EMEA-002129-PIP02-17 - paediatric investigation plan

Fluorocholine (18F)

Key facts

• Active substance:
  Fluorocholine (18F)
• Therapeutic area:
  Diagnostic
• Decision number:
  P/0029/2018
• PIP number:
  EMEA-002129-PIP02-17
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Visualisation of choline metabolism in malignant neoplasms
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  31/01/2018
• Compliance check done:
  No

Decision

P/0029/2018: EMA decision of 30 January 2018 on the refusal of a product specific waiver for fluorocholine (18F), (EMEA-002129-PIP02-17)

Reference Number: EMA/27426/2018