Belgium· BE-AMP-SAM663899-00
Hetronifly 10 mg/ml
A serplulimab product containing serplulimab, registered in Belgium by Accord Healthcare. The same ATC class is registered in 11 of our 19 countries.
Checked against FAMHP / AFMPS (Belgium) 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: Belgium, from FAMHP / AFMPS (Belgium)
- 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
FAMHP / AFMPS (Belgium)- Active substance
- Serplulimab
- Manufacturer
- Accord Healthcare
- Country
- Belgium (BE)
- ATC code
- L01FF12
- ATC class
- Serplulimab
- Defined daily dose
- 15 mg, P
- Reimbursed
- Not published by this register
- Source register
- FAMHP / AFMPS (Belgium)
- Last checked
- September 26, 2026
Packs & prices · 2
- be_apb7749203
- be_apb5821558
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.
- 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.
- 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 FAMHP / AFMPS (Belgium). 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/1c29c8d0-1c06-46d8-964e-acddee644948 GET /v1/drugs/1c29c8d0-1c06-46d8-964e-acddee644948?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",
"source": "afmps",
"status": "AUTHORIZED",
"name_en": "Hetronifly 10 mg/ml",
"name_fr": "Hetronifly 10 mg/ml",
"name_nl": "Hetronifly 10 mg/ml",
"amp_code": "SAM663899-00",
"strengths": [
"10.0000",
"10.0000",
"22.5000"
],
"pack_count": 1,
"substances": [
"Serplulimab",
"Mannitol",
"Polysorbate 80",
"Sodium"
],
"medicine_type": "ALLOPATHIC",
"atc_description": "Serplulimab",
"authorisation_numbers": [
"EU/1/24/1870/001"
]
}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.