PDF Aflunov - European Medicines Agency PDF

European Medicines Agency

European Medicines Agency 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel (44-20) 74 18 84 00 Fax (44-20) 75 23 71 29 AFLUNOV Vispārpieņemtais

European Medicines Agency decision

Mar 17, 2017 · European Medicines Agency decision EMA/104668/2017 Page 2/3 European Medicines Agency decision P/0057/2017 of 17 March 2017 on the acceptance of a modification of an agreed paediatric investigation plan for i nfluenza virus surface antigens - A/turkey/Turkey/1/05 (H5N1) (Aflunov and associated names), (EMEA-000599-

EMA revised guidelines applicable to pandemic vaccines

Apr 29, 2015 · An agency of the European Union Presented on 29 April 2015 by Thomas Girard – Regulatory Affairs Officer – Regulatory Affairs Office Manuela Mura - Scientific Officer –Anti-infectives and Vaccines Office EMA revised guidelines applicable to pandemic vaccines

Pandemic vaccines - Department of Health

The European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) have set seroconversion and seroprotection thresholds for licensure of seasonal influenza vaccines

in brief UK strong arms industry over drug pricing

The European Commission has just approved the prepandemic vaccine Prepandrix from GlaxoSmithKline, making the London-based company the first to receive the go-ahead to market Novartis of Basel, on the other hand, recently withdrew a marketing application for its own prepandemic flu vaccine, Aflunov The European Medicines Agency’s Committee for

Australian Public Assessment Report for trivalent seasonal

the use of medicines and medical devices • The TGA relies on the public, healthcare professionals and industry to report problems with medicines or medical devices TGA investigates reports received by it to determine any necessary regulatory action • To report a problem with a medicine or medical device, please see the information on

[PDF] European Medicines Agency

[PDF] European Medicines Agency decision

European Medicines Agency decision EMA/104668/2017 Page 2/3 European Medicines Agency decision P/0057/2017 of 17 March 2017 on the acceptance of a modification of an agreed paediatric investigation plan for i nfluenza virus surface antigens - A/turkey/Turkey/1/05 (H5N1) (Aflunov and associated names), (EMEA-000599-

[PDF] in brief UK strong arms industry over drug pricing

The European Commission has just approved the prepandemic vaccine Prepandrix from GlaxoSmithKline, making the London-based company the first to receive the go-ahead to market Novartis of Basel, on the other hand, recently withdrew a marketing application for its own prepandemic flu vaccine, Aflunov The European Medicines Agency’s Committee for

[PDF] Pandemic vaccines - Department of Health

The European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) have set seroconversion and seroprotection thresholds for licensure of seasonal influenza vaccines

[PDF] EMA revised guidelines applicable to pandemic vaccines

[PDF] Australian Public Assessment Report for trivalent seasonal

medicines, major variations, and extensions of indications • An AusPAR is a static document, in that it will provide information th at relates to a submission at a particular point in time • A new AusPAR will be developed to reflect changes to indications and/or major variations to a prescription medicine subject to evaluation by the TGA

Bella Antonino CV

Nomina come Esperto Biostatistico per l’European Medicines Agency (EMA) Nomina come Esperto Epidemiologo per l’Italia all’European Centre for Disease Prevention and Control (ECDC) di Stoccolma per la sorveglianza epidemiologica delle sindromi influenzali