PRO-MIRTAZAPINE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
20-10-2023
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Active ingredient:
MIRTAZAPINE
Available from:
PRO DOC LIMITEE
ATC code:
N06AX11
INN (International Name):
MIRTAZAPINE
Dosage:
30MG
Pharmaceutical form:
TABLET
Composition:
MIRTAZAPINE 30MG
Administration route:
ORAL
Units in package:
15G/50G
Prescription type:
Prescription
Therapeutic area:
MISCELLANEOUS ANTIDEPRESSANTS
Product summary:
Active ingredient group (AIG) number: 0143928002; AHFS:
Authorization status:
APPROVED
Authorization date:
2008-07-02
Summary of Product characteristics
PRO-MIRTAZAPINE
Page 1 of 43
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PRO-MIRTAZAPINE
Mirtazapine Tablets
15 mg, 30 mg and 45 mg
House Standard
ANTI-DEPRESSANT
Pro Doc Ltée.
2925, boul. Industriel
Laval, Quebec
H7L 3W9
Submission Control No.: 279376
Date of Initial
Approval:
July 02,2008
Date of Revision:
October 20, 2023
PRO-MIRTAZAPINE
Page 2 of 43
RECENT MAJOR LABEL CHANGES
7. WARNINGS AND PRECAUTIONS, Skin 08/2021
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1 INDICATIONS
..........................................................................................................................
4
1.1 Pediatrics
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4
1.2 Geriatrics
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4
2 CONTRAINDICATIONS
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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
.................................................................. 5
4.3 Administration
...................................................................................................................
6
4.4 Reconstitution
...................................................................................................................
6
4.5 Missed Dose
......................................................................................................................
6
5 OVERDOSAGE ...........
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