Daronrix

Pandemic influenza vaccine (H5N1) (whole virion, inactivated, adsorbed)

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About

The marketing authorisation for Daronrix has lapsed because it has not been marketed in the European Union in the three years following the granting of the authorisation.

Name Language First published Last updated
Daronrix : EPAR - Summary for the public BG = bălgarski 2007-04-11 2013-07-02
Daronrix : EPAR - Summary for the public ES = español 2007-04-11 2013-07-02
Daronrix : EPAR - Summary for the public CS = čeština 2007-04-11 2013-07-02
Daronrix : EPAR - Summary for the public DA = dansk 2007-04-11 2013-07-02
Daronrix : EPAR - Summary for the public DE = Deutsch 2007-04-11 2013-07-02
Daronrix : EPAR - Summary for the public ET = eesti keel 2007-04-11 2013-07-02
Daronrix : EPAR - Summary for the public EL = elliniká 2007-04-11 2013-07-02
Daronrix : EPAR - Summary for the public EN = English 2007-04-11 2013-07-02
Daronrix : EPAR - Summary for the public FR = français 2007-04-11 2013-07-02
Daronrix : EPAR - Summary for the public IT = italiano 2007-04-11 2013-07-02
Daronrix : EPAR - Summary for the public LV = latviešu valoda 2007-04-11 2013-07-02
Daronrix : EPAR - Summary for the public LT = lietuvių kalba 2007-04-11 2013-07-02
Daronrix : EPAR - Summary for the public HU = magyar 2007-04-11 2013-07-02
Daronrix : EPAR - Summary for the public MT = Malti 2007-04-11 2013-07-02
Daronrix : EPAR - Summary for the public NL = Nederlands 2007-04-11 2013-07-02
Daronrix : EPAR - Summary for the public PL = polski 2007-04-11 2013-07-02
Daronrix : EPAR - Summary for the public PT = português 2007-04-11 2013-07-02
Daronrix : EPAR - Summary for the public RO = română 2007-04-11 2013-07-02
Daronrix : EPAR - Summary for the public SK = slovenčina 2007-04-11 2013-07-02
Daronrix : EPAR - Summary for the public SL = slovenščina 2007-04-11 2013-07-02
Daronrix : EPAR - Summary for the public FI = suomi 2007-04-11 2013-07-02
Daronrix : EPAR - Summary for the public SV = svenska 2007-04-11 2013-07-02

This EPAR was last updated on 02/07/2013 .

Authorisation details

Product details

Product details for Daronrix
NameDaronrix
Agency product numberEMEA/H/C/000706
Active substance

Whole virion, inactivated, containing antigen*: A/Vietnam/1194/2004 (H5N1)

* produced in eggs

International non-proprietary name (INN) or common name

Pandemic influenza vaccine (H5N1) (whole virion, inactivated, adsorbed)

Therapeutic area Influenza, HumanImmunizationDisease Outbreaks
Anatomical therapeutic chemical (ATC) code J07BB01
Exceptional Circumstances

There were "exceptional circumstances" concerning the approval of this medicine. This happens when the applicant can show that they are unable to provide comprehensive data on the efficacy and safety of the medicine for which authorisation is being sought, due to the rarity of the condition it is intended for, limited scientific knowledge in the area concerned, or ethical considerations involved in the collection of such data.

Publication details

Publication details for Daronrix
Marketing-authorisation holder

GlaxoSmithKline Biologicals S.A.

