Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1293128
Name of medicinal product: ERBITUX
Active substances:
Estonian, English, Latin
ATC code: L01FE01
Dosage form: solution for infusion
Route of administration: intravenous use
Strengh: 5mg 1ml
Amount in package: 20ml 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Erbitux is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)- expressing, RAS wild-type metastatic colorectal cancer - in combination with irinotecan-based chemotherapy, - in first-line in combination with FOLFOX, - based therapy and who are intolerant to irinotecan. For details, see section 5.1. Erbitux is indicated for the treatment of patients with squamous cell cancer of the head and neck - in combination with radiation therapy for locally advanced disease, - in combination with platinum-based chemotherapy for recurrent and/or metastatic disease.
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Last imported to Estonia: May 3, 2024
Marketing authorization holder: Merck Europe B.V. 
Marketing authorization number: EU/1/04/281 
Marketing authorization issued on: February 20, 2007 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: November 16, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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