TEVA-APIXABAN TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

APIXABAN

Saatavilla:

TEVA CANADA LIMITED

ATC-koodi:

B01AF02

INN (Kansainvälinen yleisnimi):

APIXABAN

Annos:

2.5MG

Lääkemuoto:

TABLET

Koostumus:

APIXABAN 2.5MG

Antoreitti:

ORAL

Kpl paketissa:

15G/50G

Prescription tyyppi:

Prescription

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0153051001; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2022-09-20

Valmisteyhteenveto

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_Teva-Apixaban Tablets _
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PRODUCT MONOGRAPH
Pr
TEVA-APIXABAN
Apixaban tablets
2.5 mg and 5 mg
Teva Standard
Anticoagulant
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Date of Initial Approval:
January 21, 2019
Date of Revision:
September 16, 2022
Submission Control No: 266721
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_Teva-Apixaban Tablets _
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
..................................................................................................11
DRUG INTERACTIONS
..................................................................................................20
DOSAGE AND ADMINISTRATION
..............................................................................25
OVERDOSAGE
................................................................................................................33
ACTION AND CLINICAL PHARMACOLOGY
............................................................34
STORAGE AND STABILITY
..........................................................................................40
SPECIAL HANDLING INSTRUCTIONS
.......................................................................40
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................40
PART II: SCIENTIFIC INFORMATION
...............................................................................41
PHARMACEUTICAL INFORMATION
..........................................................................41
CLINICAL TRIALS
.........................