EMEA-001275-PIP01-12 - paediatric investigation plan

sitagliptin

atorvastatin

Key facts

• Active substance:
  • sitagliptin
  • atorvastatin
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0186/2012
• PIP number:
  EMEA-001275-PIP01-12
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of type II diabetes mellitus concomitant with hypercholesterolaemia
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  21/08/2012
• Compliance check done:
  No

Decision

P/0186/2012: EMA decision of 21 August 2012 on the granting of a product specific waiver for sitagliptin / atorvastatin (EMEA-001275-PIP01-12)

Adopted Reference Number: EMA/472398/2012