APO-TICAGRELOR TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TICAGRELOR

Available from:

APOTEX INC

ATC code:

B01AC24

INN (International Name):

TICAGRELOR

Dosage:

90MG

Pharmaceutical form:

TABLET

Composition:

TICAGRELOR 90MG

Administration route:

ORAL

Units in package:

60(6X10)/100

Prescription type:

Prescription

Therapeutic area:

PLATELET AGGREGATION INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0152934001; AHFS:

Authorization status:

APPROVED

Authorization date:

2021-03-22

Summary of Product characteristics

_APO-TICAGRELOR (ticagrelor Tablets) _
_ Page 1 of 70 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-TICAGRELOR
Ticagrelor Tablets
Tablets, 60 mg and 90 mg, oral use
Apotex Standard
Platelet Aggregation Inhibitor
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
March 22, 2021
Date of Revision:
May 18, 2023
Submission Control Number: 270287
_APO-TICAGRELOR (ticagrelor Tablets) _
_ Page 2 of 70 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Cardiovascular
05/2023
7 WARNINGS AND PRECAUTIONS, 7.1.3 Pediatrics
05/2023
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
1.2
Geriatrics
...............................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.1
Dosing Considerations
...........................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
...................................................... 5
4.4
Administration
.......................................................................................................
7
4.5
Missed Dose
......