EMEA-000886-PIP01-10 - paediatric investigation plan

amlodipine camsylate

Losartan potassium

Key facts

• Active substance:
  • amlodipine camsylate
  • Losartan potassium
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/188/2010
• PIP number:
  EMEA-000886-PIP01-10
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  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:
  24/09/2010
• Compliance check done:
  No

Decision

P/188/2010: European Medicines Agency decision of 24 September 2010 on the granting of a product specific waiver for amlodipine camsylate / losartan potassium (EMEA-000886-PIP01-10)

Adopted Reference Number: EMA/596152/2010