Drug Report History

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Below you will find the report version history. When a report is updated, a new version of the report is created. The report history allows you to see the changes between versions. You can select two versions of the report to compare. The fields that were changed between versions will be highlighted in yellow.

The translation of reports creates two separate versions which is why some reports may not seem to have any differences. In this case, only the language field below will be highlighted in yellow.

Version v4-EN Version v2-FR
Language English French
Date Updated 2025-03-28 2025-03-11
Drug Identification Number 02435136 02435136
Brand name SYLVANT SYLVANT
Common or Proper name SYLVANT SYLVANT
Company Name RECORDATI RARE DISEASES CANADA INC RECORDATI RARE DISEASES CANADA INC
Ingredients SILTUXIMAB SILTUXIMAB
Strength(s) 400MG 400MG
Dosage form(s) POWDER FOR SOLUTION POWDER FOR SOLUTION
Route of administration INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS
Packaging sizes (GTIN) (See additional packaging sizes) (See additional packaging sizes)
Additional packaging sizes 1 X 30 ML vial 1 X 30 ML vial
ATC code L04AC L04AC
ATC description IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS
Reason for shortage Requirements related to complying with good manufacturing practices. Requirements related to complying with good manufacturing practices.
Anticipated start date
Actual start date 2025-03-06 2025-03-06
Estimated end date 2025-03-31 2025-03-31
Actual end date 2025-03-27
Shortage status Resolved Actual shortage
Tier 3 Status No No
Company comments 100 mg/vial strength is available for distribution and can be used in place of the 400 mg/vial until the stock is available. 100 mg/vial strength is available for distribution and can be used in place of the 400 mg/vial until the stock is available.
Health Canada comments