COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Ekzem». (21A01208)
Estratto determina AAM/PPA n. 103/2021 del 19 febbraio 2021
Trasferimento di titolarita': MC1/2020/992
e' autorizzato il trasferimento di titolarita' dell'autorizzazione all'immissione in commercio del sotto elencato medicinale fino ad ora intestato a nome della societa' Laboratorios Salvat S.A. (codice SIS 3195), con sede legale e domicilio fiscale in C/Gall 30-36, Esplugues de Llobregat, 08950 Barcellona, Spagna (ES).
Medicinale: EKZEM.
Confezioni A.I.C. n.:
042982013 - «0,25 mg/ml gocce auricolari, soluzione in contenitore monodose» 15 fiale in LDPE da 0,40 ml
042982025 - «0,25 mg/ml gocce auricolari, soluzione in contenitore monodose» 30 fiale in LDPE da 0,40 ml
alla societa' Infectopharm Arzneimittel Und Consilium GmbH
(codice SIS 3703), con sede legale e domicilio fiscale in Von-Humboldt-Str. 1, 64646 Heppenheim, Germania (DE).
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...
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