DOVATO TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

DOLUTEGRAVIR (DOLUTEGRAVIR SODIUM); LAMIVUDINE

Tilgængelig fra:

VIIV HEALTHCARE ULC

ATC-kode:

J05AR25

INN (International Name):

LAMIVUDINE AND DOLUTEGRAVIR

Dosering:

50MG; 300MG

Lægemiddelform:

TABLET

Sammensætning:

DOLUTEGRAVIR (DOLUTEGRAVIR SODIUM) 50MG; LAMIVUDINE 300MG

Indgivelsesvej:

ORAL

Enheder i pakken:

15G/50G

Recept type:

Prescription

Terapeutisk område:

HIV INTEGRASE INHIBITORS

Produkt oversigt:

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

Autorisation status:

APPROVED

Autorisation dato:

2019-08-22

Produktets egenskaber

_ _
_ _
_DOVATO, dolutegravir sodium and lamivudine _
_ June 2023 _
_ _
_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
..............................................................................................................
4
1.1
Pediatrics
...................................................................................................................
4
1.2
Geriatrics
...................................................................................................................
4
2
CONTRAINDICATIONS
..................................................................................