ANNUAL REPORT 06 - Bosnalijek dd

Registrations in Bosnia and HerzegovinaIn year 2006, Bosnalijek got first marketing authorisation approvals inBiH for 26 products, namely:• First registrations of 14 new products in the Federation of BiH, of which9 are on the basis of three new generic names (azithromycin, loratadineand izosorbide mononitrate), and 5 of them are new pharmaceuticalforms and unit doses of the existing generics;• There were first registrations of 12 products in RS (8 new genericnames), which have previously been registered in the Federation of BiH.Registrations abroadIn accordance with development of products portfolio, activities onproducts registrations were continued in 2006, in accordance withestimated needs of each individual market.In year 2006, Bosnalijek obtained 35 new registration certificates in 8countries, renewed registration for 15 products and applied for firstregistrations of 47 products in 7 countries, thus having 236 active marketingauthorisation approvals for selling its products abroad in end of year.Post-marketing clinical trials represent a significant support to registrationactivities abroad, and more successful marketing of Bosnalijekmedications. In year 2006, multi-centre trial of administering Bosnalijekleading product Lopril®H tablets intended to patients having essentialhypertension, was successfully finalised. The trial was conducted in 12clinical centres in five countries (Bosnia and Herzegovina, Montenegro,Serbia, Ukraine and Moldova) with participation of 300 patients and 50physicians of different specialties. A formed database, with 60.000 detailson Lopril®H tablets and therapies in which this medicine was used, wasstatistically processed in licensed programme for medicinal trials, and allresults were processed and presented in the final study.A very positive effect of Lopril®H on the quality of life of patients thatadminister it, was proven in trials, as well as numerous possibilities wereopened for new marketing and more successful bringing close this drugto patients and physicians.NEW PRODUCTS IN 2006 - FIRST REGISTRATIONS:LIDOKAIN (lidocaine), injection 1% 3,5 mlLOSTOP® (loratadine), tablets 10 mgLOSTOP® (loratadine), syrup 5mg/5mlLOSTOP® (loratadine), suspension 5mg/5mlPILFUD® (minoxidil), lotion 5%RANIBOS® (ranitidine), film-coated tablets 75 mgULCOSAN® (omeprazole), capsules 40 mgserving Your health DEVELOPMENT OF NEW PRODUCTS AND REGISTRATIONS ANNUAL REPORT 06 33