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Structural formula: IvacaftorStructural formula: Ivacaftor

ORKAMBI 100 mg/125 mg, film-coated tablet 112 tablets

Active ingredients: Ivacaftor, Lumacaftor

Commercialized according to BDPMDispensing in France: Prescription only
Film-coated tablet112 tabletsorale

No current ANSM shortage notice is included

Package details

Original BDPM fields are shown in French.

Official name
ORKAMBI 100 mg/125 mg, comprimé pelliculé
Pharmaceutical form
comprimé pelliculé
Route of administration
orale
Presentation description
4 plaquette(s) (ACLAR RX) polytrifluorochloroéthylène PVC aluminium de 28 comprimé(s) (112 comprimés en conditionnement multiple de 4 boîtes de 28 comprimés)
Marketing authorisation holder
VERTEX PHARMACEUTICALS (IRELAND)
Reimbursement according to BDPM
65%
Approval for use in healthcare institutions
oui
Commercialization declaration date
17 Dec 2019
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

CIS61962699CIP73014140CIP133400930141403

Composition in BDPM

Composition in BDPM
ComponentAmount per unitSource type
LUMACAFTORcomprimé100 mg · un compriméSA
IVACAFTORcomprimé125 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.