MYLAN-DULOXETINE CAPSULE (DELAYED RELEASE)

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

DULOXETINE (DULOXETINE HYDROCHLORIDE)

Tersedia dari:

MYLAN PHARMACEUTICALS ULC

Kode ATC:

N06AX21

INN (Nama Internasional):

DULOXETINE

Dosis:

30MG

Bentuk farmasi:

CAPSULE (DELAYED RELEASE)

Komposisi:

DULOXETINE (DULOXETINE HYDROCHLORIDE) 30MG

Rute administrasi :

ORAL

Unit dalam paket:

30/100

Jenis Resep:

Prescription

Area terapi:

SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS

Ringkasan produk:

Active ingredient group (AIG) number: 0152350001; AHFS:

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2018-05-10

Karakteristik produk

_MYLAN-DULOXETINE Product Monograph_
Page 1 of 86
PRODUCT MONOGRAPH
PR MYLAN-DULOXETINE
Duloxetine Delayed Release Capsules, Mylan Standard
Duloxetine (as duloxetine hydrochloride)
30 mg and 60 mg
ANALGESIC/ANTIDEPRESSANT/ANXIOLYTIC
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Submission Control No.: 198303
Date of Revision: September 29, 2016
_MYLAN-DULOXETINE Product Monograph_
Page 2 of 86
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................. 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
...........................................................................................................
5
WARNINGS AND PRECAUTIONS
.........................................................................................
6
ADVERSE REACTIONS
.........................................................................................................
19
DRUG INTERACTIONS
.........................................................................................................
38
DOSAGE AND ADMINISTRATION
.....................................................................................
42
OVERDOSAGE
........................................................................................................................
45
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
46
STORAGE AND STABILITY
.................................................................................................
49
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 49
PART II: SCIENTIFIC INFORMATION
.........................................................................................
51
PHARMACEUTICAL INFORMATION
.....................................................