Diovan

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
Current status:
European Commission final decision

Overview

Pursuant to Article 29 of Regulation (EC) No 1901/2006, as amended, and Annex II (point 2 iv) of Regulation 1084/2003, Novartis Pharma AG submitted to the EMEA on 20 August 2009 an application for a new pharmaceutical form associated with a new strength for the above mentioned medicinal product.

The application concerns oral solution 3 mg/ml.

Licensing status:
Diovan and associated names are registered in the following EU Members States: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden and the United Kingdom as well as in Iceland and Norway.

The Rapporteur and Co-Rapporteur appointed by the CHMP were:
Rapporteur: Alan Irs Co-Rapporteur: Liv Mathiesen

Pursuant to Article 8 of Regulation (EC) No 1901/2006 as amended, the application included an EMEA Decision (P/125/2009) for the following conditions:

  • On the agreement of a Paediatric Investigation Plan (PIP) for hypertension
  • On the granting of a waiver for heart failure and heart failure following recent myocardial infarction

The PIP is completed. The PDCO issued an Opinion on compliance.

Key facts

Approved name
Diovan
International non-proprietary name (INN) or common name
valsartan
Associated names
  • Angiosan
  • Diovane
  • Tareg
  • Cordinate
  • Provas
  • Dalzad
  • Rixil
  • Kalpress Cardio
  • Diovan Cardio
  • Miten Cardio
  • Valsartan Novartis
  • Kalpress
  • Miten
Reference number
EMEA/H/A/-29 PAD/1220
Type
Article 29 paediatrics

This type of procedure may be triggered by a marketing-authorisation holder when applying for a new indication, new pharmaceutical form or new route of administration for use in children for a product authorised under Directive 2001/83/EC.

Status
European Commission final decision
Opinion date
15/12/2009
EC decision date
19/04/2010

All documents

Document description

  • Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
  • Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents are sometimes available:

  • Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes havebeen recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be takenfor the marketing authorisation(s) such as safety measures or extra studies

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