The DIRECTOR-GENERAL having regard to the European assessment Office determines 263 of March 5, 2015 concerning the marketing authorisation for the medicinal product ENVARSUS published in the official journal General series # 71 of March 26, 2015; Considering that, for clerical error concerning the description of the package of the medicine ENVARSUS 935 1/14/EU/numbering/009 A.I.C. and 043531096, should be dterminazione that rectification of the Office assessment; Having regard to official acts;
Determines: (Correcting amendment of resolution No. 263 of medicinal ENVARSUS package description A.I.C. March 5, 2015 043531096) where the medicinal product is described ENVARSUS the following container: 1/14/35/EU/009 A.I.C.: 043531096/E 19JGUS 32 4 mg-based prolonged release-oral-Blister (PVC/ALU)-30 tablets. Read 1/14/35/EU/009 A.I.C. 043531096/E 19JGUS 32-4: mg-based prolonged release-oral-Blister (PVC/ALU)-90 tablets. This determines will be published in the official journal of the Italian Republic.
Roma, April 20, 2015 Director General: Pani