EMEA-003164-PIP01-21 - paediatric investigation plan

Bilastine

Pseudoephedrine

Key facts

• Active Substance:
  • Bilastine
  • Pseudoephedrine
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0172/2022
• PIP number:
  EMEA-003164-PIP01-21
• Pharmaceutical form(s):
  Prolonged-release tablet
• Condition(s) / indication(s):
  Treatment of allergic rhinitis
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  FAES FARMA, S.A.

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  13/05/2022

Decision

P/0172/2022 : EMA decision of 13 May 2022 on the granting of a product specific waiver for bilastine / pseudoephedrine (EMEA-003164-PIP01-21)

AdoptedReference Number: EMA/204941/2022