This is a summary of the European public assessment report (EPAR) for Rapilysin. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Rapilysin.
Rapilysin : EPAR - Summary for the public (PDF/90.83 KB)
First published: 11/07/2006
Last updated: 09/03/2016
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Actavis Group PTC ehf
|Date of issue of marketing authorisation valid throughout the European Union||
21/08/2018 Rapilysin - EMEA/H/C/000105 - N/0069
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Rapilysin is indicated for the thrombolytic treatment of suspected myocardial infarction with persistent ST elevation or recent left bundle branch block within 12 hours after the onset of acute-myocardial-infarction symptoms.