Iceland· IS-EU/1/20/1480/001-002
Jyseleca
A filgotinib product containing filgotinibum inn maleat, registered in Iceland by AlfaSigma S.p.A.. The same ATC class is registered in 10 of our 19 countries.
Checked against Icelandic Medicines Agency (Iceland) on
Informational only — not a medical device.
Where it is registered
Filgotinib is registered in 10 of 19 countries.
Countries holding a registration under ATC L04AF04 (filgotinib), each read from that country’s own register.
- This record: Iceland, from Icelandic Medicines Agency (Iceland)
- 6 of them publish a price we can compare per daily dose
Filgotinib · ATC L04AF04
10 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Japan
- Netherlands
- Norwayprice
- Polandprice
- United Kingdom
The record
At a glance
Icelandic Medicines Agency (Iceland)- Active substance
- Filgotinibum INN maleat
- Manufacturer
- AlfaSigma S.p.A.
- Country
- Iceland (IS)
- ATC code
- L04AF04
- ATC class
- Filgotinib
- Defined daily dose
- 0.2 g, O
- Reimbursed
- Not published by this register
- Source register
- Icelandic Medicines Agency (Iceland)
- Last checked
- September 29, 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
Filgotinib in 11 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaJYSELECAAlfasigma S.p.A., Bologna
- SpainJYSELECA 100 mg COMPRIMIDOS RECUBIERTOS CON PELICULAAlfasigma S.P.A.
- FinlandJyselecaALFASIGMA S.p.A.
- FranceJYSELECA 100 mg, comprimé pelliculéALFASIGMA (ITALIE)
- IrelandJyseleca 100 mg film-coated tabletsAlfasigma S.p.A
- NetherlandsJyseleca 100 mg, filmomhulde tablettenAlfasigma S.p.A.
- NorwayJyselecaAlfasigma S.p.A
- PolandJyselecaAlfasigma S.p.A.
Authorised across Europe · EMA
The same active substance is authorised in 2 EEA countries. Names it is sold under:
- Liechtenstein · Jyseleca
- Norway · Jyseleca
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 Icelandic Medicines Agency (Iceland). 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/060f5d20-2a01-4a4b-958c-a018cf68c148 GET /v1/drugs/060f5d20-2a01-4a4b-958c-a018cf68c148?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": "Filmuhúðuð tafla",
"source": "lyfjastofnun",
"atc_raw": "L04AF04",
"marketed": true,
"strength": "100 mg",
"ma_number": "EU/1/20/1480/001-002",
"substance": "Filgotinibum INN maleat",
"other_info": "Ávísun lyfsins er bundin við sérfræðinga í meltingar- eða gigtarsjúkdómum.\r\nMarkaðssetning á Íslandi er háð því að Lyfjastofnun hafi staðfest að sérstök skilyrði er varða öryggi og verkun við notkun lyfsins séu uppfyllt.",
"legal_status": "(R Z) Sérfræðingsmerkt (og lyfseðilsskylt)",
"ma_issued_serial": "44098"
}See everything about filgotinib.
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.