Celvapan

RSS

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

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Celvapan has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 21/12/2016

Authorisation details

Product details
Name
Celvapan
Agency product number
EMEA/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 (MeSH)
  • Disease Outbreaks
  • Influenza, Human
  • Immunization
Anatomical therapeutic chemical (ATC) code
J07BB01
Publication details
Marketing-authorisation holder
Nanotherapeutics Bohumil, s.r.o.
Revision
11
Date of issue of marketing authorisation valid throughout the European Union
03/03/2009
Contact address
Bohumill38
28163 Jevany
Czech Republic

Product information

29/11/2015 Celvapan - EMEA/H/C/000982 - T/0031

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.

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

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