EMEA-000347-PIP03-18 - paediatric investigation plan

bilastine

Key facts

• Invented name:
  Bilaxten and associated names
• Active substance:
  bilastine
• Therapeutic area:
  Dermatology
• Decision number:
  P/0206/2018
• PIP number:
  EMEA-000347-PIP03-18
• Pharmaceutical form(s):
  Orodispersible film
• Condition(s) / indication(s):
  • Treatment of allergic rhinoconjunctivitis
  • Treatment of urticaria
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  19/07/2018
• Compliance check done:
  No

Decision

P/0206/2018: EMA decision of 19 July 2018 on the granting of a product specific waiver for bilastine (Bilaxten and associated names), (EMEA- 000347-PIP03-18)

Adopted Reference Number: EMA/421220/2018