Intanza
Withdrawn
This medicine's authorisation has been withdrawn
influenza vaccine (split virion, inactivated)
MedicineHumanWithdrawn
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 3 August 2018, the European Commission withdrew the marketing authorisation for Intanza (influenza vaccine (split virion, inactivated)) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Sanofi Pasteur Europe, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Intanza was granted marketing authorisation in the EU on 24 February 2009 for prophylaxis of influenza in individuals 60 years of age and over. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2013. There are other medicinal products similar to Intanza authorised and marketed in the EU.
The European Public Assessment Report (EPAR) for Intanza is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:II/0054
07/09/2017
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
- Intanza
- Active substance
- influenza virus (inactivated, split) of the following strains:A/California/7/2009 (H1N1)pdm09 - like strain (A/California/7/2009, NYMC X-179A)A/Hong Kong/4801/2014 (H3N2) - like strain (A/Hong Kong/4801/2014, NYMC X-263B)B/Brisbane/60/2008 - like strain (B/Brisbane/60/2008, wild type)
- International non-proprietary name (INN) or common name
- influenza vaccine (split virion, inactivated)
- Therapeutic area (MeSH)
- Influenza, Human
- Immunization
- Anatomical therapeutic chemical (ATC) code
- J07BB02
Pharmacotherapeutic group
VaccinesTherapeutic indication
Prophylaxis of influenza in individuals 60 years of age and over, especially in those who run an increased risk of associated complications.
The use of Intanza should be based on official recommendations.
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