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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The European Medicines Agency’s Committee rocetria 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.

Focetria | European Medicines Agency

Prophylaxis of influenza caused by A H1N1v virus. For further details, see the press release: 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 European Medicines Agency has published the first in its focettia of weekly pandemic influenza pharmacovigilance update reports. The data confirm the expected reactogenicity and immunogenicity profile.

Pandemic influenza: news archive | European Medicines Agency

The reference Member State for Relenza is Sweden. The European Medicines Agency has reviewed further data on the centrally authorised pandemic vaccines Celvapan, Focetria and Pandemrix. IV Zanamivir is an unauthorised medicine that is a new development of zanamivir for intravenous use. 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 more information, see the revised document: The other two vaccines, Arepanrix and Humenza, have not been marketed in the EU. 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.

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 The Coordination Group for Mutual Recognition and Decentralised Procedures — Human CMD h recommends that Relenza that is already on the market or in people’s homes may — in the event of an influenza pandemic being officially declared by the World Health Organisation WHO — be used for up to two years after its current expiry date.

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

The European Medicines Agency communicated frequently on its main developments during the H1N1 influenza 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.

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.

The recommended dose to treat this age group is 3 mg per kg body weight twice daily for five days. Leave focetroa field blank. For more information on Tamiflu, see the European public assessment report. Manufacturers and marketing-authorisation holders are encouraged to anticipate and 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 CHMP opinion on the conditions of use, conditions for distribution and target population and information on compassionate use. In addition, the Committee has also recommended the approval of detailed instructions on the preparation and dosing of ‘extemporaneous’ formulations for children under the age of one. 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.

The Agency also recommended further changes to the product information for Focetria and Pandemrix. An archive of the news related to the pandemic is available below. 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.


Once formally approved by the European Commission, this will apply to all newly manufactured Tamiflu capsules. However, the Agency is liaising with vaccine manufacturers on the production of vaccines using already approved mock-up vaccines, and is hosting a meeting with vaccine manufacturers and influenza experts from across the European Union on 30 April 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 approval of vaccines.

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. 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 of vaccines for use in a pandemic situation.

Anatomical therapeutic chemical ATC code. The Committee has concluded that the additional data, which come 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 since Septemberare sufficient to allow these vaccines to be used outside a declared influenza pandemic.

Skip to main content. For more information, see focteria press releasequestions and answersopinion and assessment report. How meea was this page? To date, no unexpected serious safety issues have been identified.

Pandemic influenza: news archive

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 vast majority of the adverse events reported in people receiving these vaccines or the antiviral Tamiflu oseltamivir are considered to be non-serious.

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The M2 inhibitors amantadine and rimantadine do not appear to be effective against the novel virus strain.