Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

Data SheetCMI
File ref: TT50-9916
Trade NameDose FormStrengthIdentifier
OpdivoConcentrate for infusion40 mg/4mL
SponsorApplication dateRegistration situationClassification
Bristol-Myers Squibb (NZ) Limited
Private Bag 92518
Auckland 1141
14/1/2016Consent given
Approval date: 28/4/2016
Prescription
 

Composition

ComponentIngredientManufacturer
concentrate for infusionActive 
 Nivolumab 47 mg equivalent to 40mg/4 mLBristol-Myers Squibb Company
6000 Thompson Road
East Syracuse
New York
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 stepManufacturer
Finished Product TestingBristol-Myers Squibb Co CPO
6000 Thompson Road
East Syracuse
New York 13057
United States of America
 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 12 Casilina N
41, Anagni FR 03012
Italy
 Lonza Biologics Porrino S L
C/La Relba s/n
Porrino
Pontevedra 36400
Spain
 Swords Laboratories trading as Bristol-Myers Squibb Cruiserath Biologics
Crusierath Rd.
Mulhuddart
Dublin 15
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 FormBristol-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 PackagingCatalent S.r.l.
Loc. Fontana Del Ceraso
Strade Provinciale 12 Casilina N
41, Anagni FR 03012
Italy
 DHL Exel Supply Chain (Australia) Pty Ltd
52 Huntingwood Drive
Huntingwood
New South Wales 2148
Australia
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, Type 1 clear. Closure: film coated butyl rubber stopper + al crimp seal1 dose units36 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
24 hours 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 24 hour 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.

Latest Regulatory Activity

Application DateApplication TypeChange(s)StatusPayment DatePriority
12/5/2020Self-Assessable Change NotificationData sheet - miscellaneous changes (Self assessable)Notified20/5/2020 
14/1/2016New Higher-risk Medicine ApplicationAbridged new higher-risk medicine containing one or more new active substanceGranted 28/4/201622/1/2016Y
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