COMMISSION DE LA TRANSPARENCE REPUBLIQUE FRAN AISE AVIS DE LA COMMISSION 10 mars 2004 FORSTEO 20 microgrammes 80 microlitres solution pour injection en stylo pr rempli B 1 Laboratoires LILLY FRANCE SA t riparatide Liste Date de l AMM 10 juin 2003 Motif de la demande Inscription S curit Sociale et Collectivit s Secr tariat de la Commission AFSSAPS Unit de la Transparence 1 CARACTERISTIQUES DU MEDICAMENT 1 1 Principe actif t
ANNEXI SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT FORSTEO 20 micrograms 80 microliters solution for injection in filled pen 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose contains 20 micrograms of teriparatide One filled pen of 2 4 ml contains 600 micrograms of teriparatide corresponding to 250 micrograms per ml Teriparatide rhPTH 1 34 produced in E coli using recombinant DNA technology is identical to the 34 N terminal
ANEXO I RESUMO DAS CARACTER STICAS DO MEDICAMENTO 1 NOME DO MEDICAMENTO FORSTEO 20 microgramas 80 microlitros solu o injet vel em caneta pr cheia 2 COMPOSI O QUALITATIVA E QUANTITATIVA Cada dose de 80 microlitros cont m 20 microgramas de teriparatida Uma caneta pr cheia de 2 4 ml cont m 600 microgramas de teriparatida correspondente a 250 microgramas por ml teriparatida rhPTH 1 34 produzida na E Coli utilizando a tecnologia de DNA recombin