FABHALTA 200 mg, hard capsule 56 capsules

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Active ingredients: CHLORHYDRATE D'IPTACOPAN MONOHYDRATÉ, IPTACOPAN

Commercialized according to BDPMDispensing in France: Prescription only

Hard capsule56 capsulesorale

No current ANSM shortage notice is included

Package details

Original BDPM fields are shown in French.

Official name: FABHALTA 200 mg, gélule
Pharmaceutical form: gélule
Route of administration: orale
Presentation description: plaquette(s) PVC polyéthylène PVDC aluminium de 56 gélule(s)
Marketing authorisation holder: NOVARTIS EUROPHARM (IRLANDE)
Reimbursement according to BDPM: 65 %
Approval for use in healthcare institutions: oui
Commercialization declaration date: 28 Aug 2024
Prescription and dispensing conditions: Prescription only
List I: prescription-only medicine
Requires special monitoring during treatment
Prescribed by a hospital doctor
Prescribed by specialists only
Original BDPM wording: liste I · médicament nécessitant une surveillance particulière pendant le traitement · prescription hospitalière · prescription réservée aux médecins compétents en maladie du sang · prescription réservée aux spécialistes et services HEMATOLOGIE · prescription réservée aux spécialistes et services MEDECINE INTERNE · prescription réservée aux spécialistes et services NEPHROLOGIE
Enhanced ANSM monitoring: Yes

BDPM identifiers

CIS62501139CIP73029462CIP133400930294628

Composition in BDPM

Composition in BDPM
Component	Amount per unit	Source type
CHLORHYDRATE D'IPTACOPAN MONOHYDRATÉgélule	—	SA
IPTACOPANgélule	200 mg · une gélule	FT

Information is based on BDPM data and is for reference only. Consult a doctor before use.

Similar medicines

Similar medicines are listed using the official BDPM catalog. Availability must be checked separately. Consult a doctor or pharmacist before switching medicines.

The current BDPM data does not list similar medicines for this product.