ARIPIPRAZOLE TABLET

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

ARIPIPRAZOLE

MAH:

SANIS HEALTH INC

ATC_code:

N05AX12

INN:

ARIPIPRAZOLE

dosage:

30MG

pharmaceutical_form:

TABLET

composition:

ARIPIPRAZOLE 30MG

administration_route:

ORAL

units_in_package:

15G/50G

prescription_type:

Prescription

therapeutic_area:

ATYPICAL ANTIPSYCHOTICS

leaflet_short:

Active ingredient group (AIG) number: 0152514005; AHFS:

authorization_status:

APPROVED

authorization_date:

2020-10-19

SPC

ARIPIPRAZOLE
Page 1 of 63
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
ARIPIPRAZOLE
Aripiprazole Tablets
Tablets, 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg, Oral
USP
Antipsychotic agent
Sanis Health Inc.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
Date of Initial Authorization:
October 19, 2020
Date of Revision:
August 1
7
, 2022
Submission Control No: 266149
ARIPIPRAZOLE
Page 2 of 63
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Skin
08/2022
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
......................................................................................2
TABLE OF CONTENTS
..............................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................5
1
INDICATIONS....................................................................................................................5
1.1
Pediatrics
..................................................................................................................5
1.2
Geriatrics
..................................................................................................................5
2.
CONTRAINDICATIONS
..................................................................................................6
3.
SERIOUS WARNINGS AND PRECAUTIONS BOX
.................................................6
4.
DOSAGE AND ADMINISTRATION
...............................................................................6
4.1
Dosing Considerations
...........................................................................................6
4.2
Recommended Dose and Dosage Adjustment
..................................................7
4.3
Administration
..........................................................................................................8
4.4
Reconstitution
..........................................................................................................8
4.5
Missed Dose
.