Celvapan

RSS

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

Withdrawn
This medicine is now withdrawn from use in the European Union.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The marketing authorisation for Celvapan has been withdrawn at the request of the marketing-authorisation holder.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 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
Publication details
Marketing-authorisation holder
Nanotherapeutics Bohumil, s.r.o.
Revision
11
Date of issue of marketing authorisation valid throughout the European Union
04/03/2009
Contact address
Bohumill38
28163 Jevany
Czech Republic

Product information

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

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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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