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Community register of medicinal products for human use


Product information

Invented name: Fluenz Tetra   
Auth. number : EU/1/13/887
Active substance : influenza vaccine (live attenuated, nasal)
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J07 - Vaccines
Pharmacological subgroup: J07B - Viral vaccines
Chemical subgroup: J07BB - Influenza vaccines
Chemical substance: J07BB03 - influenza, live attenuated
(See WHO ATC Index)
Indication: Prophylaxis of influenza in children and adolescents from 24 months to less than 18 years of age. The use of Fluenz Tetra should be based on official recommendations.
Marketing Authorisation Holder: AstraZeneca AB
151 85 Södertälje, Sverige
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
06/12/2013 Centralised - Authorisation EMEA/H/C/2617 (2013)8894 of 04/12/2013
07/02/2014 Centralised - Variation EMEA/H/C/2617/IB/8
Updated with Decision(2014)5789 of 06/08/2014
21/02/2014 Centralised - Variation EMEA/H/C/2617/IB/7
Updated with Decision(2014)5789 of 06/08/2014
02/04/2014 Corrigendum (2014)2250 of 31/03/2014
08/08/2014 Centralised - Variation EMEA/H/C/2617/II/20 (2014)5789 of 06/08/2014
08/12/2014 Centralised - Variation EMEA/H/C/2617/IAin/29/G
Updated with Decision(2015)6120 of 28/08/2015
01/09/2015 Centralised - Variation EMEA/H/C/2617/II/39 (2015)6120 of 28/08/2015
14/01/2016 Centralised - Variation EMEA/H/C/2617/IB/45
Updated with Decision(2016)5087 of 29/07/2016
16/01/2016 Centralised - Variation EMEA/H/C/2617/IB/49
Updated with Decision(2016)5087 of 29/07/2016
02/08/2016 Centralised - Variation EMEA/H/C/2617/II/56 (2016)5087 of 29/07/2016
07/10/2016 Centralised - Variation EMEA/H/C/2617/IAin/59
Updated with Decision(2017)2065 of 22/03/2017
15/12/2016 Centralised - Variation EMEA/H/C/2617/II/61
Updated with Decision(2017)2065 of 22/03/2017
24/03/2017 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2617/T/65 (2017)2065 of 22/03/2017
28/08/2017 Centralised - Variation EMEA/H/C/2617/II/72 (2017)5938 of 24/08/2017
22/03/2018 Centralised - Variation EMEA/H/C/2617/II/76