EMEA-001680-PIP01-14 - paediatric investigation plan

valsartan

amlodipine besilate

Key facts

• Invented name:
  Exforge
• Active substance:
  • valsartan
  • amlodipine besilate
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0315/2014
• PIP number:
  EMEA-001680-PIP01-14
• Pharmaceutical form(s):
  • Film-coated tablet
  • Orodispersible 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:
  05/12/2014
• Compliance check done:
  No

Decision

P/0315/2014: EMA decision of 5 December 2014 on the granting of a product specific waiver for amlodipine (besylate) / valsartan (Exforge), (EMEA-001680-PIP01-14)

Adopted Reference Number: EMA/668036/2014