Correction And Amendment Of March 5, 2015 Nellapremessa # 251 Of Determines The Description Of Authorised Pack Sizes Of Medicinaleper Human Use «Rixubis». (Resolution No. 462/2015).
Original Language Title: Rettifica e corrigendum della determina n. 251 del 5 marzo 2015 nellapremessa alla descrizione delle confezioni autorizzate del medicinaleper uso umano «Rixubis». (Determina n. 462/2015).
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The DIRECTOR-GENERAL having regard to the European assessment Office determines 251 of March 5, 2015 concerning the authorisation of medicinal products DUAVIVE RIXUBIS LYNPARZA-MOVENTIG-LILLY-DULOXETINE-published in the official journal General series # 72 of March 27, 2015; Considering that, for clerical error contained in the annexes to the determination and, in particular, in the premise of the annex describing the authorised pack sizes of medicine Rixubis, ATC-code adjustment should be active ingredient-determining the Office's assessment above; Having regard to the proceedings ex officio.
Determines: (correction corrigendum of March 5, 2015 's resolution No. 251 product authorization Duavive Suloxetina Rixubis Lynparza Moventing-Lilly---and in particular in the preamble to the description of authorised pack sizes of medicine Rixubis) where it is reported in the introduction of the attached form to determine the ATC-active substance: drugs of new registration RIXUBIS ATC-active ingredient: B02BD 250 IU nonacog range , recombinant human coagulation factor IX (rDNA). Owner: Baxter Innovations GMBH. OJEU: January 30, 2015. Read RIXUBIS ATC-active ingredient: B02BD04 nonacog range, recombinant human coagulation factor IX (rDNA). Owner: Baxter Innovations GMBH. OJEU January 30, 2015. A.I.C. Holder: Baxter Innovations GMBH. This determines will be published in the official journal of the Italian Republic.
Roma, April 20, 2015 Director General: Pani
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