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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:

2021-11-01

Original market date: See footnote 1

2021-11-01

Product name:

PONVORY

Description:

INITIATION PACK (14 TABLET BLISTER PACK OF DIFFERENT STRENGTHS)

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:

02515474

Product Monograph/Veterinary Labelling:

Date: 2021-04-28 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

JANSSEN INC
19 Green Belt Drive
Toronto
Ontario
Canada  M3C 1L9

Class: 

Human

Dosage form(s):

Tablet

Route(s) of administration:

Oral

Number of active ingredient(s):

9

Schedule(s):

Prescription  

American Hospital Formulary Service (AHFS): See footnote 3

92:20.00   Immunomodulatory Agents

Anatomical Therapeutic Chemical (ATC): See footnote 4

L04AA  SELECTIVE IMMUNOSUPPRESSANTS

Active ingredient group (AIG) number:See footnote 5

0962868001

List of active ingredient(s)
Active ingredient(s) Strength
PONESIMOD 10 MG
PONESIMOD 2 MG
PONESIMOD 3 MG
PONESIMOD 4 MG
PONESIMOD 5 MG
PONESIMOD 6 MG
PONESIMOD 7 MG
PONESIMOD 8 MG
PONESIMOD 9 MG

Risk Management Plans See footnote 7

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

Pharmacovigilance/Monitoring Activity
Registry
Drug Utilisation Study (DUS)
Observational Studies

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