COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano, a base di ibuprofene sale sodico diidrato «Vegetallumina dolore e febbre». (24A01573)
Estratto determina AAM/PPA n. 198/2024 del 15 marzo 2024
E' autorizzata la variazione di tipo IB, B.II.e.1b.1 con la conseguente immissione in commercio del medicinale VEGETALLUMINA DOLORE E FEBBRE anche nella confezione di seguito indicata:
A.I.C. n. 044912020 - VEGETALLUMINA DOLORE E FEBBRE "400 mg granulato per soluzione orale in bustina" 12 bustine in CARTA/AL/PE
(codice base 32 1BUMDN).
Principio attivo: ibuprofen sodium dihydrate.
Codice pratica: N1B/2022/1427.
Titolare A.I.C.: Pietrasanta Pharma S.p.a., (codice fiscale 01194030464), con sede legale e domicilio fiscale in via di Caprino, 7 - 55012 Capannori, LU, Italia.
Si approva altresi' il seguente adeguamento standard terms per la confezione gia' autorizzata:
da: A.I.C. n. 044912018 400 mg granulato per soluzione orale, 12 bustine in carta/pe/al/surlyn
a: A.I.C. n. 044912018 «400 mg granulato per soluzione orale in bustina», 12 bustine in carta/pe/al/surlyn.
Classificazione ai fini della rimborsabilita'
Per la nuova confezione in aggiunta e' adottata la seguente classificazione ai fini della rimborsabilita': «Cbis».
Classificazione ai fini della fornitura
Per la nuova confezione in aggiunta e' adottata la seguente classificazione ai fini della fornitura: «OTC».
Stampati
La confezione del medicinale deve essere posta in commercio con gli stampati, cosi' come precedentemente autorizzati da questa amministrazione, con le sole modifiche necessarie per...
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