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Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1300442
Name of medicinal product: IRINOTECAN KABI 20 MG/ML
Active substances:
Irinotecan
Estonian, English, Latin
ATC code: L01CE02
Dosage form: concentrate for solution for infusion
Route of administration: intravenous use
Strengh: 20mg 1ml
Amount in package: 2ml 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Irinotecan is indicated for the treatment of patients with advanced colorectal cancer: " in combination with 5-fluorouracil and folinic acid in patients without prior chemotherapy for advanced disease, " as a single agent in patients who have failed an established 5-fluorouracil containing treatment regimen. In combination with cetuximab is indicated for the treatment of patients with epidermal growth factor receptor (EGFR) -expressing, RAS wild-type metastatic colorectal cancer, who had not received prior treatment for metastatic disease or after failure of irinotecan- including cytotoxic therapy (please see 5.1). In combination with 5-fluorouracil, folinic acid and bevacizumab for first-line treatment of patients with metastatic carcinoma of the colon or rectum. In combination with capecitabine with or without bevacizumab is indicated for first-line treatment of patients with metastatic colorectal carcinoma.
Safety features: Yes
Summary of product characteristics (SPC):  (last updated May 17, 2022)
Package information leaflet (PIL): EST  (last updated May 17, 2022)
Labelling:  (last updated August 19, 2019)
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Fresenius Kabi Polska Sp. z o.o. 
Marketing authorization number: 578708 
Marketing authorization issued on: April 18, 2008 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Mutual recognition 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: November 14, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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