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Zanamivir compassionate use program
Adult patients (Tier 2 cohort) that received zanamivir aqueous solution as part of the Compassionate Use Program from May 2009 through 31 January 2011, treated at the same site as a Tier 1 patient. Exclusion Criteria: Adult patients that received zanamivir aqueous solution at non-Tier 1 sites.Compassionate Use Zanamivir. Zanamivir Aqueous Solution Compassionate Use Program as part of the Compassionate Use Program (CUP), in an effort to collect as much information as possible on the use of this investigational drug. The retrospective chart review is intended to gain a better understanding of the safety profile nbsp; Intravenous Zanamivir Requests for Severely Ill – . gov should be …Compassionate use is a treatment option that allows the use of an unauthorised medicine. Under strict conditions, products in development can be made available to groups of patients who have a disease with no satisfactory authorised therapies and who cannot enter clinical trials.Compassionate Use Programme Up until 31 January 2001, zanamivir has been provided for the treatment or prophylaxis of influenza for approximately 275 adults and children. There have been 15 deaths reported in severely ill and immunocompromised patients for whom zanamivir was requested.Intravenous zanamivir is only available through enrollment in an ongoing clinical trial or through a compassionate use program; follow dosage recommendations from the clinical trial or …Zanamivir: Request processing and management for the distribution of a non-marketed drug (IV Relenza) for compassionate use program. Disaster Event Support: During any type of disaster the CSHD can be a point of contact for Investigators. GSK Study Register: A repository of data and information from GSK studies. The GSK Study Register includes protocol summaries, scientific results …GSK is conducting a global retrospective chart review of patients treated with zanamivir as part of the Compassionate Use Program (CUP), in an effort to collect…If you are a Healthcare Professional and would like to make a request for compassionate use of a GSK investigational medicine, please email the GSK Clinical…23 Jun 2011 … Compassionate Use IV zanamivir should be considered ….. on the intravenous formulation and the Compassionate Use programme. In its 18th…Compassionate use programmes are coordinated and implemented by Member States, which set their own rules and procedures. … Active substance, Zanamivir.20 Sep 2017 … Regulatory and legal framework of compassionate use in Europe. ✓ EMA Role in compassionate … management of a compassionate use programme at the European level. Compassionate use … Zanamivir. Sweden. 2010.The term “compassionate use” is defined in Article 83 no. … the only two European countries with compassionate-use programmes incorporated into national law. … by the CHMP, was about the compassionate use of intravenous zanamivir.10 Oct 2014 … Compassionate Use of Intravenous (IV) Zanamivir During the 2013-2014 Influenza Season: Case Series of Three Patients. Punit Shah…Limited data are available; intravenous zanamivir is only available through enrollment in an ongoing clinical trial or through a compassionate use program;…The information regarding France's compassionate use programs was obtained …. (gemtuzumab ozogamicin), LENVIMA (Lenvatinib), Zanamivir i.v (Zanamavir)…ZANAMIVIR AQUEOUS SOLUTION FOR COMPASSIONATE USE IN … nebulized zanamivir in a compassionate use program conducted during 1999-2002, at.
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