Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

Data SheetCMI
File ref: TT50-10918a
Trade NameDose FormStrengthIdentifier
Trikafta 50/25/37.5Film coated tablet50mg/25mg/37.5mg + 75mg
SponsorApplication dateRegistration situationClassification
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
P O Box 62027
Sylvia Park
AUCKLAND 1644
4/6/2021Consent given
Approval date: 9/12/2021
Labelling exemption expires 13/04/2024
Prescription
 

Composition

ComponentIngredientManufacturer
film coated tablet, Elexacaftor/Tezacaftor/IvacaftorActive 
 Elexacaftor 50 mgEsteve Quimica SA
Carretera del Vendrell
a Sant Jaume dels
Domenys, km 5 Banyeres Del Pendes
Tarragona 43711
Spain
 Ivacaftor 37.5 mgHovione FarmaCiencia SA
Sete Casas
Loures 2674-506
Portugal
  Esteve Quimica SA
C/ Ter 94, Poligon Industrial
Celra
Girona 17460
Spain
  Shanghai SynTheAll Pharmaceutical Co., Ltd
9 YueGong Road
Jinshan District
Shanghai 201507
China
 Tezacaftor 25 mgF.I.S. Fabbrica Italiana Sintetici SpA
Viale Milano 26
Montecchio Maggiore
Vicenza 36075
Italy
  Esteve Quimica SA
Poligon Industrial
Celra
Girona 17460
Spain
  Shanghai SynTheAll Pharmaceutical Co., Ltd
9 YueGong Road
Jinshan District
Shanghai 201507
China
 Excipient 
 Croscarmellose sodium
 Hypromellose
 Hypromellose acetate succinate
 Magnesium stearate
 Microcrystalline cellulose
 Opadry orange 20A130039
 Sodium laurilsulfate
film coated tablet, IvacaftorActive 
 Ivacaftor 75 mg
 Excipient 
 Carnauba wax
 Colloidal silicon dioxide
 Croscarmellose sodium
 Hypromellose acetate succinate
 Lactose monohydrate
 Magnesium stearate
 Microcrystalline cellulose
 Opacode black S-1-17823
 Opadry blue 85F105098
 Sodium laurilsulfate

Production

Manufacturing stepManufacturer
Finished Product TestingPatheon Pharmaceuticals Inc
2110 East Galbraith Road
Cincinnati
Ohio 45237-1625
United States of America
 PPD Development
8551 Research Way, Suite 90
Middleton
Wisconsin 53562
United States of America
 Vertex Pharmaceutical Incorporated
50 Northern Avenue
Boston MA 02210
United States of America
Manufacture of Final Dose FormPatheon Pharmaceuticals Inc
2110 East Galbraith Road
Cincinnati
Ohio 45237-1625
United States of America
 Vertex Pharmaceutical Incorporated
50 Northern Avenue
Boston MA 02210
United States of America
 Vertex Pharmaceutical Incorporated
50 Northern Avenue
Boston MA 02210
United States of America
Manufacture of Intermediate ProductHovione FarmaCiencia SA
Sete Casas
Loures 2674-506
Portugal
 Hovione Limited
Loughbeg
Ringaskiddy
County Cork
Ireland
PackingAlmac Pharma Services Limited
20 Seagoe Industrial Estate
Craigavon
County Armagh BT63 5UA
United Kingdom
 AndersonBrecon Inc
4545 Assembly Drive
Rockford
Illinois 61109
United States of America
Secondary PackagingAlmac Pharma Services (Ireland) Limited
Finnabair Industrial Estate
Dundalk
Co. Louth 91 P9KD
Ireland
NZ Site of Product ReleasePharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
58 Richard Pearse Drive
Airport Oaks
Mangere
AUCKLAND 2022

Packaging

PackageContentsShelf Life
Blister pack, PCTFE (Aclar)/PVC/Al, 7 x IVA tablets per strip, 4 strips per pack28 tablets 
Blister pack, PCTFE (Aclar)/PVC/Al, 14 x ELX/TEZ/IVA tablets per strip, 4 strips per pack56 tablets 
Combination pack, 28-day calendar pack, PCTFE (Aclar)/PVC/Al co-pack 4 x 21 tablets (14 x ELX/TEZ/IVA and 7 x IVA)84 tablets24 months from date of manufacture stored at or below 30°C

Indications

Trikafta is indicated for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

Latest Regulatory Activity

Application DateApplication TypeChange(s)StatusPayment DatePriority
2/6/2022Changed Medicine NotificationActive ingredient manufacturing process - Grade 3; Active ingredient specifications/test methods - Grade 1; Active ingredient specifications/test methods - Grade 4; Finished product manufacturing process - Grade 1; Finished product specifications/test methods - Grade 5; Administrative fee (CMN)Granted 28/6/202210/6/2022 
4/6/2021New Higher-risk Medicine ApplicationNew higher-risk medicine containing one or more new active substancesGranted 9/12/202123/6/2021Y
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