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 Nordic Pharma
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)


Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date July 2020
Expected Registration May 2021
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Therapeutic value No judgement
Duration of treatment Not found

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

Additional comments Gemiddelde prijs per 30 stuks SIKLOS, TABLET 1000MG € 555,78.

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.