MIRTAZAPINE DIN 02496674
Health Canada record
| Active ingredient(s) | MIRTAZAPINE 30 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | N06AX11 MIRTAZAPINE |
| Original market date | 22-Oct-2020 |
| Current status date | 22-Oct-2020 |
| Source | Health Canada DPD |
Establishment licence of the holder
Sivem Pharmaceuticals ULC — licence 101965, currently licensed, last inspection rating C (2025-02-04).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing MIRTAZAPINE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02286610 | APO-MIRTAZAPINE | APOTEX INC | Tablet | MIRTAZAPINE 15 MG | Marketed |
| 02286637 | APO-MIRTAZAPINE | APOTEX INC | Tablet | MIRTAZAPINE 45 MG | Marketed |
| 02286629 | APO-MIRTAZAPINE | APOTEX INC | Tablet | MIRTAZAPINE 30 MG | Marketed |
| 02411709 | AURO-MIRTAZAPINE | AURO PHARMA INC | Tablet | MIRTAZAPINE 30 MG | Marketed |
| 02411695 | AURO-MIRTAZAPINE | AURO PHARMA INC | Tablet | MIRTAZAPINE 15 MG | Marketed |
| 02411717 | AURO-MIRTAZAPINE | AURO PHARMA INC | Tablet | MIRTAZAPINE 45 MG | Marketed |
| 02299801 | AURO-MIRTAZAPINE OD | AURO PHARMA INC | Tablet (Orally-Disintegrating) | MIRTAZAPINE 15 MG | Marketed |
| 02299828 | AURO-MIRTAZAPINE OD | AURO PHARMA INC | Tablet (Orally-Disintegrating) | MIRTAZAPINE 30 MG | Marketed |
| 02299836 | AURO-MIRTAZAPINE OD | AURO PHARMA INC | Tablet (Orally-Disintegrating) | MIRTAZAPINE 45 MG | Marketed |
| 02504626 | MIRATAZ | DECHRA LTD | Ointment | MIRTAZAPINE 2 % | Marketed |
| 02496682 | MIRTAZAPINE | SIVEM PHARMACEUTICALS ULC | Tablet | MIRTAZAPINE 45 MG | Marketed |
| 02496666 | MIRTAZAPINE | SIVEM PHARMACEUTICALS ULC | Tablet | MIRTAZAPINE 15 MG | Marketed |
| 02370689 | MIRTAZAPINE | SANIS HEALTH INC | Tablet | MIRTAZAPINE 30 MG | Marketed |
| 02532689 | MIRTAZAPINE | SANIS HEALTH INC | Tablet | MIRTAZAPINE 15 MG | Marketed |
| 02256118 | MYLAN-MIRTAZAPINE | MYLAN PHARMACEUTICALS ULC | Tablet | MIRTAZAPINE 30 MG | Marketed |
| 02256096 | MYLAN-MIRTAZAPINE | MYLAN PHARMACEUTICALS ULC | Tablet | MIRTAZAPINE 15 MG | Marketed |
| 02256126 | MYLAN-MIRTAZAPINE | MYLAN PHARMACEUTICALS ULC | Tablet | MIRTAZAPINE 45 MG | Marketed |
| 02534932 | NRA-MIRTAZAPINE | NORA PHARMA INC | Tablet | MIRTAZAPINE 30 MG | Marketed |
| 02534924 | NRA-MIRTAZAPINE | NORA PHARMA INC | Tablet | MIRTAZAPINE 15 MG | Marketed |
| 02312778 | PRO-MIRTAZAPINE | PRO DOC LIMITEE | Tablet | MIRTAZAPINE 15 MG | Marketed |
| 02312786 | PRO-MIRTAZAPINE | PRO DOC LIMITEE | Tablet | MIRTAZAPINE 30 MG | Marketed |
| 02243910 | REMERON | ORGANON CANADA INC. | Tablet | MIRTAZAPINE 30 MG | Marketed |
| 02248544 | REMERON RD | ORGANON CANADA INC. | Tablet (Orally-Disintegrating) | MIRTAZAPINE 45 MG | Marketed |
| 02248542 | REMERON RD | ORGANON CANADA INC. | Tablet (Orally-Disintegrating) | MIRTAZAPINE 15 MG | Marketed |
| 02248543 | REMERON RD | ORGANON CANADA INC. | Tablet (Orally-Disintegrating) | MIRTAZAPINE 30 MG | Marketed |
| 02250608 | SANDOZ MIRTAZAPINE | SANDOZ CANADA INCORPORATED | Tablet | MIRTAZAPINE 30 MG | Marketed |
| 02250594 | SANDOZ MIRTAZAPINE | SANDOZ CANADA INCORPORATED | Tablet | MIRTAZAPINE 15 MG | Marketed |
| 02259354 | TEVA-MIRTAZAPINE | TEVA CANADA LIMITED | Tablet | MIRTAZAPINE 30 MG | Marketed |
| 02362937 | AVA-MIRTAZAPINE | AVANSTRA INC | Tablet | MIRTAZAPINE 30 MG | Cancelled Post Market |
| 02362929 | AVA-MIRTAZAPINE | AVANSTRA INC | Tablet | MIRTAZAPINE 15 MG | Cancelled Post Market |
| 02274361 | CO MIRTAZAPINE | COBALT PHARMACEUTICALS COMPANY | Tablet | MIRTAZAPINE 30 MG | Cancelled Post Market |
| 02252287 | DOM-MIRTAZAPINE | DOMINION PHARMACAL | Tablet | MIRTAZAPINE 30 MG | Cancelled Post Market |
