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 v8-EN | Version v7-FR | |
|---|---|---|
| Language | English | French |
| Date Updated | 2019-01-03 | 2019-01-02 |
| Drug Identification Number | 02350130 | 02350130 |
| Brand name | SAIZEN | SAIZEN |
| Common or Proper name | Somatropin | Somatropin |
| Company Name | EMD SERONO, A DIVISION OF EMD INC., CANADA | EMD SERONO, A DIVISION OF EMD INC., CANADA |
| Ingredients | SOMATROPIN | SOMATROPIN |
| Strength(s) | 8MG | 8MG |
| Dosage form(s) | SOLUTION | SOLUTION |
| Route of administration | SUBCUTANEOUS | SUBCUTANEOUS |
| Packaging size | I pre-filled cartridge / 1 cartouche préremplie, 12 mg (8.00 mg/mL) | I pre-filled cartridge / 1 cartouche préremplie, 12 mg (8.00 mg/mL) |
| ATC code | H01AC | H01AC |
| ATC description | ANTERIOR PITUITARY LOBE HORMONES AND ANALOGUES | ANTERIOR PITUITARY LOBE HORMONES AND ANALOGUES |
| Reason for shortage | Disruption of the manufacture of the drug. | Disruption of the manufacture of the drug. |
| Anticipated start date | 2018-11-26 | 2018-11-26 |
| Actual start date | 2018-11-26 | 2018-11-26 |
| Estimated end date | 2019-01-02 | 2019-01-02 |
| Actual end date | 2019-01-02 | 2019-01-02 |
| Shortage status | Resolved | Actual shortage |
| Tier 3 Status | No | No |
| Company comments | Please contact EMD Serono Customer Care for any questions at 1-800-387-9749. | Please contact EMD Serono Customer Care for any questions at 1-800-387-9749. |
| Health Canada comments |