TIVICAY TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

DOLUTEGRAVIR (DOLUTEGRAVIR SODIUM)

Disponible depuis:

VIIV HEALTHCARE ULC

Code ATC:

J05AJ03

DCI (Dénomination commune internationale):

DOLUTEGRAVIR

Dosage:

25MG

forme pharmaceutique:

TABLET

Composition:

DOLUTEGRAVIR (DOLUTEGRAVIR SODIUM) 25MG

Mode d'administration:

ORAL

Unités en paquet:

30

Type d'ordonnance:

Prescription

Domaine thérapeutique:

MISCELLANEOUS ANTIRETROVIRALS*

Descriptif du produit:

Active ingredient group (AIG) number: 0154870003; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2017-02-03

Résumé des caractéristiques du produit

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_TIVICAY, dolutegravir _
_June 2023 _
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_Page 1 of 51_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
TIVICAY
dolutegravir tablets
Tablets, 10, 25 and 50 mg dolutegravir (as dolutegravir sodium), oral
dolutegravir dispersible tablets
Dispersible tablets, 5 mg dolutegravir (as dolutegravir sodium), oral
Antiretroviral Agent
ViiV Healthcare ULC
75 Queen, Street Suite 1400
Montreal, Quebec
Canada
H3C 2N6
Date of Initial Authorization:
NOV 08, 2013
Date of Revision:
JUN 27, 2023
Submission Control Number: 272507
_©_
_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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_TIVICAY, dolutegravir _
_June 2023 _
_ _
_Page 2 of 51_
RECENT MAJOR LABEL CHANGES
SECTION
DATE
1 INDICATIONS
01/2021
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
01/2021
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and
Dosage Adjustment
12/2021
7 WARNINGS AND PRECAUTIONS, General
01/2021
7 WARNINGS AND PRECAUTIONS, 7.1.3 Pediatrics
01/2021
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
10/2022
7 WARNINGS AND PRECAUTIONS, 7.1.2 Breast-feeding
10/2022
7 WARNINGS AND PRECAUTIONS, General
06/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL CHANGES
................................................................................................
2
TABLE OF CONTENTS
................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
...........................................................................
4
1
INDICATIONS
................................................................................................................
4
1.1
Pediatrics............................................................................................................
4
1.2
Geriatrics
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