NAT-DARUNAVIR TABLET

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

DARUNAVIR

から入手可能:

NATCO PHARMA (CANADA) INC

ATCコード:

J05AE10

INN（国際名）:

DARUNAVIR

投薬量:

800MG

医薬品形態:

TABLET

構図:

DARUNAVIR 800MG

投与経路:

ORAL

パッケージ内のユニット:

100

処方タイプ:

Prescription

治療領域:

HIV PROTEASE INHIBITORS

製品概要:

Active ingredient group (AIG) number: 0151656006; AHFS:

認証ステータス:

APPROVED

承認日:

2020-10-21

製品の特徴

_ _
_NAT-DARUNAVIR _
_Page 1 of 83_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
NAT-DARUNAVIR
Darunavir tablets
400 mg, 600 mg and 800 mg, Oral
Human Immunodeficiency Virus (HIV) Protease Inhibitor
Natco Pharma (Canada) Inc.
2000 Argentia Road, Plaza 1, Suite 200
Mississauga, Ontario
L5N 1P7
Date of Initial Authorization:
OCT 20, 2020
Date of Revision:
MAY 03, 2023
Submission Control Number: 270484
_ _
_NAT-DARUNAVIR _
_Page 2 of 83_
RECENT MAJOR LABEL CHANGES
None at the time of the most recent authorization
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
.........................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
.................................................................... 5
4.5
Missed Dose
......................................................................