France· FR:60397909
REPLAGAL 1 mg/ml, solution à diluer pour perfusion
A agalsidase alfa product containing agalsidase alfa, registered in France by TAKEDA PHARMACEUTICALS INTERNATIONAL (IRLANDE). The same ATC class is registered in 13 of our 19 countries.
Checked against Base de données publique des médicaments — BDPM (France) 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: France, from Base de données publique des médicaments — BDPM (France)
- 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
Base de données publique des médicaments — BDPM (France)- Active substance
- AGALSIDASE ALFA
- Manufacturer
- TAKEDA PHARMACEUTICALS INTERNATIONAL (IRLANDE)
- Country
- France (FR)
- ATC code
- A16AB03
- ATC class
- Agalsidase alfa
- Defined daily dose
- 1 mg, P
- Reimbursed
- No
- Source register
- Base de données publique des médicaments — BDPM (France)
- Last checked
- September 12, 2026
Packs & prices · 1
- cip1334009563400571 flacon(s) en verre de 3,5 ml
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.
- NetherlandsReplagal 1 mg/ml, concentraat voor oplossing voor intraveneuze infusieTakeda Pharmaceuticals International AG Ireland Branch
- CzechiaREPLAGALTakeda Pharmaceuticals International AG Ireland Branch, Dublin
- BelgiumReplagal 1 mg/mlTakeda Pharmaceuticals International Ireland Branch
- SpainREPLAGAL 1 mg/ml CONCENTRADO PARA SOLUCION PARA PERFUSIONShire Human Genetic Therapies Ab
- FinlandReplagalOrifarm Oy
- United KingdomReplagal 1mg/1ml solution for infusion vialsShire Pharmaceuticals Ltd
- NorwayReplagalTakeda Pharmaceuticals International AG Ireland Branch
- SwedenReplagal 1 mg/ml Koncentrat till infusionsvätska, lösningTakeda Pharmaceuticals International AG Ireland Branch
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 Base de données publique des médicaments — BDPM (France). 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/694642ba-c423-4d8a-8e30-e70856d9ad70 GET /v1/drugs/694642ba-c423-4d8a-8e30-e70856d9ad70?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.
{
"cis": "60397909",
"date_amm": "2001-08-03",
"type_amm": "Procédure centralisée",
"numero_ue": "EU/1/01/189",
"substance": "AGALSIDASE ALFA",
"atc_source": "fr_atc_restore_2026-09-06",
"statut_amm": "Autorisation active",
"statut_bdm": null,
"forme_pharmaceutique": "solution à diluer pour perfusion",
"voies_administration": "intraveineuse",
"etat_commercialisation": "Commercialisée",
"surveillance_renforcee": "Non"
}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.