EMEA-000268-PIP01-08 - paediatric investigation plan

naproxen

esomeprazole magnesium trihydrate

Key facts

• Active Substance:
  • naproxen
  • esomeprazole magnesium trihydrate
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/80/2008
• PIP number:
  EMEA-000268-PIP01-08
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  • Ankylosing spondylitis
  • Primary generalised osteoarthritis
  • Rheumatoid arthritis
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  19/09/2008

Decision

P/80/2008: EMA decision of of 19 September 2008 on the application for product specific waiver for naproxen, esomeprazole magnesium trihydrate, EMEA-000268-PIP01-08

AdoptedReference Number: EMEA/480433/2008