Hydroxycarbamide

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.
Therapeutic value	No judgement
Registration phase	Registration application pending

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	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	No judgement

There is currently nothing known about the expected patient volume.

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

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.