COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Sativex». (19A04429)
Estratto determina AAM/PPA n. 473/2019 del 14 giugno 2019 L'autorizzazione all'immissione in commercio del medicinale e' rinnovata con validita' illimitata a decorrere dalla data del rinnovo europeo 16 maggio 2015, a condizione che alla data di entrata in vigore della presente determina i requisiti di qualita', sicurezza ed efficacia siano ancora presenti;
viene autorizzata altresi' la variazione di tipo II: C.I.4) con la quale vengono modificati i paragrafi 1,7,9 delle etichette esterne e tutti i paragrafi delle etichette interne;
si aggiungono i paragrafi 17 e 18 delle etichette esterne;
le etichette vengono adeguate al QRD template relativamente al medicinale SATIVEX (AIC n 040548) nelle seguenti forme e confezioni autorizzate all'immissione in commercio: confezioni: 040548099 - «spray per mucosa orale» 1 flacone nebulizzatore con pompa dosatrice da 10 ml - 90 erogazioni;
040548101 - «spray per mucosa orale» 2 flaconi nebulizzatori con pompa dosatrice da 10 ml - 90 erogazioni;
040548113 - «spray per mucosa orale» 3 flaconi nebulizzatori con pompa dosatrice da 10 ml - 90 erogazioni;
040548125 - «spray per mucosa orale» 4 flaconi nebulizzatori con pompa dosatrice da 10 ml - 90 erogazioni;
040548137 - «spray per mucosa orale» 5 flaconi nebulizzatori con pompa dosatrice da 10 ml - 90 erogazioni;
040548149 - «spray per mucosa orale» 6 flaconi nebulizzatori con pompa dosatrice da 10 ml - 90 erogazioni;
040548152 - «spray per mucosa orale» 10 flaconi nebulizzatori con pompa dosatrice da 10 ml - 90 erogazioni;
040548164 - «spray per mucosa orale» 12 flaconi nebulizzatori con pompa dosatrice da 10 ml - 90 erogazioni. Titolare AIC: GW Pharma (International) B.V., con sede legale e domicilio fiscale in Amersfoort A1, Databankweg,26 3821, Al Amersfoort (NL). Procedura: rinnovo. Codice procedure europee: UK/H/2462/001/R/001 - UK/H/2462/001/II/016. Codice pratica: FVRMC/2018/194 - VC2/2016/504. Gli stampati corretti ed approvati, sono allegati alla determina di cui al presente estratto. Stampati...
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