FEBUCIP

Main information

  • Trade name:
  • FEBUCIP 10 TAB
  • Dosage:
  • 40MG
  • Pharmaceutical form:
  • TAB
  • Composition:
  • 10
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FEBUCIP 10 TAB
    India
  • Language:
  • English

Other information

Status

  • Source:
  • Central Drugs Standard Control Organization
  • Last update:
  • 09-08-2016

22-8-2018

FDA Drug Safety Communication: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric)

FDA Drug Safety Communication: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric)

The U.S. Food and Drug Administration (FDA) is warning that preliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat (Uloric) compared to another gout medicine called allopurinol. We required the Uloric drug manufacturer, Takeda Pharmaceuticals, to conduct this safety study when we approved the medicine in 2009. Once we receive the final results from the manufacturer, we will conduct a comprehensive review and will update the public with any new inf...

FDA - U.S. Food and Drug Administration

1-2-2019


Summary of opinion: Febuxostat Krka,febuxostat,  01/02/2019,  Positive

Summary of opinion: Febuxostat Krka,febuxostat, 01/02/2019, Positive

Summary of opinion: Febuxostat Krka,febuxostat, 01/02/2019, Positive

Europe - EMA - European Medicines Agency

22-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Adenuric,febuxostat, decision type: , therapeutic area: , PIP number: P/0226/2018

Opinion/decision on a Paediatric investigation plan (PIP): Adenuric,febuxostat, decision type: , therapeutic area: , PIP number: P/0226/2018

Opinion/decision on a Paediatric investigation plan (PIP): Adenuric,febuxostat, decision type: , therapeutic area: , PIP number: P/0226/2018

Europe - EMA - European Medicines Agency