Pumarix
pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Table of contents
Overview
The marketing authorisation for Pumarix has been withdrawn at the request of the marketing authorisation holder.
Authorisation details
| Product details | |
|---|---|
| Name |
Pumarix
|
| Agency product number |
EMEA/H/C/001212
|
| Active substance |
pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
|
| International non-proprietary name (INN) or common name |
pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
|
| Therapeutic area (MeSH) |
|
| Anatomical therapeutic chemical (ATC) code |
J07BB02
|
Exceptional circumstances |
This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance. |
| Publication details | |
|---|---|
| Marketing-authorisation holder |
GlaxoSmithKline Biologicals S.A.
|
| Revision |
4
|
| Date of issue of marketing authorisation valid throughout the European Union |
04/03/2011
|
| Contact address |
GlaxoSmithKline Biologicals S.A.
89, rue de l'Institut B-1330 Rixensart Belgium |
Product information
28/02/2014 Pumarix - EMEA/H/C/001212 - P46/0016
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
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 in an officially declared pandemic situation.
Pandemic-influenza vaccine should be used in accordance with official guidance.