APO-MIRTAZAPINE TABLET 30MG
Country: Singapore
Language: English
Source: HSA (Health Sciences Authority)
Summary of Product characteristics
(SPC)
22-10-2020
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Active ingredient:
Mirtazapine
Available from:
PHARMAFORTE SINGAPORE PTE LTD
ATC code:
N06AX11
Dosage:
30.0mg/tab
Pharmaceutical form:
TABLET, FILM COATED
Composition:
Mirtazapine 30 mg
Administration route:
ORAL
Prescription type:
Prescription Only
Manufactured by:
Apotex Inc. (Etobicoke Site)
Authorization status:
ACTIVE
Authorization date:
2011-09-09
Summary of Product characteristics
Page 1 of 29
SINGAPORE PACKAGE INSERT
PR
APO-MIRTAZAPINE
Mirtazapine Tablets
USP
15 mg, 30 mg and 45 mg
Antidepressant
DATE OF PREPARATION:
October 02, 2006
DATE OF REVISION:
February 02, 2011
Page 2 of 29
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
....................................................... 3
SUMMARY PRODUCT INFORMATION
.............................................................................
3
INDICATIONS AND CLINICAL USE
...................................................................................
3
CONTRAINDICATIONS
........................................................................................................
3
WARNINGS AND PRECAUTIONS
.......................................................................................
3
ADVERSE REACTIONS
.........................................................................................................
7
DRUG INTERACTIONS
.........................................................................................................
9
DOSAGE AND ADMINISTRATION
...................................................................................
10
OVERDOSAGE
......................................................................................................................
12
ACTION AND CLINICAL PHARMACOLOGY
................................................................. 12
STORAGE AND STABILITY
...............................................................................................
15
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 15
PART II: SCIENTIFIC INFORMATION
.............................................................................
16
PHARMACEUTICAL INFORMATION
...............................................................................
16
CLINICAL TRIALS
...............................................................................................................
17
DETAILED PHARMACOLOGY
........................................................................
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