EMEA-001510-PIP01-13 - paediatric investigation plan

amlodipine

atorvastatin

Key facts

• Active substance:
  • amlodipine
  • atorvastatin
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0261/2013
• PIP number:
  EMEA-001510-PIP01-13
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  • Treatment of dyslipidaemia
  • Treatment of hypertension
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  29/10/2013
• Compliance check done:
  No

Decision

P/0261/2013: EMA decision of 29 October 2013 on the granting of a product specific waiver for amlodipine / atorvastatin (EMEA-001510-PIP01-13)

Reference Number: EMA/602360/2013