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 v17-FR | Version v7-EN | |
---|---|---|
Language | French | English |
Date Updated | 2024-10-30 | 2024-07-09 |
Drug Identification Number | 02513579 | 02513579 |
Brand name | BIPAZEN | BIPAZEN |
Common or Proper name | Desmopressin Acetate Injection | Desmopressin Acetate Injection |
Company Name | KVR PHARMACEUTICALS INC. | KVR PHARMACEUTICALS INC. |
Ingredients | DESMOPRESSIN ACETATE | DESMOPRESSIN ACETATE |
Strength(s) | 4MCG | 4MCG |
Dosage form(s) | SOLUTION | SOLUTION |
Route of administration | SUBCUTANEOUS INTRAVENOUS INTRAMUSCULAR | SUBCUTANEOUS INTRAVENOUS INTRAMUSCULAR |
Packaging size | Cartons of 10 ampoules | Cartons of 10 ampoules |
ATC code | H01BA | H01BA |
ATC description | POSTERIOR PITUITARY LOBE HORMONES | POSTERIOR PITUITARY LOBE HORMONES |
Reason for shortage | Disruption of the manufacture of the drug. | Disruption of the manufacture of the drug. |
Anticipated start date | 2024-07-19 | 2024-07-19 |
Actual start date | ||
Estimated end date | 2024-11-26 | 2024-09-09 |
Actual end date | ||
Shortage status | Actual shortage | Anticipated shortage |
Tier 3 Status | No | No |
Company comments | Discovered a quality issue with the lot of glass ampoules to be used in the next production. A new lot of glass ampoules have been ordered for rush delivery. Upon arrival, a new Bipazen batch will be produced. | Discovered a quality issue with the lot of glass ampoules to be used in the next production. A new lot of glass ampoules have been ordered for rush delivery expected July 27. Upon arrival, a new batch will be produced. |
Health Canada comments |