SANDOZ AFATINIB DIN 02512785
Status: Marketed
Holder: SANDOZ CANADA INCORPORATED
Molecule: AFATINIB (AFATINIB DIMALEATE)
Available to quote
Health Canada record
| Active ingredient(s) | AFATINIB (AFATINIB DIMALEATE) 30 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | L01EB03 AFATINIB |
| Original market date | 28-Oct-2024 |
| Current status date | 28-Oct-2024 |
| Source | Health Canada DPD |
Establishment licence of the holder
Sandoz Canada Incorporated — licence 101370, currently licensed, last inspection rating C (2025-02-25).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing AFATINIB (AFATINIB DIMALEATE)
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02415666 | GIOTRIF | BOEHRINGER INGELHEIM (CANADA) LTD LTEE | Tablet | AFATINIB (AFATINIB DIMALEATE) 20 MG | Marketed |
| 02415674 | GIOTRIF | BOEHRINGER INGELHEIM (CANADA) LTD LTEE | Tablet | AFATINIB (AFATINIB DIMALEATE) 30 MG | Marketed |
| 02415682 | GIOTRIF | BOEHRINGER INGELHEIM (CANADA) LTD LTEE | Tablet | AFATINIB (AFATINIB DIMALEATE) 40 MG | Marketed |
| 02517035 | MAR-AFATINIB | MARCAN PHARMACEUTICALS INC | Tablet | AFATINIB (AFATINIB DIMALEATE) 40 MG | Marketed |
| 02517019 | MAR-AFATINIB | MARCAN PHARMACEUTICALS INC | Tablet | AFATINIB (AFATINIB DIMALEATE) 20 MG | Marketed |
| 02517027 | MAR-AFATINIB | MARCAN PHARMACEUTICALS INC | Tablet | AFATINIB (AFATINIB DIMALEATE) 30 MG | Marketed |
| 02512777 | SANDOZ AFATINIB | SANDOZ CANADA INCORPORATED | Tablet | AFATINIB (AFATINIB DIMALEATE) 20 MG | Marketed |
| 02512793 | SANDOZ AFATINIB | SANDOZ CANADA INCORPORATED | Tablet | AFATINIB (AFATINIB DIMALEATE) 40 MG | Marketed |
| 02514605 | TEVA-AFATINIB | TEVA CANADA LIMITED | Tablet | AFATINIB (AFATINIB DIMALEATE) 30 MG | Cancelled Pre Market |
| 02514613 | TEVA-AFATINIB | TEVA CANADA LIMITED | Tablet | AFATINIB (AFATINIB DIMALEATE) 40 MG | Cancelled Pre Market |
| 02514591 | TEVA-AFATINIB | TEVA CANADA LIMITED | Tablet | AFATINIB (AFATINIB DIMALEATE) 20 MG | Cancelled Pre Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 34187 | 2024-10-11 | Abbreviated New Drug Submission (ANDS) |