FOCETRIA EMEA PDF

Vaccines are one of the most important tools in the management of an influenza pandemic, helping to reduce illness and deaths by building up immune protection against the pandemic flu virus. Decisions on the granting of European Union-wide marketing authorisations for the vaccines by the European Commission are expected shortly. Vaccination strategies are decided by the government in each EU Member State, taking into account the information provided by the Agency for each vaccine. The Committee is currently recommending a two-dose vaccination schedule, at an interval of three weeks, for adults, including pregnant women, and children from six months of age. The Committee acknowledged that there are preliminary data suggesting that one dose may be sufficient in adults.

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Either your web browser doesn't support Javascript or it is currently turned off. In the latter case, please turn on Javascript support in your web browser and reload this page. Vaccine , 16 Apr , 29 26 : DOI: Read article at publisher's site DOI : Vaccine , 35 15 , 09 Mar Cited by 5 articles PMID: Vaccine , 33 51 , 09 Aug Cited by 1 article PMID: Hum Vaccin Immunother , 10 10 , 21 Nov Vaccine , 33 1 , 06 Nov Cited by 4 articles PMID: Pharmacol Res , , 10 Nov To arrive at the top five similar articles we use a word-weighted algorithm to compare words from the Title and Abstract of each citation.

Cited by 28 articles PMID: Vaccine , 29 6 , 18 Dec Cited by 10 articles PMID: BMJ , d, 25 Jan Cited by 13 articles PMID: Pediatrics , Suppl 1:S, 18 Apr Cited by 22 articles PMID: Vaccine , 29 43 , 05 Aug Cited by 11 articles PMID: Coronavirus: Find the latest articles and preprints.

Europe PMC requires Javascript to function effectively. Recent Activity. Recent history Saved searches. Abstract Available from publisher site using DOI. A subscription may be required. Xavier Kurz Search articles by 'Xavier Kurz'. Kurz X ,. Domergue F ,. Jim Slattery Search articles by 'Jim Slattery'. Slattery J ,. Andrej Segec Search articles by 'Andrej Segec'.

Segec A ,. Agnieszka Szmigiel Search articles by 'Agnieszka Szmigiel'. Szmigiel A ,. Hidalgo-Simon A. Affiliations All authors 1. Share this article Share with email Share with twitter Share with linkedin Share with facebook. The number of vaccinees on 30 April was estimated to be at least 37,, with a reporting rate of per million vaccinees. Areas to be reinforced in order to improve the response to a future pandemic and to strengthen vaccine pharmacovigilance systems in general are highlighted.

Observed-to-expected analyses were affected by uncertainties regarding the numbers of vaccinated individuals and age-specific background incidence rates. Imbalance analysis used by the Agency may overcome some of these limitations but needs further development.

A multinational vaccine health outcome resource is needed to assess the burden of vaccine preventable diseases and the epidemiology of potential adverse outcomes, and to quickly evaluate safety signals, estimate the utilization, benefits and risks of vaccines and evaluate the effectiveness of public health measures.

Pandemic Influenza A H1N1 v vaccines authorised via the core dossier procedure. Explanatory note on scientific considerations regarding the licensing of pandemic A H1N1 v vaccines.

European Medicines Agency. CHMP recommendations for the pharmacovigilance plan as part of the risk management plan to be submitted with the marketing authorisation application for a pandemic influenza vaccine.

Revision 1. Committee for Human Medicinal Products CHMP Guideline on the conduct of pharmacovigilance for vaccines for pre- and post-exposure prophylaxis against infectious diseases.

Twenty-second pandemic pharmacovigilance update. Postlicensure safety surveillance for quadrivalent human papillomavirus recombinant vaccine. Show 10 more references 10 of Smart citations by scite. The number of the statements may be higher than the number of citations provided by EuropePMC if one paper cites another multiple times or lower if scite has not yet processed some of the citing articles. Explore citation contexts and check if this article has been supported or contradicted.

The incidence of childhood and adolescent seizures in the UK from to A retrospective cohort study using the Clinical Practice Research Datalink. Safety of ASadjuvanted inactivated split virion A H1N1 pdm09 and H5N1 influenza virus vaccines administered to adults: pooled analysis of 28 clinical trials.

Events supposedly attributable to vaccination or immunization during pandemic influenza A H1N1 vaccination campaigns in Latin America and the Caribbean. Ongoing pharmacovigilance on vaccines. Spontaneous reporting of adverse events following immunisation against pandemic influenza in Denmark November March Immunization-safety monitoring systems for the H1N1 monovalent influenza vaccination program.

Safety of pandemic H1N1 vaccines in children and adolescents. This website requires cookies, and the limited processing of your personal data in order to function. By using the site you are agreeing to this as outlined in our privacy notice and cookie policy. I agree, dismiss this banner. Wicket Ajax Debug Window drag me here.

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FOCETRIA EMEA PDF

Focetria suspension for injection in pre-filled syringe. Influenza vaccine H1N1v surface antigen, inactivated, adjuvanted. Adjuvant MF59C. For a full list of excipients, see section 6.

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Focetria® pandemic influenza vaccine receives positive European Union regulatory agency op

The marketing authorisation for Focetria has been expired following the marketing-authorisation holder's decision not to apply for a renewal. More detail is available in the summary of product characteristics. Skip to main content. Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation. Focetria RSS.

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