NORVIR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

RITONAVIR

Available from:

ABBVIE CORPORATION

ATC code:

J05AE03

INN (International Name):

RITONAVIR

Dosage:

80MG

Pharmaceutical form:

SOLUTION

Composition:

RITONAVIR 80MG

Administration route:

ORAL

Units in package:

240ML(1BTLE)

Prescription type:

Prescription

Therapeutic area:

HIV PROTEASE INHIBITORS

Product summary:

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

Authorization status:

CANCELLED POST MARKET

Authorization date:

2019-03-31

Summary of Product characteristics

_ _
_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