SANDOZ ADAPALENE / BENZOYL PEROXIDE GEL

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ADAPALENE; BENZOYL PEROXIDE

Available from:

SANDOZ CANADA INCORPORATED

ATC code:

D10AD53

INN (International Name):

ADAPALENE, COMBINATIONS

Dosage:

0.1%; 2.5%

Pharmaceutical form:

GEL

Composition:

ADAPALENE 0.1%; BENZOYL PEROXIDE 2.5%

Administration route:

TOPICAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

KERATOLYTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0252888001; AHFS:

Authorization status:

APPROVED

Authorization date:

2019-09-09

Summary of Product characteristics

_SANDOZ ADAPALENE/BENZOYL PEROXIDE Product Monograph _
_Page 1 of 41_
PRODUCT MONOGRAPH
Pr
SANDOZ ADAPALENE/BENZOYL PEROXIDE
adapalene and benzoyl peroxide topical gel, 0.1%/2.5% w/w
Acne Therapy
SANDOZ CANADA INC.
110 rue de Lauzon
Boucherville, Québec J4B1E6
Date of Preparation:
September 5, 2019
Submission Control No: 230590
_SANDOZ ADAPALENE/BENZOYL PEROXIDE Product Monograph _
_Page 2 of 41_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................6
DRUG INTERACTIONS
..................................................................................................12
DOSAGE AND ADMINISTRATION
..............................................................................13
OVERDOSAGE
................................................................................................................13
ACTION AND CLINICAL PHARMACOLOGY
............................................................14
STORAGE AND STABILITY
..........................................................................................17
SPECIAL HANDLING INSTRUCTIONS
.......................................................................17
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................17
PART II: SCIENTIFIC INFORMATION
................................................................................18
PHARMACEUTICAL INFORMATION
.........................................................................