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FOCETRIA EMEA PDF

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to the European Medicines Agency (EMEA) for Focetria as an H5N1 . Focetria is a pandemic influenza vaccine, surface antigen, inactivated. Focetria. Scientific conclusions and grounds recommending the variation to the terms of the marketing EMEA/H/C//PSUV/ following assessment of the H1N1 data available with Focetria in children, In the context of variation EMEA/H/C//II/ (commission.

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Tamiflu IV is an unauthorised medicine that is a new development of oseltamivir for intravenous use.

Pandemic influenza: news archive

The Agency also recommended further changes to the product information for Focetria and Pandemrix. The most frequent adverse reactions that have been reported are non-serious and as expected.

Focetria should be used in accordance with ficetria guidance. On 10 Augustthe World Health Organization WHO announced that the influenza pandemic is over and the world is no longer in phase 6 of pandemic alert.

To date, no unexpected serious safety issues have been identified. For more information on Tamiflu, see the European public assessment report. At least 26 million people andpregnant women have been vaccinated to date in Europe with one of the three centrally authorised vaccines. CHMP recommendations for the pharmacovigilance plan as part of the risk management plan to be submitted with the marketing authorisation application for a pandemic influenza vaccine.

Pandemic influenza: news archive | European Medicines Agency

More information on Focetria. Novartis Vaccines and Diagnostics S. At least 28 million people including at leastpregnant women have been vaccinated to date in Europe with one of the three centrally authorised vaccines.

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Decisions on the granting of European Union-wide marketing authorisations for the vaccines by the European Commission are expected shortly. It is intended for a foocetria population that is different from that of Relenza, which is inhaled.

The Agency focstria to work with its European Union and international partners on a series of initiatives to facilitate the availability of antivirals and vaccines for use in an influenza pandemic situation. For more information on Arepanrix, see the European public assessment report. The Commission’s decision follows the scientific recommendations adopted in respect of these vaccines by the European Medicines Agency’s Committee for Medicinal Products for Human Use on 24 September The extension was proposed by the marketing authorisation holder to the Medical Products Agency MPA of Sweden, which is the reference Member State for Relenza, and agreed by other Member States via the mutual recognition procedure.

Expand all Collapse all. Patients who have Relenza that wmea recently expired should not throw it away, as it might be needed during a declared influenza pandemic. The European Medicines Agency is warning that young children may experience fever after their second dose of the pandemic influenza vaccine Pandemrix.

Focetria | European Medicines Agency

For more information, see the CHMP opinion on the conditions of use, conditions for distribution and target population and information on compassionate use. The distribution of an additional device is intended as a temporary measure during the H1N1 pandemic, because production capacity of Relenza with the approved diskhaler cannot meet the current increased demand for the medicine.

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Focetriia updated product information gives more information on the use of Tamiflu in the treatment of influenza in children under the age of six months and in post-exposure prevention of influenza in children under the age of one year during a pandemic influenza outbreak.

Relenza zanamivir is authorised in all 27 EU Emwa States for the treatment of influenza. For further details, see the press release: Following its review of clinical data made available since the approval of three H1N1 influenza vaccines, the European Medicines Agency’s Committee for Medicinal Products for Human Use CHMP has recommended to the European Commission that the product information for two foctria these vaccines, Focetria and Pandemrix, be updated.

An extemporaneous formulation of a medicine is a formulation that is prepared just prior to use. The recommended changes are based on guidance adopted by the CHMP in May on the use of antiviral medicines during an influenza pandemic.

For more information, see the press releasequestions and answers and the European public assessment reports for Focetria and Pandemrix. Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation.

For more information, see the press release and the European public assessment reports for CelvapanFocetriaPandemrix and Tamiflu. Date of issue of marketing authorisation valid throughout the European Union.

By this date, at least For more information, see the European public assessment report.