EMEA-000397-PIP01-08 - paediatric investigation plan

valsartan

hydrochlorothiazide

amlodipine besilate

Key facts

• Invented name:
  • Copalia HCT
  • Copalia HCT
• Active substance:
  • valsartan
  • hydrochlorothiazide
  • amlodipine besilate
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/14/2009
• PIP number:
  EMEA-000397-PIP01-08
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  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:
  27/01/2009
• Compliance check done:
  No

Decision

P/14/2009: European Medicines Agency decision of 27 January 2009 on the granting of a product specific waiver for amlodipine besylate, valsartan, hydrochlorothiazide, (Copalia HCT), (EMEA-000397-PIP01-08) in accordance w...

Adopted Reference Number: EMEA/24151/2009