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
• Contact for public enquiries:

  Quark Pharmaceuticals, Inc.

  Tel. [phone]; E-mail: [e-mail]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  19/12/2017

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