OPDIVO SOLUTION

देश: कनाडा

भाषा: अंग्रेज़ी

स्रोत: Health Canada

सक्रिय संघटक:

NIVOLUMAB

थमां उपलब्ध:

BRISTOL-MYERS SQUIBB CANADA

ए.टी.सी कोड:

L01FF01

INN (इंटरनेशनल नाम):

NIVOLUMAB

डोज़:

10MG

फार्मास्यूटिकल फॉर्म:

SOLUTION

रचना:

NIVOLUMAB 10MG

प्रशासन का मार्ग:

INTRAVENOUS

पैकेज में यूनिट:

4ML

प्रिस्क्रिप्शन प्रकार:

Prescription

चिकित्सीय क्षेत्र:

ANTINEOPLASTIC AGENTS

उत्पाद समीक्षा:

Active ingredient group (AIG) number: 0157410001; AHFS:

प्राधिकरण का दर्जा:

APPROVED

प्राधिकरण की तारीख:

2015-09-25

उत्पाद विशेषताएं

_ _
_ _
_OPDIVO_
_®_
_ (nivolumab) Product Monograph _
_Page 1 of 225_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
OPDIVO
®
nivolumab for injection
Intravenous Infusion, 10 mg nivolumab /mL
40 mg and 100 mg single-use vials
Antineoplastic
(Anatomical Therapeutic Chemical index code: L01FF01)
Pr
OPDIVO
®
, indicated for:
•
Classical Hodgkin Lymphoma (cHL) that has relapsed or progressed
after:
•
autologous stem cell transplantation (ASCT) and brentuximab vedotin,
or
•
3 or more lines of systemic therapy including ASCT.
•
In combination with ipilimumab, for the treatment of adult patients
with microsatellite
instability-high (MSI-H) or mismatch repair deficient (dMMR)
metastatic colorectal cancer after:
•
prior fluoropyrimidine-based therapy in combination with oxaliplatin
or irinotecan.
•
The adjuvant treatment of adult patients with urothelial carcinoma
(UC) who are at high risk of
recurrence after undergoing radical resection of UC.
has been issued market authorization WITH CONDITIONS, pending the
results of trials to verify its clinical
benefit. Patients should be advised of the nature of the
authorization. For further information for
Pr
OPDIVO
®
please refer to Health Canada’s Notice of Compliance with conditions
- drug products web
site:
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-
products/notice-compliance/conditions.html.
Pr
OPDIVO
®
, indicated for:
•
Unresectable or metastatic melanoma who have not received prior
systemic therapy for
unresectable or metastatic melanoma, as monotherapy or in combination
with ipilimumab.
•
Unresectable or metastatic melanoma and disease progression following
ipilimumab and, if BRAF
V600 mutation positive, a BRAF inhibitor.
•
Melanoma with regional lymph node involvement, in transit
metastases/satellites without
metastatic nodes, or distant metastases, as adjuvant therapy after
complete resection.
•
Opdivo, as monotherapy, is indicated for the adjuvant treatment of
adult patients with Stage IIB
or I