REMERON RD TABLET (ORALLY DISINTEGRATING)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
10-05-2021
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Active ingredient:
MIRTAZAPINE
Available from:
ORGANON CANADA INC.
ATC code:
N06AX11
INN (International Name):
MIRTAZAPINE
Dosage:
30MG
Pharmaceutical form:
TABLET (ORALLY DISINTEGRATING)
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:
2021-05-11
Summary of Product characteristics
_REMERON RD_
®
_ (mirtazapine)_
_ _
_Page 1 of 39_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
REMERON RD
®
mirtazapine orally disintegrating tablets
15, 30 and 45 mg
ANTI-DEPRESSANT
ORGANON CANADA INC.
16766 route Transcanadienne
Kirkland, Quebec
H9H 4M7
www.organon.ca
Date of Initial Approval:
December 19, 2003
Date of Revision:
May 10, 2021
Submission Control No. 250922
_REMERON RD_
®
_ (mirtazapine)_
_ _
_Page 2 of 39_
TABLE OF CONTENTS
Warnings and Precautions, Skin (7)
12/2020
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
.......................................................... 5
4.3 Administration
............................................................................................................
6
4.4 Reconstitution
............................................................................................................
6
5
OVERDOSAGE
...............................................................................................................
6
6
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
......................... 7
7. WARNINGS
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