TEVA-ARIPIPRAZOLE TABLET

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

ARIPIPRAZOLE

Prieinama:

TEVA CANADA LIMITED

ATC kodas:

N05AX12

INN (Tarptautinis Pavadinimas):

ARIPIPRAZOLE

Dozė:

15MG

Vaisto forma:

TABLET

Sudėtis:

ARIPIPRAZOLE 15MG

Vartojimo būdas:

ORAL

Vienetai pakuotėje:

30/100

Recepto tipas:

Prescription

Gydymo sritis:

ATYPICAL ANTIPSYCHOTICS

Produkto santrauka:

Active ingredient group (AIG) number: 0152514003; AHFS:

Autorizacija statusas:

CANCELLED POST MARKET

Leidimo data:

2021-07-29

Prekės savybės

PRODUCT MONOGRAPH
PR TEVA-ARIPIPRAZOLE
Aripiprazole Tablets, USP
2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg
Antipsychotic agent
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
Date of Preparation:
July 03, 2020
www.tevacanada.com
Submission Control No: 240750
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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
.........................................................................................................
14
DRUG INTERACTIONS
.........................................................................................................
31
DOSAGE AND ADMINISTRATION
.....................................................................................
35
OVERDOSAGE
........................................................................................................................
37
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
38
STORAGE AND STABILITY
.................................................................................................
40
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 40
PART II: SCIENTIFIC INFORMATION
...................................................................................
42
PHARMACEUTICAL INFORMATION
.................................................................................
42
CLINICAL TRIALS
..................................................