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 v12-FR | Version v3-EN | |
|---|---|---|
| Language | French | English |
| Date Updated | 2023-11-17 | 2023-04-03 |
| Drug Identification Number | 02439409 | 02439409 |
| Brand name | ROPIVACAINE HYDROCHLORIDE INJECTION, USP | ROPIVACAINE HYDROCHLORIDE INJECTION, USP |
| Common or Proper name | ROPIVACAINE HYDROCHLORIDE INJECTION, USP | ROPIVACAINE HYDROCHLORIDE INJECTION, USP |
| Company Name | FRESENIUS KABI CANADA LTD | FRESENIUS KABI CANADA LTD |
| Ingredients | ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE |
| Strength(s) | 10MG | 10MG |
| Dosage form(s) | SOLUTION | SOLUTION |
| Route of administration | EPIDURAL EPIDURAL | EPIDURAL EPIDURAL |
| Packaging size | 20mL | 20mL |
| ATC code | N01BB | N01BB |
| ATC description | ANESTHETICS, LOCAL | ANESTHETICS, LOCAL |
| Reason for shortage | Disruption of the manufacture of the drug. | Disruption of the manufacture of the drug. |
| Anticipated start date | ||
| Actual start date | 2023-01-01 | 2023-01-01 |
| Estimated end date | 2023-11-15 | 2023-08-01 |
| Actual end date | 2023-10-25 | |
| Shortage status | Resolved | Actual shortage |
| Tier 3 Status | No | No |
| Company comments | We will be facing a supply interruption on our Ropivacaine Hydrochloride Injection, USP 10 mg/mL Ampoule 20 mL effective February 1, 2023 until November 15, 2023. | Product is on 100% allocation. We will be facing a supply interruption on our Ropivacaine Hydrochloride Injection, USP 10 mg/mL Ampoule 20 mL effective February 1, 2023 until August 1, 2023. During this time, allocations for our Ropivacaine Hydrochloride Injection, USP 10 mg/mL Ampoule 10 mL will be increased. Contract customers will be allocated 100% of historical 10 mL demand plus 100% of 20 mL demand at a 2:1 ratio (2 vials of 10 mL = 1 vial of 20 mL). |
| Health Canada comments |