Rapilysin

RSS

reteplase

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 18/09/2018

Authorisation details

Product details
Name
Rapilysin
Agency product number
EMEA/H/C/000105
Active substance
reteplase
International non-proprietary name (INN) or common name
reteplase
Therapeutic area (MeSH)
Myocardial Infarction
Anatomical therapeutic chemical (ATC) code
B01AD08
Publication details
Marketing-authorisation holder
Actavis Group PTC ehf
Revision
25
Date of issue of marketing authorisation valid throughout the European Union
29/08/1996
Contact address
Reykjavikurvegi 76-78
220 Hafnarfjordur
Iceland

Product information

21/08/2018 Rapilysin - EMEA/H/C/000105 - N/0069

Contents

  • 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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

B01 Antithrombotic agents

Therapeutic indication

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.

Assessment history

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