EMEA-002407-PIP01-18 - paediatric investigation plan

Lentiviral vector containing the human ABCA4 gene

Key facts

• Active Substance:
  Lentiviral vector containing the human ABCA4 gene
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/0213/2019
• PIP number:
  EMEA-002407-PIP01-18
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of inherited retinal disorders
• Route(s) of administration:
  Intraocular use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  14/06/2019

Decision

P/0213/2019: EMA decision of 14 June 2019 on the agreement of a paediatric investigation plan and on the granting of a waiver for lentiviral vector containing the human ABCA4 gene (SAR422459) (EMEA-002407-PIP01-18)

AdoptedReference Number: EMA/299187/2019