DOVATO TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

DOLUTEGRAVIR (DOLUTEGRAVIR SODIUM); LAMIVUDINE

Dostępny od:

VIIV HEALTHCARE ULC

Kod ATC:

J05AR25

INN (International Nazwa):

LAMIVUDINE AND DOLUTEGRAVIR

Dawkowanie:

50MG; 300MG

Forma farmaceutyczna:

TABLET

Skład:

DOLUTEGRAVIR (DOLUTEGRAVIR SODIUM) 50MG; LAMIVUDINE 300MG

Droga podania:

ORAL

Sztuk w opakowaniu:

15G/50G

Typ recepty:

Prescription

Dziedzina terapeutyczna:

HIV INTEGRASE INHIBITORS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0261731001; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2019-08-22

Charakterystyka produktu

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_DOVATO, dolutegravir sodium and lamivudine _
_ June 2023 _
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_Page 1 of 46_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
DOVATO
dolutegravir and lamivudine tablets
50 mg dolutegravir (as dolutegravir sodium) and 300 mg lamivudine,
Oral
Antiretroviral Agent
ViiV Healthcare ULC
75 Queen Street, Suite 1400
Montreal, Quebec
Canada
H3C 2N6
Date of Initial Authorization:
AUG 22, 2019
Date of Revision:
JUN 27, 2023
Submission Control Number: 272489
_©_
_2023 ViiV Healthcare group of companies or its licensor _
_Trademarks are owned by or licensed to the ViiV Healthcare group of
companies_
_ _
_ _
_DOVATO, dolutegravir sodium and lamivudine _
_February 2023 _
_ _
_Page 2 of 46_
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
09/2021
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and
Dosage Adjustment
09/2021
7 WARNINGS AND PRECAUTIONS, Renal
09/2021
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
09/2022
7 WARNINGS AND PRECAUTIONS, 7.1.2 Breast Feeding
09/2022
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
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4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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