Diovan - referral

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.

Assessment Report for Diovan - EMEA/H/A/-29 PAD/1220

Adopted Reference Number: EMA/296507/2010

Key facts

About this medicine

• 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

About this procedure

• Current status:
  European Commission final decision
• 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.

Key dates and outcomes

• CHMP opinion date:
  15/12/2009
• EC decision date:
  19/04/2010

All documents

Diovan - EMEA/H/A/-29 PAD/1220 - Artical 29 Paediatrics referral - Annex I, II, III

Adopted

Assessment Report for Diovan - EMEA/H/A/-29 PAD/1220

Adopted Reference Number: EMA/296507/2010

Description of documents published

Please note that some of the listed documents apply only to certain procedures.

• Overview - lay-language summary of the stage of the procedure
• Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
• Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
• List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
• Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
• List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
• List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
• Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
• Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
• Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
• Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
• Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
• Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
• Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
• Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)

Note that older documents may have different titles.