Czechia· CZ-0268192
NULIBRY
A fosdenopterin product containing fosdenopterin hydrobromide dihydrate, registered in Czechia by TMC Pharma (EU) Limited, Waterford. The same ATC class is registered in 11 of our 19 countries.
Checked against SÚKL (Czech Republic) 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: Czechia, from SÚKL (Czech Republic)
- 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
SÚKL (Czech Republic)- Active substance
- FOSDENOPTERIN HYDROBROMIDE DIHYDRATE
- Manufacturer
- TMC Pharma (EU) Limited, Waterford
- Country
- Czechia (CZ)
- ATC code
- A16AX19
- ATC class
- Fosdenopterin
- Defined daily dose
- 63 mg, P
- Reimbursed
- Not published by this register
- Source register
- SÚKL (Czech Republic)
- Last checked
- September 28, 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
Fosdenopterin in 10 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- BelgiumNulibry 9.5 mgTMC Pharma (EU)
- United KingdomNulibry 9.5mg powder for solution for injection vialsSentynl Therapeutics, Inc.
- IcelandNulibryTMC Pharma (EU) Limited
- NorwayNulibryTmc Pharma (EU) Limited
- PolandNULIBRYTMC Pharma (EU) Ltd.
- SwedenNULIBRY 9,5 mg Pulver till injektionsvätska, lösningTMC Pharma (EU) Limited
- United StatesNulibrySentynl Therapeutics, Inc.
- FinlandNULIBRYTMC Pharma (EU) Limited
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 SÚKL (Czech Republic). 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/fb490df5-52b1-46fc-9eef-8600d1828e80 GET /v1/drugs/fb490df5-52b1-46fc-9eef-8600d1828e80?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": "INJ PLV SOL",
"source": "sukl",
"strength": "9,5MG",
"pack_size": "1",
"substance": "FOSDENOPTERIN HYDROBROMIDE DIHYDRATE",
"cz_kod_sukl": "0268192",
"product_type": "CH",
"substance_codes": "2623",
"registration_state": "R",
"registration_number": "EU/1/22/1684/001"
}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.