Safety change – article 45 pediatrics + Level II safety changes to bring SPC-PIL in line with revised CCDS (incl Type II update SPC and PIL according to the European Core Safety Profile following PSUR synchronization /14
Article 45 pediatrics++ Level II safety changes to bring SPC-PIL in line with revised CCDS (incl Type II update SPC and PIL according to the European Core Safety Profile following PSUR synchronization -1-