Netherlands· NL-4dc1c76b0da4
Nulibry 9,5 mg, poeder voor oplossing voor injectie
A fosdenopterin product containing fosdenopterinehydrobromide 2-water, registered in Netherlands by TMC Pharma (EU) Limited. The same ATC class is registered in 11 of our 19 countries.
Checked against CBG-MEB (Netherlands) on
Informational only — not a medical device.
Where it is registered
Fosdenopterin is registered in 11 of 19 countries.
Countries holding a registration under ATC A16AX19 (fosdenopterin), each read from that country’s own register.
- This record: Netherlands, from CBG-MEB (Netherlands)
- 7 of them publish a price we can compare per daily dose
Fosdenopterin · ATC A16AX19
11 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- United Kingdom
- United Statesprice
The record
At a glance
CBG-MEB (Netherlands)- Active substance
- FOSDENOPTERINEHYDROBROMIDE 2-WATER
- Manufacturer
- TMC Pharma (EU) Limited
- Country
- Netherlands (NL)
- ATC code
- A16AX19
- ATC class
- Fosdenopterin
- Defined daily dose
- 63 mg, P
- Reimbursed
- Not published by this register
- Source register
- CBG-MEB (Netherlands)
- Last checked
- September 29, 2026
Packs & prices · 1
- cbg_meb_idEU/1/22/1684
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Fosdenopterin in 10 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United StatesNulibrySentynl Therapeutics, Inc.
- CzechiaNULIBRYTMC Pharma (EU) Limited, Waterford
- FinlandNULIBRYTMC Pharma (EU) Limited
- United KingdomNulibry 9.5mg powder for solution for injection vialsSentynl Therapeutics, Inc.
- IrelandNULIBRY 9.5 mg powder for solution for injectionTMC Pharma (EU) Limited
- BelgiumNulibry 9.5 mgTMC Pharma (EU)
- NorwayNulibryTmc Pharma (EU) Limited
- PolandNULIBRYTMC Pharma (EU) Ltd.
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Nulibry
- Liechtenstein · Nulibry
- Norway · Nulibry
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 CBG-MEB (Netherlands). 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/6ed1a842-2449-4aef-8a73-e93a64f1c05a GET /v1/drugs/6ed1a842-2449-4aef-8a73-e93a64f1c05a?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": "Poeder voor oplossing voor injectie",
"route": "Intraveneus gebruik",
"soort": null,
"source": "cbg_meb",
"smpc_url": "https://www.ema.europa.eu/en/documents/product-information/nulibry-epar-product-information_nl.pdf",
"strength": null,
"atc_label": "Fosdenopterin",
"detail_url": "https://www.geneesmiddeleninformatiebank.nl/nl/cp129214",
"excipients": [
"ASCORBINEZUUR (E 300)",
"MANNITOL (D-) (E 421)",
"NATRIUMHYDROXIDE (E 524)",
"SACCHAROSE",
"STIKSTOF (HEAD SPACE) (E 941)",
"ZOUTZUUR (E 507)"
],
"substances": [
"FOSDENOPTERINEHYDROBROMIDE 2-WATER"
],
"leaflet_url": null,
"authorised_at": "2022/09/21",
"procedure_number": "EMEA/H/C/005378",
"dispensing_status": "Uitsluitend recept",
"registration_number": "EU/1/22/1684",
"additional_monitoring": "Y"
}See everything about fosdenopterin.
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.