Carmustine medac (previously Carmustine Obvius) (carmustine)
- Region
- 🇪🇺 EU
- Active substance
- carmustine
- Company
- medac Gesellschaft für klinische Spezialpräparate mbH
- Status
- Authorised
- Therapeutic area
- Hodgkin Disease; Lymphoma, Non-Hodgkin
- CHMP opinion
- Thu 26 Apr 2018
- EU approval
- Wed 18 Jul 2018
- Designations
- Generic
- Application
- EMEA/H/C/004326
- ATC
- L01AD01
- Official record
- www.ema.europa.eu
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).
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.