Bromfenac sodium sesquihydrate - paediatric investigation plan

bromfenac sodium sesquihydrate

Key facts

• Active Substance:
  bromfenac sodium sesquihydrate
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/84/2009
• PIP number:
  Bromfenac sodium sesquihydrate
• Pharmaceutical form(s):
  • Eye drops, solution
  • Solution
• Condition(s) / indication(s):
  Postoperative ocular inflammation
• Route(s) of administration:
  Ocular use
• Contact for public enquiries:

  Croma Pharma GmbH

  E-mail: [e-mail]; Country: Austria; Phone: [phone]; Fax: [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  15/05/2009

Decision

P/84/2009: European medicines agency decision of 18 May 2009 on the granting of a product specific waiver for bromfenac sodium sesquihydrate (EMEA-000269-PIP01-08) in accordance with Regulation (EC) No 1901/2006 of the E...

AdoptedReference Number: EMEA/289744/2009