TEVA-QUETIAPINE TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

QUETIAPINE (QUETIAPINE FUMARATE)

Dostępny od:

TEVA CANADA LIMITED

Kod ATC:

N05AH04

INN (International Nazwa):

QUETIAPINE

Dawkowanie:

100MG

Forma farmaceutyczna:

TABLET

Skład:

QUETIAPINE (QUETIAPINE FUMARATE) 100MG

Droga podania:

ORAL

Sztuk w opakowaniu:

30/100/500

Typ recepty:

Prescription

Dziedzina terapeutyczna:

ATYPICAL ANTIPSYCHOTICS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0131858002; AHFS:

Status autoryzacji:

CANCELLED POST MARKET

Data autoryzacji:

2021-07-30

Charakterystyka produktu

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_TEVA-QUETIAPINE Page 1 of 56 _
PRODUCT MONOGRAPH
Pr
TEVA-QUETIAPINE
(Quetiapine as Quetiapine Fumarate)
25 mg, 100 mg, 150 mg, 200 mg and 300 mg Tablets
Teva Standard
Antipsychotic Agent
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
www.tevacanada.com
Submission Control No: 239062
Date of Preparation:
January 11, 2011
Date of Revision:
June 3, 2020
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_TEVA-QUETIAPINE Page 2 of 56 _
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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
.................................................................................................
15
DRUG INTERACTIONS
.................................................................................................
28
DOSAGE AND ADMINISTRATION
.............................................................................
30
OVERDOSAGE
...............................................................................................................
32
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 33
STORAGE AND STABILITY
.........................................................................................
35
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 35
PART II: SCIENTIFIC INFORMATION
..............................................................................
37
PHARMACEUTICAL INFORMATION
..............