VOSEVI DIN 02467542
Health Canada record
| Active ingredient(s) | SOFOSBUVIR 400 MG; VELPATASVIR 100 MG; VOXILAPREVIR 100 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | J05AP56 SOFOSBUVIR, VELPATASVIR AND VOXILAPREVIR |
| Original market date | 18-Sep-2017 |
| Current status date | 18-Sep-2017 |
| Source | Health Canada DPD |
Establishment licence of the holder
Gilead Sciences Canada Inc — licence 101221, currently licensed, last inspection rating C (2022-09-20).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing SOFOSBUVIR
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02456370 | EPCLUSA | GILEAD SCIENCES CANADA INC | Tablet | SOFOSBUVIR 400 MG; VELPATASVIR 100 MG | Marketed |
| 02432226 | HARVONI | GILEAD SCIENCES CANADA INC | Tablet | SOFOSBUVIR 400 MG; LEDIPASVIR 90 MG | Marketed |
| 02418355 | SOVALDI | GILEAD SCIENCES CANADA INC | Tablet | SOFOSBUVIR 400 MG | Marketed |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 25927 | 2021-05-21 | Supplement to a New Drug Submission (SNDS) | To update the Adverse Reactions and Patient Medication Information sections of the Product Monograph with the postmarket adverse reaction of Stevens-Johnson Syndrome (SJS) |
| 19660 | 2017-08-16 | New Drug Submission (NDS) |
International API supply for SOFOSBUVIR
10 active FDA Drug Master Files.
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