ALPHA1-PROTEINASE INHIBITOR (HUMAN) DIN 02223651
Status: Cancelled Pre Market
Holder: GRIFOLS THERAPEUTICS LLC
Molecule: ALPHA1-PROTEINASE INHIBITOR (HUMAN)
Health Canada record
| Active ingredient(s) | ALPHA1-PROTEINASE INHIBITOR (HUMAN) 1 G |
|---|---|
| Dosage form | Powder For Solution |
| Route | Intravenous |
| Schedule | SCHEDULE D |
| Class | Human |
| ATC | B02AB02 ALFA1 ANTITRYPSIN |
| Original market date | |
| Current status date | 16-Jul-2024 |
| Source | Health Canada DPD |
Establishment licence of the holder
Grifols Therapeutics LLC — licence , not currently licensed, last inspection rating C (2023-06-03).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing ALPHA1-PROTEINASE INHIBITOR (HUMAN)
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02571250 | GLASSIA | TAKEDA CANADA INC | Solution | ALPHA1-PROTEINASE INHIBITOR (HUMAN) 5000 MG | Approved |
| 02522438 | GLASSIA | TAKEDA CANADA INC | Solution | ALPHA1-PROTEINASE INHIBITOR (HUMAN) 1000 MG | Marketed |
| 02571242 | GLASSIA | TAKEDA CANADA INC | Solution | ALPHA1-PROTEINASE INHIBITOR (HUMAN) 4000 MG | Approved |
| 02204606 | PROLASTIN-C | GRIFOLS THERAPEUTICS LLC | Powder For Solution | ALPHA1-PROTEINASE INHIBITOR (HUMAN) 1000 MG | Marketed |
| 02488787 | PROLASTIN-C LIQUID | GRIFOLS THERAPEUTICS LLC | Solution | ALPHA1-PROTEINASE INHIBITOR (HUMAN) 1000 MG | Approved |
| 02543028 | PRONEXTICA LIQUID | GRIFOLS THERAPEUTICS LLC | Solution | ALPHA1-PROTEINASE INHIBITOR (HUMAN) 1000 MG | Approved |
| 02494760 | ZEMAIRA | CSL BEHRING CANADA INC | Kit; Powder For Solution | ALPHA1-PROTEINASE INHIBITOR (HUMAN) 4000 MG | Approved |
| 02457911 | ZEMAIRA | CSL BEHRING CANADA INC | Powder For Solution; Kit | ALPHA1-PROTEINASE INHIBITOR (HUMAN) 1000 MG | Approved |
| 02494779 | ZEMAIRA | CSL BEHRING CANADA INC | Kit; Powder For Solution | ALPHA1-PROTEINASE INHIBITOR (HUMAN) 5000 MG | Approved |
| 02223643 | ALPHA1-PROTEINASE INHIBITOR (HUMAN) | GRIFOLS THERAPEUTICS LLC | Powder For Solution | ALPHA1-PROTEINASE INHIBITOR (HUMAN) 500 MG | Cancelled Pre Market |
| 00803529 | PROLASTIN INJ 25.0MG/ML | CUTTER BIOLOGICAL, DIVISION OF MILES LAB INC. | Powder For Solution | ALPHA1-PROTEINASE INHIBITOR (HUMAN) 25 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 12989 | 2012-02-02 | New Drug Submission (NDS) | Manufacturer name change |
| 7197 | 2005-06-28 | New Drug Submission (NDS) | NEW MANUFACTURER NAME |
| 4184 | 1996-06-25 | New Drug Submission (NDS) |