AURO-ARIPIPRAZOLE TABLET
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
17-03-2022
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Aktiva substanser:
ARIPIPRAZOLE
Tillgänglig från:
AURO PHARMA INC
ATC-kod:
N05AX12
INN (International namn):
ARIPIPRAZOLE
Dos:
15MG
Läkemedelsform:
TABLET
Sammansättning:
ARIPIPRAZOLE 15MG
Administreringssätt:
ORAL
Enheter i paketet:
30/50/100
Receptbelagda typ:
Prescription
Terapiområde:
ATYPICAL ANTIPSYCHOTICS
Produktsammanfattning:
Active ingredient group (AIG) number: 0152514003; AHFS:
Bemyndigande status:
APPROVED
Tillstånd datum:
2018-07-10
Produktens egenskaper
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
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