Czechia· CZ-0272380
FABHALTA
A iptacopan product containing iptacopan hydrochloride monohydrate, registered in Czechia by Novartis Europharm Limited, Dublin. The same ATC class is registered in 14 of our 19 countries.
Checked against SÚKL (Czech Republic) on
Informational only — not a medical device.
Where it is registered
Iptacopan is registered in 14 of 19 countries.
Countries holding a registration under ATC L04AJ08 (iptacopan), each read from that country’s own register.
- This record: Czechia, from SÚKL (Czech Republic)
- 8 of them publish a price we can compare per daily dose
Iptacopan · ATC L04AJ08
14 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Ireland
- Japan
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
Price per daily dose
What a daily dose of iptacopan costs, country by country.
Normalised to the WHO defined daily dose (0.4 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
Iptacopan · price per daily dose (0.4 g)
USD · FX 28 Sept 2026
- CH Switzerland$1117.78
The record
At a glance
SÚKL (Czech Republic)- Active substance
- IPTACOPAN HYDROCHLORIDE MONOHYDRATE
- Manufacturer
- Novartis Europharm Limited, Dublin
- Country
- Czechia (CZ)
- ATC code
- L04AJ08
- ATC class
- Iptacopan
- Defined daily dose
- 0.4 g, O
- Reimbursed
- Not published by this register
- Source register
- SÚKL (Czech Republic)
- Last checked
- September 28, 2026
Packs & prices · 1
1 priced- cz_kod_sukl027238056CZK 702482.33
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.
- 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
- IcelandFabhaltaNovartis Europharm Limited*
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Fabhalta
- 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 SÚKL (Czech Republic). 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/d27e4477-da5e-4ae5-9a5e-c96c5f21352d GET /v1/drugs/d27e4477-da5e-4ae5-9a5e-c96c5f21352d?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": "CPS DUR",
"source": "sukl",
"strength": "200MG",
"pack_size": "56",
"substance": "IPTACOPAN HYDROCHLORIDE MONOHYDRATE",
"cz_kod_sukl": "0272380",
"product_type": "CH",
"substance_codes": "23454",
"registration_state": "R",
"registration_number": "EU/1/24/1802/002"
}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.