Ireland· IE-PA-EU/1/00/169/006
Metalyse 10 000 units (50 mg) powder and solvent for solution for injection
A enzymes product containing tenecteplase, registered in Ireland by Boehringer Ingelheim International GmbH.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
The record
At a glance
HPRA (Ireland)- Active substance
- Tenecteplase
- Manufacturer
- Boehringer Ingelheim International GmbH
- Country
- Ireland (IE)
- ATC code
- B01AD
- ATC class
- Enzymes
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/00/169/006
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Tenecteplase in 13 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- FinlandMetalyseOrifarm Oy
- BelgiumMetalyse 10000 UBoehringer Ingelheim International
- SpainMETALYSE 10.000 UNIDADES (50 MG) POLVO Y DISOLVENTE PARA SOLUCION INYECTABLEBoehringer Ingelheim International Gmbh
- SwedenMetalyse 10 000 enheter Pulver och vätska till injektionsvätska, lösningBoehringer Ingelheim International GmbH
- CzechiaMETALYSEBoehringer Ingelheim International GmbH, Ingelheim am Rhein
- United KingdomMetalyse 10,000unit powder and solvent for solution for injection vialsBoehringer Ingelheim Ltd
- IcelandMetalyseBoehringer Ingelheim International GmbH*
- NetherlandsMetalyse 10.000 units, poeder en oplosmiddel voor oplossing voor injectieBoehringer Ingelheim International GmbH
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Metalyse
- Liechtenstein · Metalyse
- Norway · Metalyse
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of HPRA (Ireland). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/119c394e-9749-4ff3-b971-a7f2e42fa29d GET /v1/drugs/119c394e-9749-4ff3-b971-a7f2e42fa29d?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"form": "Powder and solvent for solution for injection",
"routes": [
"Intravenous use"
],
"source": "hpra",
"atc_all": [
"B01AD"
],
"strength": null,
"pa_number": "EU/1/00/169/006",
"substances": [
"Tenecteplase"
],
"legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "23/02/2001",
"dispensing_status": "Product subject to prescription which may not be renewed (A)",
"registration_status": "AU",
"supply_legal_status": "Supply through pharmacies only",
"interchangeable_code": null
}See everything about tenecteplase.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.