EMEA-001986-PIP01-16 - paediatric investigation plan

radium (223Ra) dichloride

Key facts

• Invented name:
  • Xofigo
  • Xofigo
• Active Substance:
  radium (223Ra) dichloride
• Therapeutic area:
  Oncology
• Decision number:
  P/0178/2017
• PIP number:
  EMEA-001986-PIP01-16
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  • Treatment of Multiple Myeloma
  • 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:
  Intravenous use
• Contact for public enquiries:

  Bayer AG

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  03/07/2017

Decision

P/0178/2017: EMA decision of 3 July 2017 on the granting of a product specific waiver for radium Ra223 dichloride (Xofigoe), (EMEA-001986-PIP01-16)

AdoptedReference Number: EMA/348033/2017