Basic Information
Carmustine medac (previously Carmustine Obvius)
Regulatory Information
EMEA/H/C/004326
July 18, 2018
April 26, 2018
11
September 3, 2024
Company Information
Germany
Theaterstrasse 6 22880 Wedel
medac Gesellschaft für klinische Spezialpräparate mbH
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Carmustine is indicated n adults 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).
Overview Summary
Carmustine medac 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; - tumours of stomach and bowel; - malignant melanoma (a type of skin cancer). Carmustine medac 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 medac contains the active substance carmustine and is a ‘generic medicine’. This means that Carmustine medac contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Carmubris.