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 23/09/2022

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
21
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

14/09/2022 Metalyse - EMEA/H/C/000306 - IB/0066/G

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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

How useful was this page?

Add your rating
Average
2 ratings