Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
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
Strength: 100mg
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
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
Marketing authorization holder: Medac Gesellschaft für klinische Spezialpräparate mbH 
Marketing authorization number: EU/1/18/1278 
Marketing authorization issued on: July 23, 2018 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1777080  CARMUSTINE MEDAC  powder and solvent for concentrate for solution for infusion  100mg 1TK  Prescription      30.04.2024     
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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