EMEA-001680-PIP01-14 - paediatric investigation plan

valsartan
Amlodipine besilate
PIPHuman

Key facts

Invented name
  • Exforge
  • 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
Contact for public enquiries

Novartis Europharm Ltd. 

United Kingdom 
E-mail: paediatric.enquiries@novartis.com 
Tel. +41 613241111 
Fax +41 613248001

Decision type
W: decision granting a waiver in all age groups for all conditions or indications
Decision date

Decision

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