This page brings together the European Medicines Agency's latest information on diseases affecting the heart and blood vessels.
the ten newest and recently updated medicines authorised for the treatment of cardiovascular diseases in the European Union (EU);
the most recent opinions on cardiovascular medicines that are pending authorisation by the European Commission (EC);
the latest news and press releases related to cardiovascular diseases;
the Agency's events on cardiovascular topics.
New and recently updated medicines
Opinions pending EC decision
Orphan medicine Zalmoxis recommended by CAT and CHMP for marketing authorisation ... Read more
Coagadex recommended for approval for prevention of bleeding episodes for patients with factor X deficiency ... Read more
Can measuring anticoagulant activity and concentration in the body play a role in clinical use of medicines used to prevent blood clots?
Registration opens for public workshop ... Read more
Entresto brings a new mechanism of action to the treatment of heart failure ... Read more
The role of pharmacokinetic and pharmacodynamic measurements in the use of direct oral anticoagulants (DOACs)
This EMA workshop will bring together experts and stakeholders to discuss the utility of pharmacokinetic (PK) and pharmacodynamic (PD) measurements in the clinical use of the new direct oral anticoagulants (DOACs) and whether those could enhance the benefit-risk profile of these medicines by further reducing the risk of major bleedings while maintaining or improving the protection against thromboembolic events. The objectives of the workshop are to improve the understanding of the clinical use of DOACs, issues in relation to PK and PD measurements as well as priorities in future research. ... Read more
01/07/2015 - 02/07/2015
Independent, disease-based registries are a potential source of valuable safety and efficacy data on products. The European Medicines Agency (EMA) is currently embarking on a strategy for patient registries. This initiative provides an appropriate starting point to consider what regulators need from haemophilia registries. The aim is to get the best capture of data in the European Union (EU) and build on existing expertise in this area. It is proposed to work with stakeholders on this topic, commencing with this EMA workshop. Places limited. Registration open until 01/06/2015. ... Read more
28/11/2013 - 29/11/2013
Joint European Medicines Agency / European Directorate for the Quality of Medicines and Healthcare workshop on characterisation of new clotting-factor concentrates (factor VIII and factor IX) with respect to potency assays used for labelling and testing of post-infusion samples
The purpose of this workshop is to provide an overview of the current knowledge of the characterisation of new factor-VIII (FVIII) and factor-IX (FIX) concentrates with respect to potency assays and testing of post-infusion material. This overview will allow both the European Medicines Agency and the European Directorate for the Quality of Medicines and Healthcare to gather information on the new coagulation factors and help to guide future discussion on potency assays. Invitations have been sent to companies developing new FVIII and FIX products. Other invited paticipants are listed in the draft programme. Registration open until 31/10/2013. Places limited. ... Read more
This event focused on experience gained from clinical trials in patients with, or at risk of, thromboembolism, and to gather opinions on how non-clinical, and paediatric clinical studies should be conducted. Information on demographics, biology and treatments as well as on the relationship between paediatric and adult population subsets, and between different disease conditions was also discussed. ... Read more
The meeting is identifying priorities for and the optimal design of studies on drug development in paediatric heart failure (HF) for the purpose of the evaluation of paediatric investigation plans. The main topics include new drug classes in the pipeline and priority list for HF drugs in children, types of paediatric HF to be studied, trial design issues and the establishment of a paediatric cardiology network. ... Read more