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Belgium· BE-AMP-SAM255306-00

Aldurazyme 100 U/ml

A laronidase product containing laronidase, registered in Belgium by Sanofi. The same ATC class is registered in 12 of our 19 countries.

ATC A16AB05

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedAldurazyme 100 U/mlATCA16AB05REGISTER NO.BE-AMP-SAM255306-00PACKS LISTED2CHECKEDSeptember 26, 2026

Where it is registered

Laronidase is registered in 12 of 19 countries.

Countries holding a registration under ATC A16AB05 (laronidase), 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

Laronidase · ATC A16AB05

12 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Ireland
  • Netherlands
  • Norwayprice
  • Polandprice
  • United Kingdom
  • United Statesprice
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

FAMHP / AFMPS (Belgium)
Active substance
Laronidase
Manufacturer
Sanofi
Country
Belgium (BE)
ATC code
A16AB05
ATC class
Laronidase
Defined daily dose
1 TSD, E
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 2

  • be_apb
    0776864
  • be_apb
    2160554

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Interactions

2 interactions on record for laronidase.

Graded by severity as the source publishes them — 2 minor. Severity grades are free for everyone; mechanism and management come with Growth.

  • Severity for every pair — free, no plan needed
  • The source, licence and sync date on every record
  • Mechanism and what to do for each pair — Growth plan

Laronidase · interactions on record

2 records

Interaction register. Grades as the source publishes them.

Same medicine, other countries

Laronidase in 14 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All laronidase products

Authorised across Europe · EMA

The same active substance is authorised in 3 EEA countries. Names it is sold under:

  • Iceland · Aldurazyme
  • Liechtenstein · Aldurazyme
  • Norway · Aldurazyme

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/335bd241-051b-437e-a2c8-aa6d7ea19923
GET /v1/drugs/335bd241-051b-437e-a2c8-aa6d7ea19923?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": "Aldurazyme 100 U/ml",
  "name_fr": "Aldurazyme 100 U/ml",
  "name_nl": "Aldurazyme 100 U/ml",
  "amp_code": "SAM255306-00",
  "strengths": [
    "100.0000",
    "100.0000"
  ],
  "pack_count": 3,
  "substances": [
    "Laronidase",
    "Disodium Hydrogen Phosphate Heptahydrate",
    "Sodium Chloride",
    "Sodium Phosphate Monobasic Monohydrate",
    "Polysorbate 80"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Laronidase",
  "authorisation_numbers": [
    "EU/1/03/253/001",
    "EU/1/03/253/002",
    "EU/1/03/253/003"
  ]
}

See everything about laronidase.

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.