TEVA-QUETIAPINE TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

QUETIAPINE (QUETIAPINE FUMARATE)

Tilgængelig fra:

TEVA CANADA LIMITED

ATC-kode:

N05AH04

INN (International Name):

QUETIAPINE

Dosering:

25MG

Lægemiddelform:

TABLET

Sammensætning:

QUETIAPINE (QUETIAPINE FUMARATE) 25MG

Indgivelsesvej:

ORAL

Enheder i pakken:

30/100/500

Recept type:

Prescription

Terapeutisk område:

ATYPICAL ANTIPSYCHOTICS

Produkt oversigt:

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

Autorisation status:

CANCELLED POST MARKET

Autorisation dato:

2021-07-30

Produktets egenskaber

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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
_____________________________________________________________________________
_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
..............