Iceland· IS-EU/1/24/1870/001
HETRONIFLY
A serplulimab product containing serplulimab, registered in Iceland by Accord Healthcare S.L.U.. The same ATC class is registered in 11 of our 19 countries.
Checked against Icelandic Medicines Agency (Iceland) on
Informational only — not a medical device.
Where it is registered
Serplulimab is registered in 11 of 19 countries.
Countries holding a registration under ATC L01FF12 (serplulimab), each read from that country’s own register.
- This record: Iceland, from Icelandic Medicines Agency (Iceland)
- 8 of them publish a price we can compare per daily dose
Serplulimab · ATC L01FF12
11 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Icelandprice
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
The record
At a glance
Icelandic Medicines Agency (Iceland)- Active substance
- Serplulimab
- Manufacturer
- Accord Healthcare S.L.U.
- Country
- Iceland (IS)
- ATC code
- L01FF12
- ATC class
- Serplulimab
- Defined daily dose
- 15 mg, P
- Reimbursed
- Not published by this register
- Source register
- Icelandic Medicines Agency (Iceland)
- Last checked
- September 29, 2026
Packs & prices · 0
No packs listed by the register for this record.
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.
- IrelandHETRONIFLY 10 mg/ml concentrate for solution for infusionAccord 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 3 EEA countries. Names it is sold under:
- United Kingdom (Northern Ireland) · 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 Icelandic Medicines Agency (Iceland). 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/ed416921-630e-4465-926d-8031c6946e5b GET /v1/drugs/ed416921-630e-4465-926d-8031c6946e5b?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": "Innrennslisþykkni, lausn",
"source": "lyfjastofnun",
"atc_raw": "L01FF12",
"marketed": false,
"strength": "10 mg/ml",
"ma_number": "EU/1/24/1870/001",
"substance": "Serplulimab",
"other_info": "Markaðssetning á Íslandi er háð því að Lyfjastofnun hafi staðfest að sérstök skilyrði er varða öryggi og verkun við notkun lyfsins séu uppfyllt.",
"legal_status": "(R) Lyfseðilsskylt\r\n(H) Sjúkrahúsmerkt",
"ma_issued_serial": "45691"
}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.