EMEA-001595-PIP01-13 - paediatric investigation plan

bromfenac sodium sesquihydrate

Key facts

• Active Substance:
  bromfenac sodium sesquihydrate
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/0232/2014
• PIP number:
  EMEA-001595-PIP01-13
• Pharmaceutical form(s):
  • Eye drops, solution
  • Solution
• Condition(s) / indication(s):
  • Prevention of postoperative pain and inflammation associated with cataract surgery
  • Treatment of postoperative pain and inflammation associated with cataract surgery
• Route(s) of administration:
  Ocular use
• Contact for public enquiries:

  InSite Vision Incorporated

  USA ; E-mail: [e-mail]; Tel. [phone] ; Fax [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  05/09/2014

Decision

P/0232/2014: EMA decision of 5 September 2014 on the granting of a product specific waiver for bromfenac (sodium sesquihydrate) (EMEA-001595-PIP01-13)

AdoptedReference Number: EMA/469254/2014