EMEA-002269-PIP01-17-M01 - paediatric investigation plan

Olaparib

Key facts

• Invented name:
  Lynparza
• Active Substance:
  Olaparib
• Therapeutic area:
  Oncology
• Decision number:
  P/0250/2020
• PIP number:
  EMEA-002269-PIP01-17-M01
• Pharmaceutical form(s):
  • Capsule (hard)
  • Film-coated tablet
• Condition(s) / indication(s):
  Treatment of all conditions included in the category of malignant neoplasms (except central nervous system tumours, haematopoietic and lymphoid tissue neoplasms)
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  AstraZeneca AB (Sweden)

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  15/07/2020

Decision

P/0250/2020: EMA decision of 15 July 2020 on the acceptance of a modification of an agreed paediatric investigation plan for olaparib (Lynparza), (EMEA-002269-PIP01-17-M01)

AdoptedReference Number: EMA/358974/2020