NRA-ARIPIPRAZOLE TABLET
Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
Tabia za bidhaa
(SPC)
15-05-2023
Hati zingine za bidhaa hii hazipatikani kwa sasa, unaweza kutuma ombi kwa huduma ya wateja wetu na tutakuarifu mara tu tutakapopata.
Tuma ombi.
Tuma ombi.
Viambatanisho vya kazi:
ARIPIPRAZOLE
Inapatikana kutoka:
NORA PHARMA INC
ATC kanuni:
N05AX12
INN (Jina la Kimataifa):
ARIPIPRAZOLE
Kipimo:
15MG
Dawa fomu:
TABLET
Tungo:
ARIPIPRAZOLE 15MG
Njia ya uendeshaji:
ORAL
Vitengo katika mfuko:
15G/50G
Dawa ya aina:
Prescription
Bidhaa muhtasari:
Active ingredient group (AIG) number: 0152514003; AHFS:
Idhini hali ya:
APPROVED
Idhini ya tarehe:
2023-06-01
Tabia za bidhaa
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
....
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