EMEA-000044-PIP01-08 - paediatric investigation plan

TGp1PTH1-34 L-Asparaginyl-L-glutaminyl-L-glutamyl-L-glutaminyl-L-valy1-L-seryl-L-prolyl-L-leucyl-L-tyrosyl-L-lysil-L-asparaginyl-L-arginyl-L-seryl-L-valyl-L-seryl-L-glutamyl-L-isoleucyl-L-glutaminyl-Lleucyl-L-methionyl-L-histidyl-L-asparaginyl-L-leucyl-L-glycyl-L-lysyl-L-histidyl-L-leucyl-Lasparaginyl-L-seryl-L-methionyl-L-glutamyl-L-arginyl-L-valyl-L-glutamyl-L-tryptophanyl-L-leucyl-L-arginyl-L-lysyl-L-lysyl-L-leucyl-L-glutamyl-L-asparty-L-valyl-L-histidyl-L-asparaginyl-Lphenylalanine-, acetate salt

Key facts

• Active Substance:
  TGp1PTH1-34 L-Asparaginyl-L-glutaminyl-L-glutamyl-L-glutaminyl-L-valy1-L-seryl-L-prolyl-L-leucyl-L-tyrosyl-L-lysil-L-asparaginyl-L-arginyl-L-seryl-L-valyl-L-seryl-L-glutamyl-L-isoleucyl-L-glutaminyl-Lleucyl-L-methionyl-L-histidyl-L-asparaginyl-L-leucyl-L-glycyl-L-lysyl-L-histidyl-L-leucyl-Lasparaginyl-L-seryl-L-methionyl-L-glutamyl-L-arginyl-L-valyl-L-glutamyl-L-tryptophanyl-L-leucyl-L-arginyl-L-lysyl-L-lysyl-L-leucyl-L-glutamyl-L-asparty-L-valyl-L-histidyl-L-asparaginyl-Lphenylalanine-, acetate salt
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/110/2008
• PIP number:
  EMEA-000044-PIP01-08
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Solitary bone cysts
• Route(s) of administration:
  Intraosseous use
• Contact for public enquiries:

  Kuros Biosurgery International AG

  E-mail: [e-mail]; Country: Switzerland; Phone: [phone]; Fax: [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  01/12/2008

Decision

P110/2008: EUROPEAN MEDICINES AGENCY DECISION of 1 December 2008 on application for agreement of Paediatric Investigation Plan for TGp1PTH1-34 L-Asparaginyl-L-glutaminyl-L-glutamyl-L-glutaminyl-L-valy1-L-seryl-L-prolyl-L...

AdoptedReference Number: EMEA/620766/2008