Overview
Hydroxocobalamin, also known as vitamin B12a and hydroxycobalamin, is an injectable form of vitamin B 12 that has been used therapeutically to treat vitamin B 12 deficiency. It is also used in cyanide poisoning, Leber's optic atrophy, and toxic amblyopia.
Indication
For treatment of pernicious anemia and the prevention and treatment of vitamin B12 deficiency arising from alcoholism, malabsorption, tapeworm infestation, celiac, hyperthyroidism, hepatic-biliary tract disease, persistent diarrhea, ileal resection, pancreatic cancer, renal disease, prolonged stress, vegan diets, macrobiotic diets or other restrictive diets. Also for the treatment of known or suspected cyanide poisoning.
Associated Conditions
- Anemia, Pernicious
- Cyanide Poisoning
- Vitamin B complex deficiency
- Vitamin B12 Deficiency
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/12/07 | Phase 2 | Completed | |||
2022/09/13 | Phase 2 | Not yet recruiting | |||
2020/11/13 | Phase 4 | UNKNOWN | Christian Medical College, Vellore, India | ||
2020/02/06 | Phase 2 | Withdrawn | Joshua Korzenik | ||
2019/08/13 | Phase 4 | Completed | |||
2018/12/20 | Phase 2 | Completed | |||
2018/11/08 | Phase 2 | Terminated | |||
2018/02/27 | Phase 2 | Withdrawn | |||
2017/12/13 | Phase 4 | Completed | Hospital Universitario Dr. Jose E. Gonzalez | ||
2014/10/21 | Phase 4 | Completed | Rijnstate Hospital |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Meridian Medical Technologies, Inc. | 11704-370 | INTRAVENOUS | 5 g in 250 mL | 10/15/2021 | |
| BTG INTERNATIONAL INC. | 50633-310 | INTRAVENOUS | 5 g in 250 mL | 5/31/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 11/23/2007 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Hydroxocobalamine Hydrochloride Injection | 国药准字H41024838 | 化学药品 | 注射剂 | 3/5/2024 | |
| Hydroxocobalamine Hydrochloride Injection | 国药准字H11021930 | 化学药品 | 注射剂（小容量注射剂） | 8/11/2021 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| HEPATOSWISS FOR IV INFUSION INJ | N/A | N/A | N/A | 11/12/1982 | |
| HEPATOSWISS IM INJ | N/A | N/A | N/A | 8/13/1982 | |
| HYCOBAL INJ 5MG/2ML | N/A | N/A | N/A | 8/13/1982 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| Adrenal Adapt | 444375 | Medicine | A | 3/25/2024 | |
| ORGANIC Iron COMPLETE | 372450 | Medicine | A | 8/9/2021 | |
| Hydroxy B12 100 drops | 448450 | RN Labs Pty Ltd | Medicine | A | 5/13/2024 |
| Preconception Multi for Women | 476988 | Medicine | A | 1/29/2025 | |
| Pure Children’s Essentials | 371280 | Medicine | A | 7/19/2021 | |
| Iron & Brain Support | 446232 | Medicine | A | 4/23/2024 | |
| Prenatal Trimester 2 & 3 Plus Breastfeeding | 456175 | Medicine | A | 7/24/2024 | |
| BioActive B-Complex | 488900 | RN Labs Pty Ltd | Medicine | A | 5/15/2025 |
| Total B Folinic | 432050 | RN Labs Pty Ltd | Medicine | A | 1/2/2024 |
| FOREST PHARMA WITH AMINO ACIDS capsule carton | 51067 | Forest Pharmatech Pty Limited | Medicine | A | 12/7/1994 |
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