Market Authorisation Date: 07 August, 2018

Treatment: Method of treating cystic fibrosis using n-(5-hydroxy-2,4-ditert-butyl-phenyl)-4-oxo-1h-quinoline-3-carboxamide and 3-(6-(1-2,2-difluorobenzo[d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid; Treatment of cystic fibrosis in a patient age 2-5 years who is homozygous for the f508del mutation in the cftr gene using lumacaftor and ivacaftor; Treatment of cystic fibrosis in a patient age 2-5 years who is homozygous for the f508del mutation in the cftr gene using lumacaftor and a solid composition comprising amorphous and less than about 30% crystalline ivacaftor; Method of treating a patient having cystic fibrosis using ivacaftor and lumacaftor; Method of treating cystic fibrosis; Method of treating cystic fibrosis in a patient, the patient having the f508del mutation in cftr, using ivacaftor and form i lumacaftor; Treatment of cystic fibrosis in patients 6 years and older who are homozygous for the f508del mutation in the cftr gene using the tablet according to claim 1 of u.s. patent no. 11,052,075, where the tablet further comprises ivacaftor; Treatment of cystic fibrosis in a patient age 12 years or older who is homozygous for the f508del mutation in the cftr gene using the tablet comprising lumacaftor as recited in claim 1, 19, or 21 of u.s. patent no. 10,076,513 and ivacaftor; Treatment of cystic fibrosis in a patient age 2-5 years who is homozygous for the f508del mutation in the cftr gene using lumacaftor form i and ivacaftor; Treatment of cystic fibrosis in a patient age 2-5 years who is homozygous for the f508del mutation in the cftr gene using the dosage unit comprising lumacaftor and ivacaftor as recited in claim 1 of us patent 9192606; Method of treating cystic fibrosis in a patient, the patient having the f508del mutation in cftr, using the dosage unit of claim 1 of u.s. patent no. 8,716,338; Method of treating cystic fibrosis in patients who have the f508del mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene.; Treatment of cystic fibrosis in patients 2 to 5 years old who are homozygous for the f508del mutation in the cftr gene using a pharmaceutical composition according to claim 2 of u.s. patent no. 10,597,384, further comprising ivacaftor

Dosage: GRANULE;ORAL