MedPath

ORKAMBI 100 MG/125 MG COMPRIMIDOS RECUBIERTOS CON PELICULA

ORKAMBI 100 MG/125 MG COMPRIMIDOS RECUBIERTOS CON PELICULA

Commercialized
Register Number

1151059005

Prescription Type

Uso Hospitalario

Authorization Date

Apr 5, 2018

Dosage Form

COMPRIMIDO RECUBIERTO CON PELÍCULA

Route: VÍA ORAL

Product Details

Detailed information about this CIMA AEMPS approved pharmaceutical product.

Basic Information

Key regulatory and product classification details

Regulatory Details

Register Number1151059005
EMA Approved
Yes

Drug Classification

Generic
No
Orphan
No
Biosimilar
No
Commercialized
Yes
CIMA AEMPS Classification

INGREDIENTS (2)

IVACAFTORActive
Quantity: 125 mg
Name: IVACAFTOR
LUMACAFTORActive
Quantity: 100 mg
Name: LUMACAFTOR

ATC CLASSIFICATION (3)

R07A
R07AX
R07AX30

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.