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Sarizotan

Extended indication Rett syndrome with respiratory symptoms
Therapeutic value No judgement
Registration phase Clinical trials

Product

Active substance Sarizotan
Domain Lung diseases
Reason of inclusion New medicine (specialité)
Main indication Lung other
Extended indication Rett syndrome with respiratory symptoms
Manufacturer Newron
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Extramural (GVS)
Additional remarks A serotonin (5-HT)1A receptor agonist and a partial agonist/antagonist at D2 receptor.

Registration

Registration route Centralised (EMA)
Submission date 2019
Expected Registration 2020
Orphan drug Yes
Registration phase Clinical trials

Therapeutic value

Current treatment options geen
Therapeutic value No judgement
Frequency of administration 1 times a day
Dosage per administration 2 - 10 mg
References NCT02790034

Expected patient volume per year

Patient volume

< 250

Market share is generally not included unless otherwise stated.
References De Nederlandse Rett Syndroom Vereniging (NRSV)
Additional remarks Het Rett syndroom heeft een incidentie van 1 op de 10.000 tot 23.000 geboren meisjes, het is extreem zeldzaam bij jongens. Het is beschreven bij alle rassen en etnische groepen. In Nederland zijn op dit moment ruim 250 meisjes met het Rett syndroom bekend.

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 No

Other information

There is currently no futher information available.