REDDY-NILOTINIB DIN 02556626
Status: Approved
Holder: DR REDDY'S LABORATORIES LTD
Health Canada record
| Active ingredient(s) | NILOTINIB (NILOTINIB HYDROCHLORIDE MONOHYDRATE) 50 MG |
|---|---|
| Dosage form | Capsule |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | L01EA03 NILOTINIB |
| Original market date | |
| Current status date | 01-Apr-2025 |
| Source | Health Canada DPD |
Establishment licence of the holder
Dr Reddy's Laboratories (UK) Limited — licence , not currently licensed, last inspection rating C (2019-02-12).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing NILOTINIB (NILOTINIB HYDROCHLORIDE MONOHYDRATE)
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02550881 | APO-NILOTINIB | APOTEX INC | Capsule | NILOTINIB (NILOTINIB HYDROCHLORIDE MONOHYDRATE) 150 MG | Marketed |
| 02550903 | APO-NILOTINIB | APOTEX INC | Capsule | NILOTINIB (NILOTINIB HYDROCHLORIDE MONOHYDRATE) 200 MG | Marketed |
| 02556642 | REDDY-NILOTINIB | DR REDDY'S LABORATORIES LTD | Capsule | NILOTINIB (NILOTINIB HYDROCHLORIDE MONOHYDRATE) 200 MG | Marketed |
| 02556634 | REDDY-NILOTINIB | DR REDDY'S LABORATORIES LTD | Capsule | NILOTINIB (NILOTINIB HYDROCHLORIDE MONOHYDRATE) 150 MG | Marketed |
| 02315874 | TASIGNA | NOVARTIS PHARMACEUTICALS CANADA INC | Capsule | NILOTINIB (NILOTINIB HYDROCHLORIDE MONOHYDRATE) 200 MG | Marketed |
| 02368250 | TASIGNA | NOVARTIS PHARMACEUTICALS CANADA INC | Capsule | NILOTINIB (NILOTINIB HYDROCHLORIDE MONOHYDRATE) 150 MG | Marketed |
| 02481715 | TASIGNA | NOVARTIS PHARMACEUTICALS CANADA INC | Capsule | NILOTINIB (NILOTINIB HYDROCHLORIDE MONOHYDRATE) 50 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 35104 | 2025-04-01 | Abbreviated New Drug Submission (ANDS) |