EMEA-002293-PIP01-17 - paediatric investigation plan

Calcium, N,N'-1,2-ethanediylbis[N-[[3-(hydroxy-2-methyl-5-[(phosphonooxy)methyl]-4-pyridinyl]methyl]glycine] manganese complexes

Key facts

• Active substance:
  Calcium, N,N'-1,2-ethanediylbis[N-[[3-(hydroxy-2-methyl-5-[(phosphonooxy)methyl]-4-pyridinyl]methyl]glycine] manganese complexes
• Therapeutic area:
  Oncology
• Decision number:
  P/0115/2018
• PIP number:
  EMEA-002293-PIP01-17
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Prevention of oxaliplatin induced peripheral neuropathy
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  11/04/2018
• Compliance check done:
  No

Decision

P/0115/2018: EMA decision of 11 April 2018 on the granting of a product specific waiver for calcium, N,N'-1,2-ethanediylbis[N-[[3-(hydroxy-2- methyl-5-[(phosphonooxy)methyl]-4-pyridinyl]methyl]glycine] manganese complex...

Adopted Reference Number: EMA/194478/2018