Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

Data SheetCMI
File ref: TT50-10549a
Trade NameDose FormStrengthIdentifier
ImfinziConcentrate for infusion500 mg/10 mL
SponsorApplication dateRegistration situationClassification
AstraZeneca Limited
P O Box 87453
Meadowbank
Auckland 1742
7/1/2019Consent given
Approval date: 10/10/2019
Labelling exemption expires 11/12/2022
Prescription
 

Composition

ComponentIngredientManufacturer
concentrate for infusionActive 
 Durvalumab 500 mgAstraZeneca 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 stepManufacturer
Finished Product TestingAstraZeneca 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 - MicrobiologicalAstraZeneca 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 FormCatalent 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
PackingCatalent Indiana LLC
1300 South Patterson Drive
Bloomington
IN 47403
United States of America
Secondary PackagingAstraZeneca AB
Forskargatan 18
Sodertalje S-151 85
Sweden
 AstraZeneca Pty Ltd
10-14 Khartoum Road
North Ryde
NSW 2113
Australia
NZ Site of Product ReleasePharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
58 Richard Pearse Drive
Airport Oaks
Mangere
AUCKLAND 2022

Packaging

PackageContentsShelf Life
Vial, glass, Type I glass vial closed with rubber stopper and flip-off seal, 10ml volume1 dose units36 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 DateApplication TypeChange(s)StatusPayment DatePriority
9/12/2020Changed Medicine NotificationActive ingredient method of manufacture - Grade 2; Administrative fee (CMN)Granted 20/1/202115/12/2020 
7/1/2019New Higher-risk Medicine ApplicationAbridged new higher-risk medicine containing one or more new active substanceGranted 10/10/201914/1/2019 
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