Country: Canada
Language: English
Source: Health Canada
NILOTINIB (NILOTINIB HYDROCHLORIDE MONOHYDRATE)
NOVARTIS PHARMACEUTICALS CANADA INC
L01EA03
NILOTINIB
50MG
CAPSULE
NILOTINIB (NILOTINIB HYDROCHLORIDE MONOHYDRATE) 50MG
ORAL
120
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0152484003; AHFS:
CANCELLED POST MARKET
2023-10-04
_Tasigna_ _® _ _(nilotinib, as nilotinib hydrochloride monohydrate) _ _Page 1 of 85 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR TASIGNA ® (Nilotinib Capsules) Capsules, 50 mg, 150 mg and 200 mg nilotinib (as nilotinib hydrochloride monohydrate), Oral use Novartis Standard Protein kinase inhibitor Novartis Pharmaceuticals Canada Inc. 700 Saint-Hubert St., Suite 100 Montreal, Quebec, H2Y 0C1 www.novartis.ca Date of Initial Authorization: SEP 30, 2008 Submission Control No: 273430 Date of Revision: JUL 20, 2023 _ _ _ _ _TASIGNA is a registered trademark _ _Tasigna_ _® _ _(nilotinib, as nilotinib hydrochloride monohydrate) _ _Page 2 of 85 _ RECENT MAJOR LABEL CHANGES None at the time of the most recent authorization _ (Migration to the Product Monograph Master _ _Template)_. TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION................................................................................4 1 INDICATIONS .................................................................................................................4 1.1 Pediatrics .......................................................................................................................... 4 1.2 Geriatrics .......................................................................................................................... 4 2 CONTRAINDICATIONS ....................................................................................................5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ................................................................5 4 DOSAGE AND ADMINISTRATION ....................................................................................5 4.1 Dosing Considerations ...................................................................................................... 5 4.2 Recommended Dose and Dosage Adjustment ................................................................ 6 4.4 Administration .............................................................................................. Read the complete document