CELSENTRI TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MARAVIROC

Available from:

VIIV HEALTHCARE ULC

ATC code:

J05AX09

INN (International Name):

MARAVIROC

Dosage:

300MG

Pharmaceutical form:

TABLET

Composition:

MARAVIROC 300MG

Administration route:

ORAL

Units in package:

60

Prescription type:

Prescription

Therapeutic area:

HIV FUSION INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0152296002; AHFS:

Authorization status:

APPROVED

Authorization date:

2009-12-08

Summary of Product characteristics

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_CELSENTRI, maraviroc _
_ July 2023 _
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_Page 1 of 56_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
CELSENTRI
maraviroc tablets
Tablets, 150 and 300 mg maraviroc, oral
CCR5 antagonist
ViiV Healthcare ULC
75 Queen Street, Suite 1400
Montreal, Quebec
Canada
H3C 2N6
Date of Initial Authorization:
SEP 19, 2007
Date of Revision:
JUL 12, 2023
Submission Control Number: 272471
_©_
_2023 ViiV Healthcare group of companies or its licensor _
_Trademarks are owned by or licensed to the ViiV Healthcare group of
companies _
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_CELSENTRI, maraviroc _
_ July 2023 _
_ _
_Page 2 of 56_
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
TABLE OF CONTENTS
............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1
INDICATIONS
.............................................................................................................
4
1.1
Pediatrics
..................................................................................................................
4
1.2
Geriatrics
..................................................................................................................
4
2
CONTRAINDICATIONS
................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................................... 4
4
DOSAGE AND ADMINISTRATION
................................................................................
4
4.1
Dosing Considerations
.............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
........................................................ 5
4.5
Missed Dose
.............................................................................................................
6
5
OVERDOS