EMEA-001054-PIP01-10-M03 - paediatric investigation plan

L-Cysteinyl-L-prolyl-L-alanyl-L-valyl-L-lysyl-L-arginyl-L-aspartyl-L-valyl-L-aspartyl-L-leucyl-L-phenylalanyl-L-leucyl-L-threonine, acetate salt

L-glutamyl-L-glutaminyl-L-valyl-L-alanyl-Lglutaminyl-L-tyrosyl-L-lysyl-L-alanyl-L-leucyl-L-prolyl-L-valyl-L-valyl-L-leucyl-L-glutamyl-L-asparaginyl-L-alanine, acetate salt

L-lysyl-L-alanyl-L-leucyl-L-prolyl-L-valyl-L-valyl-L-leucyl-L-glutamyl-L-asparaginyl-L-alanyl-L-arginyl-L-isoleucyl-L-leucyl-L-lysyl-L-asparaginyl-L-cysteinyl-L-valine, acetate salt...

Key facts

• Invented name:
  Katclari
• Active Substance:
  • L-Cysteinyl-L-prolyl-L-alanyl-L-valyl-L-lysyl-L-arginyl-L-aspartyl-L-valyl-L-aspartyl-L-leucyl-L-phenylalanyl-L-leucyl-L-threonine, acetate salt
  • L-glutamyl-L-glutaminyl-L-valyl-L-alanyl-Lglutaminyl-L-tyrosyl-L-lysyl-L-alanyl-L-leucyl-L-prolyl-L-valyl-L-valyl-L-leucyl-L-glutamyl-L-asparaginyl-L-alanine, acetate salt
  • L-lysyl-L-alanyl-L-leucyl-L-prolyl-L-valyl-L-valyl-L-leucyl-L-glutamyl-L-asparaginyl-L-alanyl-L-arginyl-L-isoleucyl-L-leucyl-L-lysyl-L-asparaginyl-L-cysteinyl-L-valine, acetate salt...
• Therapeutic area:
  Oto-rhino-laryngology
• Decision number:
  P/0170/2015
• PIP number:
  EMEA-001054-PIP01-10-M03
• Pharmaceutical form(s):
  Powder for solution for injection
• Condition(s) / indication(s):
  Treatment of perennial allergic rhinitis
• Route(s) of administration:
  Intradermal use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  07/08/2015

Decision

P/0170/2015: EMA decision of 7 August 2015 on the acceptance of a modification of an agreed paediatric investigation plan for EMEA-001054-PIP01-10-M03

AdoptedReference Number: EMA/508507/2015