Authorisation For The Medicinal Product For Usoumano «Tuberlot».

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-19&atto.codiceRedazionale=15A01905&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved February 23, 2015 TUBERLOT # 165/2015 determines the medication: Mah: So if PHARM s.r.l.-Via dei Castelli Romani, 22-00040 Pomezia (RM) packaging: "0.5% solution" 1 bottle of 15 ml-AIC # 042526018 (10) 18KYB2 (based on 32) dosage form: solution.
Composition: 100 ml of solution contains: active ingredient: 500 mg salbutamol (salbutamol sulphate 600 mg as) other ingredients: methyl-parahydroxybenzoate E218, ethyl-parahydroxybenzoate E 214, butyl-parahydroxybenzoate, sodium chloride, sulfuric acid, purified water.
Production active ingredient: Lusochimica SpA-Via Giotto, 9-23871 Lomagna-Lecco production, primary and secondary packaging, quality control, batch release: Special Product's Line SpA-Street Paduni, 240-03012 Anagni (FR) medical indications: bronchial asthma treatment.
Obstructive pulmonary diseases with asthmatic component.
New listings for the purposes of classification is packaging: "0.5% solution" 1 bottle of 15 ml-AIC # 042526018 (10) 18KYB2 (based on 32) new listings ' class: C Classification for the purpose of the classification for the purposes of the supply of the medicine Tuberlot and ' the following medicinal product subject to medical prescription (RR).
Printed packaging of the medicinal product should be marketed with labels and package leaflets comply with the text annexed to this determination.
It approved the summary of the product characteristics attached to this determination.
Periodic safety update reports PSUR-at the time of granting the authorisation, the submission of the periodic safety update reports not required for this product. However, the marketing authorisation holder shall submit periodic safety update reports for this product if the product is listed as reference dates (EURD list) referred to in article 107-quater, para. 7 of Directive 2010/84/EC and published on the web portal of the European Medicines Agency.
Date of application of the determination on the day following its publication in the official journal of the Italian Republic.