EMEA-002717-PIP02-20 - paediatric investigation plan

sepofarsen

Key facts

• Active Substance:
  sepofarsen
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/0129/2021
• PIP number:
  EMEA-002717-PIP02-20
• Pharmaceutical form(s):
  Solution for injection in a cartridge
• Condition(s) / indication(s):
  Treatment of Leber's Congenital Amaurosis
• Route(s) of administration:
  Intravitreal use
• Contact for public enquiries:

  ProQR Therapeutics

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

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  14/04/2021

Decision

P/0129/2021: EMA decision of 14 April 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral for sepofarsen (EMEA-002717-PIP02-20)

AdoptedReference Number: EMA/151843/2021