EMEA-000527-PIP04-13-M01 - paediatric investigation plan

ranibizumab

Key facts

• Invented name:
  • Lucentis
  • Lucentis
• Active Substance:
  ranibizumab
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/0010/2017
• PIP number:
  EMEA-000527-PIP04-13-M01
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of retinopathy of prematurity
• Route(s) of administration:
  Intravitreal use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  31/01/2017
• Compliance procedure number:
  EMEA-C-000527-PIP04-13-M01
• Compliance opinion date:
  19/10/2018
• Compliance outcome:
  Positive

Decision

P/0010/2017: EMA decision of 31 January 2017 on the acceptance of a modification of an agreed paediatric investigation plan for ranibizumab (Lucentis), (EMEA-000527-PIP04-13-M01)

AdoptedReference Number: EMA/38628/2017