Ireland· IE-PA-EU/1/07/393/001
Soliris 300 mg concentrate for solution for infusion
A eculizumab product containing eculizumab, registered in Ireland by Alexion Europe SAS.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
The record
At a glance
HPRA (Ireland)- Active substance
- Eculizumab
- Manufacturer
- Alexion Europe SAS
- Country
- Ireland (IE)
- ATC code
- L04AA25
- ATC class
- Eculizumab
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/07/393/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
2 interactions on record for eculizumab.
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
Eculizumab · interactions on record
2 records
Same medicine, other countries
Eculizumab in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- BelgiumBekemv 300 mgAmgen Europe
- CzechiaBEKEMVAmgen Europe B.V., Breda
- FinlandBEKEMVAmgen Europe B.V.
- IcelandBekemvAmgen Technology (Ireland) UC*
- NorwayBekemvAmgen Technology Ireland
- SwedenBEKEMV 300 mg Koncentrat till infusionsvätska, lösningAmgen Europe B.V.
- PolandBekemvAmgen Technology (Ireland) UC
- United StatesBKEMVAmgen Inc
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Bekemv, Soliris
- Liechtenstein · Soliris
- Norway · Bekemv, Soliris
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/dafc7ef5-801f-42d0-9fbd-435ab1eee8bd GET /v1/drugs/dafc7ef5-801f-42d0-9fbd-435ab1eee8bd?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",
"routes": [
"Intravenous use"
],
"source": "hpra",
"atc_all": [
"L04AA",
"L04AA25"
],
"strength": null,
"pa_number": "EU/1/07/393/001",
"substances": [
"Eculizumab"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": null,
"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 eculizumab.
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.