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Netherlands· NL-c797c03d4e04

Skyclarys 50 mg harde capsules

A omaveloxolone product containing omaveloxolon, registered in Netherlands by Biogen Netherlands B.V.. The same ATC class is registered in 11 of our 19 countries.

ATC N07XX25

Checked against CBG-MEB (Netherlands) on

Informational only — not a medical device.

SOURCE REGISTER · NLCBG-MEB (Netherlands)normalisedSkyclarys 50 mg harde capsulesATCN07XX25REGISTER NO.NL-c797c03d4e04PACKS LISTED1CHECKEDSeptember 29, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about omaveloxolonAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Omaveloxolone is registered in 11 of 19 countries.

Countries holding a registration under ATC N07XX25 (omaveloxolone), 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
Search omaveloxolone products by name

Omaveloxolone · ATC N07XX25

11 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Icelandprice
  • Ireland
  • Netherlands
  • Switzerlandprice
  • United Kingdom
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

Price per daily dose

What a daily dose of omaveloxolone costs, country by country.

Normalised to the WHO defined daily dose (0.15 g), so markets compare like for like.

  • 1 market with a comparable price for this class
  • Public list prices, converted to USD at the rate date shown
Open the full comparison — free accountDrug prices for market access

Omaveloxolone · price per daily dose (0.15 g)

USD · FX 28 Sept 2026

  • CH Switzerland$859.97
Median listed price per WHO defined daily dose, in each market that publishes a price. Open the full comparison

The record

At a glance

CBG-MEB (Netherlands)
Active substance
OMAVELOXOLON
Manufacturer
Biogen Netherlands B.V.
Country
Netherlands (NL)
ATC code
N07XX25
ATC class
Omaveloxolone
Defined daily dose
0.15 g, O
Reimbursed
Not published by this register
Source register
CBG-MEB (Netherlands)
Last checked
September 29, 2026

Packs & prices · 1

  • cbg_meb_id
    EU/1/23/1786

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Omaveloxolone in 12 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All omaveloxolone products

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 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/3a2aa7c1-7da7-4c12-b29d-943205f3d7f1
GET /v1/drugs/3a2aa7c1-7da7-4c12-b29d-943205f3d7f1?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": "Capsule, hard",
  "route": "Oraal gebruik",
  "soort": null,
  "source": "cbg_meb",
  "smpc_url": "https://www.ema.europa.eu/en/documents/product-information/skyclarys-epar-product-information_nl.pdf",
  "strength": null,
  "atc_label": "Omaveloxolone",
  "detail_url": "https://www.geneesmiddeleninformatiebank.nl/nl/cp130856",
  "excipients": [
    "BRILJANTBLAUW FCF (E 133)",
    "CELLULOSE, MICROKRISTALLIJN (E 460(i))",
    "CROSCARMELLOSE  NATRIUM  (E 468)",
    "HYPROMELLOSE (E 464)",
    "IJZEROXIDE GEEL (E 172)",
    "MAGNESIUMSTEARAAT (E 470b)",
    "MAÏSZETMEEL, GEPREGELATINEERD",
    "SCHELLAK (E 904)",
    "SILICIUMDIOXIDE (E 551)",
    "TITAANDIOXIDE (E 171)",
    "TITAANDIOXIDE (E 171)",
    "WITTE INKT"
  ],
  "substances": [
    "OMAVELOXOLON"
  ],
  "leaflet_url": null,
  "authorised_at": "2024/02/09",
  "procedure_number": "EMEA/H/C/006084",
  "dispensing_status": "Uitsluitend recept",
  "registration_number": "EU/1/23/1786",
  "additional_monitoring": "Y"
}
API referenceMCP serverPlans

See everything about omaveloxolone.

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.

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