NAT-APIXABAN TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

APIXABAN

Commercializzato da:

NATCO PHARMA (CANADA) INC

Codice ATC:

B01AF02

INN (Nome Internazionale):

APIXABAN

Dosaggio:

2.5MG

Forma farmaceutica:

TABLET

Composizione:

APIXABAN 2.5MG

Via di somministrazione:

ORAL

Confezione:

15G/50G

Tipo di ricetta:

Prescription

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2022-09-20

Scheda tecnica

IMPORTANT: PLEASE READ
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_NAT-APIXABAN (apixaban) Product Monograph_
_Page 1 of 80 _
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PRODUCT MONOGRAPH
PR
NAT-APIXABAN
Apixaban Tablets
2.5 mg and 5 mg
Anticoagulant
Natco Pharma (Canada) Inc.
Date of Revision:
2000 Argentia Road, Plaza 1, Suite 200
June 18, 2022
Mississauga ON L5N 1P7
Submission
Control No: 260519
_Pr_
_NAT-APIXABAN Product Monograph_
_Page 2 of 80 _
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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
................................................................................................
10
DRUG INTERACTIONS
.................................................................................................
20
DOSAGE AND ADMINISTRATION
.............................................................................
25
OVERDOSAGE
...............................................................................................................
32
ACTION AND CLINICAL PHARMACOLOGY
............................................................33
SPECIAL HANDLING INSTRUCTIONS
......................................................................
38
DOSAGE FORMS, COMPOSITION AND
PACKAGING............................................. 38
PART II: SCIENTIFIC INFORMATION
..............................................................................
39
PHARMACEUTICAL INFORMATION
........................................................................
39
CLINICAL TRIALS
.........................................................................................................
40
DETAILED PH