TEVA-APIXABAN TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

APIXABAN

Commercializzato da:

TEVA CANADA LIMITED

Codice ATC:

B01AF02

INN (Nome Internazionale):

APIXABAN

Dosaggio:

5MG

Forma farmaceutica:

TABLET

Composizione:

APIXABAN 5MG

Via di somministrazione:

ORAL

Confezione:

15G/50G

Tipo di ricetta:

Prescription

Dettagli prodotto:

Active ingredient group (AIG) number: 0153051002; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2022-09-20

Scheda tecnica

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