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Ireland· IE-PA-EU/1/97/053/004

Cerezyme 400 Units Powder for concentrate for solution for infusion

A imiglucerase product containing imiglucerase, registered in Ireland by Sanofi B.V.. The same ATC class is registered in 14 of our 19 countries.

ATC A16AB02

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedCerezyme 400 Units Powder for concent…ATCA16AB02REGISTER NO.IE-PA-EU/1/97/053/004PACKS LISTED1CHECKEDSeptember 28, 2026

Where it is registered

Imiglucerase is registered in 14 of 19 countries.

Countries holding a registration under ATC A16AB02 (imiglucerase), each read from that country’s own register.

  • This record: Ireland, from HPRA (Ireland)
  • 9 of them publish a price we can compare per daily dose

Imiglucerase · ATC A16AB02

14 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Icelandprice
  • Ireland
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
  • 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

HPRA (Ireland)
Active substance
Imiglucerase
Manufacturer
Sanofi B.V.
Country
Ireland (IE)
ATC code
A16AB02
ATC class
Imiglucerase
Defined daily dose
300 E, P
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    EU/1/97/053/004

Regulatory notes

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

Interactions

1 interaction on record for imiglucerase.

Graded by severity as the source publishes them — 1 moderate. 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

Imiglucerase · interactions on record

1 record

  • 1 moderate

Most severe, free to view

  • MiglustatA16AX06moderate
  • Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

Same medicine, other countries

Imiglucerase in 14 other countries

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

All imiglucerase products

Authorised across Europe · EMA

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

  • Iceland · Cerezyme
  • Liechtenstein · Cerezyme
  • Norway · Cerezyme

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 HPRA (Ireland). 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/75017eaa-0aee-4210-a1b8-ddfa2f53153c
GET /v1/drugs/75017eaa-0aee-4210-a1b8-ddfa2f53153c?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 concentrate for solution for infusion",
  "routes": [
    "Intravenous use"
  ],
  "source": "hpra",
  "atc_all": [
    "A16AB",
    "A16AB02"
  ],
  "strength": null,
  "pa_number": "EU/1/97/053/004",
  "substances": [
    "Imiglucerase"
  ],
  "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": "28/01/2000",
  "dispensing_status": "Product subject to prescription which may not be renewed (A)",
  "registration_status": "AU",
  "supply_legal_status": "Supply through pharmacies only",
  "interchangeable_code": null
}

See everything about imiglucerase.

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.