COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Benifema» (14A04397)
Estratto determinazione n. 548/2014 del 30 maggio 2014 Medicinale: BENIFEMA. Titolare AIC: Actavis Group PTC ehf. - Reykjavikurvegur 76 - 78 - 220 Hafnarfjörður (Islanda) Confezione «150 microgrammi/30 microgrammi compresse rivestite con film» 1X21 compresse in blister PVC/PVDC/AL - AIC n. 042425049 (in base 10) 18GQQT (in base 32) Confezione «150 microgrammi/30 microgrammi compresse rivestite con film» 3X21 compresse in blister PVC/PVDC/AL - AIC n. 042425052 (in base 10) 18GQQW (in base 32);
Confezione «150 microgrammi/30 microgrammi compresse rivestite con film» 6X21 compresse in blister PVC/PVDC/AL - AIC n. 042425064 (in base 10) 18GQR8 (in base 32). Forma Farmaceutica: Compressa rivestita con film. Composizione: Ogni compressa contiene: Principio attivo: 150 microgrammi di desogestrel e 30 microgrammi di etinilestradiolo. Eccipienti: Nucleo della compressa: Lattosio monoidrato Amido di mais Povidone K-30 (E1201) RRR-alfa-tocoferolo (E307) Olio di soia Silice colloidale idrata (E551) Silice colloidale anidra (E551) Acido stearico (E570) Rivestimento con film della compressa: Ipromellosa 2910 (E464) Triacetina (E1518) Polisorbato 80 Titanio diossido (E171) Produzione del principio attivo: etinilestradiolo Organon N.V. - Kloosterstraat 6 - 5349 AB OSS - Paesi Bassi Organon N.V. - Veersemeer 4 - 5347 JN OSS - Paesi Bassi desogestrel Industriale Chimica S.r.l. - Via E.H. Grieg, 13;
21047 Saronno (Varese) - Italy. Rilascio lotti, controllo dei lotti, produzione, confezionamento primario e secondario: Laboratorios Leon Farma S.A. - C/La Vallina s/n, Pol.Ind.Navatejera, 24008 Navatejera - Leon - Spagna. Controllo lotti: Analisi microbiologiche: Laboratorios de analisis Dr. Echevarne, S.A. C/Provença 312 baixos 08037 Barcellona (Spagna) Analisi microbiologiche: Biolab S.L. - Pol.Industrial La Mina, Avda. Los Reyes, nave 59, Colmenar Viejo, 28770 Madrid (Spagna) Confezionamento secondario: Manantial Integra S.L. - Poligono Industrial Neinor-Henares, E-3 Local 23 Y 24 28880 Meco - Madrid (Spagna) Indicazioni terapeutiche: Contraccezione orale. Classificazione ai fini della rimborsabilita' Confezione «150 microgrammi/30 microgrammi compresse rivestite con film» 1X21 compresse in blister PVC/PVDC/AL - AIC n. 042425049 (in base 10) 18GQQT (in base 32)...
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