Spain· ES:00169006
METALYSE 10.000 UNIDADES (50 MG) POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE
A medicinal product containing tenecteplasa, registered in Spain by Boehringer Ingelheim International Gmbh.
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- tenecteplasa
- Manufacturer
- Boehringer Ingelheim International Gmbh
- Country
- Spain (ES)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- AEMPS CIMA (Spain)
- Last checked
- September 12, 2026
Packs & prices · 0
No packs listed by the register for this record.
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Tenecteplasa in 13 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- FinlandMetalyseBoehringer Ingelheim International GmbH
- BelgiumMetalyse 10000 UBoehringer Ingelheim International
- 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
- IrelandMetalyse 10 000 units (50 mg) powder and solvent for solution for injectionBoehringer Ingelheim International GmbH
- 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 AEMPS CIMA (Spain). 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/bc42ad57-22bc-4c12-8549-343c9dbc6d14 GET /v1/drugs/bc42ad57-22bc-4c12-8549-343c9dbc6d14?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.
{
"cpresc": "Uso Hospitalario",
"estado": "{\"aut\":985129200000}",
"nregistro": "00169006",
"substance": "tenecteplasa"
}See everything about tenecteplasa.
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.