- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
The European Medicines Agency (EMEA) has completed a review of Diovan Comp and associated names. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Diovan Comp in the European Union (EU) and the European Economic Area (EEA).
The review was carried out under an 'Article 30' referral1.
The European Commission issued a decision on 26 May 2009.
1 Article 30 of Directive 2001/83/EC as amended, referral on the grounds of divergent decisions adopted by member States
|International non-proprietary name (INN) or common name||
valsartan and hydrochlorothiazide
Article 30 referrals
This type of referral is triggered when Member States have adopted different decisions over the years for some medicines (e.g. different indications, contraindications or posology) and there is a need to harmonise across the EU.
European Commission final decision
|EC decision date||
Questions and answers on the referral for Diovan Comp and associated names tablets containing valsartan (80, 160 or 320 mg) and hydrochlorothiazide (12.5 or 25 mg) (PDF/44.21 KB)Adopted
First published: 28/05/2009
Last updated: 28/05/2009
Diovan Comp - Article 30 referral - Annex I, II, III (PDF/228.29 KB)Adopted
First published: 11/06/2009
Last updated: 11/06/2009
- 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