NORITATE CREAM

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

METRONIDAZOLE

Available from:

BAUSCH HEALTH, CANADA INC.

ATC code:

D06BX01

INN (International Name):

METRONIDAZOLE

Dosage:

1%

Pharmaceutical form:

CREAM

Composition:

METRONIDAZOLE 1%

Administration route:

TOPICAL

Units in package:

45G

Prescription type:

Prescription

Therapeutic area:

ANTIBIOTICS

Product summary:

Active ingredient group (AIG) number: 0102572009; AHFS:

Authorization status:

APPROVED

Authorization date:

2002-02-04

Summary of Product characteristics

_Pr_
_NORITATE _
_®_
_ Metronidazole Cream Product Monograph Page 1 of 20_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
NORITATE
®
Metronidazole
Cream 1% w/w, topical
Anti-Rosacea Agent
Bausch Health, Canada Inc.
2150 St-Elzear Blvd. West
Laval, Quebec
H7L 4A8
Date of Initial Authorization:
July 7, 1995
Date of Revision:
June 27, 2022
Submission Control Number: 260705
_ _
_Pr_
_NORITATE _
_®_
_ Metronidazole Cream Product Monograph Page 2 of 20_
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT
LISTED.
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
.............................................................................
4
4.1
Dosing Considerations
.......................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
................................................... 4
4.5
Missed
Dose......................................................................................................
5
5
OVERDOSAGE
..........................................................................................................
5
6
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
....................... 5
7
WARNINGS AND PRECAUTIONS
.............................................................................