Czechia· CZ-0290711
OPZELURA
A ruxolitinib product containing ruxolitinib phosphate, registered in Czechia by Incyte Biosciences Distribution B.V., Amsterdam. The same ATC class is registered in 14 of our 19 countries.
Checked against SÚKL (Czech Republic) on
Informational only — not a medical device.
Where it is registered
Ruxolitinib is registered in 14 of 19 countries.
Countries holding a registration under ATC D11AH09 (ruxolitinib), each read from that country’s own register.
- This record: Czechia, from SÚKL (Czech Republic)
- 9 of them publish a price we can compare per daily dose
Ruxolitinib · ATC D11AH09
14 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Italyprice
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
The record
At a glance
SÚKL (Czech Republic)- Active substance
- RUXOLITINIB PHOSPHATE
- Manufacturer
- Incyte Biosciences Distribution B.V., Amsterdam
- Country
- Czechia (CZ)
- ATC code
- D11AH09
- ATC class
- Ruxolitinib
- Defined daily dose
- 30 mg, T
- 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
Ruxolitinib in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SwitzerlandOpzelura 15 mg/g, crèmeIncyte Biosciences International Sàrl
- United StatesOPZELURAIncyte Corporation
- FinlandOpzeluraIncyte Biosciences Distribution B.V.
- FranceOPZELURA 15 mg/g, crèmeINCYTE BIOSCIENCES DISTRIBUTION (PAYS-BAS)
- IrelandOpzelura 15 mg/g CreamIncyte Biosciences Distribution B.V.
- IcelandOpzeluraIncyte Biosciences Distribution B.V.
- NetherlandsOpzelura 15 mg/g crèmeIncyte Biosciences Distribution B.V.
- NorwayOpzeluraIncyte Biosciences Distribution B.V.
Authorised across Europe · EMA
The same active substance is authorised in 22 EEA countries. Names it is sold under:
- Austria · Polink, Ruxib
- Bulgaria · Руджави, Руксолитиниб Сандоз
- Cyprus · Ruxolitinib Sandoz
- Denmark · Ruxolitinib "sandoz", Ruxolitinib Devatis
- Estonia · Ruxolitinib Msn
- Spain · Ruxolitinib Cipla, Ruxolitinib Vivanta
- Finland · Ruxolitinib Orion
- France · Ruxolitinib Biogaran, Ruxolitinib Olpha
- United Kingdom (Northern Ireland) · Ruxolitinib Msn Laboratories Europe, Ruxolitinib Torrent
- Greece · Jakulya
- Croatia · Ruksolitinib Devatis, Ruksolitinib Msn
- Hungary · Ruxolitinib Sandoz
- Iceland · Jakavi, Jakulya
- Italy · Ruxolitinib Vivanta
- Liechtenstein · Jakavi, Opzelura
- Lithuania · Ruxolitinib Msn, Ruxolitinib Olpha
- Latvia · Ruxolitinib Msn
- Malta · Donlize, Ruxolitinib Medichem
- Netherlands · Ruxolitinib Accord, Ruxolitinib Advanz Pharma
- Norway · Jakavi, Opzelura
- Romania · Ruxolitinib Msn
- Sweden · Ruxolitinib Devatis, Ruxolitinib Orion
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/00b0ab59-27da-4891-98a9-859a0935e4ba GET /v1/drugs/00b0ab59-27da-4891-98a9-859a0935e4ba?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": "CRM",
"source": "sukl",
"strength": "15MG/G",
"pack_size": "1X5G I",
"substance": "RUXOLITINIB PHOSPHATE",
"cz_kod_sukl": "0290711",
"product_type": null,
"substance_codes": "19748",
"registration_state": "R",
"registration_number": "EU/1/23/1726/003"
}See everything about ruxolitinib.
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.