Pharmaceuticals - Community Register

  

List of referrals for human medicinal products

Diovan (1219)

Product name: Diovan (1219)
Also marketed in the EU under the name(s): Angiosan, Cordinate, Dalzad, Diovane, Kalpress Cardio, Miten Cardio, Novacard, Provas, Rixil, Tareg, Valsartan Novartis, Varexan
INN: Valsartan
Indication: Hypertension: Treatment of hypertension in adults.Recent myocardial infarction: Treatment of clinically stable adult patients with symptomatic heart failure or asymptomatic left ventricular systolic dysfunction after a recent (12 hours-10 days) myocardial infarction (all except 320 mg film-coated tablets)Heart failure: Treatment of symptomatic heart failure in adult patients when angiotensin converting enzyme (ACE) inhibitors cannot be used, or as add-on therapy to ACE inhibitors when beta-blockers cannot be used. (all except 320 mg film-coated tablets)
Marketing Authorisation Holder: Not applicable

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
20/04/2010 Referral EMEA/H/A-29/PAD/1219 (2010)2577 of 19/04/2010