Страна: Канада
Язык: английский
Источник: Health Canada
NIVOLUMAB
BRISTOL-MYERS SQUIBB CANADA
L01FF01
NIVOLUMAB
10MG
SOLUTION
NIVOLUMAB 10MG
INTRAVENOUS
10ML
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0157410001; AHFS:
APPROVED
2015-09-25
_ _ _ _ _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 Прочитать полный документ