Ireland· IE-PA-EU/1/25/2001/001-002
Dawnzera 80mg solution for injection in pre-filled pen
A donidalorsen product containing donidalorsen sodium, registered in Ireland by Otsuka Pharmaceutical Netherlands B.V.. The same ATC class is registered in 10 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Donidalorsen is registered in 10 of 19 countries.
Countries holding a registration under ATC B06AC09 (donidalorsen), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 8 of them publish a price we can compare per daily dose
Donidalorsen · ATC B06AC09
10 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Norwayprice
- Spainprice
- Switzerlandprice
- United Statesprice
The record
At a glance
HPRA (Ireland)- Active substance
- Donidalorsen sodium
- Manufacturer
- Otsuka Pharmaceutical Netherlands B.V.
- Country
- Ireland (IE)
- ATC code
- B06AC09
- ATC class
- Donidalorsen
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/25/2001/001-002
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Donidalorsen in 5 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
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/aeb86839-bec7-4274-9794-b3eb31609af0 GET /v1/drugs/aeb86839-bec7-4274-9794-b3eb31609af0?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 pen",
"routes": [
"Subcutaneous use"
],
"source": "hpra",
"atc_all": [
"B06AC09"
],
"strength": null,
"pa_number": "EU/1/25/2001/001-002",
"substances": [
"Donidalorsen sodium"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "19/01/2026",
"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 donidalorsen.
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.