PMS-DULOXETINE CAPSULE (DELAYED RELEASE)

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

DULOXETINE (DULOXETINE HYDROCHLORIDE)

Commercializzato da:

PHARMASCIENCE INC

Codice ATC:

N06AX21

INN (Nome Internazionale):

DULOXETINE

Dosaggio:

30MG

Forma farmaceutica:

CAPSULE (DELAYED RELEASE)

Composizione:

DULOXETINE (DULOXETINE HYDROCHLORIDE) 30MG

Via di somministrazione:

ORAL

Confezione:

30/100

Tipo di ricetta:

Prescription

Area terapeutica:

SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2016-05-02

Scheda tecnica

PRODUCT MONOGRAPH
Pr
PMS-DULOXETINE
Duloxetine Delayed-Release Capsules, House Standard
Duloxetine (as duloxetine hydrochloride)
30 mg and 60 mg
ANALGESIC/ANTIDEPRESSANT/ANXIOLYTIC
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Canada
H4P 2T4
www.pharmascience.com
DATE OF REVISION:
October 29, 2021
SUBMISSION CONTROL NO: 253685
_ _
_pms-DULOXETINE Product Monograph _
_Page 2 of 84_
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
..................................................................................................18
DRUG INTERACTIONS
..................................................................................................37
DOSAGE AND ADMINISTRATION
..............................................................................40
OVERDOSAGE
................................................................................................................43
ACTION AND CLINICAL PHARMACOLOGY
............................................................44
STORAGE AND STABILITY
..........................................................................................47
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................48
PART II: SCIENTIFIC INFORMATION
................................................................................49
PHARMACEUTICAL INFORMATION
..........................................................................49
CLINICAL TRIALS
......................................................................................