EMEA-000527-PIP02-10 - paediatric investigation plan

ranibizumab

Key facts

• Invented name:
  • Lucentis
  • Lucentis
• Active Substance:
  ranibizumab
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/291/2010
• PIP number:
  EMEA-000527-PIP02-10
• Pharmaceutical form(s):
  • Solution for injection – single-use vial
  • Solution for injection – single-use pre-filled syringe
• Condition(s) / indication(s):
  Treatment of visual impairment due to choroidal neovascularisation secondary to pathologic myopia
• Route(s) of administration:
  Intravitreal use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  22/12/2010

Decision

P/291/2010: EMA decision of 22 December 2010 on the granting of a product specific waiver for ranibizumab (Lucentis), (EMEA-000527-PIP02-10)

AdoptedReference Number: EMA/773522/2010