NRA-ARIPIPRAZOLE TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

ARIPIPRAZOLE

Dostupno od:

NORA PHARMA INC

ATC koda:

N05AX12

INN (International ime):

ARIPIPRAZOLE

Doziranje:

15MG

Farmaceutski oblik:

TABLET

Sastav:

ARIPIPRAZOLE 15MG

Administracija rute:

ORAL

Jedinice u paketu:

15G/50G

Tip recepta:

Prescription

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2023-06-01

Svojstava lijeka

NRA-ARIPIPRAZOLE (Aripiprazole Tablets)
Page 1 of 74
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATIO N
PR
NRA-ARIPIPRAZOLE
Aripiprazole Tablets
Tablets, 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg, Oral
USP
Antipsychotic agent
Nora Pharma Inc.
1565, boul. Lionel-Boulet
Varennes, Québec, Canada
J3X 1P7
Date of Initial Authorization:
January 19, 2018
Date of Revision:
May 15, 2023
Submission Control No: 270875
NRA-ARIPIPRAZOLE (Aripiprazole Tablets)
Page 2 of 74
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
05/2023
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
....................................................................................................
4
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
..........................................................................................................
6
4.4
Reconstitution
....