EMEA-002601-PIP01-19 - paediatric investigation plan

adeno-associated viral vector serotype 8 containing the human RPGR gene

Key facts

• Active substance:
  adeno-associated viral vector serotype 8 containing the human RPGR gene
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/0229/2020
• PIP number:
  EMEA-002601-PIP01-19
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  Treatment of X-linked retinitis pigmentosa
• Route(s) of administration:
  Ophthalmic use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  17/06/2020
• Compliance check done:
  Nej

Decision

P/0229/2020: of 17 June 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for adeno-associated viral vector serotype 8 containing the human RPGR...(AAV8-RPGR) (EMEA-002601-PIP01-19)

Adopted Reference Number: EMA/305290/2020