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Teduglutide

Revestive

Extended indication

Extension of indication to include patients from 4 months corrected gestational aged 1 year and abov

Therapeutic value

No estimate possible yet
Registration phase

Registration application pending

Product

Active substance

Teduglutide
Domain

Chronic immune diseases
Reason of inclusion

Indication extension
Main indication

Bowel diseases
Extended indication

Extension of indication to include patients from 4 months corrected gestational aged 1 year and above With Short Bowel Syndrome
Proprietary name

Revestive
Manufacturer

Takeda
Mechanism of action

Glucagon analogue
Route of administration

Subcutaneous
Therapeutical formulation

Injection
Budgetting framework

Extramural (GVS)

Registration

Registration route

Centralised (EMA)
Submission date

August 2021
Expected Registration

February 2023
Orphan drug

Yes
Registration phase

Registration application pending

Therapeutic value

Therapeutic value

No estimate possible yet
Substantiation

Op termijn is er mogelijk een plaats voor teduglutide bij een bepaalde groep patiënten met short bowel syndroom. Op dit moment is er geen uitspraak te doen over de therapeutische waarde.
Frequency of administration

1 times a day
Dosage per administration

0.05 mg per kg body weight
References 
NCT03571516

Expected patient volume per year

References 
Expert opinie;
Additional remarks 
Er wordt voorlopig geen groot patiëntvolume verwacht voor deze indicatie.

Expected cost per patient per year

Additional remarks 
Prijs in Nederland is nog niet bekend. In Canada kost een flesje $904.00 dit is omgerekend €657,76.

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.