EMEA-000527-PIP01-08 - paediatric investigation plan

ranibizumab

Key facts

• Invented name:
  • Lucentis
  • Lucentis
• Active Substance:
  ranibizumab
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/183/2009
• PIP number:
  EMEA-000527-PIP01-08
• Pharmaceutical form(s):
  • Solution for injection in a vial
  • Solution for injection in pre-filled syringe
• Condition(s) / indication(s):
  • Visual impairment due to diabetic macular edema
  • Visual impairment due to macular edema associated with branch retinal vein occlusion
  • Visual impairment due to macular edema associated with central retinal vein occlusion
• Route(s) of administration:
  Intravitreal use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  07/09/2009

Decision

P/183/2009: European Medicines Agency decision of 7 September 2009 on the granting of a product specific waiver for ranibizumab (Lucentis), (EMEA-000527-PIP01-08) in accordance with Regulation (EC) No 1901/2006 of the Eu...

AdoptedReference Number: EMEA/516566/2009