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Marktzulassung mit Orphan-Drug-Designation - USA
- Produkt: SYMDEKO
- ATC-Code : R07AX31
- EU-Nummer: -
- MA date : 12/02/2018
- Zulassungsinhaber: VERTEX PHARMACEUTICALS, INC.
Treatment of patients with cystic fibrosis (CF) aged 6 years and older who are homozygous for the F508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence.