MUSE DIN 02238595
Status: Cancelled Post Market
Holder: KNIGHT THERAPEUTICS INC.
Molecule: ALPROSTADIL
Available to quote
Health Canada record
| Active ingredient(s) | ALPROSTADIL 1000 MCG |
|---|---|
| Dosage form | Suppository |
| Route | Urethral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | G04BE01 ALPROSTADIL |
| Original market date | 24-Sep-1998 |
| Current status date | 20-May-2026 |
| Source | Health Canada DPD |
Establishment licence of the holder
Knight Therapeutics Inc. — licence 3-002350, currently licensed, last inspection rating C (2025-11-05).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing ALPROSTADIL
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02215756 | CAVERJECT STERILE POWDER | PFIZER CANADA ULC | Liquid; Kit; Powder For Solution | ALPROSTADIL 20 MCG | Marketed |
| 02215187 | CAVERJECT STERILE POWDER - PWS 23.2MCG/VIAL | PFIZER CANADA ULC | Powder For Solution | ALPROSTADIL 20 MCG | Marketed |
| 00559253 | PROSTIN VR STERILE SOLUTION | PFIZER CANADA ULC | Solution | ALPROSTADIL 500 MCG | Marketed |
| 02359421 | VITAROS | BGP PHARMA ULC | Cream | ALPROSTADIL 330 MCG | Approved |
| 02359413 | VITAROS | BGP PHARMA ULC | Cream | ALPROSTADIL 220 MCG | Approved |
| 02285282 | ALPROSTADIL INJECTION USP | ADVANCED DOSAGE FORMS INC. | Solution | ALPROSTADIL 500 MCG | Dormant |
| 02241680 | ALPROSTADIL INJECTION, USP | NOVOPHARM LIMITED | Liquid | ALPROSTADIL 500 MCG | Cancelled Post Market |
| 02215748 | CAVERJECT STERILE POWDER - KIT 11.9MCG /VIAL | PFIZER CANADA ULC | Powder For Solution; Liquid; Kit | ALPROSTADIL 11.9 MCG; WATER 99.1 % | Cancelled Post Market |
| 02215179 | CAVERJECT STERILE POWDER - PWS 11.9MCG/VIAL | PFIZER CANADA ULC | Powder For Solution | ALPROSTADIL 11.9 MCG | Cancelled Post Market |
| 02238594 | MUSE | KNIGHT THERAPEUTICS INC. | Suppository | ALPROSTADIL 500 MCG | Cancelled Post Market |
| 02238592 | MUSE | PALADIN PHARMA INC. | Suppository | ALPROSTADIL 125 MCG | Cancelled Pre Market |
| 02238593 | MUSE | KNIGHT THERAPEUTICS INC. | Suppository | ALPROSTADIL 250 MCG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 37530 | 2026-05-13 | New Drug Submission (NDS) | Administrative: Change in product ownership |
| 35329 | 2025-05-09 | New Drug Submission (NDS) | Update to package labels. Update to package insert. Administrative: Change in product ownership. Product Monograph reformatted to the Master Template |
| 10240 | 2009-06-05 | New Drug Submission (NDS) | Manufacturer name change |
| 7795 | 2006-03-02 | New Drug Submission (NDS) | MANUFACTURER NAME CHANGE |
| 1700 | 2001-01-09 | New Drug Submission (NDS) | MANUFACTURER NAME CHANGE |
| 2671 | 1998-08-13 | New Drug Submission (NDS) |
International API supply for ALPROSTADIL
2 valid EDQM Certificates of Suitability from 2 holders. 6 active FDA Drug Master Files.
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