Celvapan

influenza vaccine (H1N1)v (whole virion, inactivated, prepared in cell culture)

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The marketing authorisation for Celvapan has been withdrawn at the request of the marketing-authorisation holder.

Name Language First published Last updated
Celvapan : EPAR - Summary for the public BG = bălgarski 2009-10-08 2016-12-21
Celvapan : EPAR - Summary for the public ES = español 2009-10-08 2016-12-21
Celvapan : EPAR - Summary for the public CS = čeština 2009-10-08 2016-12-21
Celvapan : EPAR - Summary for the public DA = dansk 2009-10-08 2016-12-21
Celvapan : EPAR - Summary for the public DE = Deutsch 2009-10-08 2016-12-21
Celvapan : EPAR - Summary for the public ET = eesti keel 2009-10-08 2016-12-21
Celvapan : EPAR - Summary for the public EL = elliniká 2009-10-08 2016-12-21
Celvapan : EPAR - Summary for the public EN = English 2009-10-08 2016-12-21
Celvapan : EPAR - Summary for the public FR = français 2009-10-08 2016-12-21
Celvapan : EPAR - Summary for the public IT = italiano 2009-10-08 2016-12-21
Celvapan : EPAR - Summary for the public LV = latviešu valoda 2009-10-08 2016-12-21
Celvapan : EPAR - Summary for the public LT = lietuvių kalba 2009-10-08 2016-12-21
Celvapan : EPAR - Summary for the public HU = magyar 2009-10-08 2016-12-21
Celvapan : EPAR - Summary for the public MT = Malti 2009-10-08 2016-12-21
Celvapan : EPAR - Summary for the public NL = Nederlands 2009-10-08 2016-12-21
Celvapan : EPAR - Summary for the public PL = polski 2009-10-08 2016-12-21
Celvapan : EPAR - Summary for the public PT = português 2009-10-08 2016-12-21
Celvapan : EPAR - Summary for the public RO = română 2009-10-08 2016-12-21
Celvapan : EPAR - Summary for the public SK = slovenčina 2009-10-08 2016-12-21
Celvapan : EPAR - Summary for the public SL = slovenščina 2009-10-08 2016-12-21
Celvapan : EPAR - Summary for the public FI = suomi 2009-10-08 2016-12-21
Celvapan : EPAR - Summary for the public SV = svenska 2009-10-08 2016-12-21
Celvapan : EPAR - Summary for the public HR = Hrvatski 2009-10-08 2016-12-21

This EPAR was last updated on 21/12/2016 .

Authorisation details

Product details

Product details for Celvapan
NameCelvapan
Agency product numberEMEA/H/C/000982
Active substance

whole virion, inactivated containing antigen: A/California/07/2009 (H1N1)v

International non-proprietary name (INN) or common name

influenza vaccine (H1N1)v (whole virion, inactivated, prepared in cell culture)

Therapeutic area Influenza, HumanDisease OutbreaksImmunization
Anatomical therapeutic chemical (ATC) code J07BB01

Publication details

Publication details for Celvapan
Marketing-authorisation holder

Nanotherapeutics Bohumil, s.r.o.

Revision11
Date of issue of marketing authorisation valid throughout the European Union04/03/2009

Contact address:

Nanotherapeutics Bohumil, s.r.o.
Bohumill38 
28163 Jevany
Czech Republic

Product information

Product information

30/11/2015  Celvapan -EMEA/H/C/000982 -T/0031

Name Language First published Last updated
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-12-21
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-12-21
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-12-21
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-12-21
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-12-21
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-12-21
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-12-21
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-12-21
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-12-21
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-12-21
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-12-21
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-12-21
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-12-21
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-12-21
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-12-21
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-12-21
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-12-21
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-12-21
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-12-21
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-12-21
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-12-21
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-12-21
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-12-21
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-12-21
Celvapan : EPAR - Product Information HR = Hrvatski 2009-11-15 2016-12-21

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
Celvapan : EPAR - All Authorised presentations HR = Hrvatski 2009-10-08 2016-12-21
Celvapan : EPAR - All Authorised presentations HR = Hrvatski 2009-10-08 2016-12-21
Celvapan : EPAR - All Authorised presentations HR = Hrvatski 2009-10-08 2016-12-21
Celvapan : EPAR - All Authorised presentations HR = Hrvatski 2009-10-08 2016-12-21
Celvapan : EPAR - All Authorised presentations HR = Hrvatski 2009-10-08 2016-12-21
Celvapan : EPAR - All Authorised presentations HR = Hrvatski 2009-10-08 2016-12-21
Celvapan : EPAR - All Authorised presentations HR = Hrvatski 2009-10-08 2016-12-21
Celvapan : EPAR - All Authorised presentations HR = Hrvatski 2009-10-08 2016-12-21
Celvapan : EPAR - All Authorised presentations HR = Hrvatski 2009-10-08 2016-12-21
Celvapan : EPAR - All Authorised presentations HR = Hrvatski 2009-10-08 2016-12-21
Celvapan : EPAR - All Authorised presentations HR = Hrvatski 2009-10-08 2016-12-21
Celvapan : EPAR - All Authorised presentations HR = Hrvatski 2009-10-08 2016-12-21
Celvapan : EPAR - All Authorised presentations HR = Hrvatski 2009-10-08 2016-12-21
Celvapan : EPAR - All Authorised presentations HR = Hrvatski 2009-10-08 2016-12-21
Celvapan : EPAR - All Authorised presentations HR = Hrvatski 2009-10-08 2016-12-21
Celvapan : EPAR - All Authorised presentations HR = Hrvatski 2009-10-08 2016-12-21
Celvapan : EPAR - All Authorised presentations HR = Hrvatski 2009-10-08 2016-12-21
Celvapan : EPAR - All Authorised presentations HR = Hrvatski 2009-10-08 2016-12-21
Celvapan : EPAR - All Authorised presentations HR = Hrvatski 2009-10-08 2016-12-21
Celvapan : EPAR - All Authorised presentations HR = Hrvatski 2009-10-08 2016-12-21
Celvapan : EPAR - All Authorised presentations HR = Hrvatski 2009-10-08 2016-12-21
Celvapan : EPAR - All Authorised presentations HR = Hrvatski 2009-10-08 2016-12-21
Celvapan : EPAR - All Authorised presentations HR = Hrvatski 2009-10-08 2016-12-21
Celvapan : EPAR - All Authorised presentations HR = Hrvatski 2009-10-08 2016-12-21
Celvapan : EPAR - All Authorised presentations HR = Hrvatski 2009-10-08 2016-12-21

Pharmacotherapeutic group

Vaccines

Therapeutic indication

Prophylaxis of influenza caused by A(H1N1)v 2009 virus.

Celvapan should be used in accordance with official guidance.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Celvapan : EPAR - Public assessment report HR = Hrvatski 2009-04-08 2016-12-21
Committee for medicinal products for human use summary of positive opinion for Celvapan HR = Hrvatski 2008-12-17 2016-12-21

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on Celvapan