Correction And Amendment Of Directions To Authorized Packaging Determines The # 55, January 26, 2015 Kau Medicine Human Peruso «Jakavi». (Resolution No. 254/2015).

Original Language Title: Rettifica e corrigendum delle indicazioni alla determina UAE n. 55del 26 gennaio 2015 delle confezioni autorizzate del medicinale peruso umano «Jakavi». (Determina n. 254/2015).

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-26&atto.codiceRedazionale=15A02242&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

The DIRECTOR-GENERAL having regard to the European assessment Office determines 55 of 26.01.2015 regarding the marketing authorisation for the medicinal product JAKAVI 042226136/AIC code and AIC: 042226148/and 042226163/042226151/E: AIC: AIC and published in the official journal General series n. 41 del 19.02.2015; Considering that, for clerical error contained in the annexes to the determination, particularly in the description of authorised pack sizes of medicine JAKAVI, the Office's determination that rectification should be European assessment; Having regard to official acts: Determines: (Corrigendum corrigendum description of authorised pack sizes with determination of the medicine 26.01.2015 # 55 KAU JAKAVI) where it is reported: authorised pack sizes: authorised pack sizes: EU/1/12/773/013 AIC: 042226136/E in base 10 (188NGS) based 32 10 mg-tablets-oral-blister (PVC/PCTFE/aluminium)-60 tablets 1/12/014 EU/773/AIC : 042226148/E based 10 (188NH4) based 32 10 mg-tablets-oral-blister (PVC/PCTFE/aluminium)-1/12/14 EU/tablets 773/015 AIC: 042226151/E in base 10 (188NH7) based 32 10 mg-tablets-oral-blister (PVC/PCTFE/aluminium)-56 tablets 1/12/016/773/EU AIC: 042226163/E in base 10 (188NHM) based 32 10 mg-tablets-oral-blister (PVC/PCTFE/aluminium)-168 tablets (3X56) Multipack Read authorised pack sizes in the classroom C (nn): authorised pack sizes: EU/1/12/773/013 AIC: 042226136/E in base 10 (188NGS) based 32 10 mg-tablets-oral-bottle (HDPE)-60 tablets 1/12/014 EU/773/AIC: 042226148/E in base 10 (188NH4) based 32 10 mg-tablets-oral-blister (PVC/PCTFE/aluminium)-1/12/14 EU/tablets 773/015 AIC: 042226151/E in base 10 (188NH7) based 32 10 mg-tablets-oral-blister (PVC/PCTFE/aluminium)-56 tablets EU/1/12/773/016 AIC: 042226163/E in base 10 (188NHM) based 32 10 mg-tablets-oral-blister (PVC/PCTFE/aluminium)-168 tablets (3X56) Multipack Mah: Novartis Europharm LTD this determines will be published in the Official Gazette of the Italian Republic.
Roma, March 5, 2015 Director General: Pani