EMEA-000527-PIP05-17 - paediatric investigation plan

ranibizumab

Key facts

• Invented name:
  • Lucentis
  • Lucentis
• Active Substance:
  ranibizumab
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/0142/2018
• PIP number:
  EMEA-000527-PIP05-17
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Diabetic retinopathy
• Route(s) of administration:
  Intravitreal use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  07/05/2018

Decision

P/0142/2018: EMA decision of 7 May 2018 on the granting of a product specific waiver for ranibizumab (Lucentis), (EMEA-000527-PIP05-17)

AdoptedReference Number: EMA/258310/2018