PAT-DARUNAVIR TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

DARUNAVIR (DARUNAVIR ETHANOLATE)

Disponible depuis:

PATRIOT A DIVISION OF JANSSEN INC

Code ATC:

J05AE10

DCI (Dénomination commune internationale):

DARUNAVIR

Dosage:

150MG

forme pharmaceutique:

TABLET

Composition:

DARUNAVIR (DARUNAVIR ETHANOLATE) 150MG

Mode d'administration:

ORAL

Unités en paquet:

240

Type d'ordonnance:

Prescription

Domaine thérapeutique:

HIV PROTEASE INHIBITORS

Descriptif du produit:

Active ingredient group (AIG) number: 0151656005; AHFS:

Statut de autorisation:

CANCELLED PRE MARKET

Date de l'autorisation:

2020-03-12

Résumé des caractéristiques du produit

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_Page 1 of 78 _
PRODUCT
MONOGRAPH
PR
PAT-DARUNAVIR
darunavir tablets 75 mg, 150 mg, 400 mg, 600 mg, 800 mg
(as darunavir ethanolate)
Human Immunodeficiency Virus (HIV) Protease Inhibitor
Patriot, a division of Janssen Inc.
19 Green Belt Drive
Toronto, Ontario
M3C 1L9
Date of Preparation:
November 30, 2012
www.patriot-canada.ca
Submission Control No: 159996
© JANSSEN Inc. 2012
All trademarks used under license.
Draft Date: Oct 26, 2012
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_Page 2 of 78 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
....................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
4
ADVERSE REACTIONS
...........................................................................................................
9
DRUG INTERACTIONS
.........................................................................................................
20
DOSAGE AND ADMINISTRATION
.....................................................................................
32
OVERDOSAGE
.......................................................................................................................
35
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 35
STORAGE AND STABILITY
.................................................................................................
38
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 38
PART II: SCIENTIFIC INFORMATION
..............................................................................
40
PHARMACEUTICAL INFORMATION
.............................