NRA-ARIPIPRAZOLE TABLET

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

ARIPIPRAZOLE

Verfügbar ab:

NORA PHARMA INC

ATC-Code:

N05AX12

INN (Internationale Bezeichnung):

ARIPIPRAZOLE

Dosierung:

5MG

Darreichungsform:

TABLET

Zusammensetzung:

ARIPIPRAZOLE 5MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

15G/50G

Verschreibungstyp:

Prescription

Produktbesonderheiten:

Active ingredient group (AIG) number: 0152514002; AHFS:

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2023-06-01

Fachinformation

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
....