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:

Marketed

Current status date:

2022-10-24

Original market date: See footnote 1

2021-08-04

Product name:

ILUMYA

Description:

SINGLE-DOSE PREFILLED SYRINGE

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:

02516098

Product Monograph/Veterinary Labelling:

Date: 2022-01-24 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

SUN PHARMACEUTICAL INDUSTRIES LIMITED
Sun House, Plot 201 B/1, Western Express Highway, Goregaon (E)
Mumbai
Maharashtra
India 400063

Class:

Human

Dosage form(s):

Solution

Route(s) of administration:

Subcutaneous

Number of active ingredient(s):

1

Schedule(s):

Schedule D ,  Prescription

 

American Hospital Formulary Service (AHFS): See footnote 3

84:92.00 

Anatomical Therapeutic Chemical (ATC): See footnote 4

L04AC17 TILDRAKIZUMAB

Active ingredient group (AIG) number:See footnote5

0162907001

List of active ingredient(s)
Active ingredient(s) Strength
TILDRAKIZUMAB 100 MG / ML

Risk Management Plans See footnote 7

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

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