Focetria

Expired

This medicine's authorisation has expired

influenza vaccine H1N1v (surface antigen, inactivated, adjuvanted)

Overview

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

Focetria : EPAR - Summary for the public

Product information

Focetria : EPAR - Product Information

Latest procedure affecting product information: PSUV/0033

15/01/2015

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Product information documents contain:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

Focetria : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Focetria
• Active substance:
  Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: A/California/7/2009 (H1N1)-derived strain used NYMC X-181
• International non-proprietary name (INN) or common name:
  influenza vaccine H1N1v (surface antigen, inactivated, adjuvanted)
• Therapeutic area (MeSH):
  • Influenza, Human
  • Immunization
  • Disease Outbreaks
• Anatomical therapeutic chemical (ATC) code:
  J07BB02

Pharmacotherapeutic group

Influenza vaccines

Therapeutic indication

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

Focetria should be used in accordance with official guidance.

Authorisation details

• EMA product number:
  EMEA/H/C/000710
• Marketing authorisation holder:
  Novartis Vaccines and Diagnostics S.r.l.

  Via Fiorentina, 1; IT-53100 Siena; Italy

• Marketing authorisation issued:
  02/05/2007
• Expiry of marketing authorisation:
  13/08/2015
• Revision:
  9

Assessment history

Changes since initial authorisation of medicine

Focetria : EPAR - Procedural steps taken and scientific information after authorisation

Focetria-H-C-710-PSUV-0033 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/CHMP/26367/2015

Focetria-H-C-710-SW-0024 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/CHMP/326579/2010

Focetria-H-C-710-II-0020 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/172703/2010

Focetria-H-C-710-II-0018 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/CHMP/842825/2009

Focetria-H-C-710-II-0015 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMEA/CHMP/759929/2009

Focetria-H-C-710-II-0013 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMEA/CHMP/759928/2009

Focetria-H-C-710-II-0011 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMEA/CHMP/704703/2009

Focetria-H-C-710-II-0010 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMEA/CHMP/704698/2009

Focetria-H-C-710-II-0009 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMEA/CHMP/704696/2009

Initial marketing authorisation documents

Focetria : EPAR - Assessment Report

Focetria : EPAR - Procedural steps taken before authorisation

Focetria : EPAR - Scientific Discussion