MYLAN-DULOXETINE CAPSULE (DELAYED RELEASE)

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

DULOXETINE (DULOXETINE HYDROCHLORIDE)

Tilgjengelig fra:

MYLAN PHARMACEUTICALS ULC

ATC-kode:

N06AX21

INN (International Name):

DULOXETINE

Dosering :

60MG

Legemiddelform:

CAPSULE (DELAYED RELEASE)

Sammensetning:

DULOXETINE (DULOXETINE HYDROCHLORIDE) 60MG

Administreringsrute:

ORAL

Enheter i pakken:

30/100/500

Resept typen:

Prescription

Terapeutisk område:

SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS

Produkt oppsummering:

Active ingredient group (AIG) number: 0152350002; AHFS:

Autorisasjon status:

CANCELLED POST MARKET

Autorisasjon dato:

2018-05-10

Preparatomtale

_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
.....................................................