EMEA-001817-PIP01-15 - paediatric investigation plan

Fluoroestradiol (18F)

Key facts

• Active Substance:
  Fluoroestradiol (18F)
• Therapeutic area:
  Oncology
• Decision number:
  P/0262/2015
• PIP number:
  EMEA-001817-PIP01-15
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Detection of pathological expression of estrogen receptors in organs and tissues
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Laboratoires Cyclopharma

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  30/10/2015

Decision

P/0262/2015: EMA decision of 30 October 2015 on the granting of a product specific waiver for 18F-fluoroestradiol (EMEA-001817-PIP01-15)

AdoptedReference Number: EMA/627027/2015