Carmustine Obvius
carmustine
Table of contents
Overview
Carmustine Obvius is a cancer medicine that is used, on its own or with other cancer medicines and treatments, to treat the following types of cancer:
- brain tumours, both those that develop directly in the brain and cancers that have spread from elsewhere in the body (metastatic brain tumours);
- Hodgkin’s lymphoma and non-Hodgkin’s lymphomas, types of cancer that originate from white blood cells. The medicine is used when initial treatment has not worked or the cancer has come back.
-
Carmustine Obvius is also used as a ‘conditioning’ treatment before transplantation of the patient’s own haematopoietic progenitor cells (immature cells that are able to produce the cells of the blood) to treat Hodgkin’s lymphoma and non-Hodgkin’s lymphomas. It is used to clear the patient’s bone marrow and make room for the transplanted cells.
Carmustine Obvius is a ‘generic medicine’. This means that Carmustine Obvius contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Carmubris.
-
List item
Carmustine Obvius : EPAR - Medicine overview (PDF/167.15 KB)
First published: 20/08/2018
Last updated: 16/07/2020
EMA/276728/2020 -
-
List item
Carmustine Obvius : EPAR - Risk-management-plan summary (PDF/166.17 KB)
First published: 23/06/2020
Authorisation details
Product details | |
---|---|
Name |
Carmustine Obvius
|
Agency product number |
EMEA/H/C/004326
|
Active substance |
carmustine
|
International non-proprietary name (INN) or common name |
carmustine
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
L01AD01
|
Generic |
This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines. |
Publication details | |
---|---|
Marketing-authorisation holder |
Obvius Investment B.V.
|
Revision |
5
|
Date of issue of marketing authorisation valid throughout the European Union |
18/07/2018
|
Contact address |
Product information
02/09/2020 Carmustine Obvius - EMEA/H/C/004326 - N/0004
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Pharmacotherapeutic group
Antineoplastic agents
Therapeutic indication
Carmustine is effective in the following malignant neoplasms as a single agent or in combination with other antineoplastic agents and/or other therapeutic measures (radiotherapy, surgery):
- Brain tumours (glioblastoma, brain-stem gliomas, medulloblastoma, astrocytoma and ependymoma), brain metastases
- Secondary therapy in non-Hodgkin’s lymphoma and Hodgkin’s disease
- as conditioning treatment prior to autologous haematopoietic progenitor cell transplantation (HPCT) in malignant haematological diseases (Hodgkin’s disease / Non-hodgkin’s lymphoma).