Celvapan

Withdrawn

This medicine's authorisation has been withdrawn

influenza vaccine (H1N1)v (whole virion, Vero cell derived, inactivated)

Overview

On 21 November 2016, the European Commission withdrew the marketing authorisation for Celvapan (pandemic influenza vaccine (H1N1) (whole virion, inactivated, prepared in cell culture)) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Nanotherapeutics Bohumil sro, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Celvapan was granted marketing authorisation in the EU on 6 October 2009 for prophylaxis of influenza caused by A/H1N1v 2009 virus. The marketing authorisation was initially valid for a 5-year period and was then renewed with unlimited validity on 26 February 2015. The product has not been marketed in the EU since 2010. 

Nanotherapeutics Bohumil sro is the marketing authorisation holder for another pandemic vaccine, Pandemic Influenza Vaccine H5N1 Baxter AG, which is authorised in the EU for pandemic preparedness. Nanotherapeutics Bohumil sro will maintain the marketing authorisation for Pandemic Influenza Vaccine H5N1 Baxter AG. 

The European Public Assessment Report (EPAR) for Celvapan is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Celvapan : EPAR - Summary for the public

Product information

Celvapan : EPAR - Product Information

Celvapan : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Celvapan
• Active substance:
  whole virion influenza vaccine, inactivated containing antigen of strain A/California/07/2009 (H1N1)v
• International non-proprietary name (INN) or common name:
  influenza vaccine (H1N1)v (whole virion, Vero cell derived, inactivated)
• Therapeutic area (MeSH):
  • Disease Outbreaks
  • Influenza, Human
  • Immunization
• Anatomical therapeutic chemical (ATC) code:
  J07BB01

Pharmacotherapeutic group

Vaccines

Therapeutic indication

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

Celvapan should be used in accordance with official guidance.

Authorisation details

• EMA product number:
  EMEA/H/C/000982
• Marketing authorisation holder:
  Nanotherapeutics Bohumil, s.r.o.

  Bohumill38 ; 28163 Jevany; Czech Republic

• Marketing authorisation issued:
  04/03/2009
• Withdrawal of marketing authorisation:
  21/11/2016
• Revision:
  11

Assessment history

Changes since initial authorisation of medicine

Celvapan : EPAR - Procedural steps taken and scientific information after authorisation

Celvapan-H-C-982-II-0019-G : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/664781/2012

Celvapan-H-C-982-II-0017-G : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/CHMP/283690/2011

Celvapan-H-C-982-SW-0014 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/CHMP/487986/2010

Celvapan-H-C-982-II-0012 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/257008/2010

Celvapan-H-C-982-II-0009 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/843807/2009

Celvapan-H-C-832-II-0006 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMEA/CHMP/733392/2009

Celvapan-H-C-982-PU-0002 : EPAR - Assessment Report - Variation

Reference Number: EMEA/CHMP/629184/2009

Initial marketing authorisation documents

Celvapan : EPAR - Public assessment report

Committee for medicinal products for human use summary of positive opinion for Celvapan

Reference Number: EMEA/CHMP/657005/2008