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Version v19-FR Version v7-EN
Language French English
Date Updated 2024-11-20 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 2024-12-09 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