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 v2-FR | Version v2-FR | |
|---|---|---|
| Language | French | French |
| Date Updated | 2023-07-04 | 2023-07-04 |
| Drug Identification Number | 00701785 | 00701785 |
| Brand name | OPTIMYXIN | OPTIMYXIN |
| Common or Proper name | Gramicidin and Polymyxin B Sulfate Oto-Ophthalmic Solution | Gramicidin and Polymyxin B Sulfate Oto-Ophthalmic Solution |
| Company Name | EURO-PHARM INTERNATIONAL CANADA INC | EURO-PHARM INTERNATIONAL CANADA INC |
| Ingredients | GRAMICIDIN POLYMYXIN B | GRAMICIDIN POLYMYXIN B |
| Strength(s) | 0.025MG 10000UNIT | 0.025MG 10000UNIT |
| Dosage form(s) | DROPS | DROPS |
| Route of administration | OTIC OPHTHALMIC OTIC OPHTHALMIC | OTIC OPHTHALMIC OTIC OPHTHALMIC |
| Packaging size | 10 mL | 10 mL |
| ATC code | S03AA | S03AA |
| ATC description | ANTIINFECTIVES | ANTIINFECTIVES |
| Reason for shortage | Other (Please describe in comments) | Other (Please describe in comments) |
| Anticipated start date | 2021-12-31 | 2021-12-31 |
| Actual start date | 2022-01-01 | 2022-01-01 |
| Estimated end date | 2025-07-01 | 2025-07-01 |
| Actual end date | ||
| Shortage status | Actual shortage | Actual shortage |
| Tier 3 Status | No | No |
| Company comments | Reason for shortage: Transfer of manufacturing site. The new manufacturing site which was in process of approval by Health Canada from 2021 to 2022, has received FDA warning letter in 2022, which forced Euro-Pharm to look actively for new manufacturing sites. The estimated end date depends on approval timelines for the manufacturing site transfer. | Reason for shortage: Transfer of manufacturing site. The new manufacturing site which was in process of approval by Health Canada from 2021 to 2022, has received FDA warning letter in 2022, which forced Euro-Pharm to look actively for new manufacturing sites. The estimated end date depends on approval timelines for the manufacturing site transfer. |
| Health Canada comments |