Revision0
Date of issue of marketing authorisation valid throughout the European Union21/03/2007

Contact address:

GlaxoSmithKline Biologicals S.A.
Rue de l'Institut, 89
B-1330 Rixensart
Belgium

Product information

Product information

21/03/2007  Daronrix -EMEA/H/C/000706

Name Language First published Last updated
Daronrix : EPAR - Product Information SV = svenska 2007-04-11 2013-07-02
Daronrix : EPAR - Product Information SV = svenska 2007-04-11 2013-07-02
Daronrix : EPAR - Product Information SV = svenska 2007-04-11 2013-07-02
Daronrix : EPAR - Product Information SV = svenska 2007-04-11 2013-07-02
Daronrix : EPAR - Product Information SV = svenska 2007-04-11 2013-07-02
Daronrix : EPAR - Product Information SV = svenska 2007-04-11 2013-07-02
Daronrix : EPAR - Product Information SV = svenska 2007-04-11 2013-07-02
Daronrix : EPAR - Product Information SV = svenska 2007-04-11 2013-07-02
Daronrix : EPAR - Product Information SV = svenska 2007-04-11 2013-07-02
Daronrix : EPAR - Product Information SV = svenska 2007-04-11 2013-07-02
Daronrix : EPAR - Product Information SV = svenska 2007-04-11 2013-07-02
Daronrix : EPAR - Product Information SV = svenska 2007-04-11 2013-07-02
Daronrix : EPAR - Product Information SV = svenska 2007-04-11 2013-07-02
Daronrix : EPAR - Product Information SV = svenska 2007-04-11 2013-07-02

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Daronrix : EPAR - All Authorised presentations SV = svenska 2007-04-11 2013-07-02
Daronrix : EPAR - All Authorised presentations SV = svenska 2007-04-11 2013-07-02
Daronrix : EPAR - All Authorised presentations SV = svenska 2007-04-11 2013-07-02
Daronrix : EPAR - All Authorised presentations SV = svenska 2007-04-11 2013-07-02
Daronrix : EPAR - All Authorised presentations SV = svenska 2007-04-11 2013-07-02
Daronrix : EPAR - All Authorised presentations SV = svenska 2007-04-11 2013-07-02
Daronrix : EPAR - All Authorised presentations SV = svenska 2007-04-11 2013-07-02
Daronrix : EPAR - All Authorised presentations SV = svenska 2007-04-11 2013-07-02
Daronrix : EPAR - All Authorised presentations SV = svenska 2007-04-11 2013-07-02
Daronrix : EPAR - All Authorised presentations SV = svenska 2007-04-11 2013-07-02
Daronrix : EPAR - All Authorised presentations SV = svenska 2007-04-11 2013-07-02
Daronrix : EPAR - All Authorised presentations SV = svenska 2007-04-11 2013-07-02
Daronrix : EPAR - All Authorised presentations SV = svenska 2007-04-11 2013-07-02
Daronrix : EPAR - All Authorised presentations SV = svenska 2007-04-11 2013-07-02
Daronrix : EPAR - All Authorised presentations SV = svenska 2007-04-11 2013-07-02
Daronrix : EPAR - All Authorised presentations SV = svenska 2007-04-11 2013-07-02
Daronrix : EPAR - All Authorised presentations SV = svenska 2007-04-11 2013-07-02
Daronrix : EPAR - All Authorised presentations SV = svenska 2007-04-11 2013-07-02
Daronrix : EPAR - All Authorised presentations SV = svenska 2007-04-11 2013-07-02
Daronrix : EPAR - All Authorised presentations SV = svenska 2007-04-11 2013-07-02
Daronrix : EPAR - All Authorised presentations SV = svenska 2007-04-11 2013-07-02
Daronrix : EPAR - All Authorised presentations SV = svenska 2007-04-11 2013-07-02
Daronrix : EPAR - All Authorised presentations SV = svenska 2007-04-11 2013-07-02

Pharmacotherapeutic group

Vaccines

Therapeutic indication

Prophylaxis of influenza in an officially declared pandemic situation. Pandemic influenza vaccine should be used in accordance with official guidance.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Daronrix : EPAR - Procedural steps taken before authorisation SV = svenska 2007-04-11 2013-07-02
Daronrix : EPAR - Scientific Discussion SV = svenska 2007-04-11 2013-07-02

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on Daronrix