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Netherlands· NL-8c717a730285

Replagal 1 mg/ml, concentraat voor oplossing voor intraveneuze infusie

A agalsidase alfa product containing agalsidase alfa (recombinant) "bscp", registered in Netherlands by Takeda Pharmaceuticals International AG Ireland Branch. The same ATC class is registered in 13 of our 19 countries.

ATC A16AB03

Checked against CBG-MEB (Netherlands) on

Informational only — not a medical device.

SOURCE REGISTER · NLCBG-MEB (Netherlands)normalisedReplagal 1 mg/ml, concentraat voor op…ATCA16AB03REGISTER NO.NL-8c717a730285PACKS LISTED1CHECKEDSeptember 29, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about agalsidase alfa (recombinant) "bscp"Answers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

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: Netherlands, from CBG-MEB (Netherlands)
  • 8 of them publish a price we can compare per daily dose
Search agalsidase alfa products by name

Agalsidase alfa · ATC A16AB03

13 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Icelandprice
  • Ireland
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
  • United Kingdom
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

CBG-MEB (Netherlands)
Active substance
AGALSIDASE ALFA (RECOMBINANT) "BSCP"
Manufacturer
Takeda Pharmaceuticals International AG Ireland Branch
Country
Netherlands (NL)
ATC code
A16AB03
ATC class
Agalsidase alfa
Defined daily dose
1 mg, P
Reimbursed
Not published by this register
Source register
CBG-MEB (Netherlands)
Last checked
September 29, 2026

Packs & prices · 1

  • cbg_meb_id
    EU/1/01/189

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.

All agalsidase alfa products

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 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/c35582b4-0594-441b-a3f1-2e92fdaa749c
GET /v1/drugs/c35582b4-0594-441b-a3f1-2e92fdaa749c?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": "Concentraat voor oplossing voor infusie",
  "route": "Intraveneus gebruik",
  "soort": null,
  "source": "cbg_meb",
  "smpc_url": "https://www.ema.europa.eu/en/documents/product-information/replagal-epar-product-information_nl.pdf",
  "strength": null,
  "atc_label": "Agalsidase Alfa",
  "detail_url": "https://www.geneesmiddeleninformatiebank.nl/nl/cp71067",
  "excipients": [
    "NATRIUMCHLORIDE",
    "NATRIUMDIWATERSTOFFOSFAAT 1-WATER (E 339)",
    "NATRIUMHYDROXIDE (E 524)",
    "POLYSORBAAT 20 (E 432)",
    "STIKSTOF (HEAD SPACE) (E 941)",
    "WATER VOOR INJECTIE"
  ],
  "substances": [
    "AGALSIDASE ALFA (RECOMBINANT) \"BSCP\""
  ],
  "leaflet_url": null,
  "authorised_at": "2001/08/03",
  "procedure_number": "EMEA/H/C/000369",
  "dispensing_status": "Uitsluitend recept",
  "registration_number": "EU/1/01/189",
  "additional_monitoring": "N"
}
API referenceMCP serverPlans

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.

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