XYNTHA DIN 02309483
Status: Marketed
Holder: PFIZER CANADA ULC
Health Canada record
| Active ingredient(s) | MOROCTOCOG ALFA 250 UNIT |
|---|
| Dosage form | Powder For Solution; Kit |
|---|
| Route | Intravenous |
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| Schedule | SCHEDULE D |
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| Class | Human |
|---|
| ATC | B02BD02 COAGULATION FACTOR VIII |
|---|
| Original market date | 23-Jan-2009 |
|---|
| Current status date | 17-Feb-2012 |
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| Source | Health Canada DPD |
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Establishment licence of the holder
Pfizer Canada ULC — licence 100255, currently licensed, last inspection rating C (2023-08-07).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing MOROCTOCOG ALFA
| DIN | Product | Company | Form | Strength | Status |
|---|
| 02309491 | XYNTHA | PFIZER CANADA ULC | Powder For Solution; Kit | MOROCTOCOG ALFA 500 UNIT | Marketed |
| 02374099 | XYNTHA SOLOFUSE | PFIZER CANADA ULC | Powder For Solution | MOROCTOCOG ALFA 3000 UNIT | Marketed |
| 02374064 | XYNTHA SOLOFUSE | PFIZER CANADA ULC | Powder For Solution | MOROCTOCOG ALFA 500 UNIT | Marketed |
| 02374072 | XYNTHA SOLOFUSE | PFIZER CANADA ULC | Powder For Solution | MOROCTOCOG ALFA 1000 UNIT | Marketed |
| 02374080 | XYNTHA SOLOFUSE | PFIZER CANADA ULC | Powder For Solution | MOROCTOCOG ALFA 2000 UNIT | Marketed |
| 02374056 | XYNTHA SOLOFUSE | PFIZER CANADA ULC | Powder For Solution | MOROCTOCOG ALFA 250 UNIT | Approved |
| 02245951 | REFACTO | WYETH CANADA | Powder For Solution | MOROCTOCOG ALFA 1000 UNIT | Cancelled Post Market |
| 02309505 | XYNTHA | PFIZER CANADA ULC | Powder For Solution; Kit | MOROCTOCOG ALFA 1000 UNIT | Dormant |
| 02309513 | XYNTHA | PFIZER CANADA ULC | Powder For Solution; Kit | MOROCTOCOG ALFA 2000 UNIT | Dormant |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|
| 11896 | 2010-10-20 | New Drug Submission (NDS) | Manufacturer name change |
| 9503 | 2008-04-23 | Supplement to a New Drug Submission (SNDS) | NEW MANUFACTURING FACILITY, NEW MANUFACTURING PROCESS, NEW 2000 IU PRESENTATION, NAME CHANGE FROM REFACTO TO XYNTHA |
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