COMUNICATO - Modificazione dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Mirena». (13A07728)
Estratto determinazione V &
A/1429 del 9 settembre 2013 Titolare AIC: BAYER OY con sede legale e domicilio in PANSIONTIE 47, 20210 - TURKU (FINLANDIA) Medicinale: MIRENA Variazione AIC: C.I.4 Variazioni collegate a importanti modifiche nel riassunto delle caratteristiche del prodotto, dovute in particolare a nuovi dati in materia di qualita', di prove precliniche e cliniche o di farmacovigilanza L'autorizzazione all'immissione in commercio e' modificata come di seguito indicata: E' autorizzata la modifica degli stampati relativamente alla confezione sottoelencata: AIC N. 029326016 - "20 MICROGRAMMI/24...
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