IBRANCE DIN 02453177
Health Canada record
| Active ingredient(s) | PALBOCICLIB 125 MG |
|---|---|
| Dosage form | Capsule |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | L01EF01 PALBOCICLIB |
| Original market date | 19-Apr-2016 |
| Current status date | 06-Jun-2024 |
| Source | Health Canada DPD |
Establishment licence of the holder
Pfizer Canada ULC — licence 100255, currently licensed, last inspection rating C (2023-08-07).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing PALBOCICLIB
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02493535 | IBRANCE | PFIZER CANADA ULC | Tablet | PALBOCICLIB 75 MG | Marketed |
| 02493543 | IBRANCE | PFIZER CANADA ULC | Tablet | PALBOCICLIB 100 MG | Marketed |
| 02493551 | IBRANCE | PFIZER CANADA ULC | Tablet | PALBOCICLIB 125 MG | Marketed |
| 02570149 | NAT-PALBOCICLIB | NATCO PHARMA (CANADA) INC | Tablet | PALBOCICLIB 100 MG | Approved |
| 02570130 | NAT-PALBOCICLIB | NATCO PHARMA (CANADA) INC | Tablet | PALBOCICLIB 75 MG | Approved |
| 02570157 | NAT-PALBOCICLIB | NATCO PHARMA (CANADA) INC | Tablet | PALBOCICLIB 125 MG | Approved |
| 02552124 | PMS-PALBOCICLIB | PHARMASCIENCE INC | Tablet | PALBOCICLIB 75 MG | Marketed |
| 02552140 | PMS-PALBOCICLIB | PHARMASCIENCE INC | Tablet | PALBOCICLIB 125 MG | Marketed |
| 02552132 | PMS-PALBOCICLIB | PHARMASCIENCE INC | Tablet | PALBOCICLIB 100 MG | Marketed |
| 02547651 | TARO-PALBOCICLIB | TARO PHARMACEUTICALS INC | Tablet | PALBOCICLIB 125 MG | Marketed |
| 02547635 | TARO-PALBOCICLIB | TARO PHARMACEUTICALS INC | Tablet | PALBOCICLIB 75 MG | Marketed |
| 02547643 | TARO-PALBOCICLIB | TARO PHARMACEUTICALS INC | Tablet | PALBOCICLIB 100 MG | Marketed |
| 02453150 | IBRANCE | PFIZER CANADA ULC | Capsule | PALBOCICLIB 75 MG | Cancelled Post Market |
| 02453169 | IBRANCE | PFIZER CANADA ULC | Capsule | PALBOCICLIB 100 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 17885 | 2016-03-16 | New Drug Submission (NDS) |
International API supply for PALBOCICLIB
26 active FDA Drug Master Files.
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