EMEA-001191-PIP01-11-M03 - paediatric investigation plan

Daclatasvir

Key facts

• Invented name:
  Daklinza
• Active Substance:
  Daclatasvir
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0367/2019
• PIP number:
  EMEA-001191-PIP01-11-M03
• Pharmaceutical form(s):
  • Chewable tablet
  • Film-coated 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:
  08/11/2019

Decision

P/0367/2019: EMA decision of 8 November 2019 on the acceptance of a modification of an agreed paediatric investigation plan for daclatasvir (Daklinza), (EMEA-001191-PIP01-11-M03)

AdoptedReference Number: EMA/590910/2019