EMEA-001810-PIP01-15 - paediatric investigation plan

L-Cysteine, L-leucyl-L-α-glutamyl-L-α-glutamyl-L-lysyl-L-lysylglycyl-L-asparaginyl-L-tyrosyl-L-valyl-L-valyl-L-threonyl-L-α -aspartyl-L-histidyl-S-[1-[(4-carboxycyclohexyl)methyl]-2,5-dioxo-3-pyrrolidinyl]-, complex with keyhole limpet haemocyanin

Key facts

• Active substance:
  L-Cysteine, L-leucyl-L-α-glutamyl-L-α-glutamyl-L-lysyl-L-lysylglycyl-L-asparaginyl-L-tyrosyl-L-valyl-L-valyl-L-threonyl-L-α -aspartyl-L-histidyl-S-[1-[(4-carboxycyclohexyl)methyl]-2,5-dioxo-3-pyrrolidinyl]-, complex with keyhole limpet haemocyanin
• Therapeutic area:
  Oncology
• Decision number:
  P/0259/2015
• PIP number:
  EMEA-001810-PIP01-15
• Pharmaceutical form(s):
  Powder for solution for injection
• Condition(s) / indication(s):
  Treatment of high-grade glioma
• Route(s) of administration:
  Intradermal use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  30/10/2015
• Compliance check done:
  No

Decision

P/0259/2015: EMA decision of 30 October 2015 on the granting of a product specific waiver for L-Cysteine, L-leucyl-L-α-glutamyl-L-α-glutamyl-L-lysyl-L-lysylglycyl-L-asparaginyl-L-tyrosyl-L-valyl-L-valyl-L-threonyl-L-Î...

Adopted Reference Number: EMA/627030/2015