EMEA-000005-PIP01-07-M01

Adopted

First published: 11/08/2009
Last updated: 11/08/2009
EMEA/386713/2009

Invented name	Diovan
Active substance	valsartan
Therapeutic area	Cardiovascular diseases
Decision number	P/125/2009
PIP number	EMEA-000005-PIP01-07-M01
Pharmaceutical form(s)	Film-coated tablet Age-appropriate liquid dosage form
Condition(s) / indication(s)	Heart failure following recent myocardial infarction Treatment of heart failure Treatment of hypertension
Route(s) of administration	Oral use
Contact for public enquiries	Novartis Europharm Limited E-mail: paediatric.enquiries@novartis.com Tel. +41 613246715
Decision type	PM: decision on the application for modification of an agreed PIP
Compliance procedure number	EMEA-C-000005-PIP01-07-M01
Compliance opinion date	21/08/2009
Compliance outcome	positive