Balaglitazone - paediatric investigation plan

balaglitazone

Key facts

• Active substance:
  balaglitazone
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/65/2008
• PIP number:
  Balaglitazone
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of type II diabetes mellitus
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  15/08/2008
• Compliance check done:
  No

Decision

P/65/2008: European medicines agency decision of 15 August 2008 on the application for agreement of a Paediatric Investigation Plan for balaglitazone (EMEA-000106-PIP01-07), in accordance with Regulation (EC) No 1901/20...

Adopted Reference Number: EMEA/429922/2008