MILEY 28 DIN 02556561
Health Canada record
| Active ingredient(s) | DESOGESTREL 0.15 MG; ETHINYL ESTRADIOL 0.03 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | G03AA09 DESOGESTREL AND ESTROGEN |
| Original market date | 18-Aug-2025 |
| Current status date | 18-Aug-2025 |
| Source | Health Canada DPD |
Establishment licence of the holder
Ambicare Pharmaceuticals Inc — licence 3-002607, currently licensed, last inspection rating C (2025-08-13).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing DESOGESTREL
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02317192 | APRI 21 | TEVA CANADA LIMITED | Tablet | DESOGESTREL 0.15 MG; ETHINYL ESTRADIOL 0.03 MG | Marketed |
| 02317206 | APRI 28 | TEVA CANADA LIMITED | Tablet | DESOGESTREL 0.15 MG; ETHINYL ESTRADIOL 0.03 MG | Marketed |
| 02396491 | FREYA 21 | MYLAN PHARMACEUTICALS ULC | Tablet | DESOGESTREL 0.15 MG; ETHINYL ESTRADIOL 0.03 MG | Marketed |
| 02396610 | FREYA 28 | MYLAN PHARMACEUTICALS ULC | Tablet | DESOGESTREL 0.15 MG; ETHINYL ESTRADIOL 0.03 MG | Marketed |
| 02272903 | LINESSA 21 | ASPEN PHARMACARE CANADA INC. | Tablet | DESOGESTREL 0.1 MG; ETHINYL ESTRADIOL 0.025 MG; DESOGESTREL 0.125 MG; ETHINYL ESTRADIOL 0.025 MG; DESOGESTREL 0.15 MG; ETHINYL ESTRADIOL 0.025 MG | Marketed |
| 02257238 | LINESSA 28 | ASPEN PHARMACARE CANADA INC. | Tablet | DESOGESTREL 0.1 MG; ETHINYL ESTRADIOL 0.025 MG; DESOGESTREL 0.125 MG; ETHINYL ESTRADIOL 0.025 MG; DESOGESTREL 0.15 MG; ETHINYL ESTRADIOL 0.025 MG | Marketed |
| 02042487 | MARVELON 21 | ORGANON CANADA INC. | Tablet | DESOGESTREL 0.15 MG; ETHINYL ESTRADIOL 0.03 MG | Marketed |
| 02042479 | MARVELON 28 | ORGANON CANADA INC. | Tablet | DESOGESTREL 0.15 MG; ETHINYL ESTRADIOL 0.03 MG | Marketed |
| 02556553 | MILEY 21 | AMBICARE PHARMACEUTICALS INC. | Tablet | DESOGESTREL 0.15 MG; ETHINYL ESTRADIOL 0.03 MG | Marketed |
| 02410249 | MIRVALA 21 | APOTEX INC | Tablet | DESOGESTREL 0.1500 MG; ETHINYL ESTRADIOL 0.0300 MG | Marketed |
| 02410257 | MIRVALA 28 | APOTEX INC | Tablet | DESOGESTREL 0.1500 MG; ETHINYL ESTRADIOL 0.0300 MG | Marketed |
| 02328828 | MARFEM 21 | NOVOPHARM LIMITED | Tablet | DESOGESTREL 0.15 MG; ETHINYL ESTRADIOL 0.03 MG | Cancelled Pre Market |
| 02328836 | MARFEM 28 | NOVOPHARM LIMITED | Tablet | DESOGESTREL 0.15 MG; ETHINYL ESTRADIOL 0.03 MG | Cancelled Pre Market |
| 02042533 | ORTHO-CEPT TABLETS (28 DAY) | JANSSEN INC | Tablet | DESOGESTREL 0.15 MG; ETHINYL ESTRADIOL 0.03 MG | Cancelled Post Market |
| 02420813 | RECLIPSEN 21 | ACTAVIS PHARMA COMPANY | Tablet | DESOGESTREL 0.15 MG; ETHINYL ESTRADIOL 0.03 MG | Cancelled Post Market |
| 02417464 | RECLIPSEN 28 | ACTAVIS PHARMA COMPANY | Tablet | DESOGESTREL 0.15 MG; ETHINYL ESTRADIOL 0.03 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 35047 | 2025-03-21 | Abbreviated New Drug Submission (ANDS) |
International API supply for DESOGESTREL
5 valid EDQM Certificates of Suitability from 5 holders. 8 active FDA Drug Master Files.
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