Sitagliptin phosphate monohydrate / simvastatin - paediatric investigation plan

sitagliptin phosphate monohydrate

simvastatin

Key facts

• Active Substance:
  • sitagliptin phosphate monohydrate
  • simvastatin
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/172/2009
• PIP number:
  Sitagliptin phosphate monohydrate / simvastatin
• Pharmaceutical form(s):
  Film-coated tablet
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  07/09/2009

Decision

P/172/2009: European Medicines Agency decision of 28 August 2009 on the granting of a product specific waiver for sitagliptin phosphate monohydrate / simvastatin (EMEA-000538-PIP01-09) in accordance with Regulation (EC) ...

AdoptedReference Number: EMEA/531555/2009