Extended indication

Anticonceptie. Hevig menstrueel bloedverlies.

Therapeutic value

Possible equal value

Registration phase

Registration application pending

Product

Active substance

Levonorgestrel

Domain

Metabolism and Endocrinology

Reason of inclusion

Generic

Main indication

Other metabolism and Endocrinology

Extended indication

Anticonceptie. Hevig menstrueel bloedverlies.

Current proprietary name

Mirena

Proprietary name

Levosert

Manufacturer

Gedeon

Mechanism of action

Hormonal therapy

Route of administration

Intrauterine

Therapeutical formulation

Implant

Budgetting framework

Extramural (GVS)

Registration

Registration route

Decentralised

Type of trajectory

Informed consent application

ATMP

No

Submission date

2021

Expected Registration

2022

Orphan drug

No

Registration phase

Registration application pending

Additional comments
RMS goedkeuring ontvangen - in nationale afsluitfase

Therapeutic value

Current treatment options

Mirena, Kyleena

Therapeutic value

Possible equal value

Substantiation

generiek - zelfde samenstelling als Mirena alsook single handed insertie

Duration of treatment

Maximal 6 year / years

Dosage per administration

1 IUD voor max. 6 jaar

References
SmPC

Expected patient volume per year

Patiëntvolume is niet van toepassing bij generieke geneesmiddelen of biosimilars.

Expected cost per patient per year

Horizonscan vermeldt geen prijsinformatie van generieke geneesmiddelen of biosimilars om het eventueel beïnvloeden van de markt te voorkomen.

Potential total cost per year

Horizonscan vermeldt geen prijsinformatie van generieke geneesmiddelen of biosimilars om het eventueel beïnvloeden van de markt te voorkomen.

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.