Ireland· IE-PA-EU/1/01/185/021-022
Aranesp 300 micrograms solution for injection pre-filled syringe
A other antianemic preparations product containing darbepoetin alfa, registered in Ireland by Amgen Europe B.V.,.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
The record
At a glance
HPRA (Ireland)- Active substance
- Darbepoetin alfa
- Manufacturer
- Amgen Europe B.V.,
- Country
- Ireland (IE)
- ATC code
- B03XA
- ATC class
- Other antianemic preparations
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/01/185/021-022
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Darbepoetin alfa in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaARANESPAmgen Europe B.V., Breda
- FinlandAranespAmgen Europe B.V.
- Japanダルベポエチンアルファ（遺伝子組換え）協和キリン
- SpainARANESP 10 microgramos SOLUCION INYECTABLE EN JERINGA PRECARGADAAmgen Europe B.V.
- IcelandAranespAmgen Europe B.V.*
- SwedenAranesp 10 mikrogram Injektionsvätska, lösning i förfylld injektionspennaAmgen Europe B.V.
- BelgiumAranesp 10 µg/0.4 mlAmgen Europe
- NetherlandsAranesp 10 microgram, oplossing voor injectie in een voorgevulde pen (SureClick)Amgen Europe B.V.
Authorised across Europe · EMA
The same active substance is authorised in 2 EEA countries. Names it is sold under:
- Iceland · Aranesp
- Norway · Aranesp
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/efdd0583-82e3-4b06-a0f9-379bbd55fcdb GET /v1/drugs/efdd0583-82e3-4b06-a0f9-379bbd55fcdb?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": "Solution for injection in pre-filled syringe",
"routes": [
"Intravenous use",
"Subcutaneous use"
],
"source": "hpra",
"atc_all": [
"B03XA"
],
"strength": null,
"pa_number": "EU/1/01/185/021-022",
"substances": [
"Darbepoetin alfa"
],
"legal_basis": "New active substance (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 darbepoetin 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.