how to report drugs shortages published An EU task force, set up to deal with problems with medicines supply, has published guidance to improve communication about medicines shortages.…
EMA committee says cough medicines containing fenspiride should not be marketed A European Medicines Agency committee has recommended that marketing authorisations for cough medicines containing fenspiride should be revoked, meaning they will no longer be marketed in the EU.…
EMA launches ‘urgent safety review’ of alemtuzumab after two patient deaths The European Medicines Agency (EMA) has launched a safety review of alemtuzumab following reports of two deaths and several other cases of people experiencing life-threatening reactions shortly after taking the medicine.…
Substandard and falsified medicines: global and local efforts to address a growing problem Substandard and falsified medicines pose a risk to public health all around the world.…
Long-lasting buprenorphine implant recommended by EMA committee A long-lasting implant has been recommended for marketing authorisation as a substitution treatment for opioid dependence by the European Medicines Agency’s human medicines committee.…
EMA recommends sartan manufacturers review processes to avoid contamination The European Medicines Agency has recommended that manufacturers making sartan blood pressure medicines review their processes after impurities were found in a small number of products.…
