Review Product Marketing Authorisation For Human Use «Erdotin».

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-02&atto.codiceRedazionale=15A01404&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved February 10, 2015 V&A # 213/2015 determines the authorized the following variation: 1. b B Review of the manufacturer of a raw material, a reactive 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 supporting a ASMF (Master File of the active substance), relative to medicine ERDOTIN, shapes and wrappings AIC # 026283059-"225 MG/3 ML powder and solvent for solution" 6 bottles powder + 6 vials solvent, AIC # 026283061-"300 mg capsule" 20 capsules, 225 mg # 026283073-"AIC granules for oral suspension" 20 sachets, AIC # 026283097-"150 mg capsule 026283109 20 capsules," AIC 175 mg/# 5-"ml" bottle 100 ml granules for oral suspension, AIC # 026283111-"300 mg dispersible" tablets 20: introduction of Renee S Srl as new producer for the active substance ERDOSTEINE, as follows: === === === === === === === === === === === === === === === === === === === === === === === | Da: | A: | +=========================+=========================================+ | 2.1.3.2. S. | Manufacturer of principle | |: EDMOND PHARMA S.R.L. Via dei | | Giovi, 131 20037 Paderno Dugnano (MI) | | (Italy) Societa ' italiana s. 2.1 3.2 medicinal | |. Manufacturer of | Scandicci S.R.L. (S.I.M.S. S.R.L.) | | active ingredient: EDMOND | Localita ' Filarone 50066 Reggello | PHARMA S.R.L. Via dei | (Florence) (Italy) Version DMF: | | Giovi, 131 20037 Paderno | DMF AIN/2011/289, with status updates | Dugnano (MI) (Italy) | August/November 2013 and March/June 2014 | +--------------------------+------------------------------------------+ retest Period: 5 years.
Mah: ROTTAPHARM S.P.A. with registered office and tax domicile in 3, Union Gallery 5, 20122-Milan (MI) Italy, (tax 04472830159) disposal stocks 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 AIFA 14/04/2014 # 371 of Determines published in the Official Gazette No. 101 of 03/05/2014.
Date of determination: from the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica Italiana.