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Fibrinogen

Extended indication Patients With Congenital Fibrinogen Deficiency
Therapeutic value Possible equal value
Registration phase Clinical trials

Product

Active substance Fibrinogen
Domain Cardiovascular diseases
Reason of inclusion New medicine (specialité)
Main indication Hemostasis promoting medication
Extended indication Patients With Congenital Fibrinogen Deficiency
Manufacturer Biotest
Mechanism of action Coagulant
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Stollingsfactor I, gepurificeerd uit humaan plasma.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date 2022
Expected Registration 2023
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options Bij Congenital Fibrinogen Deficiency is de behandeling met fibrinogeenconcentraat de eerste keuze (conform richtlijn hemofilie en aanverwante stollingsstoornissen). Er is op dit moment één alternatief voor fibrinogeenconcentraat genaamd Haemocomplettan op de markt.
Therapeutic value Possible equal value
Substantiation Naar verwachting zal fibrinogen voor deze indicatie beperkt in gebruik genomen worden.
References NCT02065882
Additional remarks Wordt met name gebruikt bij behandelingen van korte duur.

Expected patient volume per year

Patient volume

17 - 153

Market share is generally not included unless otherwise stated.
References Orphanet
Additional remarks De incidentie wordt geschat tussen de 1 en 9 per 1.000.000 inwoners. Voor Nederland betekent dit tussen de 17 en 153 patiënten.

Expected cost per patient per year

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions Acquired fibrinogen deficiency
References Website Biotest
Additional remarks Zal met name gebruikt worden voor tekorten die optreden na groot trauma, bloedverlies en na bevallingen et cetera.

Other information

There is currently no futher information available.