Novoseven, novoseven rt, Novoseven(eptacog alfa (activated))
NovoSeven (eptacog alfa (activated)) is a protein pharmaceutical. Eptacog alfa (activated) was first approved as Novoseven on 1996-02-23. It has been approved in Europe to treat factor VII deficiency, hemophilia a, hemophilia b, and thrombasthenia.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Novoseven, novoseven rt, Sevenfact (discontinued: Novoseven, novoseven rt)
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)
Coagulation factor viia (recombinant)
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Sevenfact | coagulation factor VIIa (recombinant)-jncw | Laboratoire Francais du Fractionnement et des Biotechnologies S.A. | A-125641 RX | 2020-04-01 | 3 products |
| Novoseven, Novoseven Rt | Coagulation Factor VIIa (Recombinant) | Novo Nordisk | A-103665 RX | 2008-05-09 | 4 products |
Show 1 discontinued
Indications
FDA
EMA
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Agency Specific
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ATC Codes
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HCPCS
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Clinical
Clinical Trials
131 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hemophilia a | D006467 | EFO_0007267 | D66 | 20 | 11 | 16 | 6 | 19 | 68 |
| Blood coagulation disorders | D001778 | EFO_0009314 | D68.9 | 11 | 22 | 6 | 3 | 18 | 59 |
| Hemostatic disorders | D020141 | — | — | 11 | 21 | 6 | 3 | 18 | 58 |
| Hemophilia b | D002836 | — | D67 | 15 | 9 | 9 | 4 | 12 | 46 |
| Hemorrhage | D006470 | MP_0001914 | R58 | 5 | 15 | 5 | 3 | 13 | 41 |
| Postpartum hemorrhage | D006473 | — | O72 | — | — | — | 1 | 4 | 5 |
| Cardiac surgical procedures | D006348 | — | — | — | 1 | 1 | 1 | — | 3 |
| Deficiency diseases | D003677 | EFO_1001067 | E63 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cerebral hemorrhage | D002543 | — | — | — | 8 | 2 | — | — | 10 |
| Wounds and injuries | D014947 | — | T14.8 | — | 3 | 2 | — | 1 | 6 |
| Factor vii deficiency | D005168 | HP_0008169 | D68.2 | 2 | 1 | 1 | — | 3 | 6 |
| Congenital heart defects | D006330 | HP_0001627 | Q24.9 | — | — | 1 | — | — | 1 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | 1 | — | — | 1 |
| Hemorrhagic stroke | D000083302 | — | — | — | — | 1 | — | — | 1 |
| Coronary artery disease | D003324 | — | I25.1 | — | — | 1 | — | — | 1 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | — | 1 | — | — | 1 |
| Heart valve diseases | D006349 | EFO_0009551 | I08 | — | — | 1 | — | — | 1 |
| Burns | D002056 | — | T30.0 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Thrombasthenia | D013915 | — | D69.1 | 1 | 1 | — | — | 4 | 5 |
| Hematoma | D006406 | EFO_0010680 | — | — | 1 | — | — | 1 | 2 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | 2 | — | — | — | 2 |
| Coronary disease | D003327 | — | — | — | 1 | — | — | — | 1 |
| Acute coronary syndrome | D054058 | EFO_0005672 | — | — | 1 | — | — | — | 1 |
| Fever | D005334 | HP_0001945 | R50.9 | — | 1 | — | — | — | 1 |
| Dengue | D003715 | — | A90 | — | 1 | — | — | — | 1 |
| Severe dengue | D019595 | — | A91 | — | 1 | — | — | — | 1 |
| Viral hemorrhagic fevers | D006482 | — | A99 | — | 1 | — | — | — | 1 |
| Cystitis | D003556 | EFO_1000025 | N30 | — | 1 | — | — | — | 1 |
Show 6 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 9 | — | — | — | — | 9 |
| Hemorrhagic disorders | D006474 | — | D69.9 | 1 | — | — | — | 2 | 3 |
| Hemostasis | D006487 | — | — | 2 | — | — | — | — | 2 |
| Intracranial hemorrhages | D020300 | EFO_0000551 | I62 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | — | — | — | — | 1 | 1 |
| Thrombocytopenia | D013921 | HP_0001873 | D69.6 | — | — | — | — | 1 | 1 |
| Cardiopulmonary bypass | D002315 | — | — | — | — | — | — | 1 | 1 |
| Hemorrhagic shock | D012771 | — | — | — | — | — | — | 1 | 1 |
| Traumatic brain hemorrhage | D020201 | — | — | — | — | — | — | 1 | 1 |
| Traumatic brain injuries | D000070642 | — | S06 | — | — | — | — | 1 | 1 |
| Contusions | D003288 | — | T14.8 | — | — | — | — | 1 | 1 |
| Brain injuries | D001930 | — | S06.9 | — | — | — | — | 1 | 1 |
| Brain contusion | D000070624 | — | — | — | — | — | — | 1 | 1 |
| Factor xi deficiency | D005173 | — | D68.1 | — | — | — | — | 1 | 1 |
Show 7 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Eptacog alfa (activated) |
| INN | eptacog beta (activated) |
| Description | NovoSeven (eptacog alfa (activated)) is a protein pharmaceutical. Eptacog alfa (activated) was first approved as Novoseven on 1996-02-23. It has been approved in Europe to treat factor VII deficiency, hemophilia a, hemophilia b, and thrombasthenia. |
| Classification | Protein |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL2108334 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | — |
| UNII ID | AC71R787OV (ChemIDplus, GSRS) |
Target
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Variants
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Novoseven – Novo Nordisk
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Additional graphs summarizing 1,046 documents
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Safety
Black-box Warning
Black-box warning for: Novoseven, Sevenfact
Adverse Events
Top Adverse Reactions
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3,168 adverse events reported
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