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PRODUCT DETAIL

Kalydeco 59,5 mg granulát vo vrecku

Code 5546E
MA number EU/1/12/782/008
Product Form: gra sac 28(4x7)x59,5 mg (vre.BOPET/PE/fólia/PE - multibal.)
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: 48
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: 28.02.2024
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