EMEA-001908-PIP01-15 - paediatric investigation plan

levocetirizine (dihydrochloride)

montelukast sodium

Key facts

• Invented name:
  P/0114/2016
• Active substance:
  • levocetirizine (dihydrochloride)
  • montelukast sodium
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0114/2016
• PIP number:
  EMEA-001908-PIP01-15
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of asthma
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  15/04/2016
• Compliance check done:
  No

Decision

P/0114/2016: EMA decision of 15 April 2016 on the granting of a product specific waiver for montelukast (sodium) / levocetirizine (dihydrochloride) (EMEA-001908-PIP01-15)

Adopted Reference Number: EMA/195529/2016