Revised: 31 May 2019
Medicines
Medsafe Product Detail |   | |
|---|---|---|
| File ref: TT50-10052a |
| Trade Name | Dose Form | Strength | Identifier |
| Tagrisso | Film coated tablet | 80 mg | |
| Sponsor | Application date | Registration situation | Classification |
| AstraZeneca Limited P O Box 87453 Meadowbank Auckland 1742 | 10/10/2016 | Consent given Approval date: 5/10/2017 | Prescription |
Composition
| Component | Ingredient | Manufacturer |
| film coated tablet | Active | |
| Osimertinib mesilate 95.4mg equivalent to osimertinib 80 mg | Dottikon Exclusive Synthesis AG Hembrunnstrasse 17 Dottikon CH 5605 SWITZERLAND | |
| Lonza AG Lonzastrasse Walliser Werke Visp CH-3930 SWITZERLAND | ||
| Excipient | ||
| Hyprolose | ||
| Iron oxide black | ||
| Iron oxide red | ||
| Iron oxide yellow | ||
| Macrogol 3350 | ||
| Mannitol | ||
| Microcrystalline cellulose | ||
| Polyvinyl alcohol | ||
| Purified talc | ||
| Sodium stearyl fumarate | ||
| Titanium dioxide |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | AstraZeneca AB Gartunavagen Sodertalje 152 57 SWEDEN |
| Manufacture of Final Dose Form | AstraZeneca AB Gartunavagen Sodertalje 152 57 SWEDEN |
| Packing | AstraZeneca AB Gartunavagen Sodertalje 152 57 SWEDEN |
| 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, PVC/Al/PA laminate/Al foil blister | 30 tablets | 36 months from date of manufacture stored at or below 30°C |
Indications
Tagrisso is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) mutations.
Tagrisso is indicated for the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive non-small cell lung cancer.
Tagrisso is indicated for the adjuvant treatment after tumour resection in adult patients with non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) mutations.
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 19/12/2023 | Changed Medicine Notification | Contraindications, warnings and precautions - G1; Administrative fee (CMN) | Granted 29/1/2024 | 9/1/2024 | |
| 12/10/2023 | CMN 24(5) | Indications/dosage - G3 (NCE); Administrative fee (CMN) | Pending | 25/10/2023 | |
| 10/10/2016 | New Higher-risk Medicine Application | Abridged new higher-risk medicine containing one or more new active substance | Granted 5/10/2017 | 19/10/2016 |
