Product class: Authorized package
Medicinal product class: For human use
Package code: 1567986
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: 150mg
Amount in package: 60TK
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: 13 June 2024
Marketing authorization holder: Accord Healthcare S.L.U. 
Marketing authorization number: EU/1/12/762 
Marketing authorization issued on: 20 April 2012 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Percent Valid from Valid until Valid Diagnosis Doctor's speciality Primary Age Other
100  05/04/2024     Yes      No  until 4 years   
100  05/04/2024     Yes  C18-C20  Onkoloog  No  until 4 years  kolorektaalvähi adjuvantseks ja palliatiivseks monokemoteraapiaks 
100  05/04/2024     Yes  C22-C25  Onkoloog  No     biliopankreaatilise süsteemi kasvajate adjuvantraviks 
50  05/04/2024     Yes      No      
100  05/04/2024     Yes  C18-C20  Onkoloog  No     kolorektaalvähi adjuvantseks ja palliatiivseks monokemoteraapiaks 
100  05/04/2024     Yes  C22-C25  Onkoloog  No  until 4 years  biliopankreaatilise süsteemi kasvajate adjuvantraviks 
Reference price: 17.43 EUR 
Under reference price: Yes 
Reference price of daily dose: 8.33 EUR 
Entry/Changing date: 24 November 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription