MOCLOBEMIDE TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

MOCLOBEMIDE

Dostupno od:

AA PHARMA INC

ATC koda:

N06AG02

INN (International ime):

MOCLOBEMIDE

Doziranje:

150MG

Farmaceutski oblik:

TABLET

Sastav:

MOCLOBEMIDE 150MG

Administracija rute:

ORAL

Jedinice u paketu:

100

Tip recepta:

Prescription

Područje terapije:

MONOAMINE OXIDASE INHIBITORS

Proizvod sažetak:

Active ingredient group (AIG) number: 0122658002; AHFS:

Status autorizacije:

APPROVED

Datum autorizacije:

2017-11-14

Svojstava lijeka

_Pr_
_MOCLOBEMIDE Product Monograph _
_ _
_Page 1 of 41_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
MOCLOBEMIDE
Moclobemide Tablets
Tablets 100 mg, 150 mg and 300 mg, Oral
Apotex Standard
Antidepressant
ATC Code: N06AG02
AA PHARMA INC
1165 Creditstone Road, Unit #1
Vaughan, Ontario
L4K 4N7
http://www.aapharma.ca
Date of Initial Approval:
NOV 14, 2017
Date of Revision:
JUN 22, 2023
Submission Control No: 269925
_Pr_
_MOCLOBEMIDE Product Monograph _
_ _
_Page 2 of 41_
RECENT MAJOR LABEL CHANGES:
None
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL
CHANGES............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATION
..................................................................................................................
4
1.1
Pediatrics
..........................................................................................................
4
1.2
Geriatrics
..........................................................................................................
4
2
CONTRAINDICATIONS
...................................................................................................
4
4
DOSAGE AND ADMINISTRATION
...................................................................................
5
4.1
Dosing Considerations
.......................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
.................................................... 5
5
OVERDOSAGE................................................................................................................
5
6
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
................................... 6
7
WA