Click on the country tabs for additional country specific information: Product Information Leaflet, Multidose vial usage, Adverse event form, Link to EMEA page for National Public Health Authorities, Medical Information Contact.
Focetria®
Focetria, the Novartis Influenza A(H1N1) 2009 monovalent vaccine is an inactivated influenza virus vaccine indicated for active immunization of persons of six months of age and older against influenza disease caused by the novel pandemic A(H1N1) influenza virus.
European Public Assessment Report
Full Product Information (including SPC, Labelling and Patient Information Leaflet)
Instructions for use of Multidose vials and Prefilled syringes
Focetria Traceability stickers
EMEA - European Medicines Agency
Report Adverse Event
Celtura®
Celtura, the Novartis Influenza A(H1N1) 2009 monovalent vaccine is an inactivated, Cell culture based influenza virus vaccine indicated for active immunization of persons of six months of age and older against influenza disease caused by the novel pandemic A(H1N1) influenza virus.
Full Product Information (including SPC, Labelling and Patient Information Leaflet)
Instructions for use of Multidose vials and Prefilled syringes
Official sites monitoring the evolution of the current H1N1v pandemic:
Report Adverse Event
Focetria®
NL = Nederlands
Focetria betreft het Novartis Influenza A (H1N1) 2009 monovalent vaccin en is een geïnactiveerd influenza virus vaccin. Het vaccin is geïndiceerd voor actieve immunisatie van personen met een leeftijd van 6 maanden en ouder tegen de Mexicaanse griep. De Mexicaanse griep wordt veroorzaakt door het huidige (nieuwe) pandemisch griepvirus A(H1N1).
Europees openbaar beoordelingsrapport
Volledige product informatie (inclusief SmPC en patienten bijsluiter)
Gebruiksinstructies voor de Multidosis flacon en voorgevulde spuiten
Focetria traceerbaarheid stikkers
Dit is het Bijwerkingen Registratie Formulier, Influenza A (H1N1). Vul de ontbrekende gegevens in en fax het formulier naar 0031 (0) 26 3782414 of via e-mail naar bijwerkingen.phnlar@novartis.com
Medisch informatie Contact: +31 26 3782546
Rijks Instituut voor Volksgezondheid en Milieu (RIVM)
College ter Beoordeling van Geneesmiddelen (CBG)
EMEA - European Medicines Agency
Focetria®
FR = français
Focetria, le vaccin Novartis monovalent grippe A (H1N1) pandémique est un vaccin grippal inactivé indiqué pour l'immunisation active, chez les personnes à partir de l'âge de 6 mois, contre la grippe causée par le nouveau virus pandémique A(H1N1).
Rapport publique européen d'évaluation
Informations completes sur le produit (comprenant RCP, étiquettage et notice d'information patient)
Instructions pour l'utilisation de flacons multidoses et de seringues pré-remplies
Stickers (étiquettes) de traçabilité Focetria
Vous trouverez en pièce jointe le formulaire de déclaration d'évènement indésirable en français. Merci de le remplir et de le faxer au 01 41 38 84 08 ou le scanner et l'envoyer à l'adresse suivante : claire.nguyen_le@novartis.com
Medical Information Contact: +33 01 55 49 00 30
Agence Francaise de Securite Sanitaire des Produits de Sante
EMEA - European Medicines Agency
Focetria®
ES = español
Focetria, la vacuna antigripal pandémica monovalente A(H1N1)2009 de Novartis, es una vacuna de virus gripal inactivada. Está indicada para la prevención de la gripe pandémica A(H1N1) en personas a partir de los seis meses de edad.
Informe Europeo público de evaluación
Información de producto (incluyendo Ficha técnica, Eqtiquetado y Folleto de información para el paciente)
Instrucciones para el uso de los viales multidosis y las jeringas pre-cargadas
Adhesivos de Trazabilidad de Focetria
Formulario de recogida de reacciones adversas en español. Por favor, complételo y envíelo por fax al :34 93.306.44.12 o por correo electrónico a novartis.responde@novartis.com
Medical Information Contact: +34 900 312 312
Agencia espanola del medicamento
EMEA - European Medicines Agency
Focetria®
IT = italiano
Focetria, vaccino antinfluenzale monovalente pandemico A(H1N1) di Novartis è un vaccino antinfluenzale inattivato indicato per l'immunizzazione attiva di persone a partire dai 6 mesi d’età. Il vaccino è indicato per la prevenzione dell’influenza causata dal nuovo virus pandemico A(H1N1).
- Relazione pubblica di valutazione europea (European public assessment report, EPAR)
- Informazioni sul prodotto (include il Riassunto delle caratteristiche del prodotto, l'etichettatura ed il foglio illustrativo con informazioni per l'utilizzatore)
Istruzioni per l'uso di Focetria in flacone multi-dose e siringa pre-riempita
Etichetta di Tracciabilita' di Focetria
Modello di segnalazione di ADR a vaccino contro l'influenza pandemica (suina) – Come compilare la scheda?
Scheda di segnalazione di evento avverso in Italiano. Per favore, compilare ed inviare via fax al numero +39-0577 278500 oppure via e-mail all’indirizzo vaccinopandemico.NVDIT@novartis.com.
Numero verde per informazione Medico-scientifica sul vaccino (Italia): 800-908078
Numero verde per informazione Medico-scientifica sul vaccino (Italia):800-916028
Informazione Medico-scientifica sul vaccino (estero):+39-0577-539030
Informazione Medico-scientifica sul vaccino (estero): +39-0577-539031
eMail: vaccinopandemico.NVDIT@novartis.com
Ministero della Salute
Agenzia Italiana del Farmaco (AIFA)
EMEA - European Medicines Agency
Focetria®
Non-EU Countries
Focetria, the Novartis Influenza A(H1N1) 2009 monovalent vaccine is an inactivated influenza virus vaccine indicated for active immunization of persons of six months of age and older against influenza disease caused by the novel pandemic A(H1N1) influenza virus.
Instructions for use of Multidose vials and Prefilled syringes
Focetria Traceability stickers
Celtura®
Celtura, the Novartis Influenza A(H1N1) 2009 monovalent vaccine is an inactivated, Cell culture based influenza virus vaccine indicated for active immunization of persons of six months of age and older against influenza disease caused by the novel pandemic A(H1N1) influenza virus.
Full Product Information (including SPC, Labelling and Patient Information Leaflet)
Instructions for use of Multidose vials and Prefilled syringes
Report Adverse Event
Call Centre/Switchboard Numbers
Switzerland
+41 (0)31 377 51 11
Croatia
+38 514 683 004
+38 514 683 005
Oman
+968 24790801
Kuwait
+965 22458049
Israel
1 800 250 255
Japan
+81-0120-003-293 (Toll-free)
Fax +81-3-3797-3458
eMail: webmaster.japan@novartis.com
Jordan
+962 6 551 0832
Macau
+852 2882 5222
Saudi Arabia
+966 1 465 8882
Taiwan
+886 2 2341 6580
Tunisia
+216 71 808 002
Turkey
+90 216 6812000
USA
+1 800 244 7668
Last updated 21 Dec 2009
