SPIKEVAX DIN 02527685
Status: Cancelled Post Market
Holder: MODERNA BIOPHARMA CANADA CORPORATION
Health Canada record
| Active ingredient(s) | ELASOMERAN 0.1 MG |
|---|
| Dosage form | Dispersion |
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| Route | Intramuscular |
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| Schedule | SCHEDULE D |
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| Class | Human |
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| ATC | J07BN01 COVID-19, RNA-BASED VACCINE |
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| Original market date | 14-Jul-2022 |
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| Current status date | 19-Jan-2024 |
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| Source | Health Canada DPD |
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Establishment licence of the holder
Moderna Biopharma Canada Corporation — licence 3-002801, currently licensed, last inspection rating C (2024-06-10).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing ELASOMERAN
| DIN | Product | Company | Form | Strength | Status |
|---|
| 02510014 | SPIKEVAX | MODERNA BIOPHARMA CANADA CORPORATION | Dispersion | ELASOMERAN 0.2 MG | Cancelled Post Market |
| 02530252 | SPIKEVAX BIVALENT | MODERNA BIOPHARMA CANADA CORPORATION | Dispersion | ELASOMERAN 0.05 MG; IMELASOMERAN 0.05 MG | Cancelled Post Market |
| 02532352 | SPIKEVAX BIVALENT (ORIGINAL / OMICRON BA.4/5) | MODERNA BIOPHARMA CANADA CORPORATION | Dispersion | ELASOMERAN 0.05 MG; DAVESOMERAN 0.05 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|
| 31785 | 2023-10-04 | New Drug Submission (NDS) | Administrative - Change in Product Ownership |
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