TYBOST TABLET

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

COBICISTAT

Beschikbaar vanaf:

GILEAD SCIENCES CANADA INC

ATC-code:

V03AX03

INN (Algemene Internationale Benaming):

COBICISTAT

Dosering:

150MG

farmaceutische vorm:

TABLET

Samenstelling:

COBICISTAT 150MG

Toedieningsweg:

ORAL

Eenheden in pakket:

30

Prescription-type:

Prescription

Therapeutisch gebied:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Product samenvatting:

Active ingredient group (AIG) number: 0154670001; AHFS:

Autorisatie-status:

APPROVED

Autorisatie datum:

2013-08-27

Productkenmerken

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TYBOST
®
cobicistat tablets
150 mg, Oral
Pharmacokinetic Enhancer
Gilead Sciences Canada, Inc.
Mississauga, ON L5N 2W3
www.gilead.ca
Submission Control No.: 250376_ _
Date of Initial Authorization:
August 27, 2013
Date of Revision: August 17, 2021
_Product Monograph _
_TYBOST (cobicistat) tablets _
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_Page 2 of 42_
RECENT MAJOR LABEL CHANGES
2 Contraindications
05/2020
7 Warnings and Precautions, General
05/2020
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
.................................................................................
2
PART I.
HEALTH PROFESSIONAL INFORMATION
....................................................... 4
1
INDICATIONS
.............................................................................................................
4
1.1
Pediatrics
..........................................................................................................
4
1.2
Geriatrics
..........................................................................................................
4
2
CONTRAINDICATIONS...............................................................................................
4
4
DOSAGE AND ADMINISTRATION
..............................................................................
7
4.2
Recommended Dose and Dosage Adjustment
................................................... 7
4.5
Missed Dose
.....................................................................................................
8
5
OVERDOSAGE
...........................................................................................................
8
6
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
........................ 8
7
WARNINGS AND PRECAUTIONS
..............................................................................
9
7.1
Special Populations
.......................................................................