Focetria
influenza vaccine H1N1v (surface antigen, inactivated, adjuvanted)
Table of contents
Overview
The marketing authorisation for Focetria has been expired following the marketing-authorisation holder's decision not to apply for a renewal.
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
|
| International non-proprietary name (INN) or common name |
influenza vaccine H1N1v (surface antigen, inactivated, adjuvanted)
|
| Therapeutic area (MeSH) |
|
| 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
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Therapeutic indication
Prophylaxis of influenza caused by A (H1N1v) 2009 virus.
Focetria should be used in accordance with official guidance.