EMEA-001479-PIP01-13 - paediatric investigation plan

Metformin

rosuvastatin

Key facts

• Active substance:
  • Metformin
  • rosuvastatin
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0233/2013
• PIP number:
  EMEA-001479-PIP01-13
• Pharmaceutical form(s):
  Modified-release 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:
  23/09/2013
• Compliance check done:
  No

Decision

P/0233/2013: EMA decision of 23 September 2013 on the granting of a product specific waiver for metformin / rosuvastatin, (EMEA-001479-PIP01-13)

Adopted Reference Number: EMA/561761/2013