EMEA-001993-PIP01-16 - paediatric investigation plan

synthetic double-stranded siRNA oligonucleotide directed against p53 mRNA (QPI-1002)

Key facts

• Active substance:
  synthetic double-stranded siRNA oligonucleotide directed against p53 mRNA (QPI-1002)
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0347/2016
• PIP number:
  EMEA-001993-PIP01-16
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Prevention of delayed graft function (DGF) after kidney transplantation
• Route(s) of administration:
  Solution for injection
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  05/12/2016
• Compliance check done:
  No

Decision

P/0347/2016: EMA decision of 5 December 2016 on the granting of a product specific waiver for synthetic double-stranded siRNA oligonucleotide directed against p53 mRNA (QPI-1002) (EMEA-001993-PIP01-16)

Adopted Reference Number: EMA/760455/2016