Netherlands· NL-79c2e06f8f44
Ondexxya 200 mg poeder voor oplossing voor infusie
A andexanet alfa product containing andexanet alfa, registered in Netherlands by AstraZeneca AB. The same ATC class is registered in 12 of our 19 countries.
Checked against CBG-MEB (Netherlands) on
Informational only — not a medical device.
Where it is registered
Andexanet alfa is registered in 12 of 19 countries.
Countries holding a registration under ATC V03AB38 (andexanet alfa), each read from that country’s own register.
- This record: Netherlands, from CBG-MEB (Netherlands)
- 7 of them publish a price we can compare per daily dose
Andexanet alfa · ATC V03AB38
12 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
The record
At a glance
CBG-MEB (Netherlands)- Active substance
- ANDEXANET ALFA
- Manufacturer
- AstraZeneca AB
- Country
- Netherlands (NL)
- ATC code
- V03AB38
- ATC class
- Andexanet alfa
- Reimbursed
- Not published by this register
- Source register
- CBG-MEB (Netherlands)
- Last checked
- September 29, 2026
Packs & prices · 1
- cbg_meb_idEU/1/18/1345
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Andexanet alfa in 13 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaONDEXXYAAstraZeneca AB, Södertälje
- SwitzerlandOndexxya 200 mg, Pulver zur Herstellung einer InfusionslösungAstraZeneca AG
- SpainONDEXXYA 200 MG POLVO PARA SOLUCION PARA PERFUSIONAstrazeneca Ab
- FinlandOndexxyaAstraZeneca AB
- United KingdomOndexxya 200mg powder for solution for infusion vialsAstraZeneca UK Ltd
- IrelandOndexxya Powder for solution for infusionAstraZeneca AB
- IcelandOndexxyaAstraZeneca AB*
- Japanアンデキサネット アルファ(遺伝子組換え)アストラゼネカ
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Ondexxya
- Liechtenstein · Ondexxya
- Norway · Ondexxya
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 CBG-MEB (Netherlands). 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/1a3f691d-b354-412f-8853-2c5105950bf9 GET /v1/drugs/1a3f691d-b354-412f-8853-2c5105950bf9?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": "Poeder voor oplossing voor infusie",
"route": "Intraveneus gebruik",
"soort": null,
"source": "cbg_meb",
"smpc_url": "https://www.ema.europa.eu/en/documents/product-information/ondexxya-epar-product-information_nl.pdf",
"strength": null,
"atc_label": "Andexanet alfa",
"detail_url": "https://www.geneesmiddeleninformatiebank.nl/nl/cp119837",
"excipients": [
"ARGININEHYDROCHLORIDE, (L-)",
"MANNITOL (D-) (E 421)",
"POLYSORBAAT 80 (E 433)",
"SACCHAROSE",
"STIKSTOF (HEAD SPACE) (E 941)",
"TROMETAMOL",
"TROMETAMOLHYDROCHLORIDE"
],
"substances": [
"ANDEXANET ALFA"
],
"leaflet_url": null,
"authorised_at": "2019/04/26",
"procedure_number": "EMEA/H/C/004108",
"dispensing_status": "Uitsluitend recept",
"registration_number": "EU/1/18/1345",
"additional_monitoring": "Y"
}See everything about andexanet alfa.
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.