OPDIVO SOLUTION

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

NIVOLUMAB

Доступна з:

BRISTOL-MYERS SQUIBB CANADA

Код атс:

L01FF01

ІПН (Міжнародна Ім'я):

NIVOLUMAB

Дозування:

10MG

Фармацевтична форма:

SOLUTION

Склад:

NIVOLUMAB 10MG

Адміністрація маршрут:

INTRAVENOUS

Одиниць в упаковці:

4ML

Тип рецепту:

Prescription

Терапевтична области:

ANTINEOPLASTIC AGENTS

Огляд продуктів:

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

Статус Авторизація:

APPROVED

Дата Авторизація:

2015-09-25

Характеристики продукта

_ _
_ _
_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