EMEA-000074-PIP01-07 - paediatric investigation plan

Rosiglitazone Maleate

Key facts

• Active Substance:
  Rosiglitazone Maleate
• Therapeutic area:
  Neurology
• Decision number:
  P/8/2008
• PIP number:
  EMEA-000074-PIP01-07
• Pharmaceutical form(s):
  Prolonged-release tablet
• Condition(s) / indication(s):
  Alzheimer's Disease
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  GlaxoSmithKline R&D Limited

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  01/02/2008

Decision

P/8/2008: European medicines agency decision of 1 February 2008 on the application for product specific waiver for Rosiglitazone Maleate EMEA-000074-PIP01-07 in accordance with Regulation (EC) No 1901/2006 of the Europea...

AdoptedReference Number: EMEA/43606/2008