Active substance | ELX/TEZ/IVA and IVA alone |
Holder | Vertex Pharmaceuticals (Netherlands) BV |
Status | closed |
Indication | Cystic fibrosis (CF) in patients from 6 to 11 years old who are homozygous for F508del (F/F genotype) or heterozygous for F508del and a minimal function (F/MF genotype) mutation. |
Public documents | Approbation |
Approbation amendment | |
Information for the patient | |
Informed consent | |
Last update | 09/01/2023 |