EMEA-003629-PIP01-24 - paediatric investigation plan

Montelukast sodium

rupatadine fumarate

Key facts

• Active substance:
  • Montelukast sodium
  • rupatadine fumarate
• Therapeutic area:
  Respiratory, thoracic and mediastinal disorders
• Decision number:
  P/0318/2024
• PIP number:
  EMEA-003629-PIP01-24
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of allergic rhinitis
• Route(s) of administration:
  Oral use
• Decision type:
  RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
• Decision date:
  13/09/2024
• Compliance check done:
  No

Decision

P/0318/2024 : EMA decision of 13 September 2024 on the refusal of a product-specific waiver for montelukast sodium / rupatadine fumarate (EMEA-003629-PIP01-24)

Adopted Reference Number: EMA/411054/2024