Drug Report History
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 v14-EN | Version v3-EN | |
|---|---|---|
| Language | English | English |
| Date Updated | 2021-05-12 | 2021-05-10 |
| Drug Identification Number | 02230697 | 02230697 |
| Brand name | HYPERTET S/D | HYPERTET S/D |
| Common or Proper name | TETANUS IMMUNOGLOBULIN (HUMAN), SOLVENT DETERGENT TREATED | TETANUS IMMUNOGLOBULIN (HUMAN), SOLVENT DETERGENT TREATED |
| Company Name | GRIFOLS THERAPEUTICS LLC | GRIFOLS THERAPEUTICS LLC |
| Ingredients | TETANUS IMMUNOGLOBULIN | TETANUS IMMUNOGLOBULIN |
| Strength(s) | 250UNIT | 250UNIT |
| Dosage form(s) | SOLUTION | SOLUTION |
| Route of administration | INTRAMUSCULAR INTRAMUSCULAR | INTRAMUSCULAR INTRAMUSCULAR |
| Packaging size | 250 IU Syringe | 250 IU Syringe |
| ATC code | J06BB | J06BB |
| ATC description | IMMUNOGLOBULINS | IMMUNOGLOBULINS |
| Reason for shortage | Other (Please describe in comments) | Other (Please describe in comments) |
| Anticipated start date | 2021-05-11 | 2021-05-11 |
| Actual start date | ||
| Estimated end date | 2021-05-12 | 2021-05-12 |
| Actual end date | 2021-05-11 | |
| Shortage status | Resolved | Anticipated shortage |
| Tier 3 Status | No | No |
| Company comments | To ensure continuous supply while Grifols implements a planned manufacturing process update for this product, Grifols has received authorization from Health Canada to distribute HyperTET® S/D Lot No. T2MDE00023 that has a US label on its pre-filled syringe. | Grifols has received an exemption from Health Canada to distribute HyperTET® S/D Lot No. T2MDE00023 that has a US label on its pre-filled syringe, to ensure continuous supply while Grifols implements a planned manufacturing process update for this product . |
| Health Canada comments |