EVOTAZ TABLET

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

ATAZANAVIR (ATAZANAVIR SULFATE); COBICISTAT

Disponibbli minn:

BRISTOL-MYERS SQUIBB CANADA

Kodiċi ATC:

J05AR15

INN (Isem Internazzjonali):

ATANAZAVIR AND COBICISTAT

Dożaġġ:

300MG; 150MG

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

ATAZANAVIR (ATAZANAVIR SULFATE) 300MG; COBICISTAT 150MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

30

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

HIV PROTEASE INHIBITORS

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0257430001; AHFS:

L-istatus ta 'awtorizzazzjoni:

CANCELLED POST MARKET

Data ta 'l-awtorizzazzjoni:

2017-09-22

Karatteristiċi tal-prodott

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_Page 1 of 60_
PRODUCT MONOGRAPH
Pr
EVOTAZ*
atazanavir / cobicistat tablets
300 mg atazanavir (as atazanavir sulfate)/150 mg cobicistat
Azapeptide Inhibitor of HIV-1 Protease
Bristol-Myers Squibb Canada
Montreal, Canada
Date of Revision:
September 8, 2017
* TM of Bristol-Myers Squibb Company used under licence by
Bristol-Myers Squibb Canada
Submission Control No: 206829
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_EVOTAZ Product Monograph _
_Page 2 of 60_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
..................................................................................................13
DRUG INTERACTIONS
..................................................................................................17
DOSAGE AND ADMINISTRATION
..............................................................................26
OVERDOSAGE
................................................................................................................27
ACTION AND CLINICAL PHARMACOLOGY
............................................................28
STORAGE AND STABILITY
..........................................................................................32
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................32
PART II: SCIENTIFIC INFORMATION
...............................................................................33
PHARMACEUTICAL INFORMATION
..........................................................................33
CLINICAL TRIALS
............................................................