ENTECAVIR DIN 02527162
Health Canada record
| Active ingredient(s) | ENTECAVIR 1 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | J05AF10 ENTECAVIR |
| Original market date | |
| Current status date | 06-May-2022 |
| Source | Health Canada DPD |
Establishment licence of the holder
Sanis Health Inc. — licence 101796, currently licensed, last inspection rating I (2024-07-23).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing ENTECAVIR
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02396955 | APO-ENTECAVIR | APOTEX INC | Tablet | ENTECAVIR 0.5 MG | Marketed |
| 02282224 | BARACLUDE | BRISTOL-MYERS SQUIBB CANADA | Tablet | ENTECAVIR 0.5 MG | Marketed |
| 02527154 | ENTECAVIR | SANIS HEALTH INC | Tablet | ENTECAVIR 0.5 MG | Marketed |
| 02430576 | PMS-ENTECAVIR | PHARMASCIENCE INC | Tablet | ENTECAVIR 0.5 MG | Marketed |
| 02430584 | PMS-ENTECAVIR | PHARMASCIENCE INC | Tablet | ENTECAVIR 1 MG | Marketed |
| 02418312 | SANDOZ ENTECAVIR | SANDOZ CANADA INCORPORATED | Tablet | ENTECAVIR 0.5 MG | Cancelled Pre Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 28107 | 2022-05-06 | Abbreviated New Drug Submission (ANDS) | Administrative: Licensing Agreement Between Two Companies |
International API supply for ENTECAVIR
14 active FDA Drug Master Files.
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