AG-QUETIAPINE XR TABLET (EXTENDED-RELEASE)

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

QUETIAPINE (QUETIAPINE FUMARATE)

Pieejams no:

ANGITA PHARMA INC.

ATĶ kods:

N05AH04

SNN (starptautisko nepatentēto nosaukumu):

QUETIAPINE

Deva:

200MG

Zāļu forma:

TABLET (EXTENDED-RELEASE)

Kompozīcija:

QUETIAPINE (QUETIAPINE FUMARATE) 200MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

15G/50G

Receptes veids:

Prescription

Ārstniecības joma:

ATYPICAL ANTIPSYCHOTICS

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2021-09-21

Produkta apraksts

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
.................................................................................