FOCETRIA EMEA PDF

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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For more information, see the CMD h meeting report. Product details Name Focetria. Following the World Health Organization’s announcement that the world has moved into a post-pandemic focetrria, the European Medicines Agency has published the last of its pandemic pharmacovigilance updates.

The updated product information in all EU languages for Tamiflu will be published shortly.

Relenza is currently authorised in all 27 European Union Member States, plus Iceland, Liechtenstein and Norway to treat or prevent influenza in adults and children from the age of five years onwards. 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 of these vaccines, Focetria and Pandemrix, be updated.

This advice was based on a information indicating that influenza activity worldwide has returned to levels that are normally seen for seasonal influenza. The European Medicines Agency has reviewed further data on the centrally authorised pandemic medicines, the pandemic influenza vaccines Celvapan, Focetria and Pandemrix, and the antiviral Tamiflu oseltamivir. Influenza, Human Immunization Disease Outbreaks.

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.

It is intended for a target population that is different from that of the centrally authorised medicine Tamiflu, which is taken by mouth.

Once formally approved by the European Commission, this will apply to all newly manufactured Tamiflu capsules.

Pandemic influenza: news archive | European Medicines Agency

Influenza virus surface antigens haemagglutinin and neuraminidase of strain: Information on Arepanrix was evaluated in an accelerated timeframe using a rolling review that started with the submission of the first available data on 17 July The M2 inhibitors amantadine and rimantadine do not appear to be effective against the novel virus strain. As part of its review of data from clinical studies and post-marketing experience for centrally authorised pandemic influenza vaccines, the Agency’s Committee for Medicinal Products for Human Use CHMP has recommended changes to the product information of Celvapan to include additional information on the vaccine’s immunogenicity and safety.

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The European Medicines Agency has reviewed further data on the centrally authorised pandemic vaccines Celvapan, Focetria and Pandemrix.

For more information, see the report. No vaccines are currently available for this novel virus. At least 26 million people andpregnant women have been vaccinated to date in Europe with one of the three centrally authorised vaccines.

The Agency will publish any changes to the marketing authorisations for these medicines that may become necessary emeaa the future. Prescribers and parents should monitor the temperature of the vaccinated child emez, if necessary, take measures to lower the fever e.

How useful was this page? Further information on Relenza is available in the summary of product characteristics and the patient information leaflet.

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. Following the authorisation of Focetria and Pandemrix on 29 Septemberthe Agency has recommended that a third pandemic-influenza vaccine, Celvapan from Baxter, be authorised by the European Commission for use in protecting European Union citizens against pandemic influenza.

At least 28 million people including at leastpregnant women have been vaccinated to date in Europe with one of the three centrally authorised vaccines. IV Zanamivir is an unauthorised medicine that is a new development of zanamivir for intravenous use.

If the medicine is prescribed to these children, the recommended dose is 2 to 3 mg per kilogram body weight. In the margins of the February meeting of the Agency’s Committee for Medicinal Products for Human Use CHMPa group of vaccination experts was convened to further analyse the variability seen in the serological tests used to measure the immune response following vaccination of children and adults with the centrally authorised pandemic vaccine Celvapan.

The Agency also recommended further changes to the product information for Focetria and Pandemrix. Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation. By this date, at least The European Medicines Agency’s Committee for Medicinal Products for Human Use CHMP has adopted recommendations to update the product information for Tamiflu oseltamivir with more information on the medicine’s use in children over six months of age and in pregnant and breastfeeding women.

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The marketing authorisation for Focetria has been expired following the marketing-authorisation holder’s decision not to apply for a renewal. Tamiflu IV is an unauthorised medicine that is a new development of oseltamivir for intravenous use. Skip to main content. For more information, see the revised document: Additional clinical trials in adults and children are currently being initiated by the vaccine manufacturers and the results will be reviewed in the coming months as they become available.

The European Commission has granted authorisations that will allow the influenza vaccines Focetria and Pandemrix to be used to vaccinate people against the virus causing the current H1N1 influenza pandemic. An archive of the news related to the pandemic is available below. For more information, see the press release and the European public assessment reports for CelvapanFocetria and Pandemrix. Novartis Vaccines and Diagnostics S. The Agency will continue to publish these reports on a regular basis while the influenza pandemic is ongoing.

It is intended for a target population that is different from that of Relenza, which is inhaled. For more information, see the CMD h meeting report announcing the approval of the extension of shelf-life of Relenza.

The European Medicines Agency has published the first in its series of weekly pandemic influenza pharmacovigilance update reports.

Pandemic influenza: news archive

The European Medicines Agency’s Committee for Medicinal Products for Human Use CHMP has adopted revised recommendations for pharmacovigilance plans included in risk-management plans submitted as part of marketing-authorisation applications for pandemic-influenza vaccines.

For more information, see the follow-up recommendations. The updated product information gives information on the use of Tamiflu in premature infants and its use to prevent influenza in immunocompromised patients who have been exposed to the virus.

In addition, the Committee has also recommended the approval focetdia detailed instructions on the preparation and dosing of ‘extemporaneous’ formulations for children under the age of one. Decisions on the granting of European Union-wide marketing authorisations meea the vaccines by the European Commission are expected shortly.

Date of issue of marketing authorisation valid throughout the European Union.