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 remarks 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.