EMEA-001390-PIP01-12 - paediatric investigation plan

Losartan potassium

amlodipine besilate

Key facts

• Active substance:
  • Losartan potassium
  • amlodipine besilate
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0113/2013
• PIP number:
  EMEA-001390-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:
  30/04/2013
• Compliance check done:
  No

Decision

P/0113/2013: EMA decision of 30 April 2013 on the granting of a product-specific waiver for amlodipine (besilate) / losartan (potassium) (EMEA-001390-PIP01-12)

Adopted Reference Number: EMA/203291/2013