AG-QUETIAPINE XR TABLET (EXTENDED-RELEASE)

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

QUETIAPINE (QUETIAPINE FUMARATE)

Dostępny od:

ANGITA PHARMA INC.

Kod ATC:

N05AH04

INN (International Nazwa):

QUETIAPINE

Dawkowanie:

200MG

Forma farmaceutyczna:

TABLET (EXTENDED-RELEASE)

Skład:

QUETIAPINE (QUETIAPINE FUMARATE) 200MG

Droga podania:

ORAL

Sztuk w opakowaniu:

15G/50G

Typ recepty:

Prescription

Dziedzina terapeutyczna:

ATYPICAL ANTIPSYCHOTICS

Podsumowanie produktu:

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

Status autoryzacji:

APPROVED

Data autoryzacji:

2021-09-21

Charakterystyka produktu

PRODUCT MONOGRAPH
PR
AG-QUETIAPINE XR
Quetiapine Fumarate Extended-Release Tablets
50 mg, 150 mg, 200 mg, 300 mg and 400 mg quetiapine (as quetiapine
fumarate)
House Standard
Antipsychotic / Antidepressant Agent
Angita Pharma Inc.
Date of Preparation:
1310 rue Nobel
September 20, 2021
Boucherville, Québec
J4B 5H3, Canada
Submission Control No: 255711
Product Monograph of AG-Quetiapine XR
Page 2 of 79
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
................................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
...........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
4
ADVERSE REACTIONS
.........................................................................................................
17
DRUG INTERACTIONS
.........................................................................................................
37
DOSAGE AND ADMINISTRATION
.....................................................................................
39
OVERDOSAGE
........................................................................................................................
43
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
44
STORAGE AND STABILITY
.................................................................................................
47
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 47
PART II: SCIENTIFIC INFORMATION
...............................................................................48
PHARMACEUTICAL INFORMATION
.................................................................................