en

PRODUCT DETAIL

Orkambi 100 mg/125 mg granulát vo vrecku

Code 0890D
MA number EU/1/15/1059/006
Product Form: gra 56x100 mg/125 mg (vre.BOPET/PE/fólia/PE)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
Therapeutic Class: 14 - BRONCHODILATANTIA, ANTIASTHMATICA
ATC:
R RESPIRATORY SYSTEM
R07 OTHER RESPIRATORY SYSTEM PRODUCTS
R07A OTHER RESPIRATORY SYSTEM PRODUCTS
R07AX Other respiratory system products
R07AX30 Ivacaftor and lumacaftor
Shelf life: 36
Route of admin.: Oral use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 08.01.2018
Validity: 24.11.2025
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 23.11.2020
eu-flag.png sk-flag.png