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 v8-EN | |
|---|---|---|
| Language | English | English |
| Date Updated | 2019-03-27 | 2019-03-27 |
| Drug Identification Number | 02247208 | 02247208 |
| Brand name | DUKORAL | DUKORAL |
| Common or Proper name | Oral, Inactivated Cholera and ETEC Diarrhea Vaccine | Oral, Inactivated Cholera and ETEC Diarrhea Vaccine |
| Company Name | VALNEVA SWEDEN AB | VALNEVA SWEDEN AB |
| Ingredients | VIBRIO CHOLERAE INABA 6973 E1 TOR BIOTYPE, FORMALIN INACTIVATED VIBRIO CHOLERAE INABA 48 CLASSICAL BIOTYPE, HEAT INACTIVATED VIBRIO CHOLERAE OGAWA 50 CLASSICAL BIOTYPE, HEAT INACTIVATED VIBRIO CHOLERAE OGAWA 50 CLASSICAL BIOTYPE, FORMALIN INACTIVATED RECOMBINANT CHOLERA TOXIN B SUBUNIT | VIBRIO CHOLERAE INABA 6973 E1 TOR BIOTYPE, FORMALIN INACTIVATED VIBRIO CHOLERAE INABA 48 CLASSICAL BIOTYPE, HEAT INACTIVATED VIBRIO CHOLERAE OGAWA 50 CLASSICAL BIOTYPE, HEAT INACTIVATED VIBRIO CHOLERAE OGAWA 50 CLASSICAL BIOTYPE, FORMALIN INACTIVATED RECOMBINANT CHOLERA TOXIN B SUBUNIT |
| Strength(s) | 25000000000UNIT 25000000000UNIT 25000000000UNIT 25000000000UNIT 1MG | 25000000000UNIT 25000000000UNIT 25000000000UNIT 25000000000UNIT 1MG |
| Dosage form(s) | SUSPENSION | SUSPENSION |
| Route of administration | ORAL | ORAL |
| Packaging size | Box of 1 single-dose vial of vaccine and 1 sachet (5.6 g) sodium hydrogen carbonate | Box of 1 single-dose vial of vaccine and 1 sachet (5.6 g) sodium hydrogen carbonate |
| ATC code | J07AE | J07AE |
| ATC description | BACTERIAL VACCINES | BACTERIAL VACCINES |
| Reason for shortage | Delay in shipping of the drug. | Delay in shipping of the drug. |
| Anticipated start date | 2019-02-19 | 2019-02-19 |
| Actual start date | ||
| Estimated end date | 2019-03-13 | 2019-03-13 |
| Actual end date | 2019-03-26 | 2019-03-26 |
| Shortage status | Resolved | Resolved |
| Tier 3 Status | No | No |
| Company comments | Dukoral boxes of 1 single-dose vial are currently on allocation; some deliveries may be delayed. Potential Shortage has ended (March 26, 2019). | Dukoral boxes of 1 single-dose vial are currently on allocation; some deliveries may be delayed. Potential Shortage has ended (March 26, 2019). |
| Health Canada comments |