EMEA-000611-PIP01-09 - paediatric investigation plan

pegaptanib sodium

Key facts

• Invented name:
  • Macugen
  • Macugen
• Active substance:
  pegaptanib sodium
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/195/2009
• PIP number:
  EMEA-000611-PIP01-09
• 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:
  07/10/2009
• Compliance check done:
  No

Decision

P/195/2009: European Medicines Agency decision of 7 October 2009 on the granting of a product specific waiver for pegaptanib sodium, Macugen (EMEA-000611-PIP01-09) in accordance with Regulation (EC) No 1901/2006 of the E...

Adopted Reference Number: EMEA/604653/2009