REYATAZ CAPSULE

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

ATAZANAVIR (ATAZANAVIR SULFATE)

Διαθέσιμο από:

BRISTOL-MYERS SQUIBB CANADA

Φαρμακολογική κατηγορία (ATC):

J05AE08

INN (Διεθνής Όνομα):

ATAZANAVIR

Δοσολογία:

150MG

Φαρμακοτεχνική μορφή:

CAPSULE

Σύνθεση:

ATAZANAVIR (ATAZANAVIR SULFATE) 150MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

60

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

HIV PROTEASE INHIBITORS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0149741002; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2022-04-28

Αρχείο Π.Χ.Π.

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_Page 1 of 77_
PRODUCT MONOGRAPH
PR REYATAZ
®
Atazanavir capsules
150, 200 and 300 mg
(as atazanavir sulfate)
Azapeptide Inhibitor of HIV-1 Protease
Bristol-Myers Squibb Canada Co.
Date of Preparation:
Montreal, Canada
December 3, 2003
Date of Revision:
April 28, 2020
®
Registered trademark of Bristol-Myers Squibb Holdings Ireland used
under licence by Bristol-Myers Squibb
Canada Co.
CONTROL NUMBER: 236039
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_Page 2 of 77_
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
..................................................................................................11
DRUG INTERACTIONS
..................................................................................................22
DOSAGE AND ADMINISTRATION
..............................................................................39
OVERDOSAGE
.................................................................................................................41
ACTION AND CLINICAL PHARMACOLOGY
............................................................42
STORAGE AND STABILITY
..........................................................................................46
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................47
PART II : SCIENTIFIC INFORMATION
...............................................................................48
PHARMACEUTICAL INFORMATION
..........................................................................48
CLINICAL TRIALS
...........................................