Revised: 31 May 2019
Medicines
Medsafe Product Detail |   | |
|---|---|---|
| File ref: TT50-9989 |
| Trade Name | Dose Form | Strength | Identifier |
| Lynparza | Capsule | 50 mg | |
| Sponsor | Application date | Registration situation | Classification |
| AstraZeneca Limited P O Box 87453 Meadowbank Auckland 1742 | 8/6/2016 | Not available Approval date: 10/11/2016 Notification date: 2/3/2023 | Prescription |
Composition
| Component | Ingredient | Manufacturer |
| capsule | Active | |
| Olaparib 50mg | Lonza AG Lonzastrasse Walliser Werke Visp CH-3930 Switzerland | |
| Excipient | ||
| Gellan gum | ||
| Hypromellose | ||
| Lauroyl macrogol-32 glycerides | ||
| Iron oxide black | ||
| Potassium acetate | ||
| Shellac | ||
| Titanium dioxide |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | AstraZeneca UK Ltd Silk Road Business Park Macclesfield Cheshire SK10 2NA United Kingdom |
| Patheon Pharmaceuticals Inc 2110 East Galbraith Road Cincinnati Ohio 45237-1625 United States of America | |
| Manufacture of Final Dose Form | Patheon Pharmaceuticals Inc 2110 East Galbraith Road Cincinnati Ohio 45237-1625 United States of America |
| Micronisation | Jetpharma SA via Sottobisio 42a Balerna CH-6828 Switzerland |
| Packing | AstraZeneca UK Ltd Silk Road Business Park Macclesfield Cheshire SK10 2NA United Kingdom |
| 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 |
| Bottle, plastic, HDPE bottle with PP CRC, 4 bottles x 112 capsules | 448 capsules | 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 3 months opened stored at or below 25°C |
Indications
LYNPARZA is indicated as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed BRCA-mutated (germline or somatic) high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) after platinum-based chemotherapy. Prior treatment must have included at least 2 courses of platinum-based regimens.
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 28/1/2022 | Self-Assessable Change Notification | Data sheet - miscellaneous changes (Self assessable) | Notified | 2/2/2022 | |
| 8/6/2016 | New Higher-risk Medicine Application | Abridged new higher-risk medicine containing one or more new active substance | Granted 10/11/2016 | 14/6/2016 | Y |
