VX-445/Tezacaftor/Ivacaftor and Ivacaftor

Active substance

VX-445/Tezacaftor/Ivacaftor and Ivacaftor

Holder

Vertex Pharmaceuticals Incorporated

Status

Closed

Indication

Cystic fibrosis (CF) patients in critical need who are 12 years of age and older, homozygous for F508del (F/F genotypes).

Public documents

Approbation

Approbation amendment

Approbation amendment 2

Information for the patient

Information for the patient amendment

Information for the patient amendment 2

Informed consent

Informed consent amendment

Informed consent amendment 2

Last update

09/08/2022