Product information

From Health Canada

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:

Approved

Current status date:

2023-08-24

Product name:

JAMP ACITRETIN

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:

02540703

Product Monograph/Veterinary Labelling:

Date: 2023-08-21 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

JAMP PHARMA CORPORATION
1310 Rue Nobel
Boucherville
Quebec
Canada J4B 5H3

Class:

Human

Dosage form(s):

Capsule

Route(s) of administration:

Oral

Number of active ingredient(s):

1

Schedule(s):

Prescription

 

American Hospital Formulary Service (AHFS): See footnote 3

84:92.00 

Anatomical Therapeutic Chemical (ATC): See footnote 4

D05BB02 ACITRETIN

Active ingredient group (AIG) number:See footnote5

0122473001

List of active ingredient(s)
Active ingredient(s) See footnote8 Strength
ACITRETIN 25 MG

Risk Management Plans See footnote 7

A Risk Management Plan (RMP) for this product was submitted.

Additional Risk Minimization Measures
Healthcare Professional Education
Patient Consent
Patient Education
Version 4.0.3

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