Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
|---|---|---|
| File ref: TT50-9912a |
| Trade Name | Dose Form | Strength | Identifier |
| Cyramza | Concentrate for infusion | 500 mg/50mL | |
| Sponsor | Application date | Registration situation | Classification |
| Eli Lilly and Company (NZ) Limited P O Box 109 197 Newmarket AUCKLAND 1149 | 6/1/2016 | Not available Approval date: 18/8/2016 Notification date: 27/9/2016 | Prescription |
Composition
| Component | Ingredient | Manufacturer |
| concentrate for infusion | Active | |
| Ramucirumab 10 mg/mL | Imclone 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 step | Manufacturer |
| Finished Product Testing | Eli Lilly and Company Inc Lilly Corporate Center Indianapolis Indiana 46285 UNITED STATES OF AMERICA |
| Imclone LLC 33 ImClone Drive Branchburg NJ 08876 UNITED STATES OF AMERICA | |
| Manufacture of Final Dose Form | Eli Lilly and Company Inc Lilly Corporate Center Indianapolis Indiana 46285 UNITED STATES OF AMERICA |
| Secondary Packaging | Lilly SA Avda de la Industria, 30 Poligono Industrial Alcobendas Madrid E-28108 SPAIN |
| NZ Site of Product Release | DHL Supply Chain (New Zealand) Ltd 6 Manu Tapu Drive Mangere Auckland 2022 |
Packaging
| Package | Contents | Shelf Life |
| Vial, glass, type 1, Closure: Chlorobutyl rubber stopper, PE Cap with Al seal | 1 dose units | 24 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 Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 19/7/2021 | Self-Assessable Change Notification | Data sheet - reformatting only (Self assessable) | Notified | 20/7/2021 | |
| 6/1/2016 | New Higher-risk Medicine Application | Abridged new higher-risk medicine containing one or more new active substance | Granted 18/8/2016 | 22/1/2016 | Y |
