Retrieved determines the Permission to March 4, 2015 # 389 V & variation: C.I. 4) one or more amendments to the summary of product characteristics, labelling and package leaflet after new data on quality, preclinical, clinical or pharmacovigilance medicine ALPHANATE;
Authorized updating of the summary of product characteristics, relative to medicine «Alphanate», in the forms and packages listed below: A.I.C. # 033077088-250 IU powder and solvent for solution for infusion»-1 vial powder + 1 syringe 5 ml water p.p.i. + adapter;
A.I.C. # 033077090-«500 IU powder and solvent for solution for infusion»-1 vial powder + 1 syringe 5 ml water p.p.i. + adapter;
A.I.C. # 033077102-«1000 IU powder and solvent for solution for infusion» 1 1 10 ml syringe water bottle p.p.i. powder + + adapter;
A.I.C. # 033077114-«1500 IU powder and solvent for solution for infusion» -1 10 ml 1 vial syringe p.p.i. powder + water + adapter.
Handouts are fixed and approved shall be annexed to the assessment, referred to in this excerpt.
Holder A.I. c: Grifols Italy S.p.a. (tax 10852890150) with registered office and tax domicile in Via Torino, 15-56010 Vicopisano-Pisa (PI) Italy.
Printed 1. The marketing authorisation holder should make the changes, after the date of entry into force of this determination, the summary of product characteristics; no later than six months from the same date the package leaflet and labelling.
Inventory disposal Both lots already products on the date of entry into force of this determination that the batches produced during the period referred to in art. 2, paragraph 1, of the present, not bearing approved changes can be kept on the market until the expiration date printed on the label of the medicine.
Date of determination: from the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica italiana.