Metalyse

RSS

tenecteplase

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

Overview

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 10/09/2021

Authorisation details

Product details
Name
Metalyse
Agency product number
EMEA/H/C/000306
Active substance
tenecteplase
International non-proprietary name (INN) or common name
tenecteplase
Therapeutic area (MeSH)
Myocardial Infarction
Anatomical therapeutic chemical (ATC) code
B01AD11
Publication details
Marketing-authorisation holder
Boehringer Ingelheim International GmbH
Revision
19
Date of issue of marketing authorisation valid throughout the European Union
23/02/2001
Contact address
Binger Str 173
D-55216 Ingelheim am Rhein
Germany

Product information

13/07/2021 Metalyse - EMEA/H/C/000306 - N/0063

Contents

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

Antithrombotic agents

Therapeutic indication

Metalyse is indicated for the thrombolytic treatment of suspected myocardial infarction with persistent ST elevation or recent left-bundle-branch block within six hours after the onset of acute-myocardial-infarction symptoms.

Assessment history

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