AFINITOR DIN 02369257
Health Canada record
| Active ingredient(s) | EVEROLIMUS 2.5 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | L04AH02 EVEROLIMUS |
| Original market date | 05-Aug-2011 |
| Current status date | 05-Aug-2011 |
| 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 |
|---|---|---|---|---|---|
| 02339501 | AFINITOR | NOVARTIS PHARMACEUTICALS CANADA INC | Tablet | EVEROLIMUS 5 MG | Marketed |
| 02339528 | AFINITOR | NOVARTIS PHARMACEUTICALS CANADA INC | Tablet | EVEROLIMUS 10 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 |
|---|---|---|---|
| 12476 | 2011-06-30 | Supplement to a New Drug Submission (SNDS) | New indication: For the treatment of patients 3 years of age or older with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) that have demonstrated serial growth, who are not candidates for surgical resection and for whom immediate surgical intervention is not required, at a starting dose of 2.5mg, 5mg or 7.5mg once per day |
International API supply for EVEROLIMUS
1 valid EDQM Certificates of Suitability from 1 holders. 20 active FDA Drug Master Files.
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