Belgium· BE-AMP-SAM543386-00
Ondexxya 200 mg
A andexanet alfa product containing andexanet alfa, registered in Belgium by AstraZeneca. The same ATC class is registered in 12 of our 19 countries.
Checked against FAMHP / AFMPS (Belgium) 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: Belgium, from FAMHP / AFMPS (Belgium)
- 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
FAMHP / AFMPS (Belgium)- Active substance
- Andexanet alfa
- Manufacturer
- AstraZeneca
- Country
- Belgium (BE)
- ATC code
- V03AB38
- ATC class
- Andexanet alfa
- Reimbursed
- Not published by this register
- Source register
- FAMHP / AFMPS (Belgium)
- Last checked
- September 26, 2026
Packs & prices · 1
- be_apb4616157
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.
- SwitzerlandOndexxya 200 mg, Pulver zur Herstellung einer InfusionslösungAstraZeneca AG
- CzechiaONDEXXYAAstraZeneca AB, Södertälje
- SpainONDEXXYA 200 MG POLVO PARA SOLUCION PARA PERFUSIONAstrazeneca Ab
- FinlandOndexxyaAstraZeneca AB
- United KingdomOndexxya 200mg powder for solution for infusion vialsAstraZeneca UK Ltd
- IcelandOndexxyaAstraZeneca AB*
- PolandOndexxyaAstraZeneca AB
- SwedenOndexxya 200 mg Pulver till infusionsvätska, lösningAstraZeneca AB
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 FAMHP / AFMPS (Belgium). 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/e0cdc260-2ff0-464b-a464-1f41250a08dc GET /v1/drugs/e0cdc260-2ff0-464b-a464-1f41250a08dc?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 for solution for infusion",
"source": "afmps",
"status": "AUTHORIZED",
"name_en": "Ondexxya 200 mg",
"name_fr": "Ondexxya 200 mg",
"name_nl": "Ondexxya 200 mg",
"amp_code": "SAM543386-00",
"strengths": [
"200.0000",
"200.0000",
"200.0000"
],
"pack_count": 2,
"substances": [
"Andexanet alfa",
"Mannitol",
"Sucrose",
"Polysorbate 80"
],
"medicine_type": "ALLOPATHIC",
"atc_description": "Andexanet Alfa",
"authorisation_numbers": [
"EU/1/18/1345/001",
"EU/1/18/1345/002"
]
}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.