Retrieved February 24, 2015 2015 # 363/V&A of causes _ (authorization of the change relatively to the drug RAMIPRIL HEXAL) are authorized the following variation: modification of the conditions of preservation of the finished product, from "keep at temperature not exceeding 30° C" to "keep at temperature not exceeding 25° C" in relation to the medicinal product and authorisation authorised pack sizes in Italy following the mutual recognition procedure. The packaging material should be placed on the market with handouts, as previously approved by this administration, with the only changes necessary to adapt to this determination.
Procedures: DK/H/001-003/1600/II/031 type of variation: b. II. f. 1. z) Mah: HEXAL S.P. stock 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 Determines AIFA n. 371 of 4/14/2014 published in the Official Gazette No. 101 of 5/3/2014.
Date of determination: this determination is effective on the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica Italiana and company will be notified to the holder of the marketing authorisation for the medicinal product.