EMEA-000744-PIP01-09 - paediatric investigation plan

valsartan

hydrochlorothiazide

amlodipine besilate

Key facts

• Active substance:
  • valsartan
  • hydrochlorothiazide
  • amlodipine besilate
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/6/2010
• PIP number:
  EMEA-000744-PIP01-09
• 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:
  25/01/2010
• Compliance check done:
  No

Decision

P/6/2010: European Medicines Agency decision of 25 January 2010 on the granting of a product specific waiver for amlodipine besylate / valsartan / hydrochlorothiazide (EMEA-000744-PIP01-09) in accordance with Regulation...

Adopted Reference Number: EMEA/35952/2010