ESBRIET DIN 02464500
Health Canada record
| Active ingredient(s) | PIRFENIDONE 801 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | L04AX05 PIRFENIDONE |
| Original market date | 26-Jul-2017 |
| Current status date | 26-Jul-2017 |
| Source | Health Canada DPD |
Establishment licence of the holder
Hoffmann-La Roche Limited — licence 100006, currently licensed, last inspection rating C (2024-06-25).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing PIRFENIDONE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02537761 | AURO-PIRFENIDONE | AURO PHARMA INC | Tablet | PIRFENIDONE 801 MG | Marketed |
| 02537753 | AURO-PIRFENIDONE | AURO PHARMA INC | Tablet | PIRFENIDONE 267 MG | Marketed |
| 02464489 | ESBRIET | HOFFMANN-LA ROCHE LIMITED | Tablet | PIRFENIDONE 267 MG | Marketed |
| 02509938 | JAMP PIRFENIDONE | JAMP PHARMA CORPORATION | Capsule | PIRFENIDONE 267 MG | Marketed |
| 02514710 | JAMP PIRFENIDONE | JAMP PHARMA CORPORATION | Tablet | PIRFENIDONE 801 MG | Marketed |
| 02514702 | JAMP PIRFENIDONE | JAMP PHARMA CORPORATION | Tablet | PIRFENIDONE 267 MG | Marketed |
| 02550652 | M-PIRFENIDONE | MANTRA PHARMA INC | Tablet | PIRFENIDONE 801 MG | Marketed |
| 02550644 | M-PIRFENIDONE | MANTRA PHARMA INC | Tablet | PIRFENIDONE 267 MG | Marketed |
| 02549255 | MAR-PIRFENIDONE | MARCAN PHARMACEUTICALS INC | Tablet | PIRFENIDONE 267 MG | Approved |
| 02549263 | MAR-PIRFENIDONE | MARCAN PHARMACEUTICALS INC | Tablet | PIRFENIDONE 801 MG | Approved |
| 02488833 | SANDOZ PIRFENIDONE CAPSULES | SANDOZ CANADA INCORPORATED | Capsule | PIRFENIDONE 267 MG | Marketed |
| 02488515 | SANDOZ PIRFENIDONE TABLETS | SANDOZ CANADA INCORPORATED | Tablet | PIRFENIDONE 801 MG | Marketed |
| 02488507 | SANDOZ PIRFENIDONE TABLETS | SANDOZ CANADA INCORPORATED | Tablet | PIRFENIDONE 267 MG | Marketed |
| 02393751 | ESBRIET | HOFFMANN-LA ROCHE LIMITED | Capsule | PIRFENIDONE 267 MG | Cancelled Post Market |
| 02531526 | PMS-PIRFENIDONE | PHARMASCIENCE INC | Tablet | PIRFENIDONE 267 MG | Dormant |
| 02531534 | PMS-PIRFENIDONE | PHARMASCIENCE INC | Tablet | PIRFENIDONE 801 MG | Dormant |
| 02497700 | TEVA-PIRFENIDONE | TEVA CANADA LIMITED | Tablet | PIRFENIDONE 801 MG | Cancelled Pre Market |
| 02497689 | TEVA-PIRFENIDONE | TEVA CANADA LIMITED | Tablet | PIRFENIDONE 267 MG | Cancelled Pre Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 19375 | 2017-06-02 | Supplement to a New Drug Submission (SNDS) | NEW DOSAGE FORM AND NEW MANUFACTURING AND TESTING SITES |
International API supply for PIRFENIDONE
20 valid EDQM Certificates of Suitability from 20 holders. 27 active FDA Drug Master Files.
Request a quote for ESBRIET