EMEA-000527-PIP03-13 - paediatric investigation plan

ranibizumab

Key facts

• Invented name:
  • Lucentis
  • Lucentis
• Active Substance:
  ranibizumab
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/0185/2014
• PIP number:
  EMEA-000527-PIP03-13
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  • Treatment of macular oedema
  • Treatment of choroidal neovascularisation
• Route(s) of administration:
  Intravitreal use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  06/08/2014

Decision

P/0185/2014: EMA decision of 6 August 2014 on the granting of a product specific waiver for ranibizumab (Lucentis), (EMEA-000527-PIP03-13)

AdoptedReference Number: EMA/416185/2014