Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1681961
Name of medicinal product: IRINOTECAN ACCORD
Active substances:
Estonian, English, Latin
ATC code: L01CE02
Dosage form: concentrate for solution for infusion
Route of administration: intravenous use
Strengh: 20mg 1ml
Amount in package: 15ml 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: 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. (see section 5.1) in combination with 5-fluorouracil, folinic acid and bevacizumab is indicated 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 January 9, 2024)
Package information leaflet (PIL): EST  (last updated May 6, 2024)
Labelling:  (last updated May 25, 2020)
Last imported to Estonia: March 8, 2019
Marketing authorization holder: Accord Healthcare B.V. 
Marketing authorization number: 916416 
Marketing authorization issued on: September 13, 2016 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Decentralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: May 6, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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