TARO-TICAGRELOR TABLET

Country: Canada

Language: English

Source: Health Canada

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Active ingredient:

TICAGRELOR

Available from:

TARO PHARMACEUTICALS INC

ATC code:

B01AC24

INN (International Name):

TICAGRELOR

Dosage:

90MG

Pharmaceutical form:

TABLET

Composition:

TICAGRELOR 90MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

PLATELET AGGREGATION INHIBITORS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2021-03-01

Summary of Product characteristics

                                PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
TARO-TICAGRELOR
Ticagrelor
Tablets, 60 mg and 90 mg, Oral Use
Taro Standard
Platelet Aggregation Inhibitor
Taro Pharmaceuticals Inc.
130 East Drive
Brampton, ON
L6T 1C1
Date of Initial Authorization:
March 01, 2021
Date of Revision:
June 22, 2023
Submission Control Number: 274174
_Taro-Ticagrelor Product Monograph _
_ _
_Page 2 of 69 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Cardiovascular
09/2022
7 WARNINGS AND PRECAUTIONS, 7.1.3 Pediatrics
06/2023
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
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