AURO-ARIPIPRAZOLE TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

ARIPIPRAZOLE

Saatavilla:

AURO PHARMA INC

ATC-koodi:

N05AX12

INN (Kansainvälinen yleisnimi):

ARIPIPRAZOLE

Annos:

15MG

Lääkemuoto:

TABLET

Koostumus:

ARIPIPRAZOLE 15MG

Antoreitti:

ORAL

Kpl paketissa:

30/50/100

Prescription tyyppi:

Prescription

Terapeuttinen alue:

ATYPICAL ANTIPSYCHOTICS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0152514003; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2018-07-10

Valmisteyhteenveto

Page 1 of 71
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AURO-ARIPIPRAZOLE
Aripiprazole Tablets
Tablets, 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg, Oral
House standard
Antipsychotic agent
AURO PHARMA INC.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada.
Date of initial Authorization:
July 10, 2018
SUBMISSION CONTROL NO: 257093
Date of Revision :
March 17, 2022
Page 2 of 71
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
03/2022
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
.................................................................................................
2
Table of
Contents..........................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................................
4
1 INDICATIONS
..............................................................................................................................
4
1.1 Pediatrics
....................................................................................................................
4
1.2 Geriatrics
.....................................................................................................................
4
2 CONTRAINDICATIONS
................................................................................................................
5
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
..........................................................................
5
4. DOSAGE AND ADMINISTRATION
..............................................................................................
5
4.1 Dosing Considerations
................................................................................................
5
4.2 Recommended Dose and Dosage Adjustment
........................................................... 6
4.3 Administration
............................................................................................................
7
4.4 Reconsti