Belgium· BE-AMP-SAM233475-00
Replagal 1 mg/ml
A agalsidase alfa product containing agalsidase alfa, registered in Belgium by Takeda Pharmaceuticals International Ireland Branch. The same ATC class is registered in 13 of our 19 countries.
Checked against FAMHP / AFMPS (Belgium) on
Informational only — not a medical device.
Where it is registered
Agalsidase alfa is registered in 13 of 19 countries.
Countries holding a registration under ATC A16AB03 (agalsidase alfa), each read from that country’s own register.
- This record: Belgium, from FAMHP / AFMPS (Belgium)
- 8 of them publish a price we can compare per daily dose
Agalsidase alfa · ATC A16AB03
13 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
The record
At a glance
FAMHP / AFMPS (Belgium)- Active substance
- Agalsidase Alfa
- Manufacturer
- Takeda Pharmaceuticals International Ireland Branch
- Country
- Belgium (BE)
- ATC code
- A16AB03
- ATC class
- Agalsidase alfa
- Defined daily dose
- 1 mg, P
- Reimbursed
- Not published by this register
- Source register
- FAMHP / AFMPS (Belgium)
- Last checked
- September 26, 2026
Packs & prices · 4
- be_apb0797381
- be_apb7730674
- be_apb4201927
- be_apb1687920
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Agalsidase alfa in 13 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaREPLAGALTakeda Pharmaceuticals International AG Ireland Branch, Dublin
- FinlandReplagalTakeda Pharmaceuticals International AG Ireland Branch
- IcelandReplagalTakeda Pharmaceuticals International AG Ireland Branch
- NorwayReplagalTakeda Pharmaceuticals International AG Ireland Branch
- SwedenReplagal 1 mg/ml Koncentrat till infusionsvätska, lösningTakeda Pharmaceuticals International AG Ireland Branch
- IrelandReplagal 1 mg/ml concentrate for solution for infusionTakeda Pharmaceuticals International AG Ireland Branch
- United KingdomReplagal 1mg/1ml solution for infusion vialsShire Pharmaceuticals Ltd
- SpainREPLAGAL 1 mg/ml CONCENTRADO PARA SOLUCION PARA PERFUSIONShire Human Genetic Therapies Ab
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Replagal
- Liechtenstein · Replagal
- Norway · Replagal
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/f44fd3b9-1e56-44ce-bdce-c1b027aec1ca GET /v1/drugs/f44fd3b9-1e56-44ce-bdce-c1b027aec1ca?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": "Concentrate for solution for infusion",
"source": "afmps",
"status": "AUTHORIZED",
"name_en": "Replagal 1 mg/ml",
"name_fr": "Replagal 1 mg/ml",
"name_nl": "Replagal 1 mg/ml",
"amp_code": "SAM233475-00",
"strengths": [
"1.0000",
"1.0000"
],
"pack_count": 4,
"substances": [
"Agalsidase Alfa"
],
"medicine_type": "ALLOPATHIC",
"atc_description": "Agalsidase Alfa",
"authorisation_numbers": [
"EU/1/01/189/001",
"EU/1/01/189/003",
"EU/1/01/189/002"
]
}See everything about agalsidase 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.