The symbol will need to appear on both the summary of product characteristics and package leaflet, and will be accompanied by a statement explaining that the medicine is under additional monitoring, as well as a further explanatory sentence. In addition, updated product information will encourage patients and healthcare professionals to report adverse reactions, with new label requirements to identify the different ways to report an adverse event, including electronic reporting and the appropriate postal address.
Black triangle monitoring warning to be used across EU
Other plans include the introduction of an automatic urgent procedure for review at EU level and greater transparency for pharma companies that withdraw a medicine from the market. Hamell is a full-service agency with a clear focus on delivering evidence-based, sustained behaviour change. So, whether you are looking Please login to the form below.
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Black triangle monitoring warning to be used across EU Use of symbol is part of EMA plans to strengthen pharmacovigilance All medicines subject to additional monitoring in Europe will have to carry a black inverted triangle warning in line with new pharmacovigilance rules published by the European Medicines Agency EMA.
A full list of affected medicines will be published within the next few months. PME Digital Edition.
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