NU-MIRTAZAPINE TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

MIRTAZAPINE

Tersedia dari:

NU-PHARM INC

Kode ATC:

N06AX11

INN (Nama Internasional):

MIRTAZAPINE

Dosis:

15MG

Bentuk farmasi:

TABLET

Komposisi:

MIRTAZAPINE 15MG

Rute administrasi :

ORAL

Unit dalam paket:

100

Jenis Resep:

Prescription

Area terapi:

MISCELLANEOUS ANTIDEPRESSANTS

Ringkasan produk:

Active ingredient group (AIG) number: 0143928001; AHFS:

Status otorisasi:

CANCELLED (UNRETURNED ANNUAL)

Tanggal Otorisasi:

2018-03-28

Karakteristik produk

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
...................................