www.ema.europa.eu The Committee adopted by consensus a positive opinion for a variation requiring assessment for Bravecto (fluralaner) concerning the addition of a new pharmaceutical form, 150 mg/ml powder and solvent for suspension for injection, for dogs.The Committee adopted by consensus...
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Global regulators strengthen efforts to ensure continuous availability of safe and high-quality medicines – www.ema.europa.eu
www.ema.europa.eu Close collaboration between medicines regulators worldwide is paving the way towards the development of a global Pharmaceutical Quality Knowledge Management System (PQ KMS). The goal is to ensure patients can benefit from a continuous supply of life-saving medicines in a...
Relaunched EMA website now live – www.ema.europa.eu
www.ema.europa.eu Availability of contentThe content from the previous version of this website is still available, including EMA’s bank of information on medicines.Former addresses (URLs) - such as links to pages and documents – also still work. These are either unchanged or, for the small...
EU medicines agencies reflect on lessons learned from COVID-19 – www.ema.europa.eu
www.ema.europa.eu The European Medicines Regulatory Network (EMRN) has been at the forefront of the fight against COVID-19 with its crucial role in the evaluation and monitoring of medicines, including vaccines. A joint report issued by the European Medicines Agency (EMA) and the Heads of...
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27-30 November 2023 – www.ema.europa.eu
www.ema.europa.eu PRAC recommends measures to minimise the risk of serious side effects with medicines containing pseudoephedrineEMA’s safety committee, PRAC, has recommended new measures for medicines containing pseudoephedrine to minimise the risks of posterior reversible encephalopathy...
Consumption of antimicrobials in animals reaches lowest level ever in Europe – www.ema.europa.eu
www.ema.europa.eu European countries have substantially reduced sales of veterinary antibiotics, which translates into a lower risk of bacteria becoming resistant in people and animals. Overall sales of veterinary antibiotics decreased by 53% between 2011 and 2022, reaching the lowest level...