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PRODUCT DETAIL

Kalydeco 50 mg granulát vo vrecku

Code 7336B
MA number EU/1/12/782/003
Product Form: gra sac 56(4x14)x50 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
R07AX02 Ivacaftor
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: 23.07.2012
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 15.05.2022
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