EMEA-001350-PIP02-13-M04 - paediatric investigation plan

Idelalisib

Key facts

• Invented name:
  • Zydelig
  • Zydelig
• Active Substance:
  Idelalisib
• Therapeutic area:
  Oncology
• Decision number:
  P/0345/2018
• PIP number:
  EMEA-001350-PIP02-13-M04
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age-appropriate dispersible tablet
• Condition(s) / indication(s):
  Treatment of mature B-cell neoplasms
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Gilead Sciences International Limited

  Tel. [phone]; E-mail: [e-mail]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  09/11/2018

Decision

P/0345/2018: EMA decision of 9 November 2018 on the acceptance of a modification of an agreed paediatric investigation plan for idelalisib (Zydelig) (EMEA-001350-PIP02-13-M04)

AdoptedReference Number: EMA/776168/2018