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

1. Product

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

2. 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

3. Therapeutic value

Therapeutic value
Potential equal value
Duration of treatment
Not found

4. Expected patient volume per year

Patiëntvolume is niet van toepassing bij generieke geneesmiddelen of biosimilars.

5. Expected cost per patient per year

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

6. Potential total cost per year

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

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

There is currently nothing known about indication extensions.

9. Other information

There is currently no futher information available.