Review Agency For Marketing Authorisation For Human Use «Airtal», «Kafenac» And «Sword».

Original Language Title: Modifica dell'autorizzazione all'immissione in commercio deimedicinali per uso umano «Airtal», «Kafenac» e «Gladio».

Read the untranslated law here:

Retrieved February 11, 2015 V&A # 243/2015 determines the authorized the following variation: b. II. d. 1. and Review specification parameters and/or limits of the finished product Review that is outside the bounds of the approved specification, b. II. d. 1. s) change in the specification parameters and/or finished product limits The PhEur 2.9.40 monograph introduces the uniformity of dosage units to replace the currently registered i.e. PhEur, 2.9.5 (uniformity of mass) or PhEur 2.9.6 (uniformity of content), b. II. d. 1. d) change in the specification parameters and/or finished product limits deletion of a non-significant (for example deletion of an obsolete parameter, such as aroma and flavor, or proof of identification for a flavouring or colouring material), on medicinal products AIRTAL, KAFENAC and GLADIO in the forms and 032773020-100 # AIRTAL AIC packs «mg film-coated tablets» 40 tablets, AIC # 032773069-«100 mg film-coated tablets» KAFENAC 031842014 «10 tablets, 100 mg film-coated tablets # AIC» AIC # 031842065 100 tablets, 40 mg film-coated tablets "» 10 tablets, GLADIO AIC # 031220015 «100 mg film-coated tablets» 40 tablets, AIC # 031220066 «100 mg film-coated tablets» 10 tablets: raising of specification limits for degradation product 1.0% 2.5% ≤ a ≤ Diclofenac and consequently raising the total extent of breakdown products from 1.3% 2.8% ≤ a ≤.
Besides being the only remaining solvent ethanol suppresses the specification "Total residual solvent", replacing the parameter "uniformity of mass" with "uniformity of dosage units (according to PhEu)" Mah: Almirall S.p.a. with registered office and tax domicile in Via Messina, 38, 20154-Milan (MI) Italy, (tax 06037901003) Abiogen Pharma S.p.a. with registered office and tax domicile in Via Meucci, 36-Frazione Ospedaletto 56121 Pisa (PI) Italy, (fiscal code 05200381001).
Inventory disposal 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 April 14, 2014 # 371 of AIFA Determines published in Official Gazette No 101 of May 3, 2014.
Date of determination: from the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica italiana.