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France· FR:62501139

FABHALTA 200 mg, gélule

A iptacopan product containing chlorhydrate d'iptacopan monohydraté, registered in France by NOVARTIS EUROPHARM (IRLANDE). The same ATC class is registered in 14 of our 19 countries.

ATC L04AJ08

Checked against Base de données publique des médicaments — BDPM (France) on

Informational only — not a medical device.

SOURCE REGISTER · FRBase de données publique des médicament…normalisedFABHALTA 200 mg, géluleATCL04AJ08REGISTER NO.FR:62501139PACKS LISTED1CHECKEDSeptember 12, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about chlorhydrate d'iptacopan monohydratéAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

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: France, from Base de données publique des médicaments — BDPM (France)
  • 8 of them publish a price we can compare per daily dose
Search iptacopan products by name

Iptacopan · ATC L04AJ08

14 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Ireland
  • Japan
  • Netherlands
  • Norwayprice
  • Polandprice
  • 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 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
Open the full comparison — free accountDrug prices for market access

Iptacopan · price per daily dose (0.4 g)

USD · FX 28 Sept 2026

  • CH Switzerland$1117.78
Median listed price per WHO defined daily dose, in each market that publishes a price. Open the full comparison

The record

At a glance

Base de données publique des médicaments — BDPM (France)
Active substance
CHLORHYDRATE D'IPTACOPAN MONOHYDRATÉ
Manufacturer
NOVARTIS EUROPHARM (IRLANDE)
Country
France (FR)
ATC code
L04AJ08
ATC class
Iptacopan
Defined daily dose
0.4 g, O
Reimbursed
No
Source register
Base de données publique des médicaments — BDPM (France)
Last checked
September 12, 2026

Packs & prices · 1

  • cip13
    3400930294628
    plaquette(s) PVC polyéthylène PVDC aluminium de 56 gélule(s)

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.

All iptacopan products

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 Base de données publique des médicaments — BDPM (France). 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/b768d72c-aa43-4a90-986d-2de29a1f14f8
GET /v1/drugs/b768d72c-aa43-4a90-986d-2de29a1f14f8?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.

{
  "cis": "62501139",
  "date_amm": "2024-05-17",
  "type_amm": "Procédure centralisée",
  "numero_ue": "EU/1/24/1802",
  "substance": "CHLORHYDRATE D'IPTACOPAN MONOHYDRATÉ",
  "atc_source": "fr_atc_restore_2026-09-06",
  "statut_amm": "Autorisation active",
  "statut_bdm": null,
  "forme_pharmaceutique": "gélule",
  "voies_administration": "orale",
  "etat_commercialisation": "Commercialisée",
  "surveillance_renforcee": "Oui"
}
API referenceMCP serverPlans

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.

Try it freeOpen in the console