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Hydroxycarbamide

Siklos

Extended indication Extension of indication to include treatment of severe chronic anemia (haemoglobin level <6 g/dL or
Therapeutic value Possibly no place in the treatment regimen
Registration phase No registration expected

Product

Active substance Hydroxycarbamide
Domain Cardiovascular diseases
Reason of inclusion Indication extension
Main indication Other non-oncological hematological medications
Extended indication Extension of indication to include treatment of severe chronic anemia (haemoglobin level <6 g/dL or <7 g/dL with poor clinical or functional tolerance) in adults, adolescents and children older than 2 years suffering from sickle cell syndrome.
Proprietary name Siklos
Manufacturer Addmedica
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date July 2020
Orphan drug No
Registration phase No registration expected
Additional remarks De CHMP heeft deze indicatie niet afgewezen in juli 2021 maar heeft wel besloten de studiedata op te nemen in de EPAR.

Therapeutic value

Current treatment options Hydrea
Therapeutic value Possibly no place in the treatment regimen
Substantiation Op dit moment wordt hydroxycarbamide (Hydrea) al off-label gebruikt. Er wordt geen gebruik van Siklos verwacht, zodra het geregistreerd is.
Frequency of administration 1 times a day
Dosage per administration 20 mg/kg
References NCT02516579

Expected patient volume per year

Additional remarks Er wordt geen gebruik verwacht.

Expected cost per patient per year

Cost 9,337.00
References medicijnkosten
Additional remarks Gemiddelde prijs per 30 stuks Siklos, tablet 1.000mg €555,78. Wanneer we uitgaan van gemiddeld 1.400mg voor een patiënt van 70 kg. €778 per maand en €9.337 per jaar.

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.