FIBRYGA DIN 02464616
Health Canada record
| Active ingredient(s) | FIBRINOGEN (HUMAN) 1 G |
|---|---|
| Dosage form | Powder For Solution |
| Route | Intravenous |
| Schedule | SCHEDULE D |
| Class | Human |
| ATC | B02BB01 FIBRINOGEN, HUMAN |
| Original market date | 08-Aug-2018 |
| Current status date | 08-Aug-2018 |
| Source | Health Canada DPD |
Establishment licence of the holder
Octapharma Pharmazeutika Produktionsges m.b.H. — 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 FIBRINOGEN (HUMAN)
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02565099 | FIBRYGA | OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGES M B H | Powder For Solution | FIBRINOGEN (HUMAN) 2 G | Approved |
| 02283980 | QUIXIL | OMRIX BIOPHARMACEUTICALS LTD | Kit; Solution | FIBRINOGEN (HUMAN) 60.0 MG; THROMBIN (HUMAN) 1200 UNIT; CALCIUM CHLORIDE 6.2 MG | Approved |
| 02393352 | RIASTAP | CSL BEHRING CANADA INC | Powder For Solution | FIBRINOGEN (HUMAN) 1000 MG | Marketed |
| 02439034 | TACHOSIL | CORZA MEDICAL GMBH | Patch | FIBRINOGEN (HUMAN) 5.5 MG; THROMBIN (HUMAN) 2 UNIT; COLLAGEN 2.1 MG | Approved |
| 02439026 | TACHOSIL | CORZA MEDICAL GMBH | Patch | FIBRINOGEN (HUMAN) 5.5 MG; THROMBIN (HUMAN) 2 UNIT; COLLAGEN 2.1 MG | Approved |
| 02514249 | VISTASEAL | INSTITUTO GRIFOLS S.A. | Solution | FIBRINOGEN (HUMAN) 240 MG; THROMBIN (HUMAN) 1500 UNIT | Approved |
| 02514257 | VISTASEAL | INSTITUTO GRIFOLS S.A. | Solution | FIBRINOGEN (HUMAN) 400 MG; THROMBIN (HUMAN) 2500 UNIT | Marketed |
| 02514222 | VISTASEAL | INSTITUTO GRIFOLS S.A. | Solution | FIBRINOGEN (HUMAN) 80 MG; THROMBIN (HUMAN) 500 UNIT | Marketed |
| 02514230 | VISTASEAL | INSTITUTO GRIFOLS S.A. | Solution | FIBRINOGEN (HUMAN) 160 MG; THROMBIN (HUMAN) 1000 UNIT | Marketed |
| 02348497 | EVICEL | OMRIX BIOPHARMACEUTICALS LTD | Solution; Kit | FIBRINOGEN (HUMAN) 90 MG; THROMBIN (HUMAN) 1200 UNIT | Cancelled Post Market |
| 02439042 | TACHOSIL | CORZA MEDICAL GMBH | Patch | FIBRINOGEN (HUMAN) 5.5 MG; THROMBIN (HUMAN) 2 UNIT; COLLAGEN 2.1 MG | Dormant |
| 01949020 | TISSEEL KIT VH 1.0 | OSTERREICHISCHES INSTITUT FUR HAEMODERIVATE GES M.B.H. | Powder For Solution; Liquid | FIBRINOGEN (HUMAN) 110 MG; PLASMAFIBRONECTIN (CIG) 9 MG; PLASMINOGEN 120 MCG; APROTININ (BOVINE) 300 UNIT; THROMBIN (BOVINE) 4 UNIT; THROMBIN (BOVINE) 500 UNIT; CALCIUM CHLORIDE .04 MMOL; PROTEIN 130 MG; ANTIHEMOPHILIC FACTOR (HUMAN) 50 UNIT | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 19903 | 2017-10-10 | Supplement to a New Drug Submission (SNDS) | PRODUCT NAME CHANGE |
| 19383 | 2017-06-07 | New Drug Submission (NDS) |
International API supply for FIBRINOGEN (HUMAN)
0 active FDA Drug Master Files.
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