Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

Data SheetCMI
File ref: TT50-9962
Trade NameDose FormStrengthIdentifier
OnivydeConcentrate for infusion43 mg/10mL(4.3mg/mL)
SponsorApplication dateRegistration situationClassification
Servier Laboratories Ltd
Level 4, Zurich House
21 Queen Street
Auckland Central
Auckland 1010
6/4/2016Not available
Approval date: 20/9/2018
Notification date: 27/5/2019
Prescription
 

Composition

ComponentIngredientManufacturer
concentrate for infusionActive 
 Irinotecan hydrochloride trihydrate 5 mg/mL (equiv 4.3 mg/mL irinotecan (anhydrous free base))Hubei Haosun Pharmaceutical Co Limited
No 20 Juxian Road
Gedian Economic and Technological Development Area
Hubei Province, Ezhou 436-070
China
 Excipient 
 1,2-Distearoyl-sn-glycero-3-phosphocholine
 Cholesterol
 HEPES
 N-(Carbonyl-methoxypolyethylene glycol 2000)-1,2-distearoyl-sn-glycero-3-phosphoethanolamine
 Sodium chloride
 Sucrosofate
 Water for injection

Production

Manufacturing stepManufacturer
Finished Product TestingAjinomoto Althea Inc
11040 Roselle Street
San Diego
California 92121
United States of America
 Ipsen Bioscience Inc
One Kendall Square
Building 700
Suite B7201
Cambridge MA 02139
United States of America
 SGS Institut Fresenius Berlin GmbH & Co KG
Tegeler Weg 33
Berlin 10589
Germany
 SGS Institut Fresenius GmbH
Im Maisel 14
Taunusstein D-65232
Germany
Manufacture of Final Dose FormAjinomoto Althea Inc
11040 Roselle Street
San Diego
California 92121
United States of America
 Ipsen Bioscience Inc
One Kendall Square
Building 700
Suite B7201
Cambridge MA 02139
United States of America
PackingAjinomoto Althea Inc
11040 Roselle Street
San Diego
California 92121
United States of America
Secondary PackagingBaxter Oncology GmbH
Kantstrasse 2
Halle-Kunsebeck Westfalen D-33790
Germany
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, 10 mL Type I, Closure: Chlorobutyl stopper with al & white plastic capped flip off seal1 dose units36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light
6 hours diluted stored at or below 25°C protect from light. Do not freeze
24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Indications

Treatment of metastatic adenocarcinoma of the pancreas in combination with 5-fluorouracil and folinic acid (leucovorin) in adult patients who have been previously treated with gemcitabine

Latest Regulatory Activity

Application DateApplication TypeChange(s)StatusPayment DatePriority
17/5/2020Changed Medicine NotificationFinished product packing site - Grade 1Granted 25/6/202029/5/2020 
6/4/2016New Higher-risk Medicine ApplicationNew higher-risk medicine that does not contain a new active substanceGranted 20/9/201814/4/2016 
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