Ireland· IE-PA-EU/1/23/1786/001-002
Skyclarys 50 mg hard capsules
A omaveloxolone product containing omaveloxolone, registered in Ireland by Biogen Netherlands B.V.. The same ATC class is registered in 11 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
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: Ireland, from HPRA (Ireland)
- 7 of them publish a price we can compare per daily dose
Omaveloxolone · ATC N07XX25
11 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Icelandprice
- Ireland
- Netherlands
- Switzerlandprice
- United Kingdom
- United Statesprice
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
Omaveloxolone · price per daily dose (0.15 g)
USD · FX 28 Sept 2026
- CH Switzerland$859.97
The record
At a glance
HPRA (Ireland)- Active substance
- Omaveloxolone
- Manufacturer
- Biogen Netherlands B.V.
- Country
- Ireland (IE)
- ATC code
- N07XX25
- ATC class
- Omaveloxolone
- Defined daily dose
- 0.15 g, O
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/23/1786/001-002
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.
- 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
- IcelandSkyclarysBiogen Netherlands B.V.
- NetherlandsSkyclarys 50 mg harde capsulesBiogen Netherlands B.V.
- PolandSkyclarysBiogen 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 HPRA (Ireland). 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/74fb52f5-50da-4760-b9da-1b42d883491b GET /v1/drugs/74fb52f5-50da-4760-b9da-1b42d883491b?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",
"routes": [
"Oral use"
],
"source": "hpra",
"atc_all": [
"N07XX25"
],
"strength": null,
"pa_number": "EU/1/23/1786/001-002",
"substances": [
"Omaveloxolone"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "09/02/2024",
"dispensing_status": "Product subject to prescription which may not be renewed (A)",
"registration_status": "AU",
"supply_legal_status": "Supply through pharmacies only",
"interchangeable_code": null
}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.