Revised: 31 May 2019
Medicines
Medsafe Product Detail |   | |
|---|---|---|
| File ref: TT50-9916 |
| Trade Name | Dose Form | Strength | Identifier |
| Opdivo | Concentrate for infusion | 40 mg/4mL | |
| Sponsor | Application date | Registration situation | Classification |
| Bristol-Myers Squibb (NZ) Limited Private Bag 92518 Auckland 1141 | 14/1/2016 | Consent given Approval date: 28/4/2016 | Prescription |
Composition
| Component | Ingredient | Manufacturer |
| concentrate for infusion | Active | |
| Nivolumab 10 mg/mL | Swords Laboratories Unlimited Company t/a Bristol-Myers Squibb Cruiserath Biologics Crusierath Road Mulhuddart Dublin 15 D15 H6EF Ireland | |
| LOTTE Biologics USA, LLC 6000 Thompson Road East Syracuse New York 13057 United States of America | ||
| Samsung Biologics Co Ltd 300, Songdo bio-daero Yeonsu-gu Incheon 21987 South Korea | ||
| Lonza Biologics Inc 101 International Drive Portsmouth New Hampshire 03801 United States of America | ||
| Excipient | ||
| Hydrochloric acid | ||
| Mannitol | ||
| Pentetic acid | ||
| Polysorbate 80 | ||
| Sodium chloride | ||
| Sodium citrate dihydrate | ||
| Sodium hydroxide | ||
| Water for injection |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | Bristol-Myers Squibb Company 38 Jackson Road Devens Massachusetts 01434 United States of America |
| Bristol-Myers Squibb Holdings Pharma Ltd Road 686, Km 2.3 Manati 00674 Puerto Rico | |
| Catalent S.r.l. Loc. Fontana Del Ceraso Strade Provinciale Casilina N 41, Anagni FR 03012 Italy | |
| LOTTE Biologics USA, LLC 6000 Thompson Road East Syracuse New York 13057 United States of America | |
| Swords Laboratories Unlimited Company t/a Bristol-Myers Squibb Cruiserath Biologics Crusierath Road Mulhuddart Dublin 15 D15 H6EF Ireland | |
| Vetter Pharma-Fertigung GmbH & Co KG Eisenbahnstrasse 2-4 Langenargen D-88085 Germany | |
| Vetter Pharma-Fertigung GmbH & Co KG Helmut-Vetter-Str. 10 Ravensburg Baden Wurttemberg 88213 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 Form | Bristol-Myers Squibb Holdings Pharma Ltd Road 686, Km 2.3 Manati 00674 Puerto Rico |
| Vetter Pharma-Fertigung GmbH & Co KG Mooswiesen 2 Ravensburg D-88214 Germany | |
| Secondary Packaging | Catalent S.r.l. Loc. Fontana Del Ceraso Strade Provinciale Casilina N 41, Anagni FR 03012 Italy |
| DHL Supply Chain (Australia) Pty Limited 25 Ottelia Road Kemps Creek NSW 2178 Australia | |
| 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, Type 1 clear. Closure: film coated butyl rubber stopper + al crimp seal | 1 dose units | 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 48 hours not refrigerated stored at or below 25°C 7 days diluted stored at 2° to 8°C (Refrigerate, do not freeze). Product can be stored unrefrigerated (at or below 25 deg C) for up to 8 hours in this 7 day period |
Indications
OPDIVO, as monotherapy is indicated for the treatment of patients with unresectable or metastatic melanoma.
OPDIVO, in combination with YERVOY (ipilimumab) is indicated for the treatment of patients with unresectable or metastatic melanoma.
OPDIVO, as monotherapy, is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.
OPDIVO, as monotherapy is indicated for the treatment of locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after prior chemotherapy.
OPDIVO, as monotherapy is indicated for the treatment of locally advanced or metastatic non squamous non-small cell lung cancer (NSCLC) with progression on or after prior chemotherapy. In patients with tumour EGFR or ALK genomic aberrations, Opdivo, should be used after progression on or after targeted therapy.
OPDIVO, in combination with YERVOY (ipilimumab), is indicated for the treatment of patients with intermediate/poor-risk, previously untreated advanced renal cell carcinoma.
OPDIVO, as monotherapy is indicated for the treatment of patients with advanced clear cell renal cell carcinoma after prior anti-angiogenic therapy.
OPDIVO, as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) after autologous stem cell transplant and treatment with brentuximab vedotin. The approval of this indication is based on objective response rate.
OPDIVO, as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum based therapy.
OPDIVO, as monotherapy, is indicated for the treatment of patients with locally advanced unresectable or metastatic urothelial carcinoma after prior platinum-containing therapy. The approval of this indication is based on objective response rate and duration of response in a single arm study.
OPDIVO, as monotherapy, is indicated for the treatment of patients with hepatocellular carcinoma after prior sorafenib therapy. 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.
OPDIVO, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumour aberrations.
OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of patients with unresectable malignant pleural mesothelioma.
OPDIVO, as monotherapy, is indicated for the treatment of patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine and platinum based chemotherapy.
OPDIVO, in combination with cabozantinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma.
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 3/11/2023 | Changed Medicine Notification | Data sheet - G2; Administrative fee (CMN) | Granted 16/11/2023 | 10/11/2023 | |
| 22/6/2023 | CMN 24(5) | Indications/dosage - G2; Administrative fee (CMN) | Initial evaluation | 5/7/2023 | |
| 17/4/2023 | Self-Assessable Change Notification | Data sheet - G1 (Self assessable) | Notified | 26/4/2023 | |
| 14/1/2016 | New Higher-risk Medicine Application | Abridged new higher-risk medicine containing one or more new active substance | Granted 28/4/2016 | 22/1/2016 | Y |
