AURO-ARIPIPRAZOLE TABLET

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

ARIPIPRAZOLE

Dostupné z:

AURO PHARMA INC

ATC kód:

N05AX12

INN (Medzinárodný Name):

ARIPIPRAZOLE

Dávkovanie:

15MG

Forma lieku:

TABLET

Zloženie:

ARIPIPRAZOLE 15MG

Spôsob podávania:

ORAL

Počet v balení:

30/50/100

Typ predpisu:

Prescription

Terapeutické oblasti:

ATYPICAL ANTIPSYCHOTICS

Prehľad produktov:

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

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2018-07-10

Súhrn charakteristických

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