ACH-APIXABAN TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

APIXABAN

Commercializzato da:

ACCORD HEALTHCARE 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:

2022-09-23

Scheda tecnica

PRODUCT MONOGRAPH
PR
ACH-APIXABAN
Apixaban Tablets
2.5 mg and 5 mg
Anticoagulant
Accord Healthcare Inc.
3535 boul. St. Charles, Suite 704
Kirkland, QC, H9H 5B9
Canada
Date of Initial Approval:
April 23, 2019
Date of Revision:
September 22, 2022
Submission
Control No: 264541
_Pr_
_ACH-APIXABAN Product Monograph Page 2 of 77 _
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....................................................................................................19
DOSAGE AND
ADMINISTRATION.................................................................................24
OVERDOSAGE
.................................................................................................................31
ACTION AND CLINICAL PHARMACOLOGY
................................................................32
STORAGE AND
STABILITY............................................................................................37
SPECIAL HANDLING INSTRUCTIONS
..........................................................................37
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................37
PART II: SCIENTIFIC
INFORMATION................................................................................38
PHARMACEUTICAL
INFORMATION.............................................................................38
CLINICAL TRIALS
..........................