EMEA-002575-PIP03-21 - paediatric investigation plan

pralsetinib

Key facts

• Invented name:
  Gavreto
• Active Substance:
  pralsetinib
• Therapeutic area:
  Oncology
• Decision number:
  P/0428/2021
• PIP number:
  EMEA-002575-PIP03-21
• Pharmaceutical form(s):
  Capsule (hard)
• Condition(s) / indication(s):
  • Treatment of all conditions included in the category of malignant neoplasms [except lung cancer (small cell and non-small cell cancer), thyroid neoplasms, central nervous system tumours, haematopoietic and lymphoid tissue neoplasms]
  • Treatment of malignant neoplasms of haematopoietic and lymphoid tissue
  • Treatment of malignant neoplasms of the central nervous system
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Roche Registration GmbH

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  29/10/2021

Decision

P/0428/2021 : EMA decision of 29 October 2021 on the granting of a product specific waiver for pralsetinib (EMEA-002575-PIP03-21)

AdoptedReference Number: EMA/531488/2021