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Burgemeester
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![]() Prepandrix; Pandemrix – influenza virus H5N1, inactivated, vaccine, with AS03 adjuvant; bird flu vaccine; avian influenza vaccine; pandemic influenza vaccine"
Company roles: Centers for Disease Control and Prevention (CDC) — R&D ; Tech. ; USA mark. GlaxoSmithKline Biologicals S.A. (GSK) — Manuf. ; R&D ; Tech. ; Europe mark. GlaxoSmithKline plc (GSK) — Parent Monograph size = 15988 characters (not including indexing, nomenclature, links, etc. on this page) Partial monograph text: 393 Influenza Vaccine, H5N1/GSK Pandemic Influenza vaccine, surface antigen, inactivated; influenza vaccine, pandemic – Prepandrix; Pandemrix; influenza virus H5N1 vaccine; bird flu vaccine; influenza virus H5N1, inactivated, vaccine; avian influenza vaccine; influenza H5N1 virus (A/Indonesia) vaccine Status: vaccine approved in EU in May 2008; being added to U.S. and other countries’ stockpiles Organizations involved: GlaxoSmithKline Biologicals S.A. – Manuf.: R&D; Tech.; Europe mark. GlaxoSmithKline plc – Parent Centers for Disease Control & Prevention (CDC) – R&D; Tech.; U.S. mark.. Description: Prepandrix “prepandemic vaccine” is a conventional egg-cultured influenza virus H5N1 (A/VietNam/1194/2005 NIBRG-14) clade 2 inactivated split-antigen vaccine. The H5N1 clade 2 bulk material is being manufactured from a laboratory version seed virus of the wild-type virus provided by the U.S. Centers for Disease Control and Prevention (CDC). The reference virus, A/Vietnam/1194/2004 (H5N1) NIBRG-14, was developed using reverse genetics, with reassortment strain combining the H5 and N1 segments to with an influenza virus PR8 strain backbone. In addition the H5 was engineered to eliminate the polybasic stretch of amino-acids at the HA cleava … truncated (just the beginning) Nomenclature: Infleunza Vaccine, H5N1/GSK [BIO] Prepandrix [TR] Pandemrix [TR] Pandemic Influenza vaccine, surface antigen, inactivated [EU] Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) A/VietNam/1194/2004 NIBRG-14 [EU] Pandemic influenza vaccine (H5N1) (split, inactivated, adjuvanted) [EU] avian influenza vaccine [SY] bird flu vaccines [SY] influenza H5N1 virus (A/Indonesia)vaccine [SY] influenza vaccine, pandemic [SY] influenza virus H5N1, inactivated, vaccine with AS03 adjuvant [SY] Index Terms: Product Class Index: biopharmaceutical products bovine materials used chicken source materials vaccines, inactivated vaccines, subunit vaccines, viral SB001 BIOPHARMA prod. (mainstream) Regulatory/Status Index: EU200 Currently Approved in EU EU666 Biodefense stockpile UM100 Controlled/Gov’t Distribution in US US666 Biodefense stockpile EM160 Controlled/Gov’t Distribution in EU Biological Index: chicken embryos (eggs) influenza virus, H5N1 virus culture Chemical Index: alpha-tocopherol aluminum adjuvant AS03 adjuvant Daronrix disodium phosphate formaldehyde magnesium chloride octoxynol 10 polysorbate 80 (Tween 80 potassium chloride potassium dihydrogen phosphate sodium chloride sodium deoxycholate squalene thiomersal vitamin E http://www.lookupfellowship.com/2009...o-use-666.html Laatst gewijzigd door Valentine Julien : 27 juli 2009 om 19:01. |
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