Retrieved determines the Authorization to December 16, 2014 # 2615 V & variations: 4 B. I. f, and b. II. h. VENITAL, 1. a) on medicinal products VEBIKED, KEDHBS, KEDCOM, ATKED, KLOTT, MIXED;
You authorize the following modifications: introduction of NAT test for the determination of plasma production pool HAV virus (Cs).
from: plasma pool Specifications (standard Cs): Test: HBsAg; Limit: negative tests: Anti HIV 1-2; Limit: negative Test: total protein; Limit: 100 g/ml ≥ 5.0 Test: pH; Limit: 5.7 ÷ 8.1 Test: identity; Limit: human Testing: anti-D; Limit: negative Test: HCV-RNA; HIV-1 RNA: negative Test: limit; Limit: negative Test: HBV DNA; Limit: negative: plasma pool Specifications (standard Cs): Test: HBsAg; Limit: negative tests: Anti HIV 1-2; Limit: negative Test: total protein; Limit: 100 g/ml ≥ 5.0 Test: pH; Limit: 5.7 ÷ 8.1 Test: identity; Limit: human Testing: anti-D; Limit: negative Test: HCV-RNA; HIV-1 RNA: negative Test: limit; Limit: negative Test: HBV DNA; Limit: negative Test: HAV-RNA; Limit: The grouping of variations involves modifying the section corresponding to paragraph 4.4 of the SPC and package leaflet for the MIXED medicine as follows: summary of product characteristics FIXED by: Paragraph 4.4 viral safety measures are considered effective for lipid enveloped viruses such as HIV, HBV and HCV and lipid non-enveloped viruses such as HAV. The measures taken can have little effect against non-enveloped viruses lipids as parvovirus B19.
in: Paragraph 4.4 viral safety measures are considered effective for lipid envelope viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV).
The measures taken may have limited value against non-enveloped viruses such as hepatitis lipid A (HAV) and parvovirus B19.
MIXED leaflet from: special measures are considered effective for lipid envelope viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) and non-enveloped viruses hepatitis A (HAV) lipid.
The measures taken can have little effect against non-enveloped viruses lipids as parvovirus B19.
a: special measures are considered effective for lipid envelope viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV).
The measures taken can have little effect against non-enveloped viruses such as hepatitis lipid A (HAV) and parvovirus B19.
Mah: KEDRION S.P.A. (tax 01779530466) with registered office and tax domicile in Castelvecchio Pascoli, 55051 Fraction accounts-Barga-Lucca (LU) 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.
ATKED, KEDCOM, medicines stocks disposal KEDHBS, VENITAL, VEBIKED and KLOTT: 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.
For the MIXED medicine: 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.