P/117/2010 - paediatric investigation plan

Diclofenac sodium

omeprazole

Key facts

• Active Substance:
  • Diclofenac sodium
  • omeprazole
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/117/2010
• PIP number:
  P/117/2010
• Pharmaceutical form(s):
  Modified release capsule
• Condition(s) / indication(s):
  • Rheumatoid arthritis
  • Ankylosing spondylitis
  • Osteoarthritis
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Temmler Werke GmbH

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  07/07/2010

Decision

P/117/2010: European Medicines Agency decision of 7 July 2010 on the granting of a product specific waiver for diclofenac sodium / omeprazole (EMEA-000820-PIP01-09) in accordance with Regulation (EC) No 1901/2006 of the...

AdoptedReference Number: EMA/343648/2010