Carmustine

Active substance Carmustine
Domain Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen Generic
Main indication Hematology other
Extended indication carmustine with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoieticprogenitor cell transplantation (HPCT) in haematological diseases

Product

Proprietary name Carmustine Obvius
Manufacturer Oasmia
Mechanism of action Alkylating agent
Additional comments fabrikant Obvius

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity Indication extension
Submission date July 2019
Expected Registration June 2020
Orphan drug No
Registration phase Positive CHMP opinion
Additional comments Positieve opinie april 2020

Therapeutic value

Therapeutic value Potential equal value
Duration of treatment Not found

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.