Review Product Marketing Authorisation For Human Use "solu Medrol».

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-04-20&atto.codiceRedazionale=15A02809&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved 1 April V&A the # 608 determines 2015 Authorize variations: C.I. 4) one or more amendments to the summary of product characteristics, labelling and package leaflet after new data on quality, preclinical, clinical or pharmacovigilance medicine SOLU MEDROL.
Authorized updating of the summary of product characteristics to sections 4.4 and 4.8 and corresponding paragraphs leaflet and labels, relative to medicine Solu Medrol, in shapes and packagings listed below: AIC # 023202017-"40 mg/ml powder and solvent for solution for injection" 1-Chamber bottle from 40 mg/ml AIC # 023202043-"125 mg/2 ml powder and solvent for solution for injection" 1 vial 2 ml double room 125 mg/AIC # 023202056-"500 mg/8 ml powder and solvent for solution for injection 500 mg + 1" from powder bottle 8 ml solvent vial AIC # 023202068-"1000 mg/16 ml powder and solvent for solution for injection 1000 mg 1 vial of powder" + 1 bottle 16 ml solvent AIC # 023202070-"2000 mg/32 ml powder and solvent for injectable solution 1 vial of powder" from 2000 mg + 1 bottle 32 ml solvent is authorized also, amendment of the Standard Terms of the description of the packaging of: AIC # 023202017-"40 mg/ml powder and solvent for solution for injection" 1-Chamber bottle from 40 mg/ml AIC # 023202043-"125 mg/2 ml powder and solvent for solution for injection" 1 vial 2 ml double room 125 mg/AIC # 023202056-"500 mg/8 ml powder and solvent for solution for injection 500 mg + 1" from powder bottle 8 ml solvent vial AIC # 023202068-"1000 mg/16 ml powder and solvent for solution for injection 1000 mg 1 vial of powder" + 1 bottle 16 ml solvent AIC # 023202070-"2000 mg/32 ml powder and solvent for injectable solution 1 vial of powder" from 2000 mg + 1 solvent bottle 32 ml to : AIC # 023202017-"40 mg/ml powder and solvent for solution for injection" double bedroom 1 40 mg/ml vial AIC # 023202043-"125 mg/2 ml powder and solvent for solution for injection" 1 vial 2 ml double room 125 mg/AIC # 023202056-"500 mg/8 ml powder and solvent for solution for injection 500 mg powder vial 1" + 8 ml solvent vial AIC # 023202068-"1000 mg/16 ml powder and solvent for solution for injection" 1000 mg 1 vial of powder + 1 bottle 16 ml solvent AIC # 023202070-"2000 mg/32 ml powder and solvent for solution for injection" 2000 mg + 1 powder vial 1 vial solvent from 32 ml handouts corrected and approved are attached to the assessment, referred to in this excerpt.
MAh: Pfizer Italy S.r.l. (tax number 06954380157) with registered office and tax domicile in via Isonzo, 71, 04100-Latina (LT) Italy Printed 1. The marketing authorisation holder should make the changes, after the date of entry into force of this determination, the summary of product characteristics; no later than six months from the same date the package leaflet and labelling.
2. In accordance with art. 80, paragraphs 1 and 3, of Legislative Decree No 219 April 24, 2006 and s, leaflet and labels must be written in Italian and, limited to medicinal products marketed in the province of Bolzano, in German. The mAh 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.
Inventory disposal Both lots already products on the date of entry into force of this determination that the batches produced during the period referred to in art. 2, paragraph 1, of the present, not bearing approved changes can be kept on the market until the expiration date printed on the label of the medicine. Pharmacists are required to deliver the package leaflet updated users, as from the end of 30 days from the date of publication in the Official Gazette of the Italian Republic of this determination. The Mah makes accessible to pharmacist leaflet updated within the same timeframe.
Date of determination: from the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica italiana.