Iceland· IS-EU/1/24/1802/001-003
Fabhalta
A immunosuppressants product containing iptacopan, registered in Iceland by Novartis Europharm Limited*. The same ATC class is registered in 3 of our 19 countries.
Checked against Icelandic Medicines Agency (Iceland) on
Informational only — not a medical device.
Where it is registered
Iptacopan is registered in 3 of 19 countries.
Countries holding a registration under ATC L04A (immunosuppressants), each read from that country’s own register.
- This record: Iceland, from Icelandic Medicines Agency (Iceland)
- 2 of them publish a price we can compare per daily dose
Iptacopan · ATC L04A
3 / 19 countries
- Icelandprice
- Ireland
- Polandprice
The record
At a glance
Icelandic Medicines Agency (Iceland)- Active substance
- Iptacopan
- Manufacturer
- Novartis Europharm Limited*
- Country
- Iceland (IS)
- ATC code
- L04A
- ATC class
- IMMUNOSUPPRESSANTS
- Reimbursed
- Not published by this register
- Source register
- Icelandic Medicines Agency (Iceland)
- Last checked
- September 29, 2026
Packs & prices · 1
1 priced- ean55535156 stk x1 þpakkiISK 4334416
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Iptacopan in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaFABHALTANovartis Europharm Limited, Dublin
- United StatesFABHALTANovartis Pharmaceuticals Corporation
- SwitzerlandFabhalta
- SpainFABHALTA 200 MG CAPSULAS DURASNovartis Europharm Limited
- FinlandFABHALTANovartis Europharm Limited
- FranceFABHALTA 200 mg, géluleNOVARTIS EUROPHARM (IRLANDE)
- BelgiumFabhalta 200 mgNovartis Europharm
- IrelandFABHALTA 200 mg hard capsulesNovartis Europharm Limited
Authorised across Europe · EMA
The same active substance is authorised in 2 EEA countries. Names it is sold under:
- Liechtenstein · Fabhalta
- Norway · Fabhalta
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/95aaa9e8-e5c8-4416-bf61-c1a9daee8ed6 GET /v1/drugs/95aaa9e8-e5c8-4416-bf61-c1a9daee8ed6?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": "Hart hylki",
"source": "lyfjastofnun",
"atc_raw": "L04A",
"marketed": true,
"strength": "200 mg",
"ma_number": "EU/1/24/1802/001-003",
"substance": "Iptacopan",
"other_info": "Markaðssetning 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) Lyfseðilsskylt",
"ma_issued_serial": "45429"
}See everything about iptacopan.
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.