Product class: Authorized package
Medicinal product class: For human use
Package code: 1777080
Name of medicinal product: CARMUSTINE MEDAC
Active substances:
Carmustine
Estonian, English, Latin
ATC code: L01AD01
Dosage form: powder and solvent for concentrate for solution for infusion
Route of administration: intravenous use
Strengh: 100mg
Amount in package: 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Carmustine is indicated in 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 - Tumours of the gastrointestinal tract, - Malignant melanoma in combination with other antineoplastic medicinal products. - as conditioning treatment prior to autologous haematopoietic progenitor cell transplantation (HPCT) in malignant haematological diseases (Hodgkin’s disease / Non-hodgkin’s lymphoma).
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: 30 April 2024
Marketing authorization holder: Medac Gesellschaft für klinische Spezialpräparate mbH 
Marketing authorization number: EU/1/18/1278 
Marketing authorization issued on: 23 July 2018 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: 06 February 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription