Retrieved January 14, 2015 V&A # 33/2015 of Procedure determines EU #: 001-002/0114/is/H/II/017.
Type II variation: B 1b) 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: ESOMEPRAZOLE SANDOZ and authorised pack sizes the placing in Italy following the mutual recognition procedure.
Mah: Sandoz S.P.A.
Inventory disposal 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.