ONE-ALPHA DIN 02240329
Health Canada record
| Active ingredient(s) | ALFACALCIDOL 2 MCG |
|---|---|
| Dosage form | Drops |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | A11CC03 ALFACALCIDOL |
| Original market date | 04-Dec-2000 |
| Current status date | 31-Jan-2022 |
| Source | Health Canada DPD |
Establishment licence of the holder
Cheplapharm Arzneimittel GmbH — licence , not currently licensed, last inspection rating C (2024-10-10).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing ALFACALCIDOL
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02523078 | ALFACALCIDOL CAPSULES | STRIDES PHARMA CANADA INC | Capsule | ALFACALCIDOL 1 MCG | Approved |
| 02523051 | ALFACALCIDOL CAPSULES | STRIDES PHARMA CANADA INC | Capsule | ALFACALCIDOL 0.25 MCG | Approved |
| 02242502 | ONE-ALPHA | CHEPLAPHARM ARZNEIMITTEL GMBH | Solution | ALFACALCIDOL 2 MCG | Marketed |
| 00474517 | ONE-ALPHA | CHEPLAPHARM ARZNEIMITTEL GMBH | Capsule | ALFACALCIDOL 0.25 MCG | Marketed |
| 00474525 | ONE-ALPHA | CHEPLAPHARM ARZNEIMITTEL GMBH | Capsule | ALFACALCIDOL 1 MCG | Marketed |
| 02533316 | SANDOZ ALFACALCIDOL | SANDOZ CANADA INCORPORATED | Capsule | ALFACALCIDOL 0.25 MCG | Marketed |
| 02533324 | SANDOZ ALFACALCIDOL | SANDOZ CANADA INCORPORATED | Capsule | ALFACALCIDOL 1 MCG | Marketed |
| 02239431 | ONE-ALPHA | LEO PHARMA INC | Capsule | ALFACALCIDOL 0.5 MCG | Cancelled Pre Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 27492 | 2022-01-29 | New Drug Submission (NDS) | Change in Product Ownership; Change in the layout and content of the packaging material; Converting the Product Monograph to the 2020 format. |
| 1579 | 1999-06-16 | Supplement to a New Drug Submission (SNDS) | NEW STRENGTH |
International API supply for ALFACALCIDOL
6 valid EDQM Certificates of Suitability from 6 holders.
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