P/90/2010 - paediatric investigation plan

Bisoctrizole

titanium dioxide

Key facts

• Active Substance:
  • Bisoctrizole
  • titanium dioxide
• Therapeutic area:
  Dermatology
• Decision number:
  P/90/2010
• PIP number:
  P/90/2010
• Pharmaceutical form(s):
  Cream
• Condition(s) / indication(s):
  Treatment of solar urticaria
• Route(s) of administration:
  Cutaneous use
• Contact for public enquiries:

  Orfagen

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

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  01/06/2010

Decision

P/90/2010: European Medicines Agency decision of 1 June 2010 on the agreement of a paediatric investigation plan and on the granting of a waiver for bisoctrizole / titanium dioxide (EMEA-000585-PIP01-09) in accordance wi...

AdoptedReference Number: EMA/335351/2010