France· FR:68279528
OPZELURA 15 mg/g, crème
A medicinal product containing phosphate de ruxolitinib, registered in France by INCYTE BIOSCIENCES DISTRIBUTION (PAYS-BAS), on the national reimbursement list.
Checked against Base de données publique des médicaments — BDPM (France) on
Informational only — not a medical device.
The record
At a glance
Base de données publique des médicaments — BDPM (France)- Active substance
- PHOSPHATE DE RUXOLITINIB
- Manufacturer
- INCYTE BIOSCIENCES DISTRIBUTION (PAYS-BAS)
- Country
- France (FR)
- ATC code
- —
- Reimbursed
- Yes
- Source register
- Base de données publique des médicaments — BDPM (France)
- Last checked
- September 12, 2026
Packs & prices · 2
2 priced- cip1334009302709811 tube(s) aluminium de 100 gEUR 838.39
- cip1334009302761291 tube(s) laminé de 100 gEUR 838.39
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Phosphate de ruxolitinib in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaOPZELURAIncyte Biosciences Distribution B.V., Amsterdam
- SwitzerlandOpzelura 15 mg/g, crèmeIncyte Biosciences International Sàrl
- United StatesOPZELURAIncyte Corporation
- FinlandOpzeluraIncyte Biosciences Distribution B.V.
- 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
- Czechia · Ruxolitinib Msn, Ruxolitinib Sandoz
- Denmark · Ruxolitinib "sandoz", Ruxolitinib Devatis
- Estonia · Ruxolitinib Msn
- Spain · Ruxolitinib Cipla, Ruxolitinib Vivanta
- Finland · Ruxolitinib Orion
- 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 Base de données publique des médicaments — BDPM (France). 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/07437bcf-b761-4164-a0aa-311288b6d2f9 GET /v1/drugs/07437bcf-b761-4164-a0aa-311288b6d2f9?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.
{
"cis": "68279528",
"date_amm": "2023-04-19",
"type_amm": "Procédure centralisée",
"numero_ue": "EU/1/23/1726",
"substance": "PHOSPHATE DE RUXOLITINIB",
"statut_amm": "Autorisation active",
"statut_bdm": null,
"forme_pharmaceutique": "crème",
"voies_administration": "cutanée",
"etat_commercialisation": "Commercialisée",
"surveillance_renforcee": "Non"
}See everything about phosphate de 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.