FULVESTRANT INJECTION DIN 02486792
Health Canada record
| Active ingredient(s) | FULVESTRANT 50 MG |
|---|---|
| Dosage form | Solution |
| Route | Intramuscular |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | L02BA03 FULVESTRANT |
| Original market date | 02-Mar-2022 |
| Current status date | 01-Nov-2024 |
| Source | Health Canada DPD |
Establishment licence of the holder
Accord Healthcare Inc. — licence 101566, currently licensed, last inspection rating C (2024-11-26).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing FULVESTRANT
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02486350 | APO-FULVESTRANT | APOTEX INC | Solution | FULVESTRANT 250 MG | Approved |
| 02248624 | FASLODEX | ASTRAZENECA CANADA INC | Solution | FULVESTRANT 250 MG | Marketed |
| 02530635 | FULVESTRANT INJECTABLE | JAMP PHARMA CORPORATION | Solution | FULVESTRANT 250 MG | Marketed |
| 02483610 | FULVESTRANT INJECTION | SANDOZ CANADA INCORPORATED | Solution | FULVESTRANT 250 MG | Marketed |
| 02558971 | FULVESTRANT INJECTION | STERIMAX INC | Solution | FULVESTRANT 250 MG | Marketed |
| 02533111 | FULVESTRANT INJECTION | AURO PHARMA INC | Solution | FULVESTRANT 250 MG | Approved |
| 02536293 | FULVESTRANT INJECTION | FORMATIVE PHARMA INC. | Solution | FULVESTRANT 250 MG | Marketed |
| 02536668 | FULVESTRANT INJECTION | EUGIA PHARMA INC. | Solution | FULVESTRANT 250 MG | Approved |
| 02460130 | TEVA-FULVESTRANT INJECTION | TEVA CANADA LIMITED | Solution | FULVESTRANT 250 MG | Marketed |
| 02463075 | ACT FULVESTRANT | ACTAVIS PHARMA COMPANY | Solution | FULVESTRANT 50 MG | Cancelled Pre Market |
| 02468549 | FULVESTRANT INJECTION | MYLAN PHARMACEUTICALS ULC | Solution | FULVESTRANT 50 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 22277 | 2019-06-13 | Abbreviated New Drug Submission (ANDS) |
International API supply for FULVESTRANT
8 valid EDQM Certificates of Suitability from 8 holders. 15 active FDA Drug Master Files.
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