OZANEX CREAM

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

OZENOXACIN

Available from:

FERRER INTERNACIONAL, S.A.

ATC code:

D06AX14

INN (International Name):

OZENOXACIN

Dosage:

1%

Pharmaceutical form:

CREAM

Composition:

OZENOXACIN 1%

Administration route:

TOPICAL

Units in package:

10G

Prescription type:

Prescription

Therapeutic area:

ANTIBIOTICS

Product summary:

Active ingredient group (AIG) number: 0159010001; AHFS:

Authorization status:

APPROVED

Authorization date:

2017-05-01

Summary of Product characteristics

_OZANEX™ (ozenoxacin) Product Monograph _
_Page 1 of 24_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
OZANEX™
ozenoxacin cream 1% w/w
Topical Antibiotic
MANUFACTURER:
Ferrer Internacional, S.A.
Date of Preparation:
May 1, 2017
Gran Via Carlos III, 94
08028 - Barcelona
Spain
IMPORTED AND DISTRIBUTED BY:
Cipher Pharmaceuticals Inc.
2345 Argentia Road, Suite 100A
Mississauga, Ontario
L5N 8K4
Submission Control No: 192925
_ _
_OZANEX™ (ozenoxacin) Product Monograph _
_Page 2 of 24_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................5
DRUG INTERACTIONS
....................................................................................................6
DOSAGE AND ADMINISTRATION
................................................................................6
OVERDOSAGE
..................................................................................................................7
ACTION AND CLINICAL PHARMACOLOGY
..............................................................7
STORAGE AND STABILITY
............................................................................................8
DOSAGE FORMS, COMPOSITION AND PACKAGING
...............................................8
PART II: SCIENTIFIC INFORMATION
.................................................................................9
PHARMACEUTICAL INFORMATION
............................................................................9
CLINICAL TRIALS
..................................................................................