Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1543643
Name of medicinal product: ETOPOSIDE KABI 20 MG/ML
Active substances:
Etoposide
Estonian, English, Latin
ATC code: L01CB01
Dosage form: concentrate for solution for infusion
Route of administration: intravenous use
Strengh: 20mg 1ml
Amount in package: 25ml 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Testicular cancer Etoposide is indicated in combination with other approved chemotherapeutic agents for the treatment of first line, recurrent or refractory testicular cancer in adults. Small cell lung cancer Etoposide is indicated in combination with other approved chemotherapeutic agents for the treatment of small-cell lung cancer in adults. Hodgkin’s lymphoma Etoposide is indicated in combination with other approved chemotherapeutic agents for the treatment of Hodgkin’s lymphoma in adult and paediatric patients. Non-Hodgkin’s lymphoma Etoposide is indicated in combination with other approved chemotherapeutic agents for the treatment of non-Hodgkin’s lymphoma in adult and paediatric patients. Acute myeloid leukaemia Etoposide is indicated in combination with other approved chemotherapeutic agents for the treatment of acute myeloid leukaemia in adult and paediatric patients. Gestational trophoblastic neoplasia Etoposide is indicated for first line and second line therapy in combination with other approved chemotherapeutic agents for the treatment of high risk gestational trophoblastic neoplasia in adults. Ovarian cancer Etoposide is indicated in combination with other approved chemotherapeutic agents for the treatment of non-epithelial ovarian cancer in adults. Etoposide is indicated for the treatment of platinum-resistant/refractory epithelial ovarian cancer in adults.
Safety features: Yes
Summary of product characteristics (SPC):  (last updated March 21, 2024)
Package information leaflet (PIL): EST  (last updated March 21, 2024)
Labelling:  (last updated March 21, 2024)
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Fresenius Kabi Polska Sp. z o.o. 
Marketing authorization number: 843214 
Marketing authorization issued on: April 29, 2014 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Decentralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: May 30, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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