EMEA-001977-PIP02-16 - paediatric investigation plan

fluoromisonidazole (18F)

Key facts

• Active Substance:
  fluoromisonidazole (18F)
• Therapeutic area:
  Oncology
• Decision number:
  P/0277/2016
• PIP number:
  EMEA-001977-PIP02-16
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  • Imaging of hypoxic tissue in gliomas for diagnostic purposes
  • Imaging of hypoxic tissue in head and neck squamous cell carcinoma for diagnostic purposes
  • Imaging of hypoxic tissue in non-small cell lung cancer for diagnostic purposes
  • Imaging of hypoxic tissue in renal cell carcinoma for diagnostic purposes
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  RadioMedic s.r.o.

  Czech Republic; Tel. [phone]; Fax [phone]; E-mail: [e-mail]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  05/10/2016

Decision

P/0277/2016: EMA decision of 5 October 2016 on the refusal of a product specific waiver for 18F fluoromisonidazole (EMEA-001977-PIP02-16)

AdoptedReference Number: EMA/593540/2016