EMEA-000347-PIP01-08-M06 - paediatric investigation plan

Bilastine

Key facts

• Invented name:
  Bilaxten and associated names
• Active Substance:
  Bilastine
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0189/2015
• PIP number:
  EMEA-000347-PIP01-08-M06
• Pharmaceutical form(s):
  • Tablet
  • Orodispersible tablet
  • Oral liquid
• Condition(s) / indication(s):
  • Treatment of urticaria
  • Treatment of allergic rhinoconjunctivitis
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Faes Farma S.A.

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  04/09/2015
• Compliance procedure number:
  EMEA-C-000347-PIP01-08-M06
• Compliance opinion date:
  13/11/2015
• Compliance outcome:
  Positive

Decision

P/0189/2015: EMA decision of 4 September 2015 on the acceptance of a modification of an agreed paediatric investigation plan for bilastine (Bilaxten and associated names), (EMEA-000347-PIP01-08-M06)

AdoptedReference Number: EMA/532369/2015