APO-GEFITINIB DIN 02468050
Health Canada record
| Active ingredient(s) | GEFITINIB 250 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | L01EB01 GEFITINIB |
| Original market date | 18-Oct-2017 |
| Current status date | 18-Oct-2017 |
| Source | Health Canada DPD |
Establishment licence of the holder
Apotex Inc — licence 100375, currently licensed, last inspection rating C (2026-04-21).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing GEFITINIB
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02533685 | AURO-GEFITINIB | AURO PHARMA INC | Tablet | GEFITINIB 250 MG | Approved |
| 02547546 | EUGIA-GEFITINIB | EUGIA PHARMA INC. | Tablet | GEFITINIB 250 MG | Approved |
| 02248676 | IRESSA | ASTRAZENECA CANADA INC | Tablet | GEFITINIB 250 MG | Marketed |
| 02500663 | JAMP GEFITINIB | JAMP PHARMA CORPORATION | Tablet | GEFITINIB 250 MG | Marketed |
| 02491796 | NAT-GEFITINIB | NATCO PHARMA (CANADA) INC | Tablet | GEFITINIB 250 MG | Dormant |
| 02487748 | SANDOZ GEFITINIB | SANDOZ CANADA INCORPORATED | Tablet | GEFITINIB 250 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 19732 | 2017-08-31 | Abbreviated New Drug Submission (ANDS) |
International API supply for GEFITINIB
7 valid EDQM Certificates of Suitability from 7 holders. 14 active FDA Drug Master Files.
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