AG-QUETIAPINE FUMARATE TABLET (IMMEDIATE RELEASE)

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

QUETIAPINE (QUETIAPINE FUMARATE)

Disponibil de la:

ANGITA PHARMA INC.

Codul ATC:

N05AH04

INN (nume internaţional):

QUETIAPINE

Dozare:

200MG

Forma farmaceutică:

TABLET (IMMEDIATE RELEASE)

Compoziție:

QUETIAPINE (QUETIAPINE FUMARATE) 200MG

Calea de administrare:

ORAL

Unități în pachet:

15G/50G

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ATYPICAL ANTIPSYCHOTICS

Rezumat produs:

Active ingredient group (AIG) number: 0131858003; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2021-06-14

Caracteristicilor produsului

Page 1 of 59
PRODUCT MONOGRAPH
PR
AG-QUETIAPINE FUMARATE
Quetiapine Tablets USP
25 mg, 100 mg, 200 mg and 300 mg
quetiapine (as quetiapine fumarate)
Antipsychotic Agent
_ANGITA PHARMA INC. _
_DATE OF REVISION:_
1310 rue Nobel
June 11, 2021
Boucherville, Québec
J4B 5H3
Submission Control No.: 252148
Page 2 of 59
TABLE OF CONTENTS
PRODUCT MONOGRAPH
....................................................................................................
1
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
......................................................................
3
INDICATIONS AND CLINICAL USE
...........................................................................
3
CONTRAINDICATIONS
................................................................................................
4
WARNINGS AND PRECAUTIONS
...............................................................................
4
ADVERSE REACTIONS
...............................................................................................
15
DRUG INTERACTIONS
...............................................................................................
31
DOSAGE AND ADMINISTRATION
...........................................................................
33
OVERDOSAGE
.............................................................................................................
35
ACTION AND CLINICAL PHARMACOLOGY
.......................................................... 36
STORAGE AND STABILITY
.......................................................................................
38
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 38
PART II: SCIENTIFIC INFORMATION
.............................................................................
39
PHARMACEUTICAL INFORMATION
.......................................................................
39
CLINICAL TRIALS
..........................................................................