Revised: 31 May 2019
Medicines
Medsafe Product Detail | ![]() ![]() | |
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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 Labelling exemption expires 11/12/2022 | Prescription |
Composition
Component | Ingredient | Manufacturer |
concentrate for infusion | Active | |
Durvalumab 500 mg | 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 SE-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 IN 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 85 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 | Catalent Indiana LLC 1300 South Patterson Drive Bloomington IN 47403 United States of America |
Vetter Pharma-Fertigung GmbH & Co KG Mooswiesen 2 Ravensburg D-88214 Germany | |
Packing | Catalent Indiana LLC 1300 South Patterson Drive Bloomington IN 47403 United States of America |
Secondary Packaging | AstraZeneca AB Forskargatan 18 Sodertalje S-151 85 Sweden |
AstraZeneca Pty Ltd 10-14 Khartoum Road North Ryde NSW 2113 Australia | |
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 |
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 |
9/12/2020 | Changed Medicine Notification | Active ingredient method of manufacture - Grade 2; Administrative fee (CMN) | Granted 20/1/2021 | 15/12/2020 | |
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 |