Levonorgestrel

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 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

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

Patiëntvolume is niet van toepassing bij generieke geneesmiddelen of biosimilars.

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

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

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.