Xeloda / Capecitabine Accord / Capecitabine Medac / Capecitabine Teva / Ecansya (previously Capecitabine Krka) / Teysuno - direct healthcare professional communication (DHPC)

Fluorouracil / capecitabine / tegafur

About

This direct healthcare professional communication (DHPC) contains important information for healthcare professionals prescribing, dispensing or administering the medicine(s). It also includes a communication plan with details of intended recipients and the dissemination date.

Documents

Direct healthcare professional communication (DHPC): 5-Fluorouracil (i.v.), capecitabine and tegafur containing products: Pre-treatment testing to identify DPD-deficient patients at increased risk of severe toxicity

Dissemination date: 04/06/2020

Key facts

• Medicine name:
  • Xeloda
  • Capecitabine Accord
  • Capecitabine Medac
  • Capecitabine Teva
  • Ecansya (previously Capecitabine Krka)
  • Teysuno
• Active substance:
  • Fluorouracil
  • capecitabine
  • tegafur
• Procedure number:
  EMEA/H/A-31/1488
• Regulatory outcome:
  Variation
• DHPC type:
  Referral - Article 31
• Human ATC codes:
  • L01BC06
  • L01BC53
  • L01BC02
• Dissemination date:
  04/06/2020