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.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
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
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_numberEU/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.
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.
- FinlandCerezymeOrifarm Oy
- CzechiaCEREZYMESanofi B.V., Amsterdam
- United StatesCerezymeGenzyme Corporation
- United KingdomCerezyme 200unit powder for solution for infusion vialsGenzyme Therapeutics Ltd
- IcelandCerezymeSanofi B.V.
- BelgiumCerezyme 200 USanofi
- NetherlandsCerezyme 400 E, poeder voor oplossing voor infusieGenzyme Europe BV
- NorwayCerezymeSanofi B.V.
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.