HELIXATE FS DIN 02243186
Status: Cancelled Post Market
Holder: BAYER HEALTHCARE LLC
Molecule: ANTIHEMOPHILIC FACTOR (RECOMBINANT)
Health Canada record
| Active ingredient(s) | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 250 UNIT |
|---|---|
| Dosage form | Powder For Solution |
| Route | Intravenous |
| Schedule | SCHEDULE D |
| Class | Human |
| ATC | B02BD02 COAGULATION FACTOR VIII |
| Original market date | 24-Apr-2008 |
| Current status date | 05-Apr-2018 |
| Source | Health Canada DPD |
Establishment licence of the holder
Bayer Healthcare Manufacturing S.R.L. — licence , not currently licensed, last inspection rating C (2023-07-20).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing ANTIHEMOPHILIC FACTOR (RECOMBINANT)
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02365987 | ADVATE | TAKEDA CANADA INC | Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 1500 UNIT | Approved |
| 02446448 | ADVATE | TAKEDA CANADA INC | Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 1000 UNIT | Approved |
| 02446421 | ADVATE | TAKEDA CANADA INC | Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 1000 UNIT | Approved |
| 02446413 | ADVATE | TAKEDA CANADA INC | Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 500 UNIT | Approved |
| 02446405 | ADVATE | TAKEDA CANADA INC | Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 250 UNIT | Approved |
| 02365979 | ADVATE | TAKEDA CANADA INC | Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 1000 UNIT | Approved |
| 02446480 | ADVATE | TAKEDA CANADA INC | Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 3000 UNIT | Approved |
| 02446472 | ADVATE | TAKEDA CANADA INC | Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 2000 UNIT | Approved |
| 02446464 | ADVATE | TAKEDA CANADA INC | Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 1500 UNIT | Approved |
| 02446456 | ADVATE | TAKEDA CANADA INC | Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 1500 UNIT | Approved |
| 02451492 | KOVALTRY | BAYER INC | Kit; Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 3000 UNIT | Marketed |
| 02451484 | KOVALTRY | BAYER INC | Kit; Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 2000 UNIT | Marketed |
| 02451476 | KOVALTRY | BAYER INC | Powder For Solution; Kit | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 1000 UNIT | Marketed |
| 02451468 | KOVALTRY | BAYER INC | Powder For Solution; Kit | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 500 UNIT | Marketed |
| 02451441 | KOVALTRY | BAYER INC | Powder For Solution; Kit | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 250 UNIT | Marketed |
| 02365952 | ADVATE | TAKEDA CANADA INC | Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 500 UNIT | Dormant |
| 02284138 | ADVATE | BAXTER HEALTHCARE CORPORATION | Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 250 UNIT | Cancelled Post Market |
| 02284146 | ADVATE | BAXTER HEALTHCARE CORPORATION | Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 500 UNIT | Cancelled Post Market |
| 02284154 | ADVATE | TAKEDA CANADA INC | Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 1000 UNIT | Dormant |
| 02284162 | ADVATE | TAKEDA CANADA INC | Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 1500 UNIT | Dormant |
| 02313111 | ADVATE | TAKEDA CANADA INC | Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 2000 UNIT | Dormant |
| 02337193 | ADVATE | TAKEDA CANADA INC | Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 3000 UNIT | Dormant |
| 02365944 | ADVATE | TAKEDA CANADA INC | Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 250 UNIT | Dormant |
| 02308592 | HELIXATE FS | BAYER HEALTHCARE LLC | Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 2000 UNIT | Cancelled Post Market |
| 02243187 | HELIXATE FS | BAYER HEALTHCARE LLC | Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 500 UNIT | Cancelled Post Market |
| 02243188 | HELIXATE FS | BAYER HEALTHCARE LLC | Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 1000 UNIT | Cancelled Post Market |
