Revised: 31 May 2019
Medicines
Medsafe Product Detail |   | |
|---|---|---|
| File ref: TT50-9962 |
| Trade Name | Dose Form | Strength | Identifier |
| Onivyde | Concentrate for infusion | 43 mg/10mL | (4.3mg/mL) |
| Sponsor | Application date | Registration situation | Classification |
| Servier Laboratories NZ Ltd Level 4, Zurich House 21 Queen Street Auckland Central Auckland 1010 | 6/4/2016 | Consent given Approval date: 20/9/2018 Notification date: 27/5/2019 | Prescription |
Composition
| Component | Ingredient | Manufacturer |
| concentrate for infusion | Active | |
| Irinotecan hydrochloride trihydrate 5 mg/mL (equiv 4.3 mg/mL irinotecan (anhydrous free base)) | ScinoPharm Taiwan Ltd 1 Nan-Ke 8th Road Shan-Hua Tainan 74144 TAIWAN | |
| 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 step | Manufacturer |
| Finished Product Testing | Ajinomoto 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 | |
| Ipsen Pharma Biotech Parc d'Activities du Plateau de Signes Chemin Departemental 402 Signes F-83870 FRANCE | |
| 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 Form | Ajinomoto 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 | |
| Ipsen Pharma Biotech Parc d'Activities du Plateau de Signes Chemin Departemental 402 Signes F-83870 FRANCE | |
| Packing | Ajinomoto Althea Inc 11040 Roselle Street San Diego California 92121 UNITED STATES OF AMERICA |
| Ipsen Pharma Biotech Parc d'Activities du Plateau de Signes Chemin Departemental 402 Signes F-83870 FRANCE | |
| Secondary Packaging | Baxter Oncology GmbH Kantstrasse 2 Halle-Kunsebeck Westfalen D-33790 GERMANY |
| 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, 10 mL Type I, Closure: Chlorobutyl stopper with al & white plastic capped flip off seal | 1 dose units | 36 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 Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 2/9/2022 | Changed Medicine Notification | Finished product manufacturing process - Grade 1; Data sheet - miscellaneous changes; Labelling - Grade 1 | Granted 30/1/2023 | 9/11/2022 | |
| 6/4/2016 | New Higher-risk Medicine Application | New higher-risk medicine that does not contain a new active substance | Granted 20/9/2018 | 14/4/2016 |
