P/0289/2015 - paediatric investigation plan

4-Amino-2-butoxy-8-[3-(pyrrolidin-1-ylmethyl)benzyl]-7,8-dihydropteridin-6(5H)-one (GS-9620)

Key facts

• Active Substance:
  4-Amino-2-butoxy-8-[3-(pyrrolidin-1-ylmethyl)benzyl]-7,8-dihydropteridin-6(5H)-one (GS-9620)
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0289/2015
• PIP number:
  P/0289/2015
• Pharmaceutical form(s):
  • Film-coated tablet
  • Tablet
  • Age-appropriate oral formulation
• Condition(s) / indication(s):
  Treatment of chronic viral hepatitis B
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Gilead Sciences International Ltd.

  United Kingdom; Email: [e-mail]; Tel.: [phone]; Fax: [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  27/11/2015

Decision

P/0289/2015: EMA decision of 27 November 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for 4-Amino-2-butoxy-8-[3-(pyrrolidin-1-ylmethyl)benzyl]...

AdoptedReference Number: EMA/689628/2015