Retrieved February 24, 2015 V&A # 360/2015 of authorization determines variation in relation to medicine BEACITA are authorized the following variation: expansion of specification limits approved for the finished product (impurity note "D" at the end of the period of validity), concerning the medicinal product and authorisation authorised pack sizes in Italy following the mutual recognition procedure.
Procedures: PT/H/0626/001-002/II/006 type of variation: b. II. d. 1. and Mah: ACTAVIS GROUP PTC EHF 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 Determines AIFA n. 371 of 14/04/2014 published in the Official Gazette No. 101 of 03/05/2014.
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.