HYPERRHO S/D FULL DOSE DIN 02243524
Status: Cancelled Pre Market
Holder: GRIFOLS THERAPEUTICS LLC
Molecule: ANTI-D (RH) IMMUNOGLOBULIN (HUMAN)
Health Canada record
| Active ingredient(s) | ANTI-D (RH) IMMUNOGLOBULIN (HUMAN) 1500 UNIT |
|---|---|
| Dosage form | Solution |
| Route | Intramuscular |
| Schedule | SCHEDULE D |
| Class | Human |
| ATC | J06BA01 IMMUNOGLOBULINS, NORMAL HUMAN, FOR EXTRAVASC. ADM |
| Original market date | |
| Current status date | 08-Jul-2022 |
| 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 ANTI-D (RH) IMMUNOGLOBULIN (HUMAN)
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02379457 | HYPERRHO | GRIFOLS THERAPEUTICS LLC | Solution | ANTI-D (RH) IMMUNOGLOBULIN (HUMAN) 1500 UNIT | Approved |
| 02562405 | HYPERRHO | GRIFOLS THERAPEUTICS LLC | Solution | ANTI-D (RH) IMMUNOGLOBULIN (HUMAN) 250 UNIT | Approved |
| 02302578 | WINRHO SDF | KI BIOPHARMA LLC | Solution | ANTI-D (RH) IMMUNOGLOBULIN (HUMAN) 1500 UNIT | Marketed |
| 02302551 | WINRHO SDF | KI BIOPHARMA LLC | Solution | ANTI-D (RH) IMMUNOGLOBULIN (HUMAN) 600 UNIT | Marketed |
| 02302586 | WINRHO SDF | KI BIOPHARMA LLC | Solution | ANTI-D (RH) IMMUNOGLOBULIN (HUMAN) 2500 UNIT | Approved |
| 02302608 | WINRHO SDF | KI BIOPHARMA LLC | Solution | ANTI-D (RH) IMMUNOGLOBULIN (HUMAN) 15000 UNIT | Approved |
| 02022842 | WINRHO SD KIT INJ | RH PHARMACEUTICALS INC. | Kit | ANTI-D (RH) IMMUNOGLOBULIN (HUMAN) 120 MCG; SODIUM CHLORIDE 0.9 % | Cancelled Post Market |
| 02022834 | WINRHO SD KIT INJ. | RH PHARMACEUTICALS INC. | Kit | ANTI-D (RH) IMMUNOGLOBULIN (HUMAN) 300 MCG; SODIUM CHLORIDE .9 % | Cancelled Post Market |
| 02217430 | WINRHO SDF | APTEVO BIOTHERAPEUTICS LLC | Kit | ANTI-D (RH) IMMUNOGLOBULIN (HUMAN) 600 UNIT | Cancelled Post Market |
| 02302594 | WINRHO SDF | KI BIOPHARMA LLC | Solution | ANTI-D (RH) IMMUNOGLOBULIN (HUMAN) 5000 UNIT | Dormant |
| 02217449 | WINRHO SDF | APTEVO BIOTHERAPEUTICS LLC | Kit | ANTI-D (RH) IMMUNOGLOBULIN (HUMAN) 1500 UNIT | Cancelled Post Market |
| 02230397 | WINRHO SDF | APTEVO BIOTHERAPEUTICS LLC | Kit | ANTI-D (RH) IMMUNOGLOBULIN (HUMAN) 5000 UNIT | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 12992 | 2012-02-02 | New Drug Submission (NDS) | Manufacturer name change |
| 7079 | 2005-06-08 | New Drug Submission (NDS) | MANUFACTURER AND PRODUCT NAME CHANGE |
| 2557 | 2001-02-15 | New Drug Submission (NDS) |