en

PRODUCT DETAIL

Symkevi 100 mg/150 mg filmom obalené tablety

Code 9932C
MA number EU/1/18/1306/001
Product Form: tbl flm 28x100 mg/150 mg (blis.PCTFE/PVC/Al)
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
R07AX31 Ivacaftor and tezacaftor
Shelf life: 48
Container: blister PVC/PCTFE/Al
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: 31.10.2018
Validity: 31.10.2023
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 03.02.2021
eu-flag.png sk-flag.png