COTELLIC TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

COBIMETINIB (COBIMETINIB FUMARATE)

Available from:

HOFFMANN-LA ROCHE LIMITED

ATC code:

L01EE02

INN (International Name):

COBIMETINIB

Dosage:

20MG

Pharmaceutical form:

TABLET

Composition:

COBIMETINIB (COBIMETINIB FUMARATE) 20MG

Administration route:

ORAL

Units in package:

63

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0157890001; AHFS:

Authorization status:

APPROVED

Authorization date:

2016-02-22

Summary of Product characteristics

_Pr_
_COTELLIC_
®
_ (cobimetinib) _
_Page 1 of 40_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
COTELLIC
®
cobimetinib tablets
20 mg cobimetinib (as cobimetinib fumarate), oral
Protein Kinase Inhibitor
Hoffmann-La Roche Limited
7070 Mississauga Road
Mississauga, Ontario, Canada
L5N 5M8
Date of Initial Authorization:
February 22, 2016
Date of Revision:
March 24, 2023
Submission Control Number: 265306
COTELLIC
®
, ZELBORAF
®
are registered trade-marks of F. Hoffmann-La Roche AG, used under
license
©
Copyright 2016-2023, Hoffmann-La Roche Limited
_ _
_Pr_
_COTELLIC_
®
_ (cobimetinib) _
_Page 2 of 40_
RECENT MAJOR LABEL CHANGES
1 INDICATIONS, 1.1 Pediatrics
[03/2023]
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations, 4.2
Recommended Dose and Dosage adjustment, Special Populations,
4.5 Missed Dose
[03/2023]
7 WARNINGS AND PRECAUTIONS, 7.1.3 Pediatrics
[03/2023]
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
................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 4
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.1
Dosing Considerations
.......................................................