P/111/2010 - paediatric investigation plan

Tulobuterol

Key facts

• Active Substance:
  Tulobuterol
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/111/2010
• PIP number:
  P/111/2010
• Pharmaceutical form(s):
  Transdermal patch
• Condition(s) / indication(s):
  • Episodic wheeze
  • Asthma
• Route(s) of administration:
  Transdermal use
• Contact for public enquiries:

  CSI GmbH

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  06/07/2010

Decision

P/111/2010: European Medicines Agency decision of 6 July 2010 on the refusal of a paediatric investigation plan and on the granting of a waiver for tulobuterol (EMEA-000763-PIP01-09) in accordance with Regulation (EC) N...

AdoptedReference Number: EMA/409589/2010