Authorisation For The Medicinal Product For Usoumano «Lacidipine Rivopharm»

Original Language Title: Autorizzazione all'immissione in commercio del medicinale per usoumano «Lacidipina Rivopharm»

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-01-09&atto.codiceRedazionale=14A10113&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved December 16, 2014 # 1499/2014 of Medicine determines: LACIDIPINE RIVOPHARM.
A.I.C. holder: Rivopharm (UK) Limited-6th floor, 28 Kingsway, London WC2B 6JR-Great Britain.
Packaging: «4 mg film-coated tablets» 30 tablets in AL/AL-A.I.C. # 042436055 (10) 18H1GR (based on 32);
«4 mg film-coated tablets» 90 tablets in AL/AL-A.I.C. # 042436067 (10) 18H1H3 (based on 32).
Dosage form: tablets.
Composition: each tablet contains: active ingredient: 4 mg of lacidipine.
Classification for the purposes of new listings is the packs referred to in art. 1 are placed, by virtue of art. 12, paragraph 5, of Decree-Law No September 13, 2012. 158, converted, with amendments, by law November 8, 2012, n. 189, in the section dedicated to drugs not yet evaluated for the purposes of new listings, the class of article. 8, paragraph 10) (c) of the Act December 24, 1993, no. 537 as amended, called class C (nn).
Classification for the purpose of the classification for the purposes of providing the medicine Lacidipine Rivopharm is as follows: medicinal product subject to medical prescription (RR).
Packaging of printed 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.
In accordance with art. 80 paragraphs 1 and 3 of the Legislative Decree of April 24, 2006, # 219 s and the package leaflet and labels must be written in Italian and, limited to medicinal products marketed in the province of Bolzano, in German. The holder of the A.I.C. avails itself of the complementary use of foreign languages, must give prior notice to the AIFA and keep available the certified translation of German texts and/or in another foreign language. In case of non-compliance with the provisions on the labelling and package leaflet shall apply sanctions under art. 82 of the aforementioned legislative decree.
Date of determination: from the day following its publication in the official journal of the Italian Republic.