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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:

2004-03-15

Original market date: See footnote 1

2004-03-15

Product name:

PROCTOL SUPPOSITORIES

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:

02247882

Product Monograph/Veterinary Labelling:

Date: 2019-01-31 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

ODAN LABORATORIES LTD
325 Stillview Avenue
Pointe-Claire
Quebec
Canada  H9R 2Y6

Class: 

Human

Dosage form(s):

Suppository

Route(s) of administration:

Rectal

Number of active ingredient(s):

4

Schedule(s):

Prescription  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

84:06.00   ANTI-INFLAMMATORY AGENTS

Anatomical Therapeutic Chemical (ATC): See footnote 4

C05AA01  HYDROCORTISONE

Active ingredient group (AIG) number:See footnote 5

0404592002

List of active ingredient(s)
Active ingredient(s) Strength
DIBUCAINE HYDROCHLORIDE 5 MG
ESCULIN 10 MG
FRAMYCETIN SULFATE 10 MG
HYDROCORTISONE 5 MG

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