COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Mepivacaina con Adrenalina Pierrel». (16A07770)
Estratto determina AAM/PPA n. 1712/2016 del 18 ottobre 2016 Descrizione del medicinale e attribuzione n. A.I.C. E' autorizzata l'immissione in commercio del medicinale: «MEPIVACAINA CON ADRENALINA PIERREL», nella forma e confezione: «20 mg/ml soluzione iniettabile con adrenalina 1:100.000» 10 iniettori monouso con cartucce da 1,8 ml in aggiunta alle confezioni gia' autorizzate, alle condizioni e con le specificazioni di seguito indicate. Titolare A.I.C.: Pierrel Pharma S.R.L. con sede legale e domicilio fiscale in Strada statale Appia, 46/48, 81043 - Capua - Caserta - Codice fiscale 07066640967. Confezione: «20 mg/ml soluzione iniettabile con adrenalina 1:100.000» 10 iniettori monouso con cartucce da 1,8 ml - A.I.C. n. 034342030 (in base 10) 10S14G (in base 32). Forma farmaceutica: soluzione iniettabile. Composizione: ogni ml di soluzione iniettabile contiene: principio attivo: mepivacaina HCl 20,00 mg;
adrenalina bitartrato 18,20 mcg equivalenti a adrenalina 10 mcg;
Classificazione ai fini della rimborsabilita' Confezione: A.I.C. n. 034342030 - «20 mg/ml soluzione iniettabile con adrenalina 1:100.000» 10 iniettori monouso con cartucce da 1,8 ml. Classe di rimborsabilita': apposita sezione della classe di cui all'art. 8, comma 10, lettera c) della legge 24 dicembre 1993, n. 537 e successive modificazioni, dedicata ai farmaci non ancora valutati ai fini della rimborsabilita', denominata Classe C (nn). Classificazione ai fini della fornitura Confezione: A.I.C. n. 034342030 - «20 mg/ml soluzione iniettabile con adrenalina 1:100.000» 10 iniettori monouso con cartucce da 1,8 ml -...
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