TIVICAY TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

DOLUTEGRAVIR (DOLUTEGRAVIR SODIUM)

Saatavilla:

VIIV HEALTHCARE ULC

ATC-koodi:

J05AJ03

INN (Kansainvälinen yleisnimi):

DOLUTEGRAVIR

Annos:

10MG

Lääkemuoto:

TABLET

Koostumus:

DOLUTEGRAVIR (DOLUTEGRAVIR SODIUM) 10MG

Antoreitti:

ORAL

Kpl paketissa:

30

Prescription tyyppi:

Prescription

Terapeuttinen alue:

MISCELLANEOUS ANTIRETROVIRALS*

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0154870002; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2017-02-03

Valmisteyhteenveto

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_TIVICAY, dolutegravir _
_June 2023 _
_ _
_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_
_ _
_ _
_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
..................................................................................