EMEA-001232-PIP01-11 - paediatric investigation plan

glimepiride

atorvastatin calcium

Key facts

• Active substance:
  • glimepiride
  • atorvastatin calcium
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0103/2012
• PIP number:
  EMEA-001232-PIP01-11
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  • Treatment of hyperlipidaemia
  • 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:
  30/05/2012
• Compliance check done:
  No

Decision

P/0103/2012: EMA decision of 30 May 2012 on the granting of a product specific waiver for glimepiride / atorvastatin (calcium), (EMEA-001232-PIP01-11)

Adopted Reference Number: EMA/274474/2012