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Structural formula: ErdafitinibStructural formula: Erdafitinib

BALVERSA 5 mg, film-coated tablet 28 tablets

Active ingredients: Erdafitinib

Commercialized according to BDPMDispensing in France: Prescription only
Film-coated tablet28 tabletsorale

No current ANSM shortage notice is included

Package details

Original BDPM fields are shown in French.

Official name
BALVERSA 5 mg, comprimé pelliculé
Pharmaceutical form
comprimé pelliculé
Route of administration
orale
Presentation description
1 flacon(s) polyéthylène haute densité (PEHD) avec fermeture de sécurité enfant de 28 comprimé(s)
Marketing authorisation holder
JANSSEN CILAG INTERNATIONAL NV
Reimbursement according to BDPM
100 %
Approval for use in healthcare institutions
oui
Commercialization declaration date
1 Apr 2025
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 CANCEROLOGIE · prescription réservée aux spécialistes et services ONCOLOGIE MEDICALE
Enhanced ANSM monitoring
Yes

BDPM identifiers

CIS60039171CIP73030104CIP133400930301043

Composition in BDPM

Composition in BDPM
ComponentAmount per unitSource type
ERDAFITINIBcomprimé5 mg · un compriméSA

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.