EMEA-001380-PIP01-12 - paediatric investigation plan

amlodipine

losartan

Key facts

• Active Substance:
  • amlodipine
  • losartan
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0040/2013
• PIP number:
  EMEA-001380-PIP01-12
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of essential 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:
  27/02/2013

Decision

P/0040/2013: EMA decision of 27 February 2013 on the granting of a product-specific waiver for amlodipine / losartan (EMEA-001380-PIP01-12)

AdoptedReference Number: EMA/24016/2013