Country: Canada
Language: English
Source: Health Canada
EVEROLIMUS
NATCO PHARMA (CANADA) INC
L04AH02
EVEROLIMUS
10MG
TABLET
EVEROLIMUS 10MG
ORAL
15G/50G
Prescription
Active ingredient group (AIG) number: 0152682002; AHFS:
APPROVED
2022-08-29
_ _ _NAT-EVEROLIMUS_ _Product Monograph _ _Page 1 of 93_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR NAT-EVEROLIMUS Everolimus Tablets, 2.5 mg, 5 mg, 7.5 mg, and 10 mg, Oral Protein kinase inhibitors ATC Code: L01XE10 Natco Pharma (Canada) Inc. 2000 Argentia Road Plaza 1, Suite 200 Mississauga, Ontario L5N 1P7 Date of Initial Authorization: August 22, 2022 Date of Revision: January 25, 2023 Submission Control Number: 267697 _ _ _NAT-EVEROLIMUS_ _Product Monograph _ _Page 2 of 93_ RECENT MAJOR LABEL CHANGES Not applicable. TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. RECENT MAJOR LABEL CHANGES ..................................................................................................... 2 TABLE OF CONTENTS...................................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ................................................................................ 4 1 INDICATIONS ..................................................................................................................... 4 1.1 Pediatrics................................................................................................................. 5 1.2 Geriatrics ................................................................................................................. 6 2 CONTRAINDICATIONS......................................................................................................... 6 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ....................................................................... 7 4 DOSAGE AND ADMINISTRATION .......................................................................................... 8 4.1 Dosing Considerations............................................................................................... 8 4.2 Recommended Dose and Dosage Adjustment ............................................................... 8 4.3 Reconst Read the complete document