TEVA-QUETIAPINE XR TABLET (EXTENDED-RELEASE)

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

QUETIAPINE (QUETIAPINE FUMARATE)

Commercializzato da:

TEVA CANADA LIMITED

Codice ATC:

N05AH04

INN (Nome Internazionale):

QUETIAPINE

Dosaggio:

400MG

Forma farmaceutica:

TABLET (EXTENDED-RELEASE)

Composizione:

QUETIAPINE (QUETIAPINE FUMARATE) 400MG

Via di somministrazione:

ORAL

Confezione:

15G/50G

Tipo di ricetta:

Prescription

Area terapeutica:

ATYPICAL ANTIPSYCHOTICS

Dettagli prodotto:

Active ingredient group (AIG) number: 0131858007; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2013-03-08

Scheda tecnica

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_Teva-Quetiapine XR Tablets_
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_Page 1 of 93_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
TEVA-QUETIAPINE XR
Quetiapine Fumarate Extended-Release Tablets
Tablets, 50 mg, 150 mg, 200 mg, 300 mg and 400 mg quetiapine (as
quetiapine fumarate), Oral
Teva Standard
Antipsychotic / Antidepressant Agent
Teva Canada Limited
30 Novopharm Court
Toronto, ON
M1B 2K9
Canada
www.tevacanada.com
Date of Initial Authorization:
March 08, 2013
Date of Revision:
August 25, 2022
Submission Control No: 262415
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_Teva-Quetiapine XR Tablets_
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_Page 2 of 93_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS - Musculoskeletal - Rhabdomyolysis
08/2022
7 WARNINGS AND PRECAUTIONS - Psychiatric
08/2022
7 Warnings and Precautions - Skin
08/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
............................................................................................
2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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1.
INDICATIONS
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4
1.1
Pediatrics
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5
1.2
Geriatrics
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5
2.
CONTRAINDICATIONS
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5
3.
SERIOUS WARNINGS AND PRECAUTIONS BOX
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4.
DOSAGE AND ADMINISTRATION
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5
4.1
Dosing Considerations
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