AG-QUETIAPINE FUMARATE TABLET (IMMEDIATE 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:

25MG

Zāļu forma:

TABLET (IMMEDIATE RELEASE)

Kompozīcija:

QUETIAPINE (QUETIAPINE FUMARATE) 25MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

15G/50G

Receptes veids:

Prescription

Ārstniecības joma:

ATYPICAL ANTIPSYCHOTICS

Produktu pārskats:

Active ingredient group (AIG) number: 0131858001; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

2021-06-14

Produkta apraksts

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