ACTIFEMME DIN 02568829
Status: Approved
Holder: ORB PHARMA- DIVISION OF ODAN LABORATORIES LTD.
Molecule: ESTRADIOL HEMIHYDRATE
Health Canada record
| Active ingredient(s) | ESTRADIOL HEMIHYDRATE 1 MG; NORETHINDRONE ACETATE 0.5 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | G03FA01 NORETHISTERONE AND ESTROGEN |
| Original market date | |
| Current status date | 05-Jun-2026 |
| Source | Health Canada DPD |
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing ESTRADIOL HEMIHYDRATE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02563177 | ESTRADIOL AND NORETHINDRONE ACETATE TABLETS | NOVAST LABORATORIES LTD. | Tablet | ESTRADIOL HEMIHYDRATE 1 MG; NORETHINDRONE ACETATE 0.5 MG | Approved |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 37667 | 2026-06-05 | Abbreviated New Drug Submission (ANDS) | Administrative: Licensing Agreement between two manufacturers |
International API supply for ESTRADIOL HEMIHYDRATE
8 valid EDQM Certificates of Suitability from 8 holders. 6 active FDA Drug Master Files.
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