P/16/2011 - paediatric investigation plan

nepafenac

Key facts

• Invented name:
  • Nevanac
  • Nevanac
• Active Substance:
  nepafenac
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/16/2011
• PIP number:
  P/16/2011
• Pharmaceutical form(s):
  • Eye drops, solution
  • Suspension
• Condition(s) / indication(s):
  Prevention of post operative pain and inflammation associated with cataract surgery
• Route(s) of administration:
  Ocular use
• Contact for public enquiries:

  Alcon Laboratories (UK) Ltd.

  [e-mail]; United States; Phone: [phone]; Fax: [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  21/01/2011

Decision

P/16/2011: EMA decision of 21 January 2011 on the granting of a product specific waiver for nepafenac (Nevanac) (EMEA-000913-PIP01-10) in accordance with Regulation (EC) No 1901/2006 of the European Parliament and of th...

AdoptedReference Number: EMA/800821/2010