Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: CAPECITABINE ACCORD
Active substances:
Capecitabine
Estonian, English, Latin
ATC code: L01BC06
Dosage form: film-coated tablet
Strength: 300mg
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
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
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 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1568000  CAPECITABINE ACCORD  film-coated tablet  300mg 30TK  Prescription           
1568011  CAPECITABINE ACCORD  film-coated tablet  300mg 60TK  Prescription           
1568022  CAPECITABINE ACCORD  film-coated tablet  300mg 120TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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