TEVA-TICAGRELOR TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

TICAGRELOR

Dostępny od:

TEVA CANADA LIMITED

Kod ATC:

B01AC24

INN (International Nazwa):

TICAGRELOR

Dawkowanie:

90MG

Forma farmaceutyczna:

TABLET

Skład:

TICAGRELOR 90MG

Droga podania:

ORAL

Sztuk w opakowaniu:

6X10/60

Typ recepty:

Prescription

Dziedzina terapeutyczna:

PLATELET AGGREGATION INHIBITORS

Podsumowanie produktu:

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

Status autoryzacji:

APPROVED

Data autoryzacji:

2021-04-21

Charakterystyka produktu

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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.......................................