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 full details, see the EU recommendation for the emergent novel H1N1 influenza vaccine composition. 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 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. An extemporaneous formulation of a medicine is a formulation that is prepared just prior to use. For more focetrja, see the revised document: 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 this outbreak.

Pandemic influenza: news archive | European Medicines Agency

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.

The European Medicines Agency has recommended that the shelf life of Tamiflu capsules should be extended from five to seven years.

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. Product details Name Focetria. No unexpected foocetria safety issues have been identified. As part of its review of data from clinical studies and post-marketing experience for centrally authorised pandemic influenza vaccines, foceria 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.

The benefit-risk balance of the pandemic vaccines and antivirals used for the current H1N1 influenza pandemic continues to be positive.

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Pandemic influenza: news archive

The other two vaccines, Arepanrix and Humenza, have not been marketed in the EU. By this date, at least 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 smea information, see the press release and the European public assessment reports for CelvapanFocetria and Pandemrix. Leave this field blank. For pregnant and breastfeeding women, the CHMP recommended the use of Tamiflu for treatment and post-exposure prophylaxis. Relenza is authorised individually by all EU Member States through the mutual-recognition procedure, co-ordinated by the Medical Products Agency in Sweden.

The distribution of an additional device is intended as fovetria temporary measure during the H1N1 pandemic, because production capacity of Relenza with the approved diskhaler cannot meet the current increased demand for the medicine. The Agency also recommended further changes to the product information for Focetria and Pandemrix.

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

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. 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. No vaccines are currently available for this novel virus. For further details, see the press release: Leave this field blank.

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 Standard paediatric investigation plan for non-adjuvanted or adjuvanted pandemic influenza vaccines during a pandemic. The European Medicines Agency has published the fourth in its series of weekly pandemic influenza pharmacovigilance update reports.

The recommended changes are based on guidance adopted by the CHMP in May on the use of antiviral medicines during an influenza pandemic. 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 the age of five years onwards.

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

The European Medicines Agency has published the second in its series of weekly pandemic influenza pharmacovigilance update reports. Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation. Patients who have Relenza that has recently expired should not throw it away, as it might be needed during a declared influenza pandemic.

Focetria | European Medicines Agency

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.

At present the Committee is reviewing data relating to manufacture of vaccines. The European Medicines Agency has published the third in its series of weekly pandemic influenza pharmacovigilance update reports. The Agency will publish any changes to the marketing authorisations for these medicines that may become necessary in the future.

While most countries will not be affected at this stage, the declaration of Phase 5 is a strong signal that a pandemic is imminent and that the time to finalize the organization, communication, and implementation of the planned mitigation measures is short. This advice was based on a information indicating that influenza activity worldwide has returned to levels that are normally seen for seasonal influenza.

The Agency continues to work with its European Union and international partners on a series of initiatives to facilitate the availability of antivirals and vaccines for use in an influenza pandemic situation.

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. Tamiflu IV is an unauthorised medicine that is a new development of oseltamivir for intravenous use.