EMEA-000104-PIP01-07 - paediatric investigation plan

naproxcinod

Key facts

• Active Substance:
  naproxcinod
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/16/2008
• PIP number:
  EMEA-000104-PIP01-07
• Pharmaceutical form(s):
  Capsule (hard)
• Condition(s) / indication(s):
  Primary osteoarthritis
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  NicOx S.A.

  E-mail: [e-mail]; Country: France; Phone: [phone]; Fax: [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  31/03/2008

Decision

P/16/2008: European medicines agency decision of 31 March 2008 on the application for product specific waiver for Naproxcinod (EMEA-000104-PIP01-07) in accordance with Regulation (EC) No 1901/2006 of the European Parliam...

AdoptedReference Number: EMEA/157227/2008