Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


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Product information

Invented name: FLUENZ
Auth. number : EU/1/10/661
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 individuals 24 months to less than 18 years of age. The use of INFLUENZ should be based on official recommendations.
Marketing Authorisation Holder: MedImmune, LLC
Lagelandseweg 78, NL-6545 CG Nijmegen, Nederland
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
01/02/2011 Centralised - Authorisation EMEA/H/C/1101 (2011)585 of 27/01/2011
10/05/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1101/IB/2
18/05/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1101/IB/5
18/05/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1101/IB/5
07/06/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1101/IA/10
22/06/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1101/II/4
23/06/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1101/II/1
21/07/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1101/II/9
22/09/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1101/II/3
20/10/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1101/II/8
11/05/2012 Centralised - Variation EMEA/H/C/1101/IA/22
Updated with Decision(2012)6052 of 24/08/2012
12/06/2012 Centralised - Notification EMEA/H/C/1101/N/27
Updated with Decision(2012)6052 of 24/08/2012
19/07/2012 Centralised - Variation EMEA/H/C/1101/IB/32
Updated with Decision(2012)6076 of 27/08/2012
28/08/2012 Centralised - Variation (2012)6052 of 24/08/2012
29/08/2012 Centralised - Variation EMEA/H/C/1101/II/31 (2012)6076 of 27/08/2012
06/03/2013 Centralised - Variation EMEA/H/C/1101/IB/39
Updated with Decision(2013)5486 of 14/08/2013
24/06/2013 Centralised - Variation EMEA/H/C/1101/IB/49
Updated with Decision(2013)5486 of 14/08/2013
30/07/2013 Centralised - Notification EMEA/H/C/1101/N/54
19/08/2013 Centralised - Variation EMEA/H/C/1101/II/53 (2013)5486 of 14/08/2013
21/10/2013 Centralised - Variation EMEA/H/C/1101/IAin/56
03/10/2014 Centralised - Withdrawal (2014)7194 of 01/10/2014