Focetria
Expired
This medicine's authorisation has expired
influenza vaccine H1N1v (surface antigen, inactivated, adjuvanted)
MedicineHumanExpired
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
The marketing authorisation for Focetria (influenza vaccine H1N1v (surface antigen, inactivated, adjuvanted)) expired on 13 August 2015 following the decision of the marketing authorisation holder, Novartis Vaccines and Diagnostics S.r.l., not to apply for a renewal of the marketing authorisation.
Novartis Vaccines and Diagnostics S.r.l. confirmed that it did not apply for renewal of the authorisation due to lack of demand for this product.
Focetria was granted marketing authorisation in the European Union (EU) on 12 August 2010 for prophylaxis of influenza caused by A/H1N1v 2009 virus. The marketing authorisation was valid for a 5- year period.
Novartis Vaccines and Diagnostics S.r.l. (now named Seqirus) is the marketing authorisation holder for another pandemic vaccine, Foclivia, which is authorised in the EU for pandemic preparedness. Seqirus will maintain the marketing authorisation for Foclivia.
The European Public Assessment Report (EPAR) for Focetria is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:
PSUV/0033
15/01/2015
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).
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 vaccinesTherapeutic indication
Prophylaxis of influenza caused by A (H1N1v) 2009 virus.
Focetria should be used in accordance with official guidance.
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