PRIVA-PAROXETINE TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE)

Commercializzato da:

PHARMAPAR INC

Codice ATC:

N06AB05

INN (Nome Internazionale):

PAROXETINE

Dosaggio:

10MG

Forma farmaceutica:

TABLET

Composizione:

PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) 10MG

Via di somministrazione:

ORAL

Confezione:

100/500

Tipo di ricetta:

Prescription

Area terapeutica:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Dettagli prodotto:

Active ingredient group (AIG) number: 0123131003; AHFS:

Stato dell'autorizzazione:

CANCELLED POST MARKET

Data dell'autorizzazione:

2022-07-29

Scheda tecnica

_Priva-PAROXETINE _
_Page 1 of 53 _
PRODUCT MONOGRAPH
PR PRIVA-PAROXETINE
Paroxetine Tablets USP
10 mg, 20 mg, 30 mg paroxetine (as paroxetine hydrochloride
hemihydrate)
ANTIDEPRESSANT – ANTIOBSESSIONAL – ANTIPANIC – ANXIOLYTIC AGENT
–
SOCIAL PHOBIA (SOCIAL ANXIETY DISORDER) - POSTTRAUMATIC STRESS
DISORDER THERAPY
PHARMAPAR INC.
100-5950, Ch. de la Côte de Liesse
DATE OF PREPARATION:
August 18, 2015
Mont-Royal
QC, H4T 1E2
Control # 186135
_Priva-PAROXETINE _
_Page 2 of 53 _
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
...............................................................................................................
13
DRUG INTERACTIONS
...............................................................................................................
23
DOSAGE AND ADMINISTRATION
...........................................................................................
28
OVERDOSAGE
.............................................................................................................................
30
ACTION AND CLINICAL PHARMACOLOGY
.........................................................................
31
STORAGE AND STABILITY
.......................................................................................................
33
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................................... 34
PART II: SCIENTIFIC INFORMATION
........................................