PMSC-RIVAROXABAN TABLET

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

RIVAROXABAN

Dostupné s:

PHARMASCIENCE INC

ATC kód:

B01AF01

INN (Mezinárodní Name):

RIVAROXABAN

Dávkování:

15MG

Léková forma:

TABLET

Složení:

RIVAROXABAN 15MG

Podání:

ORAL

Jednotky v balení:

100

Druh předpisu:

Prescription

Terapeutické oblasti:

Direct Factor Xa Inhibitors

Přehled produktů:

Active ingredient group (AIG) number: 0152487002; AHFS:

Stav Autorizace:

CANCELLED PRE MARKET

Datum autorizace:

2021-11-18

Charakteristika produktu

PRODUCT MONOGRAPH
PR
PMSC-RIVAROXABAN
Rivaroxaban Tablets
Tablets 2.5 mg, 10 mg, 15 mg and 20 mg
Rivaroxaban Granules for Oral Suspension
Granules for oral suspension, 1mg/mL when reconstituted
Anticoagulant
(ATC Classification: B01AF01)
PHARMASCIENCE INC.
6111 Royalmount Ave. Suite 100
Montreal, Canada
H4P 2T4
www.pharmascience.com
Submission Control No: 250929
Date of Revision:
May 10, 2021
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_pmsc-RIVAROXABAN_
_Product Monograph Page 2 of 120 _
TABLE OF CONTENTS
TABLE OF CONTENTS
......................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
..................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
5
ADVERSE REACTIONS
.........................................................................................................
13
DRUG INTERACTIONS
.........................................................................................................
30
DOSAGE AND ADMINISTRATION
.....................................................................................
35
OVERDOSAGE
.......................................................................................................................
46
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 48
STORAGE AND STABILITY
.................................................................................................
58
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 58
PART II : SCIENTIFIC INFORMATION
...........