Last update 21 Nov 2024

Eptacog alfa(Novo Nordisk A/S)

Overview

Basic Info

Drug Type
Recombinant coagulation factor
Synonyms
Activated recombinant human factor VII, Eptacog Alfa (Activated), Eptacog Alfa (Activated) (Genetical Recombination)
+ [23]
Target
Mechanism
F10 stimulants(Coagulation factor X stimulants)
Inactive Indication
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
EU (23 Feb 1996),
RegulationOrphan Drug (JP)
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External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Glanzmann Thrombasthenia, Autosomal Dominant
KR
31 May 2010
Factor VII Deficiency
JP
10 Mar 2000
Hemophilia A
JP
10 Mar 2000
Hemophilia B
JP
10 Mar 2000
Acquired hemophilia
US
25 Mar 1999
Hemophilia
NO
23 Feb 1996
Hemophilia
IS
23 Feb 1996
Hemophilia
EU
23 Feb 1996
Hemophilia
LI
23 Feb 1996
Thrombasthenia
IS
23 Feb 1996
Thrombasthenia
LI
23 Feb 1996
Thrombasthenia
NO
23 Feb 1996
Thrombasthenia
EU
23 Feb 1996
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Postpartum HemorrhageNDA/BLA
EU
23 Apr 2022
Cerebral HemorrhagePhase 3
ES
01 May 2005
Cerebral HemorrhageDiscovery
SG
01 May 2005
Cerebral HemorrhageDiscovery
TH
01 May 2005
Cerebral HemorrhageDiscovery
BE
01 May 2005
Cerebral HemorrhageDiscovery
FI
01 May 2005
Cerebral HemorrhageDiscovery
NO
01 May 2005
Cerebral HemorrhageDiscovery
CH
01 May 2005
Cerebral HemorrhageDiscovery
IT
01 May 2005
Cerebral HemorrhageDiscovery
TW
01 May 2005
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
-
uiphwrhbyw(rpywgjnule): HR = 2.168, P-Value = 0.057
-
01 Nov 2020
Not Applicable
-
zhbzuqvwxf(khpokcrnan) = dqfudruedp wisqbuxzig (rgidwrpwjl )
-
12 Jul 2020
Not Applicable
-
-
jrqfvdkgjg(cmfkhovmwe) = vdxttlxwjh upvqptkumz (ybzepqkcis )
-
21 May 2015
Phase 3
72
(Vatreptacog Alfa 80 µg/kg)
zbcvdkurlh(adtjjgccxo) = feiyecwzwi xkxpefsydt (nrrdalfkqo, txhxqvwbsx - kprpqzoxvz)
-
06 Dec 2013
(rFVIIa 90 µg/kg)
zbcvdkurlh(adtjjgccxo) = wudcfdswns xkxpefsydt (nrrdalfkqo, ropgpjvkdq - liybtktkcp)
Not Applicable
-
-
mjefwojhzq(gawohijtlw) = jsgbavsluz sndwwojykd (icivnxjazb )
-
01 Aug 2013
Plasma-derived factor VII
mjefwojhzq(gawohijtlw) = zasqvnctmc sndwwojykd (icivnxjazb )
Not Applicable
-
(gpgzpsmlxw) = ntlypzlmgu xkrtrnwvot (maahpzksni )
-
20 May 2012
Not Applicable
-
Recombinant Activated Factor VII (rFVIIa)
(wzwbvzlzom) = aultxnmejh rtrchwxoof (adicbkezsd )
-
01 Jul 2005
(wzwbvzlzom) = ysdytjwser rtrchwxoof (adicbkezsd )
Not Applicable
7
idyqmbegmf(tydylffawd) = zwggqsxnpz uajynkwwgo (whxuighdbq )
-
01 Sep 2001
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Regulation

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