Product information

From Health Canada

No match found

No other product was found with the same active ingredient group.

The product monograph is developed by a drug sponsor according to guidelines published by Health Canada that provide direction on the content and format. The veterinary labelling is developed by the drug sponsor according to the Food and Drug Regulations. While Health Canada reviews the product monograph or the veterinary labelling as part of the drug review process, it remains the responsibility of the drug sponsor to ensure that the product monograph or the veterinary labelling is complete and accurate.

Current status:

Marketed

Current status date:

2023-01-25

Original market date: See footnote 1

2017-05-08

Product name:

OTIXAL

Description:

SINGLE-USE VIALS

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

DIN:

02459655

Product Monograph/Veterinary Labelling:

Date: 2023-01-23 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

MEDEXUS PHARMACEUTICALS INC.
35 Nixon Road, Unit 10
Bolton
Ontario
Canada L7E 1K1

Class:

Human

Dosage form(s):

Solution

Route(s) of administration:

Otic

Number of active ingredient(s):

2

Schedule(s):

Prescription

 

American Hospital Formulary Service (AHFS): See footnote 3

08:12.18  ,  52:04.04  ,  52:08.08 

Anatomical Therapeutic Chemical (ATC): See footnote 4

S02CA05 FLUOCINOLONE ACETONIDE AND ANTIINFECTIVES

Active ingredient group (AIG) number:See footnote5

0258670001

List of active ingredient(s)
Active ingredient(s) See footnote8 Strength
CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) 0.3 % / W/V
FLUOCINOLONE ACETONIDE 0.025 % / W/V
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