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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Focetria | European Medicines Agency

The Agency will publish any changes to the marketing authorisations focetira these medicines that may become necessary in the future. For further details, see the press release: For more information, see the report. 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.

This is the fifth pandemic vaccine recommended for use by the Committee, and the second to be assessed using an emergency procedure which fast-tracks the evaluation of new vaccines developed during a pandemic influenza. The Member States of the European Union have approved the extension of the shelf-life emmea Relenza zanamivir oral inhalation powder, from five to seven years.

Pandemic influenza: news archive

These weekly reports will provide information on adverse reactions reported after the use of centrally authorised pandemic vaccines and antivirals in the European Union, and complement the information the Agency has been publishing regularly on the development and approval of medicines for use during the pandemic.

For more information, see the CHMP opinion on focetri conditions of use, conditions for distribution and target population and information on compassionate use.

For more focetdia, see the press release and the European public assessment reports for CelvapanFocetriaPandemrix and Tamiflu.

The recommended dose to treat this age group is 3 mg per kg body weight twice daily for five days. Further information on Relenza is available in the summary of product characteristics and the patient information leaflet.

The Agency also recommended further changes to the product information for Focetria and Pandemrix. This advice was based on a information indicating that influenza activity worldwide has returned to levels that are normally seen for seasonal influenza.

Manufacturers and marketing-authorisation holders are encouraged to anticipate smea submit a request for a PIP and a waiver, or a request for modification of an existing, agreed PIP as early as possible. For more information, see the press release and the first weekly report. The European Medicines Agency has published the first in its series of weekly pandemic influenza pharmacovigilance update reports. Product details Name Focetria. 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.

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Although an influenza pandemic has not been declared, the World Health Organization WHO increased the pandemic alert from level 3 to level 4 on 27 April in response to emex outbreak. This medicine will be used to treat critically ill patients with a life-threatening condition due to suspected or confirmed pandemic or seasonal flu, who cannot take authorised antivirals by mouth or inhalation.

Novartis Vaccines and Diagnostics S. For more information, see the CMD h meeting report.

You are therefore advised to be selective about which sections or pages you wish to print. For more information on Humenza, see the European public assessment report. The benefit-risk balance of the pandemic vaccines and antivirals used for the current H1N1 influenza pandemic continues to be positive. Leave this field blank.

Initial marketing-authorisation documents List item. Influenza, Human Immunization Disease Outbreaks. The Agency’s Committee for Medicinal Products for Human Use CHMP has recommended that Tamiflu capsules that are already on the market may be used for up to two more years after their current expiry date during a declared pandemic.

At least 28 million people including at leastpregnant women have been vaccinated to date in Europe with one of the three centrally authorised vaccines. As part of its review of smea 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.

Changes since initial authorisation of medicine Fofetria item. It is intended for a target population that is different from that of the centrally authorised medicine Tamiflu, which is taken by mouth.

The data confirm the expected reactogenicity and immunogenicity profile. For information on the CHMP’s recommendations, see the press release. The updated product information gives information on the use of Tamiflu in premature infants and its use to prevent focetri in immunocompromised patients who have been exposed to the virus.

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Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation. For more information, see the CMD h meeting report announcing the approval of the extension of focetfia of Relenza. Following the World Health Organization’s announcement that the world has moved into a post-pandemic period, the European Medicines Agency has published the last of its pandemic pharmacovigilance updates.

For more information on Arepanrix, see the European public assessment report. 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.

Leave ofcetria field blank. The most frequent adverse reactions that have been reported are non-serious and as expected. 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.

The 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. For further details, see the guidance document: A European Commission decision is expected shortly. To date, no unexpected serious safety issues have been identified.

Skip to main content. Table of contents Overview Authorisation details Product information Assessment history. Following discussion with the experts, the Committee concluded that the variability did not change the Committee’s view that the vaccine is sufficiently immunogenic in all age groups when administered in accordance with the approved dosage recommendation of two doses at an interval of at least three weeks. For more information, see the European public assessment report.

For pregnant and breastfeeding women, the CHMP recommended the use focstria Tamiflu for treatment and post-exposure prophylaxis. Relenza zanamivir is authorised in all 27 EU Member States for the treatment of influenza.