EMEA-001805-PIP01-15 - paediatric investigation plan

Dasabuvir

Ombitasvir

paritaprevir

ritonavir

Key facts

• Active Substance:
  • Dasabuvir
  • Ombitasvir
  • paritaprevir
  • ritonavir
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0228/2015
• PIP number:
  EMEA-001805-PIP01-15
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of chronic hepatitis C
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  02/10/2015

Decision

P/0228/2015: EMA decision of 2 October 2015 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of a waiver for dasabuvir / ombitasvir / paritaprevir / ritonavir (EMEA-0...

AdoptedReference Number: EMA/617396/2015