Ireland· IE-PA-EU/1/24/1870/001
HETRONIFLY 10 mg/ml concentrate for solution for infusion
A medicinal product containing serplulimab, registered in Ireland by Accord Healthcare S.L.U..
Checked against HPRA (Ireland) on
Informational only — not a medical device.
The record
At a glance
HPRA (Ireland)- Active substance
- Serplulimab
- Manufacturer
- Accord Healthcare S.L.U.
- Country
- Ireland (IE)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/24/1870/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Serplulimab in 12 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- BelgiumHetronifly 10 mg/mlAccord Healthcare
- SwitzerlandHetronifly 100 mg/10 ml, Konzentrat zur Herstellung einer InfusionslösungAccord Healthcare AG
- CzechiaHETRONIFLYAccord Healthcare S.L.U., Barcelona
- FinlandHETRONIFLYAccord Healthcare S.L.U.
- IcelandHETRONIFLYAccord Healthcare S.L.U.
- NorwayHetroniflyAccord Healthcare S.L.U.
- PolandHetroniflyAccord Healthcare S.L.U.
- SwedenHETRONIFLY 10 mg/ml Koncentrat till infusionsvätska, lösningAccord Healthcare S.L.U.
Authorised across Europe · EMA
The same active substance is authorised in 4 EEA countries. Names it is sold under:
- United Kingdom (Northern Ireland) · Hetronifly
- Iceland · Hetronifly
- Liechtenstein · Hetronifly
- Norway · Hetronifly
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/29decc25-7c4f-455a-a70a-808d712d4a89 GET /v1/drugs/29decc25-7c4f-455a-a70a-808d712d4a89?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": null,
"strength": null,
"pa_number": "EU/1/24/1870/001",
"substances": [
"Serplulimab"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "03/02/2025",
"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 serplulimab.
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.