DARUNAVIR TABLET

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

DARUNAVIR

Disponível em:

JAMP PHARMA CORPORATION

Código ATC:

J05AE10

DCI (Denominação Comum Internacional):

DARUNAVIR

Dosagem:

600MG

Forma farmacêutica:

TABLET

Composição:

DARUNAVIR 600MG

Via de administração:

ORAL

Unidades em pacote:

15G/50G

Tipo de prescrição:

Prescription

Área terapêutica:

HIV PROTEASE INHIBITORS

Resumo do produto:

Active ingredient group (AIG) number: 0151656003; AHFS:

Status de autorização:

APPROVED

Data de autorização:

2021-10-18

Características técnicas

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_Darunavir _ _Page 1 of 104 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
DARUNAVIR
Darunavir tablets
Tablets, 400 mg, 600 mg and 800 mg, Oral
Manufacturer's Standard
Human Immunodeficiency Virus (HIV) Protease Inhibitor
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Date of Initial Authorization:
OCT 18, 2021
Date of Revision:
OCT 31, 2023
Submission Control Number: 280092
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_Darunavir _ _Page 2 of 104 _
RECENT MAJOR LABEL CHANGES NOT APPLICABLE
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
.............................................................................................................
4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
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5
4.1
Dosing Considerations
...........................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
...................................................... 5
4.5
Missed Dose
..