Discontinuation report LUTREPULSE PWS 0.8MG/VIAL
| Report ID | 246470 |
| Drug Identification Number | 02046210 |
| Brand name | LUTREPULSE PWS 0.8MG/VIAL |
| Common or Proper name | Gonadorelin Acetate |
| Company Name | FERRING INC |
| Market Status | MARKETED |
| Active Ingredient(s) | GONADORELIN ACETATE |
| Strength(s) | 0.8MG |
| Dosage form(s) | POWDER FOR SOLUTION |
| Route of administration | SUBCUTANEOUS INTRAVENOUS SUBCUTANEOUS INTRAVENOUS |
|
Packaging sizes (GTIN)
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| Additional packaging sizes | 10mL vial |
| ATC code | H01CA |
| ATC description | HYPOTHALAMIC HORMONES |
| Reason for discontinuation | Manufacturing issues |
| Anticipated discontinuation date | |
| Actual discontinuation date | 2024-11-26 |
| Remaining supply date | |
| Discontinuation status | Discontinued |
| Discontinuation decision reversal | No |
| Information on remaining supply | All global remaining supply has expired. |
| Company comments | Lutrapulse 0.8mg is no longer available worldwide beyond June 30, 2024 due to expiry dating of existing supply. No new product will be manufactured or is available due to manufacturing line decommissioning. |
| Health Canada comments | |
| Tier 3 Status | No |
| Contact Address | 200 YORKLAND BLVD TORONTO, ONTARIO CANADA M2J 5C1 |
| Company contact information | 1-800-263-4057 |
Version History
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| Version Number | Date Updated | Language | |
|---|---|---|---|
| v2 | 2024-12-24 | French | Compare |
| v1 | 2024-12-24 | English | Compare |
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