TEVA-ATAZANAVIR CAPSULE

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

ATAZANAVIR (ATAZANAVIR SULFATE)

Verfügbar ab:

TEVA CANADA LIMITED

ATC-Code:

J05AE08

INN (Internationale Bezeichnung):

ATAZANAVIR

Dosierung:

300MG

Darreichungsform:

CAPSULE

Zusammensetzung:

ATAZANAVIR (ATAZANAVIR SULFATE) 300MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

10/30/60

Verschreibungstyp:

Prescription

Therapiebereich:

HIV PROTEASE INHIBITORS

Produktbesonderheiten:

Active ingredient group (AIG) number: 0149741004; AHFS:

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2017-04-18

Fachinformation

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_Teva-Atazanavir _
_Page 1 of 73_
PRODUCT MONOGRAPH
PR
TEVA-ATAZANAVIR
Atazanavir capsules
150 mg, 200 mg and 300 mg
(as atazanavir sulfate)
Azapeptide Inhibitor of HIV-1 Protease
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
www.tevacanada.com
Date of Revision: April 12, 2021
Submission Control No: 240892
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_Teva-Atazanavir _
_Page 2 of 73_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................... 3
SUMMARY PRODUCT INFORMATION
........................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
...................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
.................................................................................................
12
DRUG INTERACTIONS
.................................................................................................
23
DOSAGE AND ADMINISTRATION
.............................................................................
35
OVERDOSAGE
................................................................................................................
38
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 39
STORAGE AND STABILITY
.........................................................................................
43
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 44
PART II: SCIENTIFIC INFORMATION
....................................................................................
45
PHARMACEUTICAL INFORMATION
.........................................................................
45
CLINICAL TRIALS
......................................................................................................