NORVIR SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

RITONAVIR

Disponible depuis:

ABBVIE CORPORATION

Code ATC:

J05AE03

DCI (Dénomination commune internationale):

RITONAVIR

Dosage:

80MG

forme pharmaceutique:

SOLUTION

Composition:

RITONAVIR 80MG

Mode d'administration:

ORAL

Unités en paquet:

240ML(1BTLE)

Type d'ordonnance:

Prescription

Domaine thérapeutique:

HIV PROTEASE INHIBITORS

Descriptif du produit:

Active ingredient group (AIG) number: 0128780002; AHFS:

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2019-03-31

Résumé des caractéristiques du produit

_ _
_NORVIR Product Monograph _
_Page 1 of 72 _
_Date of Revision: February 27, 2019 and Control No. _
PRODUCT MONOGRAPH
PR
NORVIR
®
Ritonavir
film-coated tablets (100 mg)
PR
NORVIR
®
Ritonavir
oral solution (80 mg/mL)
Human Immunodeficiency Virus (HIV) Protease Inhibitor
Date of Initial Approval:
August 9, 1996
Date of Previous Revision:
September 25, 2018
AbbVie Corporation
Date of Revision:
8401 Trans-Canada Highway
May 15, 2019
St-Laurent, Qc H4S 1Z1
Submission Control No: 225125
_ _
_NORVIR Product Monograph _
_Page 2 of 72 _
_Date of Revision: February 27, 2019 and Control No. _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................6
ADVERSE REACTIONS
..................................................................................................14
DRUG INTERACTIONS
..................................................................................................23
DOSAGE AND ADMINISTRATION
..............................................................................42
OVERDOSAGE
................................................................................................................45
ACTION AND CLINICAL PHARMACOLOGY
............................................................45
STORAGE AND STABILITY
..........................................................................................49
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................50
PART II: SCIENTIFIC INFORMATION
................................................................................51
PHARMACEUTIC