NU-MIRTAZAPINE TABLET
国: カナダ
言語: 英語
ソース: Health Canada
製品の特徴
(SPC)
02-11-2009
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有効成分:
MIRTAZAPINE
から入手可能:
NU-PHARM INC
ATCコード:
N06AX11
INN（国際名）:
MIRTAZAPINE
投薬量:
45MG
医薬品形態:
TABLET
構図:
MIRTAZAPINE 45MG
投与経路:
ORAL
パッケージ内のユニット:
100
処方タイプ:
Prescription
治療領域:
MISCELLANEOUS ANTIDEPRESSANTS
製品概要:
Active ingredient group (AIG) number: 0143928003; AHFS:
認証ステータス:
CANCELLED (UNRETURNED ANNUAL)
承認日:
2018-03-28
製品の特徴
Page 1 of 32
PRODUCT MONOGRAPH
PR
NU-MIRTAZAPINE
Mirtazapine Tablets
USP
15 mg, 30 mg and 45 mg
Antidepressant
NU-PHARM INC.
DATE OF PREPARATION:
50 Mural St., Units 1 & 2
October 14, 2009
Richmond Hill, Ontario
L4B 1E4
Control#: 133373
Page 2 of 32
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
.......................................................................................................
12
DOSAGE AND ADMINISTRATION
...................................................................................
12
OVERDOSAGE......................................................................................................................
14
ACTION AND CLINICAL
PHARMACOLOGY..................................................................
14
STORAGE AND
STABILITY...............................................................................................
17
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 17
PART II: SCIENTIFIC INFORMATION
.............................................................................
19
PHARMACEUTICAL
INFORMATION...............................................................................
19
CLINICAL TRIALS
...............................................................................................................
20
DETAILED PHARMACOLOGY
...................................
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