Retrieved determines V&A _n. 34/January 14, 2015 2015 of How EU N°: 108/01-02/SI/H/II/022.
Are authorized the following variation: introduction of a producer of the active substance esomeprazole magnesium dihydrate, Krka, d.d., Šmarješka cesta 6, 8501 Novo mesto (Slovenia), supported by a ASMF: SMP11 version-P4-000001-AP-1.0-15.05.2014 and 000001 SMP11-P4-version-RP-1.0-20.05.2014.
With respect to medicinal product: DROPS and at authorised pack sizes the placing in Italy following the mutual recognition procedure.
MAh: KRKA D.D. NOVO MESTO Disposal stocks lots already products can be kept on the market until the expiration date printed on the label of the medicinal product in accordance with art. 1 subparagraph 5 of April 14, 2014 # 371 of AIFA determines published in Official Gazette No 101 of May 3, 2014.
Date of determination: from the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica italiana.