Focetria

RSS

influenza vaccine (H1N1) (surface antigen, inactivated, adjuvanted)

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Focetria has been expired following the marketing-authorisation holder's decision not to apply for a renewal.

This EPAR was last updated on 11/02/2016

Authorisation details

Product details
Name
Focetria
Agency product number
EMEA/H/C/000710
Active substance
Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: A/California/7/2009 (H1N1)-derived strain used NYMC X-181 7.5 microgragms per 0.5 ml dose
International non-proprietary name (INN) or common name
influenza vaccine (H1N1) (surface antigen, inactivated, adjuvanted)
Therapeutic area (MeSH)
  • Influenza, Human
  • Immunization
  • Disease Outbreaks
Anatomical therapeutic chemical (ATC) code
J07BB02
Publication details
Marketing-authorisation holder
Novartis Vaccines and Diagnostics S.r.l.
Revision
9
Date of issue of marketing authorisation valid throughout the European Union
02/05/2007
Contact address
Via Fiorentina, 1
IT-53100 Siena
Italy

Product information

15/01/2015 Focetria - EMEA/H/C/000710 - PSUV/0033

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Influenza vaccines

Therapeutic indication

Prophylaxis of influenza caused by A (H1N1v) 2009 virus.

Focetria should be used in accordance with official guidance.

Assessment history

Changes since initial authorisation of medicine

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