Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1804351
Name of medicinal product: CARMUSTINE ACCORD
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 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; - Tumours of the gastrointestinal tract; - Malignant melanoma in combination with other antineoplastic drugs; - 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):  (last updated May 24, 2023)
Package information leaflet (PIL): EST  (last updated May 24, 2023)
Labelling:  (last updated February 8, 2022)
Last imported to Estonia: May 22, 2024
Marketing authorization holder: Accord Healthcare B.V. 
Marketing authorization number: 1051322 
Marketing authorization issued on: February 8, 2022 
Marketing authorization expires on: February 8, 2027 
Marketing authorization procedure type: Decentralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: April 4, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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