Roflumilast - paediatric investigation plan

roflumilast

Key facts

• Active substance:
  roflumilast
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/21/2008
• PIP number:
  Roflumilast
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Chronic obstructive pulmonary disease
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  28/04/2008
• Compliance check done:
  No

Decision

P/21/2008: European medicines agency decision of 28 April 2008 on the application for product specific waiver for Roflumilast PIP number EMEA-000113-PIP01-07 in accordance with Regulation (EC) No 1901/2006 of the Europea...

Adopted Reference Number: EMEA/211804/2008