COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Lamictal» (16A03863)
Estratto determina V&A n. 717/2016 del 20 aprile 2016 Sono autorizzate le seguenti variazioni: C.I.4 e C.I.1.z Aggiornamento del riassunto delle caratteristiche del prodotto e corrispondenti sezioni del foglio illustrativo, con l'aggiunta di nuovi effetti indesiderati;
aggiornamento del paragrafo relativo alla gravidanza e adeguamento dei testi al nuovo formato QRD relativamente al medicinale «LAMICTAL», nelle seguenti forme e confezioni: 027807054 - «25 mg compresse masticabili/dispersibili» 28 compresse 027807066 - «5 mg compresse masticabili/dispersibili» 28 compresse in Blister Pvc/Pvdc/Foglio di alluminio 027807078 - «100 mg compresse masticabili/dispersibili» 56 compresse 027807080 - «50 mg compresse masticabili/dispersibili» 56 compresse 027807092 - «200 mg compresse masticabili/dispersibili» 56 compresse 027807130 - «25 mg compresse masticabili/dispersibili» 42 compresse Confezione starter per monoterapia 027807142 - «25 mg compresse masticabili/dispersibili» 21 compresse Confezione starter per terapia aggiuntiva con Valproato 027807155 - «50 mg compresse masticabili/dispersibili» 42 compresse Confezione starter per terapia aggiuntiva senza Valproato 027807179 - «2 mg compresse masticabili/dispersibili» 30 compresse In Flacone Hdpe con chiusura a prova di bambino 027807181 - «5 mg compresse masticabili/dispersibili» 14 compresse in flacone hdpe 027807193 - «5 mg compresse masticabili/dispersibili» 28 compresse in flacone hdpe 027807205 - «5 mg compresse masticabili/dispersibili» 30 compresse in flacone hdpe 027807217 - «5 mg compresse masticabili/dispersibili» 42 compresse in flacone hdpe 027807229 - «5 mg compresse masticabili/dispersibili» 56 compresse in flacone hdpe 027807231 - «5 mg compresse masticabili/dispersibili» 60 compresse in flacone hdpe Procedura : NL/H/xxxx/WS/158 Titolare AIC: Glaxosmithkline S.p.a. Stampati 1. Il titolare dell'autorizzazione all'immissione in commercio deve apportare le...
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