AURO-ARIPIPRAZOLE TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

ARIPIPRAZOLE

Disponibil de la:

AURO PHARMA INC

Codul ATC:

N05AX12

INN (nume internaţional):

ARIPIPRAZOLE

Dozare:

15MG

Forma farmaceutică:

TABLET

Compoziție:

ARIPIPRAZOLE 15MG

Calea de administrare:

ORAL

Unități în pachet:

30/50/100

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ATYPICAL ANTIPSYCHOTICS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2018-07-10

Caracteristicilor produsului

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