EMEA-001343-PIP01-12 - paediatric investigation plan

valsartan

amlodipine besilate

Key facts

• Active substance:
  • valsartan
  • amlodipine besilate
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0270/2012
• PIP number:
  EMEA-001343-PIP01-12
• Pharmaceutical form(s):
  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:
  20/11/2012
• Compliance check done:
  No

Decision

P/0270/2012: EMA decision of 20 November 2012 on the granting of a product-specific waiver for amlodipine (besylate) / valsartan (EMEA-001343-PIP01-12)

Adopted Reference Number: EMA/646965/2012