Review Product Marketing Authorisation For Human Use "riastap».

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-01-21&atto.codiceRedazionale=15A00242&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved December 9, 2014 2014 # 2590 V&A/determines the permission of variation in relation to medicine RIASTAP is authorized the following variation: from: manufacturing process of the active substance of non-organic ingredients: aluminum hydroxide suspension tests in house to determine the identity/purezza: 1) Atomic adsorption spectrometry identity tests; Requirement: passes the test;
2) pH value determination; Requirement: pH 5.8-6.5: production process of the active substance of non-organic ingredients: aluminum hydroxide suspension tests in house to determine the identity/purezza: 3) Atomic adsorption spectrometry identity tests; Requirement: passes the test;
4) determination of the pH value; Requirement: pH 5.8-6.5 5) determination of aluminum hydroxide suspension sedimentation volume; Requirement: ³ 20 mL/dL 6) determination of adsorption capacity of factor II by the aluminum hydroxide; Requirement: ³ 70% by: production process of the active substance auxiliary materials of non-biological origin without reference to a Monograph: suspension of aluminum hydroxide 15 g/L, supplier: General Chemicals LLC Berkley Heights, NJ, United States of America or Novartis Vaccines GmbH Marburg 35006, Germany & co., in: production process of the active substance 1) auxiliary materials of non-biological origin without reference to a Monograph : suspension of aluminum hydroxide 15 g/L, supplier: General Chemicals LLC Berkley Heights, NJ, United States of America or Novartis Vaccines GmbH Marburg 35006, Germany & co., 2) auxiliary materials of non-biological origin described in a Monograph: aluminum hydroxide suspension 22 g/L, manufacturer: Brenntag Biosector companies A/S (Brenntag Nordic A/S), 3600 Frederikssund, Denmark from: manufacturing process of the active substance production procedure P-699 "Manufacture of Fibrinogen Bulk Solution" intermediate Step "frozen" dissolution of active ingredient 2.6.2.8 paste "and ultrafiltration"
Batch size of active ingredient paste "intermediate" frozen: from 24 to 44 kg: manufacturing process of the active substance production procedure P-699 "Manufacture of Fibrinogen Bulk Solution" intermediate Step "frozen" dissolution of active ingredient 2.6.2.8 paste "and ultrafiltration" batch size of active ingredient paste "intermediate" frozen: from 33 to 48 kg minor editorial changes to the narrative sections of the dossier, in order to reflect editorial changes in manufacturing procedures updated P-668 _ 669F P-668 _ 669FGA (formerly called P-668 _ 669FG) and P-699 to harmonize the dossier. concerning the medicine RIASTAP and authorised pack sizes the placing in Italy following the mutual recognition procedure.
How to: DE/H/1936/001/II/023/G type of variation: 1. c) B.I.b. "Review specification parameters and/or limits of the active ingredient, a raw material, intermediate, or reagent used in the manufacturing process of the active ingredient-adding a new specification parameter to the corresponding test method specification" (type IB).
B 1. e) "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-The amendment concerns a biological active substance or raw material , a reagent or an intermediate product used in the manufacture of a biological/immunological product "(type II) B 3. z)" changing the size of the lot (including lot size classes) of the active substance or intermediate product used in the manufacturing process of the active substance-another variation on "Mah: CSL BEHRING GMBH 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 subparagraph 5 of determines AIFA n. 371 of 14/04/2014 published in the Official Journal No. 101 of 03/05/2014.
Date of application of determining this determination is effective on the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica italiana and company will be notified to the holder of the marketing authorisation for the medicinal product.