Discontinuation report MYLAN-NITRO SUBLINGUAL SPRAY
| Report ID | 227338 |
| Drug Identification Number | 02243588 |
| Brand name | MYLAN-NITRO SUBLINGUAL SPRAY |
| Common or Proper name | NITROGLYCERIN |
| Company Name | MYLAN PHARMACEUTICALS ULC |
| Market Status | CANCELLED POST MARKET |
| Active Ingredient(s) | NITROGLYCERIN |
| Strength(s) | 0.4MG |
| Dosage form(s) | METERED-DOSE AEROSOL |
| Route of administration | SUBLINGUAL SUBLINGUAL |
| Packaging size | 1BT |
| ATC code | C01DA |
| ATC description | VASODILATORS USED IN CARDIAC DISEASES |
| Reason for discontinuation | Manufacturing issues |
| Anticipated discontinuation date | |
| Actual discontinuation date | 2024-05-01 |
| Remaining supply date | 2024-05-01 |
| Discontinuation status | Discontinued |
| Discontinuation decision reversal | No |
| Information on remaining supply | Discontinued 2024-05-01-The last lots and expiry dates are 0F904/30-Jun-2023 and 0G910/31-Jul-2023 - Reported in shortage ID 181369 |
| Company comments | |
| Health Canada comments | |
| Tier 3 Status | No |
| Contact Address | 85 ADVANCE ROAD ETOBICOKE, ONTARIO CANADA M8Z 2S6 |
| Company contact information | Mylan Pharmaceuticals ULC, 85 Advance Road, Etobicoke, ON, M8Z 2S6 |
Version History
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| Version Number | Date Updated | Language | |
|---|---|---|---|
| v2 | 2024-05-08 | French | Compare |
| v1 | 2024-05-08 | English | Compare |
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