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-EN | Version v4-EN | |
|---|---|---|
| Language | English | English |
| Date Updated | 2022-10-03 | 2022-06-27 |
| Drug Identification Number | 02439387 | 02439387 |
| Brand name | ROPIVACAINE HYDROCHLORIDE INJECTION, USP | ROPIVACAINE HYDROCHLORIDE INJECTION, USP |
| Common or Proper name | Ropivacaine Hydrochloride Injection, USP 5 mg/mL Ampoule 10mL | Ropivacaine Hydrochloride Injection, USP 5 mg/mL Ampoule 10mL |
| Company Name | FRESENIUS KABI CANADA LTD | FRESENIUS KABI CANADA LTD |
| Ingredients | ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE |
| Strength(s) | 5MG | 5MG |
| Dosage form(s) | SOLUTION | SOLUTION |
| Route of administration | EPIDURAL BLOCK/INFILTRATION EPIDURAL BLOCK/INFILTRATION | EPIDURAL BLOCK/INFILTRATION EPIDURAL BLOCK/INFILTRATION |
| Packaging size | 10mL | 5 |
| ATC code | N01BB | N01BB |
| ATC description | ANESTHETICS, LOCAL | ANESTHETICS, LOCAL |
| Reason for shortage | Other (Please describe in comments) | Disruption of the manufacture of the drug. |
| Anticipated start date | 2022-04-01 | 2022-04-01 |
| Actual start date | 2022-04-01 | 2022-04-01 |
| Estimated end date | 2022-10-01 | 2022-07-22 |
| Actual end date | 2022-09-27 | |
| Shortage status | Resolved | Actual shortage |
| Tier 3 Status | No | No |
| Company comments | Fresenius Kabi Canada regrets to advise that due to unforeseen circumstances, we will be extending the backorder on our Ropivacaine Hydrochloride Injection, USP 5 mg/mL Ampoule 10 mL until October 1, 2022. | Backorder effective Apr. 1, 2022 until Jul. 1, 2022. Please note all available inventory of 5 mg/mL Ampoule 10mL expires March 31, 2022. |
| Health Canada comments |