Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

File ref: TT50-9912a
Trade NameDose FormStrengthIdentifier
CyramzaConcentrate for infusion500 mg/50mL
SponsorApplication dateRegistration situationClassification
Eli Lilly and Company (NZ) Limited
P O Box 109 197
Newmarket
AUCKLAND 1149
6/1/2016Not available
Approval date: 18/8/2016
Notification date: 27/9/2016
Prescription
 

Composition

ComponentIngredientManufacturer
concentrate for infusionActive 
 Ramucirumab 10 mg/mLImclone LLC
33 ImClone Drive
Branchburg NJ 08876
United States of America
 Excipient 
 Glycine
 Histidine
 Histidine hydrochloride monohydrate
 Polysorbate 80
 Sodium chloride
 Water for injection

Production

Manufacturing stepManufacturer
Finished Product TestingEli Lilly and Co Inc
Lilly Corporate Centre
Indianapolis
Indiana 46285
United States of America
 Imclone LLC
33 ImClone Drive
Branchburg NJ 08876
United States of America
Manufacture of Final Dose FormEli Lilly and Co Inc
Lilly Corporate Centre
Indianapolis
Indiana 46285
United States of America
Secondary PackagingLilly SA
Avda de la Industria, 30
Poligono Industrial
Alcobendas
Madrid E-28108
Spain
NZ Site of Product ReleaseDHL Supply Chain (New Zealand) Ltd
6 Manu Tapu Drive
Mangere
Auckland 2022

Packaging

PackageContentsShelf Life
Vial, glass, type 1, Closure: Chlorobutyl rubber stopper, PE Cap with Al seal1 dose units24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light
24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze)
4 hours diluted stored at or below 25°C

Indications

CYRAMZA, in combination with paclitaxel, is indicated for the treatment of adult patients with advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum and fluropyrimidine
chemotherapy.

CYRAMZA, as monotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric or gastro-oesophagealjunction adenocarcinoma with disease progression after prior platinum or fluoropyrimidine chemotherapy when treatment in combination with paclitaxel is not appropriate.

Latest Regulatory Activity

Application DateApplication TypeChange(s)StatusPayment DatePriority
6/1/2016New Higher-risk Medicine ApplicationAbridged new higher-risk medicine containing one or more new active substanceGranted 18/8/201622/1/2016Y
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