Bayhep b, hyperhep b s/d, Zutectra(hepatitis b immune globulin)
Hepatitis b immune globulin is an unknown pharmaceutical. It is currently being investigated in clinical studies.
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Commercial
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Bayhep b, hyperhep b s/d, Hepagam b, Nabi-hb (discontinued: Nabi-hb)
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Hepatitis b immune globulin (human)
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Nabi-HB | Hepatitis B Immune Globulin (Human) | ADMA Biologics | A-103945 RX | 2001-10-23 | 1 products |
| Nabi-HB | Hepatitis B Immune Globulin (Human) | ADMA Biologics | N-103945 RX | 2001-10-23 | 1 products |
| Bayhep B, Hyperhep B S/D | Hepatitis B Immune Globulin (Human) | Grifols | A-101146 RX | 1977-09-23 | 5 products |
| Bayhep B, Hyperhep B S/D | Hepatitis B Immune Globulin (Human) | Grifols | N-101146 RX | 1977-09-23 | 5 products |
| Hepagam B | Hepatitis B Immune Globulin (Human) | Kamada | A-125035 RX | 2006-01-27 | 2 products |
| Hepagam B | Hepatitis B Immune Globulin (Human) | Kamada | N-125035 RX | 2006-01-27 | 2 products |
Show 2 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| hyperhep b s/d | Biologic Licensing Application | 2010-10-27 |
| nabi-hb | Biologic Licensing Application | 2025-04-10 |
Indications
FDA
EMA
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Agency Specific
FDA
EMA
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Patent Expiration
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ATC Codes
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Clinical
Clinical Trials
166 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hepatitis b | D006509 | — | — | 10 | 18 | 20 | 28 | 32 | 103 |
| Hepatitis | D006505 | — | K75.9 | 7 | 12 | 16 | 22 | 24 | 78 |
| Hepatitis a | D006506 | EFO_0007305 | B15 | 7 | 12 | 10 | 20 | 16 | 62 |
| Chronic hepatitis b | D019694 | EFO_0004239 | B18.1 | 8 | 16 | 2 | 1 | 9 | 36 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | 3 | 4 | 1 | 1 | 6 | 11 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 3 | 4 | 1 | 1 | 6 | 11 |
| Hepatitis c | D006526 | — | B19.2 | — | — | — | 5 | 6 | 11 |
| Liver transplantation | D016031 | EFO_0010682 | — | 1 | 2 | 1 | 3 | 4 | 10 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | 1 | — | 1 | 7 | 9 |
| Infections | D007239 | EFO_0000544 | — | 1 | 1 | — | 2 | 3 | 7 |
Show 21 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Whooping cough | D014917 | EFO_0000650 | A37 | — | — | 7 | — | 1 | 8 |
| Tetanus | D013742 | EFO_0005593 | A35 | — | — | 7 | — | 1 | 8 |
| Diphtheria | D004165 | EFO_0005549 | A36 | — | — | 7 | — | 1 | 8 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | 1 | 1 | 1 | — | 3 | 5 |
| Virus diseases | D014777 | — | B34 | 3 | — | 1 | — | 1 | 5 |
| Poliomyelitis | D011051 | EFO_0007450 | A80 | — | — | 4 | — | 1 | 5 |
| Haemophilus influenzae type b | D019741 | — | — | — | — | 3 | — | — | 3 |
| Healthy volunteers/patients | — | — | — | 1 | — | 1 | — | — | 2 |
| Human influenza | D007251 | EFO_0007328 | J11.1 | — | — | 2 | — | — | 2 |
| Haemophilus infections | D006192 | EFO_1001127 | — | — | — | 2 | — | — | 2 |
Show 5 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic hepatitis | D006521 | — | K73.9 | 3 | 5 | — | — | 2 | 10 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | 1 | — | — | 4 | 5 |
| Neoplasms | D009369 | — | C80 | 1 | 1 | — | — | 1 | 3 |
| Malaria | D008288 | EFO_0001068 | B54 | 2 | 1 | — | — | — | 3 |
| Chronic renal insufficiency | D051436 | — | N18 | — | 1 | — | — | 1 | 2 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | 1 | — | — | — | 1 |
| Fibrosis | D005355 | — | — | — | 1 | — | — | — | 1 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | — | 1 | — | — | — | 1 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | — | 1 | — | — | — | 1 |
| B-cell leukemia | D015448 | — | — | — | 1 | — | — | — | 1 |
Show 1 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Herpesviridae infections | D006566 | EFO_0007309 | B00.4 | 2 | — | — | — | 1 | 3 |
| Ebola hemorrhagic fever | D019142 | EFO_0007243 | A98.4 | 1 | — | — | — | — | 1 |
| Marburg virus disease | D008379 | EFO_0007358 | A98.3 | 1 | — | — | — | — | 1 |
| Chronic hepatitis d | D019701 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pregnancy rate | D018873 | — | — | — | — | — | — | 2 | 2 |
| Carcinoma | D002277 | — | C80.0 | — | — | — | — | 2 | 2 |
| Thrombocytopenic purpura idiopathic | D016553 | EFO_0007160 | D69.3 | — | — | — | — | 1 | 1 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | — | — | — | 1 | 1 |
| Immunosuppression therapy | D007165 | — | — | — | — | — | — | 1 | 1 |
| B-cell lymphoma marginal zone | D018442 | — | C88.4 | — | — | — | — | 1 | 1 |
| Liver failure | D017093 | — | K72.9 | — | — | — | — | 1 | 1 |
| Acute liver failure | D017114 | — | — | — | — | — | — | 1 | 1 |
| Lymphoma | D008223 | — | C85.9 | — | — | — | — | 1 | 1 |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | — | — | — | — | 1 | 1 |
Show 27 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Hepatitis b immune globulin |
| INN | — |
| Description | Hepatitis B immunoglobulin (HBIG) is a human immunoglobulin that is used to prevent the development of hepatitis B and is used for the treatment of acute exposure to HBsAg.
|
| Classification | Protein |
| Drug class | antineoplastics (mitotic inhibitors; tubulin binders) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL2108512 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB05276 |
| UNII ID | — |
Target
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Variants
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Financial
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Trends
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Safety
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Adverse Events
Top Adverse Reactions
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176 adverse events reported
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