Retrieved February 25, 2015 V&A # 372/2015 determines the authorized the following variation: introduction of a new manufacturer in possession of ASMF (Applicant part: SMP11-P4-000001-AP-1.0-15.05.2014; Restricted part: SMP11-P4-000001-RP-1.0-20.05.2014), for the PA Esomeprazole Magnesium Dihydrate: Krka d.d., Novo mesto Šmarješka cesta 68501 Novo mesto-Slovenia.
In relation to the medicinal product and authorisation authorised pack sizes in Italy following the mutual recognition procedure.
How to: Yes/H/0115/001-002/II/015.
Type of change: 1. b B Mah: Teva Italy S.r.l.
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 Determines AIFA n. 371 of 14/04/2014 published in the Official Gazette No. 101 of May 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.