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PRODUCT DETAIL

Kaftrio 37,5 mg/25 mg/50 mg filmom obalené tablety

Code 9628D
MA number EU/1/20/1468/002
Product Form: tbl flm 56x37,5 mg/25 mg/50 mg
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU Orphan
Therapeutic Class: 14 - BRONCHODILATANTIA, ANTIASTHMATICA
ATC:
R RESPIRATORY SYSTEM
R07 OTHER RESPIRATORY SYSTEM PRODUCTS
R07A OTHER RESPIRATORY SYSTEM PRODUCTS
R07AX Other respiratory system products
R07AX32 Ivacaftor,tezacaftor and elexacaftor
Shelf life: 24
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: 21.08.2020
Validity: 21.08.2025
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 11.02.2022
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