COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano, a base di amoxicillina e acido clavulanico, «Amoxicillina e Acido Clavulanico Tecnigen». (24A00442)
Estratto determina AAM/PPA n. 56/2024 del 19 gennaio 2024
Trasferimento di titolarita': AIN/2023/2495.
Cambio nome: N1B/2023/1398.
E' autorizzato il trasferimento di titolarita' dell'autorizzazione all'immissione in commercio del sotto elencato medicinale fino ad ora registrato a nome della societa' Tecnigen S.r.l. con sede legale e domicilio fiscale in via Galileo Galilei n. 40 - 20092 Cinisello Balsamo, Milano
codice fiscale n. 08327600964.
Medicinale: AMOXICILLINA e ACIDO CLAVULANICO TECNIGEN.
Confezioni:
875 mg + 125 mg polvere per sospensione orale
12 bustine - A.I.C. n. 036815013
875 mg + 125 mg compresse rivestite con film
12 compresse - A.I.C. n. 036815025
alla societa' Pharmacare S.r.l. con sede legale e domicilio fiscale in via Marghera n. 29 - 20149 Milano
codice fiscale n. 12363980157.
Con variazione della denominazione del medicinale in AMOXICILLINA e ACIDO CLAVULANICO PHARMACARE.
Stampati
Il titolare dell'autorizzazione all'immissione in commercio del medicinale sopraindicato deve apportare le necessarie modifiche al riassunto delle caratteristiche del prodotto dalla data di entrata in vigore della determina, di cui al presente estratto
al foglio...
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