EMEA-002061-PIP01-16 - paediatric investigation plan

Small interfering RNA targeting human TRPV1 mRNA

Key facts

• Active Substance:
  Small interfering RNA targeting human TRPV1 mRNA
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/0122/2017
• PIP number:
  EMEA-002061-PIP01-16
• Pharmaceutical form(s):
  • Eye drops, solution
  • Solution
• Condition(s) / indication(s):
  Treatment of dry eye disease
• Route(s) of administration:
  Ocular use
• Contact for public enquiries:

  Sylentis SAU

  United Kingdom; Tel.: [phone]; E-mail: [e-mail], [e-mail]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  05/05/2017

Decision

P/0122/2017: EMA decision of 5 May 2017 on the granting of a product specific waiver for small interfering RNA targeting human TRPV1 mRNA (EMEA-002061-PIP01-16)

AdoptedReference Number: EMA/260021/2017