EMEA-000700-PIP02-10 - paediatric investigation plan

vildagliptin

Key facts

• Invented name:
  • Galvus
  • Galvus
• Active Substance:
  vildagliptin
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/177/2011
• PIP number:
  EMEA-000700-PIP02-10
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of type II diabetes mellitus
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Novartis Europharm Limited

  Switzerland; [e-mail]; Phone: [phone]; Fax: [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  26/08/2011

Decision

P/177/2011: EMA decision of 26 August 2011 on the granting of a product specific waiver for vildagliptin (Galvus), (EMEA-000700-PIP02-10)

AdoptedReference Number: EMA/691227/2011