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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Leave this field blank. An archive of the news related to the pandemic is available below.
Pandemic influenza: news archive | European Medicines Agency
This recommendation was made using an emergency procedure which fast-tracks the evaluation of new vaccines developed during a pandemic. At least 26 million people andpregnant women have been vaccinated to date in Europe with one of the three centrally authorised vaccines. The Member States of the European Union have approved the extension of the shelf-life of Relenza zanamivir oral inhalation powder, from five to seven years.
It is intended for a target population that is different from that of the centrally authorised medicine Tamiflu, which is taken by mouth. For more information, see the report.
The Agency also recommended further changes to the product information for Focetria and Pandemrix. Given the public-health threat posed by the current pandemic, the Agency’s goal is to ensure data submitted to support marketing authorisations for vaccines are reviewed as early as possible, before the beginning of the Northern hemisphere flu season, expected in September.
Product details Name Focetria. The latest data show no unexpected serious safety issues. The most frequent adverse reactions that have been reported are non-serious and as expected. For more information, see the press release.
Relenza is authorised individually by all EU Member States through the mutual-recognition procedure, co-ordinated by the Medical Products Agency in Sweden. No unexpected serious safety issues have been identified. The European Medicines Agency is warning that young children may experience fever after their second dose of the pandemic influenza vaccine Pandemrix.
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.
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On 10 Augustthe World Fmea Organization WHO announced that the influenza pandemic is over and the world is no longer in phase 6 of pandemic alert. You are therefore advised to be selective about which sections or pages you wish to print.
An extemporaneous formulation of a medicine is a formulation that is prepared just prior to use.
The temporary distribution of an additional device for the use of Relenza was proposed by the marketing authorisation holder to the Medical Products Agency MPA of Sweden, which is the reference Member State for Relenza. For more information, see the press release and the European public assessment reports for CelvapanFocetria and Pandemrix.
For more information, see the press release and foxetria first weekly report. 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. The Ema will publish any changes to the marketing authorisations for these medicines that may become necessary in the future.
This recommendation was based on data from clinical and non-clinical studies, from emew surveillance and from the use of these vaccines in at least 40 million people in the European Economic Area since September These weekly reports will provide information on adverse emeaa 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.
Pandemic influenza: news archive
For further details, see the guidance document: Tamiflu is a centrally authorised medicine i. More detail is available in the summary of product characteristics. For more information on Celvapan, see the European public assessment report. 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.
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. For more information, see the CMD h meeting report. Initial marketing-authorisation documents List item. For more information, see the product information showing the recommended changes for CelvapanFocetria and Pandemrix.
The European Medicines Agency communicated frequently on its main developments during the H1N1 influenza pandemic. At present the Committee is reviewing data relating to manufacture of vaccines. The European Medicines Agency has recommended that the fkcetria life of Tamiflu capsules should be extended from five to seven years.
The Agency continues to work with its European Union and international partners on a series of initiatives to foocetria the availability of antivirals emeaa vaccines for use in an focetfia pandemic focetris.
The review of these data began in July, with the commitment from the Committee for Medicinal Products for Human Use CHMP to fast-track the review of data as vaccine manufacturers make them available.
The European Medicines Agency EMEA is in continuous dialogue with vaccine manufacturers and European and international regulators to discuss scientific and regulatory issues relating to the development and emes of vaccines. There are six alert levels, with level 6 representing a pandemic situation. For more information on Humenza, see the European public assessment report. Further information on Relenza is available in the summary of product characteristics and the patient information leaflet.
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 dmea age of five years onwards.
Fcetria more information, see the European public assessment report. Prophylaxis of influenza caused by A H1N1v virus. However, the Agency noted that the second dose increases the immune response against pandemic influenza.