Revised: 31 May 2019
Medicines
Medsafe Product Detail |   | |
|---|---|---|
| File ref: TT50-10549a |
| Trade Name | Dose Form | Strength | Identifier |
| Imfinzi | Concentrate for infusion | 500 mg/10 mL | |
| Sponsor | Application date | Registration situation | Classification |
| AstraZeneca Limited P O Box 87453 Meadowbank Auckland 1742 | 7/1/2019 | Consent given Approval date: 10/10/2019 | Prescription |
Composition
| Component | Ingredient | Manufacturer |
| concentrate for infusion | Active | |
| Durvalumab 500mg | Samsung Biologics Co Ltd 300, Songdo bio-daero Yeonsu-gu Incheon 21987 South Korea | |
| AstraZeneca Pharmaceuticals LP Frederick Manufacturing Centre FMC 633 Research Court, Frederick Maryland 21703 United States of America | ||
| Excipient | ||
| Histidine | ||
| Histidine hydrochloride monohydrate | ||
| Polysorbate 80 | ||
| Trehalose dihydrate | ||
| Water for injection |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | AstraZeneca AB Gartunavagen Sodertalje 151 85 Sweden |
| AstraZeneca Pharmaceuticals LP Frederick Manufacturing Centre FMC 633 Research Court, Frederick Maryland 21703 United States of America | |
| Catalent Indiana LLC 1300 South Patterson Drive Bloomington Indiana 47403 United States of America | |
| Eurofins Lancaster Laboratories Inc 2425 New Holland Pike Lancaster Pennsylvania 17601 United States of America | |
| Finished Product Testing - Microbiological | AstraZeneca AB Forskargatan 18 Sodertalje S-151 36 Sweden |
| Vetter Pharma-Fertigung GmbH & Co KG Eisenbahnstrasse 2-4 Langenargen D-88085 Germany | |
| Vetter Pharma-Fertigung GmbH & Co KG Mooswiesen 2 Ravensburg D-88214 Germany | |
| Vetter Pharma-Fertigung GmbH & Co KG Schuetzenstrasse 87, 99-101 Ravensburg D-88212 Germany | |
| Manufacture of Final Dose Form | AstraZeneca AB Gartunavagen Sodertalje 151 85 Sweden |
| Catalent Indiana LLC 1300 South Patterson Drive Bloomington Indiana 47403 United States of America | |
| Vetter Pharma-Fertigung GmbH & Co KG Mooswiesen 2 Ravensburg D-88214 Germany | |
| Packing | AstraZeneca AB Gartunavagen Sodertalje 151 85 Sweden |
| Catalent Indiana LLC 1300 South Patterson Drive Bloomington Indiana 47403 United States of America | |
| Secondary Packaging | AstraZeneca AB Forskargatan 18 Sodertalje S-151 36 Sweden |
| AstraZeneca AB Gartunavagen Sodertalje 151 85 Sweden | |
| AstraZeneca Pty Ltd 10-14 Khartoum Road North Ryde NSW 2113 Australia | |
| Catalent Indiana LLC 1300 South Patterson Drive Bloomington Indiana 47403 United States of America | |
| 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 |
| Vial, glass, Type I glass vial closed with rubber stopper and flip-off seal, 10ml volume | 1 dose units | 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 30 days diluted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. Only if dilution has taken place in controlled and validated aseptic conditions 24 hours diluted stored at or below 25°C protect from light. Only if dilution has taken place in controlled and validated aseptic conditions |
Indications
IMFINZI (durvalumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who:
· have disease progression during or following platinum-containing chemotherapy
· have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy
This indication is approved based on objective response rate and duration of response in a single arm study. An improvement in survival or disease-related symptoms has not been established.
IMFINZI (durvalumab) is indicated for the treatment of patients with locally advanced, unresectable NSCLC whose disease has not progressed following platinum-based chemoradiation therapy.
IMFINZI in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 7/12/2022 | Changed Medicine Notification | Finished product manufacturing site; Finished product testing site; Finished product manufacturing process - G2; Container/closure/packaging - G1; Administrative fee (CMN) | Granted 20/1/2023 | 12/12/2022 | |
| 9/11/2022 | Changed Medicine Notification | Indications/dosage - Grade 4; Data sheet - miscellaneous changes; Administrative fee (CMN) | Additional evaluation started 09/01/2023 | 17/11/2022 | |
| 30/6/2022 | CMN 24(5) | Indications/dosage - Grade 1; Administrative fee (CMN) | Pending | 11/7/2022 | |
| 7/1/2019 | New Higher-risk Medicine Application | Abridged new higher-risk medicine containing one or more new active substance | Granted 10/10/2019 | 14/1/2019 |
