AFINITOR DIN 02339501
Health Canada record
| Active ingredient(s) | EVEROLIMUS 5 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | L04AH02 EVEROLIMUS |
| Original market date | 15-Mar-2010 |
| Current status date | 15-Mar-2010 |
| Source | Health Canada DPD |
Establishment licence of the holder
Novartis Pharmaceuticals Canada Inc — licence 100273, currently licensed, last inspection rating C (2025-01-14).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing EVEROLIMUS
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02339528 | AFINITOR | NOVARTIS PHARMACEUTICALS CANADA INC | Tablet | EVEROLIMUS 10 MG | Marketed |
| 02369257 | AFINITOR | NOVARTIS PHARMACEUTICALS CANADA INC | Tablet | EVEROLIMUS 2.5 MG | Marketed |
| 02425661 | AFINITOR DISPERZ | NOVARTIS PHARMACEUTICALS CANADA INC | Tablet For Suspension | EVEROLIMUS 5 MG | Marketed |
| 02425645 | AFINITOR DISPERZ | NOVARTIS PHARMACEUTICALS CANADA INC | Tablet For Suspension | EVEROLIMUS 2 MG | Marketed |
| 02425653 | AFINITOR DISPERZ | NOVARTIS PHARMACEUTICALS CANADA INC | Tablet For Suspension | EVEROLIMUS 3 MG | Marketed |
| 02375907 | CERTICAN | NOVARTIS PHARMACEUTICALS CANADA INC | Tablet | EVEROLIMUS 0.25 MG | Approved |
| 02375915 | CERTICAN | NOVARTIS PHARMACEUTICALS CANADA INC | Tablet | EVEROLIMUS 0.5 MG | Approved |
| 02375923 | CERTICAN | NOVARTIS PHARMACEUTICALS CANADA INC | Tablet | EVEROLIMUS 0.75 MG | Approved |
| 02530104 | NAT-EVEROLIMUS | NATCO PHARMA (CANADA) INC | Tablet | EVEROLIMUS 5 MG | Marketed |
| 02530120 | NAT-EVEROLIMUS | NATCO PHARMA (CANADA) INC | Tablet | EVEROLIMUS 10 MG | Marketed |
| 02530112 | NAT-EVEROLIMUS | NATCO PHARMA (CANADA) INC | Tablet | EVEROLIMUS 7.5 MG | Approved |
| 02530090 | NAT-EVEROLIMUS | NATCO PHARMA (CANADA) INC | Tablet | EVEROLIMUS 2.5 MG | Marketed |
| 02504685 | PMS-EVEROLIMUS | PHARMASCIENCE INC | Tablet | EVEROLIMUS 5 MG | Marketed |
| 02504693 | PMS-EVEROLIMUS | PHARMASCIENCE INC | Tablet | EVEROLIMUS 10 MG | Marketed |
| 02504677 | PMS-EVEROLIMUS | PHARMASCIENCE INC | Tablet | EVEROLIMUS 2.5 MG | Marketed |
| 02532433 | REDDY-EVEROLIMUS | DR REDDY'S LABORATORIES LTD | Tablet | EVEROLIMUS 10 MG | Marketed |
| 02532409 | REDDY-EVEROLIMUS | DR REDDY'S LABORATORIES LTD | Tablet | EVEROLIMUS 2.5 MG | Marketed |
| 02532417 | REDDY-EVEROLIMUS | DR REDDY'S LABORATORIES LTD | Tablet | EVEROLIMUS 5 MG | Marketed |
| 02532425 | REDDY-EVEROLIMUS | DR REDDY'S LABORATORIES LTD | Tablet | EVEROLIMUS 7.5 MG | Approved |
| 02492911 | SANDOZ EVEROLIMUS | SANDOZ CANADA INCORPORATED | Tablet | EVEROLIMUS 2.5 MG | Marketed |
| 02492938 | SANDOZ EVEROLIMUS | SANDOZ CANADA INCORPORATED | Tablet | EVEROLIMUS 5 MG | Marketed |
| 02492946 | SANDOZ EVEROLIMUS | SANDOZ CANADA INCORPORATED | Tablet | EVEROLIMUS 10 MG | Marketed |
| 02463253 | TEVA-EVEROLIMUS | TEVA CANADA LIMITED | Tablet | EVEROLIMUS 10 MG | Marketed |
| 02463237 | TEVA-EVEROLIMUS | TEVA CANADA LIMITED | Tablet | EVEROLIMUS 5 MG | Marketed |
| 02463229 | TEVA-EVEROLIMUS | TEVA CANADA LIMITED | Tablet | EVEROLIMUS 2.5 MG | Marketed |
| 02450267 | AFINITOR | NOVARTIS PHARMACEUTICALS CANADA INC | Tablet | EVEROLIMUS 7.5 MG | Cancelled Post Market |
| 02463245 | TEVA-EVEROLIMUS | TEVA CANADA LIMITED | Tablet | EVEROLIMUS 7.5 MG | Cancelled Pre Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 10860 | 2009-12-14 | New Drug Submission (NDS) |
International API supply for EVEROLIMUS
1 valid EDQM Certificates of Suitability from 1 holders. 20 active FDA Drug Master Files.
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