DARUNAVIR TABLET

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

DARUNAVIR

Beszerezhető a:

JAMP PHARMA CORPORATION

ATC-kód:

J05AE10

INN (nemzetközi neve):

DARUNAVIR

Adagolás:

400MG

Gyógyszerészeti forma:

TABLET

Összetétel:

DARUNAVIR 400MG

Az alkalmazás módja:

ORAL

db csomag:

100

Recept típusa:

Prescription

Terápiás terület:

HIV PROTEASE INHIBITORS

Termék összefoglaló:

Active ingredient group (AIG) number: 0151656002; AHFS:

Engedélyezési státusz:

APPROVED

Engedély dátuma:

2021-10-18

Termékjellemzők

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_ Darunavir _ _Page 1 of 95 _
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
Submission Control Number: 274675
Date
of
Initial
Authorization:
OCT 18, 2021
Date of Revision:
MAY 10,
2023
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_ Darunavir _ _Page 2 of 95 _
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
................................................................................................
2
TABLE OF
CONTENTS......................................................................................................................
2
PART I: HEALTH PROFESSIONAL
INFORMATION.........................................................................
4
1
INDICATIONS
.........................................................................................................................
4
1.1 PEDIATRICS
.............................................................................................................................................
4
1.2 GERIATRICS
..............................................................................................................................................
4
2
CONTRAINDICATIONS
..........................................................................................................
4
4
DOSAGE AND ADMINISTRATION
.........................................................................................
5
4.1 DOSING
CONSIDERATIONS.................................................................................................................