TEVA-TICAGRELOR TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

TICAGRELOR

Disponible desde:

TEVA CANADA LIMITED

Código ATC:

B01AC24

Designación común internacional (DCI):

TICAGRELOR

Dosis:

90MG

formulario farmacéutico:

TABLET

Composición:

TICAGRELOR 90MG

Vía de administración:

ORAL

Unidades en paquete:

6X10/60

tipo de receta:

Prescription

Área terapéutica:

PLATELET AGGREGATION INHIBITORS

Resumen del producto:

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

Estado de Autorización:

APPROVED

Fecha de autorización:

2021-04-21

Ficha técnica

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_Teva-Ticagrelor _
_Page 1 of 61_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-TICAGRELOR
Ticagrelor Tablets
Tablets, 60 mg and 90 mg, Oral
Ph. Eur.
Platelet Aggregation Inhibitor
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Date of Initial Authorization:
April 19, 2021
Date of Revision:
January 31, 2023
Submission Control No: 266401
_ _
_Teva-Ticagrelor _
_Page 2 of 61_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Cardiovascular
01/2023
7 WARNINGS AND PRECAUTIONS, Central Sleep Apnea
01/2023
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.......................................