Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: BLEOMYCIN MEDAC
Active substances:
Estonian, English, Latin
ATC code: L01DC01
Dosage form: powder for solution for injection
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):  (last updated December 27, 2023)
Package information leaflet (PIL): EST  (last updated December 27, 2023)
Labelling:  (last updated July 23, 2018)
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
Marketing authorization holder: Medac Gesellschaft für klinische Spezialpräparate mbH 
Marketing authorization number: 730011 
Marketing authorization issued on: February 1, 2011 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Decentralised 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1423921  BLEOMYCIN MEDAC  powder for solution for injection  10TK  Prescription      26.04.2013     
1542574  BLEOMYCIN MEDAC  powder for solution for injection  1TK  Prescription      18.06.2024     
1674985  BLEOMYCIN MEDAC  powder for solution for injection  30000RÜ 1TK  Prescription           
1674996  BLEOMYCIN MEDAC  powder for solution for injection  30000RÜ 10TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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