Product class: Authorized package
Medicinal product class: For human use
Package code: 1423921
Name of medicinal product: BLEOMYCIN MEDAC
Active substances:
Estonian, English, Latin
ATC code: L01DC01
Dosage form: powder for solution for injection
Route of administration: intramuscular use
Amount in package: 10TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: The administration of bleomycin almost always takes place in combination with other cytostatic drugs and/or radiation therapy. Bleomycin is intended for the treatment of: - Squamous cell carcinoma (SCC) of the head and neck , external genitalia and cervix. - Hodgkin's lymphoma. - Non-Hodgkin's lymphoma of intermediate and high malignancy in adults. - Testis carcinoma (seminoma and non-seminoma). - Intrapleural therapy of malignant pleural effusion.
Safety features: Yes
Summary of product characteristics (SPC):  (last updated 27 December 2023)
Package information leaflet (PIL): EST  (last updated 27 December 2023)
Labelling:  (last updated 23 July 2018)
Last imported to Estonia: 26 April 2013
Marketing authorization holder: Medac Gesellschaft für klinische Spezialpräparate mbH 
Marketing authorization number: 730011 
Marketing authorization issued on: 01 February 2011 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Decentralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: 27 December 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription