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Core summary of product characteristics (SmPC) and package leaflet for fludeoxyglucose (18F) - Scientific guideline
Last updated: 14/08/2012 -
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Class waivers
Last updated: 28/05/2018 -
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Physical frailty: instruments for baseline characterisation of older populations in clinical trials - Scientific guideline
Last updated: 22/02/2018 -
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Clinical and non-clinical evaluation during the consultation procedure on medicinal substances contained in drug-eluting (medicinal-substance-eluting) coronary stents - Scientific guideline
Last updated: 30/05/2008 -
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Clinical investigation of medicinal products for the treatment of acute heart failure - Scientific guideline
Last updated: 10/06/2015 -
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Clinical investigation of medicinal products for the treatment of pulmonary arterial hypertension - Scientific guideline
Last updated: 01/12/2009 -
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Gender differences in cardiovascular diseases - Scientific guideline
Last updated: 14/12/2006by the European Society of Cardiology in their “Women at Heart” … paper the European Society of Cardiology (3) emphasises that the design …
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Clinical development of fibrinolytic medicinal products in the treatment of patients with ST -segment elevation acute myocardial infarction (STEMI) - Scientific guideline
Last updated: 26/06/2003 -
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Assessment of cardiovascular safety profile of medicinal products - Scientific guideline
Last updated: 12/06/2015 -
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Monitoring of COVID-19 medicines
Last updated: 26/04/2021 -
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Needs for paediatric medicines
Last updated: 11/05/2016 -
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Regulatory requirements for the authorisation of low-dose modified-release acetyl-salicylic-acid formulations in the secondary prevention of cardiovascular events - Scientific guideline
Last updated: 25/07/2002internationally, i.e. 75 to 325 mg in cardiology. From a regulatory perspective … the range, i.e. 75 mg in cardiology). The characteristics of …
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Clinical investigation of medicinal products in the treatment of lipid disorders - Scientific guideline
Last updated: 08/07/2016 -
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Clinical investigation of medicinal products for treatment of migraine - Scientific guideline
Last updated: 21/10/2017 -
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Paediatric addendum to the guideline on clinical investigation of medicinal products for the treatment of pulmonary arterial hypertension - Scientific guideline
Last updated: 07/02/2012 -
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Clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus - Scientific guideline
Last updated: 28/06/2022 -
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Clinical investigation on medicinal products in the treatment of hypertension - Scientific guideline
Last updated: 08/07/2016 -
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Paediatric addendum to the guideline on clinical investigation on medicinal products in the treatment of hypertension - Scientific guideline
Last updated: 26/03/2015 -
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Paediatric addendum to the guideline on clinical investigation of medicinal products in the treatment of lipid disorders - Scientific guideline
Last updated: 02/10/2012 -
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Clinical investigation of anti-anginal medicinal products in stable angina pectoris - Scientific guideline
Last updated: 01/06/2006 -
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ICH E14 Clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs - Scientific guideline
Last updated: 08/12/2020 -
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Clinical evaluation of medicinal products used in weight control - Scientific guideline
Last updated: 08/07/2016 -
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Clinical investigation of medicinal products in the treatment of Parkinson's disease - Scientific guideline
Last updated: 06/07/2012 -
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Clinical investigation of medicinal products for prevention of venous thromboembolism (VTE) in patients undergoing high VTE-risk surgery - Scientific guideline
Last updated: 30/05/2012 -
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Benefit-risk methodology
Last updated: 18/06/2018