EMEA-000012-PIP01-07-M01 - paediatric investigation plan

Montelukast sodium

Key facts

• Invented name:
  Singulair
• Active Substance:
  Montelukast sodium
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/200/2009
• PIP number:
  EMEA-000012-PIP01-07-M01
• Pharmaceutical form(s):
  • Chewable tablet
  • Oral granules
• Condition(s) / indication(s):
  Asthma
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  01/10/2009
• Compliance procedure number:
  EMEA-C-000012-PIP01-07-M01
• Compliance opinion date:
  15/01/2010
• Compliance outcome:
  Positive

Decision

P/200/2009: European Medicines Agency decision of 1 October 2009 on the acceptance of a modification of an agreed Paediatric Investigation Plan for montelukast sodium (Singulair), (EMEA-000012-PIP01-07-M01) in accordance...

AdoptedReference Number: EMEA/615793/2009