EMEA-000986-PIP02-13 - paediatric investigation plan

ocriplasmin

Key facts

• Invented name:
  • Jetrea
  • Jetrea
• Active substance:
  ocriplasmin
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/0049/2014
• PIP number:
  EMEA-000986-PIP02-13
• Pharmaceutical form(s):
  Concentrate for solution for injection
• Condition(s) / indication(s):
  Treatment of symptomatic focal vitreomacular adhesion
• Route(s) of administration:
  Intravitreal use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  07/03/2014
• Compliance check done:
  Nej

Decision

P/0049/2014: European Medicines Agency decision of 7 March 2014 on the granting of a product specific waiver for ocriplasmin (Jetrea) (EMEA-000986-PIP02-13)

Adopted Reference Number: EMA/43438/2014