STR-DULOXETINE CAPSULE (DELAYED RELEASE)

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

DULOXETINE (DULOXETINE HYDROCHLORIDE)

Saadav alates:

STAR - PHARMA PAN - AMERICA INC

ATC kood:

N06AX21

INN (Rahvusvaheline Nimetus):

DULOXETINE

Annus:

60MG

Ravimvorm:

CAPSULE (DELAYED RELEASE)

Koostis:

DULOXETINE (DULOXETINE HYDROCHLORIDE) 60MG

Manustamisviis:

ORAL

Ühikuid pakis:

100

Retsepti tüüp:

Prescription

Terapeutiline ala:

SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS

Toote kokkuvõte:

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

Volitamisolek:

CANCELLED PRE MARKET

Loa andmise kuupäev:

2021-12-13

Toote omadused

1
PRODUCT MONOGRAPH
PR
STR-DULOXETINE
Duloxetine Delayed-Release Capsules
Duloxetine (as duloxetine hydrochloride)
30 mg and 60 mg
USP
ANALGESIC / ANTIDEPRESSANT / ANXIOLYTIC
Star-Pharma Pan-America Inc.
Date of Preparation:
2985 Drew Rd., Suite 216
06 March 2017
Mississauga, Ontario
L4T 0A4
Control No.: 198169
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE:
...........................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
................................................................................
5
ADVERSE REACTIONS
..................................................................................................
17
DRUG INTERACTIONS
..................................................................................................
34
DOSAGE AND ADMINISTRATION
..............................................................................
37
OVERDOSAGE
.................................................................................................................
40
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 41
STORAGE AND STABILITY
..........................................................................................
44
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................. 44
PART II: SCIENTIFIC INFORMATION
................................................................................
46
PHARMACEUTICAL INFORMATION
..........................................................................
46
CLINICAL TRIALS
..........................................................................................................
47
DETAILED PHARMACOLOGY
..............................