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Belgium· BE-AMP-SAM662746-00

Fabhalta 200 mg

A iptacopan product containing iptacopan hydrochloride monohydrate, registered in Belgium by Novartis Europharm. The same ATC class is registered in 14 of our 19 countries.

ATC L04AJ08

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedFabhalta 200 mgATCL04AJ08REGISTER NO.BE-AMP-SAM662746-00PACKS LISTED2CHECKEDSeptember 26, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about iptacopan hydrochloride monohydrateAnswers 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: Belgium, from FAMHP / AFMPS (Belgium)
  • 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

FAMHP / AFMPS (Belgium)
Active substance
Iptacopan Hydrochloride Monohydrate
Manufacturer
Novartis Europharm
Country
Belgium (BE)
ATC code
L04AJ08
ATC class
Iptacopan
Defined daily dose
0.4 g, O
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 2

  • be_apb
    4840187
  • be_apb
    7741747

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 FAMHP / AFMPS (Belgium). 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/df6a4917-b2a7-4c27-b9fb-3ab531998bf6
GET /v1/drugs/df6a4917-b2a7-4c27-b9fb-3ab531998bf6?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",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Fabhalta 200 mg",
  "name_fr": "Fabhalta 200 mg",
  "name_nl": "Fabhalta 200 mg",
  "amp_code": "SAM662746-00",
  "strengths": [
    "200.0000",
    "200.0000"
  ],
  "pack_count": 3,
  "substances": [
    "Iptacopan Hydrochloride Monohydrate",
    "Iptacopan",
    "Potassium Hydroxide",
    "Propylene Glycol"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Iptacopan",
  "authorisation_numbers": [
    "EU/1/24/1802/001",
    "EU/1/24/1802/002",
    "EU/1/24/1802/003"
  ]
}
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