Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1568033
Name of medicinal product: CAPECITABINE ACCORD
Active substances:
Capecitabine
Estonian, English, Latin
ATC code: L01BC06
Dosage form: film-coated tablet
Route of administration: oral use
Strengh: 500mg
Amount in package: 30TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Capecitabine Accord is indicated for the treatment of: -for the adjuvant treatment of patients following surgery of stage III (Dukes’ stage C) colon cancer (see section 5.1). - metastatic colorectal cancer (see section 5.1). - first-line treatment of advanced gastric cancer in combination with a platinum based regimen (see section 5.1). in combination with docetaxel (see section 5.1) for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Accord Healthcare S.L.U. 
Marketing authorization number: EU/1/12/762 
Marketing authorization issued on: April 20, 2012 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: February 25, 2019
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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