EPCLUSA DIN 02456370
Health Canada record
| Active ingredient(s) | SOFOSBUVIR 400 MG; VELPATASVIR 100 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | J05AP55 SOFOSBUVIR AND VELPATASVIR |
| Original market date | 02-Aug-2016 |
| Current status date | 02-Aug-2016 |
| 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 |
|---|---|---|---|---|---|
| 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 |
| 02467542 | VOSEVI | GILEAD SCIENCES CANADA INC | Tablet | SOFOSBUVIR 400 MG; VELPATASVIR 100 MG; VOXILAPREVIR 100 MG | Marketed |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 18265 | 2016-07-11 | New Drug Submission (NDS) |
International API supply for SOFOSBUVIR
10 active FDA Drug Master Files.
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