Poland· PL-100493345
Skyclarys
A medicinal product containing omaveloxolonum, registered in Poland by Biogen Netherlands B.V..
Checked against URPL (Poland) on
Informational only — not a medical device.
The record
At a glance
URPL (Poland)- Active substance
- Omaveloxolonum
- Manufacturer
- Biogen Netherlands B.V.
- Country
- Poland (PL)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- URPL (Poland)
- Last checked
- September 27, 2026
Packs & prices · 1
- gtin00373179500443
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Omaveloxolonum in 12 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaSKYCLARYSBiogen Netherlands B.V., Badhoevedorp
- SwitzerlandSkyclarys 50 mg, HartkapselnBiogen Switzerland AG
- FinlandSkyclarysBiogen Netherlands B.V.
- FranceSKYCLARYS 50 mg, géluleBIOGEN NETHERLANDS (PAYS-BAS)
- United KingdomSkyclarys 50mg capsulesBiogen Idec Ltd
- IrelandSkyclarys 50 mg hard capsulesBiogen Netherlands B.V.
- IcelandSkyclarysBiogen Netherlands B.V.
- NetherlandsSkyclarys 50 mg harde capsulesBiogen Netherlands B.V.
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Skyclarys
- Liechtenstein · Skyclarys
- Norway · Skyclarys
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 URPL (Poland). 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/03a994b5-d44a-40e7-851c-2b6722b3614c GET /v1/drugs/03a994b5-d44a-40e7-851c-2b6722b3614c?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": "Kapsułki twarde",
"source": "urpl",
"strength": "50 mg",
"packaging": "00373179500443 ¦ Rpz ¦ EU/1/23/1786/001 ¦ 153215\n1 butelka 90 kaps.\nRpz ¦ EU/1/23/1786/002 ¦ 153216\n3 butelki 90 kaps.",
"substance": "Omaveloxolonum 50 mg",
"common_name": "Omaveloxolonum",
"pl_product_id": "100493345",
"pozwolenie_nr": null,
"auth_procedure": "CEN",
"authorisation_validity": null
}See everything about omaveloxolonum.
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.