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Structural formula: IvacaftorStructural formula: Ivacaftor

KALYDECO 150 mg, film-coated tablet 28 tablets

Active ingredients: Ivacaftor

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
KALYDECO 150 mg, comprimé pelliculé
Pharmaceutical form
comprimé pelliculé
Route of administration
orale
Presentation description
plaquette(s) (ACLAR RX) polytrifluorochloroéthylène aluminium de 28 comprimé(s)
Marketing authorisation holder
VERTEX PHARMACEUTICALS (IRELAND)
Reimbursement according to BDPM
65 %
Reimbursement conditions
Ce médicament peut être pris en charge ou remboursé par l'Assurance Maladie dans les cas suivants :<br><br>- Mucoviscidose chez les personnes âgés de 6 ans et plus, porteuses de certaines caractéristiques génétiques précises. ; JOURNAL OFFICIEL ; 04/02/20
Approval for use in healthcare institutions
oui
Commercialization declaration date
6 Jul 2021
Prescription and dispensing conditions
Prescription only
  • List I: prescription-only medicine
  • Initial prescription by a hospital doctor
Original BDPM wording: liste I · prescription initiale hospitalière semestrielle · renouvellement non restreint
Enhanced ANSM monitoring
No

BDPM identifiers

CIS65036318CIP73015948CIP133400930159484

Composition in BDPM

Composition in BDPM
ComponentAmount per unitSource type
IVACAFTORcomprimé150 mg · un compriméSA

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

Other packages of this medicine

The same medicine in another pack size, according to BDPM.

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 published catalog does not list other packages of similar medicines.