Revised: 31 May 2019
Medicines
Medsafe Product Detail |   | |
|---|---|---|
| File ref: TT50-10918a |
| Trade Name | Dose Form | Strength | Identifier |
| Trikafta 50/25/37.5 | Film coated tablet | 50mg/25mg/37.5mg + 75mg | |
| Sponsor | Application date | Registration situation | Classification |
| Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics P O Box 62027 Sylvia Park AUCKLAND 1644 | 4/6/2021 | Consent given Approval date: 9/12/2021 | Prescription |
Composition
| Component | Ingredient | Manufacturer |
| film coated tablet, Elexacaftor/Tezacaftor/Ivacaftor | Active | |
| Elexacaftor 50mg | Changzhou SynTheAll Pharmaceutical Co. Ltd 589 North Yulong Road Xinbei District Changzhou 213127 CHINA | |
| Esteve Quimica SA Carretera del Vendrell a Sant Jaume dels Domenys, km 5 Banyeres Del Pendes Tarragona 43711 SPAIN | ||
| Ivacaftor 37.5mg | Hovione 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 25mg | F.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, Ivacaftor | Active | |
| Ivacaftor 75mg | ||
| 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 step | Manufacturer |
| Finished Product Testing | Patheon 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 Massachusetts 02210 UNITED STATES OF AMERICA | |
| Manufacture of Final Dose Form | Patheon Pharmaceuticals Inc 2110 East Galbraith Road Cincinnati Ohio 45237-1625 UNITED STATES OF AMERICA |
| Vertex Pharmaceutical Incorporated 50 Northern Avenue Boston Massachusetts 02210 UNITED STATES OF AMERICA | |
| Vertex Pharmaceutical Incorporated 50 Northern Avenue Boston Massachusetts 02210 UNITED STATES OF AMERICA | |
| Manufacture of Intermediate Product | Hovione FarmaCiencia SA Sete Casas Loures 2674-506 PORTUGAL |
| Hovione Limited Loughbeg Ringaskiddy County Cork IRELAND | |
| Packing | Almac Pharma Services Limited 20 Seagoe Industrial Estate Craigavon BT63 5UA UNITED KINGDOM |
| AndersonBrecon Inc 4545 Assembly Drive Rockford Illinois 61109 UNITED STATES OF AMERICA | |
| Secondary Packaging | Almac Pharma Services (Ireland) Limited Finnabair Industrial Estate Dundalk Co. Louth 91 P9KD IRELAND |
| NZ Site of Product Release | Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics 58 Richard Pearse Drive Airport Oaks Mangere AUCKLAND 2022 |
Packaging
| Package | Contents | Shelf Life |
| Blister pack, PCTFE (Aclar)/PVC/Al, 7 x IVA tablets per strip, 4 strips per pack | 28 tablets | |
| Blister pack, PCTFE (Aclar)/PVC/Al, 14 x ELX/TEZ/IVA tablets per strip, 4 strips per pack | 56 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 tablets | 36 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 Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 19/1/2024 | CMN 24(5) | Indications/dosage - G3 (NCE); Administrative fee (CMN) | Initial evaluation | 26/2/2024 | Y |
| 4/6/2021 | New Higher-risk Medicine Application | New higher-risk medicine containing one or more new active substances | Granted 9/12/2021 | 23/6/2021 | Y |
