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October 25, 2013
09:09 EDTBAXCHMP recommends granting extensions of indications to 2 Baxter vaccines
The Committee for Medicinal Products for Human Use adopted a positive opinion recommending a variation to the terms of the marketing authorization for the medicinal product Vepacel. The marketing authorization holder for this medicinal product is Baxter Innovations GmbH. The CHMP adopted a new indication as follows2: "Active immunisation against H5N1 subtype of influenza A virus. This indication is based on immunogenicity data from subjects from the age of 6 months onwards following administration of two doses of vaccine prepared with H5N1 subtype strains. VEPACEL should be used in accordance with Official guidance". The CHMP also adopted a positive opinion recommending a variation to the terms of the marketing authorization for the medicinal product Pandemic Influenza Vaccine H5N1 Baxter. The CHMP adopted a new indication to include children and adolescents from the age of 6 months onwards. The full indication for Pandemic Influenza Vaccine H5N1 Baxter will be as follows: “Prophylaxis of influenza in an officially declared pandemic situation. Pandemic influenza vaccine should be used in accordance with official guidance.”
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August 27, 2015
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August 14, 2015
16:44 EDTBAXThird Point gives quarterly update on stakes
NEW STAKES: Baxter (BAX), T-Mobile (TMUS), Sealed Air (SEE), Devon (DVN), and Perrigo (PRGO). INCREASED STAKES: SunEdison (SUNE), Dow Chemical (DOW), Mohawk (MHK), Yum! Brands (YUM), and IAC/InterActiveCorp (IACI). DECREASED STAKES: Ally Financial (ALLY), Amgen (AMGN), Sensata (ST), Masco (MAS), and Delta (DAL). LIQUIDATED STAKES: Dollar General (DG), McKesson (MCK), Edgewell Personal Care (EPC), Maxim (MXIM), and FleetCor (FLT).
09:01 EDTBAXBaxter, Water Street announce FDA approval for CEFAZOLIN 2 Gram Premix
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