TEVA-CLOPIDOGREL TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

CLOPIDOGREL (CLOPIDOGREL BISULFATE)

Mevcut itibaren:

TEVA CANADA LIMITED

ATC kodu:

B01AC04

INN (International Adı):

CLOPIDOGREL

Doz:

75MG

Farmasötik formu:

TABLET

Kompozisyon:

CLOPIDOGREL (CLOPIDOGREL BISULFATE) 75MG

Uygulama yolu:

ORAL

Paketteki üniteler:

30/100/500

Reçete türü:

Prescription

Terapötik alanı:

PLATELET AGGREGATION INHIBITORS

Ürün özeti:

Active ingredient group (AIG) number: 0134440001; AHFS:

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2011-12-14

Ürün özellikleri

TEVA-CLOPIDOGREL (Clopidogrel Tablets)
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Page 1 of 68
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-CLOPIDOGREL
Clopidogrel Tablets
Tablets, 75 mg and 300 mg clopidogrel (as clopidogrel bisulfate), Oral
Teva Standard
Platelet Aggregation Inhibitor
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Canada
www.tevacanada.com
Submission Control Number: 267470
Date of Initial Authorization:
December 14, 2011
Date of Revision:
January 12, 2023
TEVA-CLOPIDOGREL (Clopidogrel Tablets)
_ _
Page 2 of 68
_ _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism
03/2021
7 WARNINGS AND PRECAUTIONS, Hematologic
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………………………………………………………………………………………………………...5
4 DOSAGE AND
ADMINISTRATION………………………………………………………………………………...........5
4.2
Recommended Dose and Dosage
Adjustment………………………………………………………………….5
4.4
Adm