Pharmaceuticals - Community Register

  

List of referrals for human medicinal products

Pravachol

Product name: Pravachol
Also marketed in the EU under the name(s): Bristacol, Elisor, Lipemol, Lipostat, Liprevil, Pravacol, Pravasin, Pravasine, Selectin, Selektine, Selip, Selipran
INN: Pravastatin
Indication: Isolated or mixed hypercholesterolaemia, Primary prevention in Coronary Heart Disease, Secondary prevention in Coronary Heart Disease,
Marketing Authorisation Holder: Bristol-Myers Squibb International Corporation

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
03/03/2004 Referral EMEA/H/A-30/529 (2004)730 of 02/03/2004