Review Product Marketing Authorisation For Human Use «Flantadin».

Original Language Title: Modifica dell'autorizzazione all'immissione in commercio delmedicinale per uso umano «Flantadin».

Read the untranslated law here:

Retrieved determines the 2558/2014 December 2, 2014 n V & Authorize the variation in relation to medicine: FLANTADIN.
Are authorized the following variation: 1. b B) change in the manufacturer of a raw material of a reagent or an intermediate product used in the manufacturing process of the active substance or review of the manufacturer of the active substance (possibly including the sites of quality control), for which you do not have a certificate of conformity to European Pharmacopoeia-introduction of a manufacturer of the active substance that has the support of a ASMF (Master File of the active substance) with respect to the medicine Flantadin, shapes and packaging and A.I.C.: A.I.C. n. 025464037-"6 mg tablet" 10 tablets;
A.I.C. n. 025464049-"30 mg tablets" 10 tablets;
A.I.C. # 025464052-22.75 "mg/ml oral drops, suspension" vial 13 ml: Add manufacturer of APIs "Deflazacort": Crystal Pharma, S.A.-Parque Tecnologico de Boecillo-Parcela 105-47151-Boecillo (Valladolid) Spain.
A.I.C. holder: Teofarma S.r.l. with registered office and tax domicile in via Fratelli Cervi # 8-27010 Valle Salimbene-Pavia (PV) Italy; (tax ID # 01423300183).
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, paragraph 5, of the causes of the April 14, 2014 # 371 AIFA 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.