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 CHMP opinion on the conditions of use, conditions for distribution and target population and information on compassionate use.
Pandemic influenza: news archive
This advice was based on a information indicating that influenza activity worldwide has returned to levels that are normally seen for seasonal influenza. They also include information on the evolution of the H1N1 pandemic, the number of doses of vaccines and antivirals distributed or administered in Europe, and the medicines’ benefits and risks. 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 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. Prescribers and parents should monitor the temperature of the vaccinated child and, if necessary, take measures to lower the fever e.
Pandemic influenza: news archive | European Medicines Agency
It is intended for a target population that is different from that of the centrally authorised medicine Tamiflu, which is taken by mouth. More detail is available in the summary of product characteristics.
You are therefore advised to be selective about which sections or pages you wish to print. The recommended dose to treat this age group is 3 mg per kg body focetriz twice daily for five days. This recommendation was based on data from clinical and non-clinical studies, from post-marketing surveillance and from the use of these vaccines in at least 40 million people in the European Economic Area emsa September A European Commission decision is expected shortly.
In this instance the instructions cover how to prepare solutions to be given to young babies using Tamiflu capsules. According to the WHO, the current phase 5 “is characterized by human-to-human spread of the virus into at least two countries in one WHO region. 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 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 For further information, see the press release from the European Commission and explanatory note on scientific considerations regarding the licensing of A H1N1 v vaccines.
Patients who have Relenza that has recently expired should not throw fovetria away, as it emra be needed during a declared influenza pandemic. Information on Humenza was evaluated in an accelerated timeframe using a rolling review that started with the submission of the first available data on 23 June It is intended for a target population that is different from that of Relenza, which is inhaled.
This recommendation was made using an emergency procedure which fast-tracks the evaluation of new vaccines developed during a pandemic. For more information on Humenza, 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 be treated with other antiviral medicines by mouth or inhalation.
Further clinical studies in children, adolescents and adults are ongoing and results will become available from March onwards. Leave this field blank. An archive of the news related to the pandemic is available below. At present the Committee is reviewing data relating to manufacture of vaccines.
Focetria | European Medicines Agency
The Agency also recommended further changes to the product information for Focetria and Pandemrix. 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. The marketing authorisation for Focetria has been expired following the marketing-authorisation holder’s decision not to apply for a renewal. Among the antiviral medicines that are authorised in the European Union EU for use in an influenza outbreak, the neuraminidase inhibitors Tamiflu oseltamivir and Relenza zanamivir have shown effectiveness against the novel influenza virus.
For more information, eema the press release and the European public assessment reports for CelvapanFocetria and Pandemrix. For more information, see the revised document: For pregnant and breastfeeding women, the CHMP recommended the use of Tamiflu for treatment and post-exposure prophylaxis. The purpose of the meeting was to share information on the novel influenza virus and discuss regulatory and scientific issues concerning the development and eventual approval emsa vaccines for use in a pandemic situation.
Human regulatory Overview Research and development Marketing foctria Post-authorisation Herbal products. For more information, see the announcement by the WHO. International non-proprietary name INN or common name. For more information, see the press release and questions and answers.
The European Medicines Agency has reviewed further data on the centrally authorised pandemic vaccines Celvapan, Focetria and Pandemrix. 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 ejea to two more years after their current expiry date during a declared pandemic. For more information, see the follow-up recommendations. Tamiflu is a centrally authorised medicine i.