EMEA-002224-PIP01-17 - paediatric investigation plan

synthetic double-stranded small interfering RNA (siRNA) oligonucleotide specific to the mRNA of the caspase 2 gene

Key facts

• Active substance:
  synthetic double-stranded small interfering RNA (siRNA) oligonucleotide specific to the mRNA of the caspase 2 gene
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/0394/2017
• PIP number:
  EMEA-002224-PIP01-17
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of optic ischaemic neuropathy
• Route(s) of administration:
  Intravitreal use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  19/12/2017
• Compliance check done:
  No

Decision

P/0394/2017: EMA decision of 19 December 2017 on the granting of a product specific waiver for synthetic double-stranded small interfering RNA (siRNA) oligonucleotide specific to the mRNA of the caspase 2 gene (QPI-1007...

Reference Number: EMA/797358/2017