| 02281716 | DOM-MIRTAZAPINE | DOMINION PHARMACAL | Tablet | MIRTAZAPINE 15 MG | Cancelled Post Market |
| 02352842 | GD-MIRTAZAPINE OD | GENMED A DIVISION OF PFIZER CANADA ULC | Tablet (Orally-Disintegrating) | MIRTAZAPINE 45 MG | Cancelled Post Market |
| 02352826 | GD-MIRTAZAPINE OD | GENMED A DIVISION OF PFIZER CANADA ULC | Tablet (Orally-Disintegrating) | MIRTAZAPINE 15 MG | Cancelled Post Market |
| 02352834 | GD-MIRTAZAPINE OD | GENMED A DIVISION OF PFIZER CANADA ULC | Tablet (Orally-Disintegrating) | MIRTAZAPINE 30 MG | Cancelled Post Market |
| 02368560 | JAMP-MIRTAZAPINE | JAMP PHARMA CORPORATION | Tablet | MIRTAZAPINE 15 MG | Dormant |
| 02368579 | JAMP-MIRTAZAPINE | JAMP PHARMA CORPORATION | Tablet | MIRTAZAPINE 30 MG | Dormant |
| 02252279 | MIRTAZAPINE | MELIAPHARM INC | Tablet | MIRTAZAPINE 30 MG | Cancelled Post Market |
| 02281732 | MIRTAZAPINE | MELIAPHARM INC | Tablet | MIRTAZAPINE 15 MG | Cancelled Post Market |
| 02296675 | MIRTAZAPINE - 15 | PRO DOC LIMITEE | Tablet | MIRTAZAPINE 15 MG | Cancelled Post Market |
| 02296683 | MIRTAZAPINE - 30 | PRO DOC LIMITEE | Tablet | MIRTAZAPINE 30 MG | Cancelled Post Market |
| 02296691 | MIRTAZAPINE - 45 | PRO DOC LIMITEE | Tablet | MIRTAZAPINE 45 MG | Cancelled Post Market |
| 02358832 | NTP-MIRTAZAPINE | TEVA CANADA LIMITED | Tablet | MIRTAZAPINE 30 MG | Cancelled Pre Market |
| 02370093 | NTP-MIRTAZAPINE OD TABLETS | TEVA CANADA LIMITED | Tablet (Orally-Disintegrating) | MIRTAZAPINE 15 MG | Cancelled Pre Market |
| 02370107 | NTP-MIRTAZAPINE OD TABLETS | TEVA CANADA LIMITED | Tablet (Orally-Disintegrating) | MIRTAZAPINE 30 MG | Cancelled Pre Market |
| 02370115 | NTP-MIRTAZAPINE OD TABLETS | TEVA CANADA LIMITED | Tablet (Orally-Disintegrating) | MIRTAZAPINE 45 MG | Cancelled Pre Market |
| 02336189 | NU-MIRTAZAPINE | NU-PHARM INC | Tablet | MIRTAZAPINE 15 MG | Cancelled (Unreturned Annual) |
| 02336200 | NU-MIRTAZAPINE | NU-PHARM INC | Tablet | MIRTAZAPINE 45 MG | Cancelled (Unreturned Annual) |
| 02336197 | NU-MIRTAZAPINE | NU-PHARM INC | Tablet | MIRTAZAPINE 30 MG | Cancelled (Unreturned Annual) |
| 02248762 | PMS-MIRTAZAPINE | PHARMASCIENCE INC | Tablet | MIRTAZAPINE 30 MG | Dormant |
| 02273942 | PMS-MIRTAZAPINE | PHARMASCIENCE INC | Tablet | MIRTAZAPINE 15 MG | Dormant |
| 02270927 | RATIO-MIRTAZAPINE | RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED | Tablet | MIRTAZAPINE 30 MG | Cancelled Post Market |
| 02265265 | RIVA-MIRTAZAPINE | LABORATOIRE RIVA INC. | Tablet | MIRTAZAPINE 30 MG | Cancelled Post Market |
| 02267292 | SANDOZ MIRTAZAPINE FC | SANDOZ CANADA INCORPORATED | Tablet | MIRTAZAPINE 30 MG | Cancelled Post Market |
| 02279894 | TEVA-MIRTAZAPINE OD | TEVA CANADA LIMITED | Tablet (Orally-Disintegrating) | MIRTAZAPINE 15 MG | Cancelled Post Market |
| 02279908 | TEVA-MIRTAZAPINE OD | TEVA CANADA LIMITED | Tablet (Orally-Disintegrating) | MIRTAZAPINE 30 MG | Cancelled Post Market |
| 02279916 | TEVA-MIRTAZAPINE OD | TEVA CANADA LIMITED | Tablet (Orally-Disintegrating) | MIRTAZAPINE 45 MG | Cancelled Post Market |
| 02325187 | ZYM-MIRTAZAPINE | ZYMCAN PHARMACEUTICALS INC | Tablet | MIRTAZAPINE 30 MG | Cancelled Post Market |
| 02325179 | ZYM-MIRTAZAPINE | ZYMCAN PHARMACEUTICALS INC | Tablet | MIRTAZAPINE 15 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 24148 | 2020-03-03 | Abbreviated New Drug Submission (ANDS) | LICENSING AGREEMENT BETWEEN TWO COMPANIES. NEW LABELLING MATERIALS |
International API supply for MIRTAZAPINE
13 valid EDQM Certificates of Suitability from 13 holders. 20 active FDA Drug Master Files.
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