| 02342723 | HELIXATE FS | BAYER HEALTHCARE LLC | Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 3000 UNIT | Cancelled Pre Market |
| 02178834 | KOGENATE - PWS IV 1000I.U./VIAL | BAYER CORPORATION | Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 1000 UNIT | Cancelled Post Market |
| 02178818 | KOGENATE - PWS IV 250I.U./VIAL | BAYER CORPORATION | Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 250 UNIT | Cancelled Post Market |
| 02178826 | KOGENATE - PWS IV 500I.U./VIAL | BAYER CORPORATION | Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 500 UNIT | Cancelled Post Market |
| 02291525 | KOGENATE FS | BAYER INC | Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 500 UNIT | Cancelled Post Market |
| 02302217 | KOGENATE FS | BAYER INC | Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 2000 UNIT | Cancelled Post Market |
| 02342731 | KOGENATE FS | BAYER INC | Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 3000 UNIT | Cancelled Post Market |
| 02254484 | KOGENATE FS | BAYER INC | Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 500 UNIT | Cancelled Post Market |
| 02254476 | KOGENATE FS | BAYER INC | Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 250 UNIT | Cancelled Post Market |
| 02242491 | KOGENATE FS | BAYER INC | Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 1000 UNIT | Cancelled Post Market |
| 02242490 | KOGENATE FS | BAYER INC | Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 500 UNIT | Cancelled Post Market |
| 02242489 | KOGENATE FS | BAYER INC | Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 250 UNIT | Cancelled Post Market |
| 02254492 | KOGENATE FS | BAYER INC | Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 1000 UNIT | Cancelled Post Market |
| 02291517 | KOGENATE FS | BAYER INC | Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 250 UNIT | Cancelled Post Market |
| 02291533 | KOGENATE FS | BAYER INC | Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 1000 UNIT | Cancelled Post Market |
| 02342758 | KOGENATE FS -(WITH BIO-SET) | BAYER INC | Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 3000 UNIT | Cancelled Post Market |
| 02302225 | KOGENATE FS -(WITH BIO-SET) | BAYER INC | Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 2000 UNIT | Cancelled Post Market |
| 02042517 | KOGENATE PWS 1000IU/VIAL | MILES INC. - PHARMACEUTICAL DIVISION | Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 1000 UNIT | Cancelled Post Market |
| 02042495 | KOGENATE PWS 250IU/VIAL | MILES INC. - PHARMACEUTICAL DIVISION | Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 250 UNIT | Cancelled Post Market |
| 02042509 | KOGENATE PWS 500IU/VIAL | MILES INC. - PHARMACEUTICAL DIVISION | Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 500 UNIT | Cancelled Post Market |
| 02451603 | KOVALTRY | BAYER INC | Powder For Solution; Kit | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 250 UNIT | Cancelled Pre Market |
| 02451638 | KOVALTRY | BAYER INC | Kit; Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 1000 UNIT | Cancelled Pre Market |
| 02451611 | KOVALTRY | BAYER INC | Kit; Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 500 UNIT | Cancelled Pre Market |
| 02451646 | KOVALTRY | BAYER INC | Powder For Solution; Kit | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 2000 UNIT | Cancelled Pre Market |
| 02451654 | KOVALTRY | BAYER INC | Kit; Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 3000 UNIT | Cancelled Pre Market |
| 02015137 | RECOMBINATE PWS INJ 1000I.U./VIAL | BAXTER HEALTHCARE CORPORATION | Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 1000 UNIT | Cancelled Post Market |
| 02015129 | RECOMBINATE PWS INJ 250I.U./VIAL | BAXTER HEALTHCARE CORPORATION | Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 250 UNIT | Cancelled Post Market |
| 02015145 | RECOMBINATE PWS INJ 500I.U./VIAL | BAXTER HEALTHCARE CORPORATION | Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 500 UNIT | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 8583 | 2007-02-08 | New Drug Submission (NDS) | MANUFACTURER NAME CHANGE |
| 933 | 2000-12-19 | New Drug Submission (NDS) |