Metalyse (tenecteplase)
- Region
- 🇪🇺 EU
- Active substance
- tenecteplase
- Company
- Boehringer Ingelheim International GmbH
- Status
- Authorised
- Therapeutic area
- Myocardial Infarction
- EU approval
- Fri 23 Feb 2001
- Application
- EMEA/H/C/000306
- ATC
- B01AD11
- Official record
- www.ema.europa.eu
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. Metalyse is indicated in adults for the thrombolytic treatment of acute ischaemic stroke (AIS) within 4.5 hours from last known well and after exclusion of intracranial haemorrhage.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Tenecteplase Boehringer Ingelheim Pharma GmbH Co. KG Withdrawn · Boehringer Ingelheim International GmbH
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.