Category list : European Medicines Agency (EMA)
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EMA committee recommends caution in use of tofacitinib owing to increased risk of blood clots
The European Medicines Agency’s Committee for Medicinal Products for Human Use has endorsed recommendations that tofacitinib could increase the risk of blood clots in the lungs and should be used with caution in all patients already at high risk.
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First non-injectable treatment for severe hypoglycaemia recommended by EMA committee
A European Medicines Agency committee has recommended the first non-injectable treatment for severe hypoglycaemia.
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Medicines recall drug alert issued for potentially contaminated ranitidine products
Pharmacists are being advised to stop supplying some ranitidine products after it was revealed that they may be contaminated with the impurity N-nitrosodimethylamine.
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Safety committee recommends limiting use of high-strength estradiol creams for postmenopausal women
The European Medicines Agency’s safety committee has recommended limiting use of high-strength creams containing 100 microgram/gram of estradiol to a single treatment period of up to four weeks.
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EMA tells drug manufacturers to test for probable carcinogen
The European Medicines Agency has told drug manufacturers to test all medicines that contain chemically synthesised active substances for the presence of nitrosamines.
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First subcutaneous infliximab recommended for approval by EMA committee
The European Medicines Agency’s human medicines committee has recommended approval of the first subcutaneous version of biosimilar infliximab.
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European Commission approves first CBD medicine for severe epilepsy
A cannabidiol-based medicine for severe epilepsy has been given marketing approval by the European Commission.
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EMA to begin review of ranitidine medicines after impurity found
The European Medicines Agency is to start a review of ranitidine medicines after tests revealed that some products contain the impurity N-nitrosodimethylamine Source: European ...
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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.
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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.
