The medicinal product has been authorised by the European Commission (EC) via centralised procedure in all EU Member States, based on the European Medicines Agency (EMA) experts' opinion.
|Active Substance||tezakaftor, ivakaftor|
|Type of prescription||ograničeni recept
|Summary of product characteristics (SmPC), labelling and package leaflet (PL)||download|
|Link to the European Medicines Agency's (EMA) product information||download|
|Link to the European Commission's (EC) decisions||download|