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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:

2016-07-13

Original market date: See footnote 1

1994-12-31

Product name:

ENTOCORT ENEMA

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:

02052431

Product Monograph/Veterinary Labelling:

Date: 2021-01-11 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

TILLOTTS PHARMA GMBH
Warmbacher Strasse 80
Rheinfelden
Baden-Wuerttemberg
Germany  79618

Class: 

Human

Dosage form(s):

Kit,  Enema,  Tablet

Route(s) of administration:

Rectal

Number of active ingredient(s):

2

Schedule(s):

Prescription  

American Hospital Formulary Service (AHFS): See footnote 3

84:06.00   ANTI-INFLAMMATORY AGENTS

Anatomical Therapeutic Chemical (ATC): See footnote 4

A07EA06  BUDESONIDE

Active ingredient group (AIG) number:See footnote 5

0224817001

List of active ingredient(s)
Active ingredient(s) Strength
BUDESONIDE 2.3 MG
SODIUM CHLORIDE 115 ML

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