Pandemic Influenza Vaccine H5N1 Baxter AG
pandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture)
Table of contents
Overview
The marketing authorisation for Pandemic Influenza Vaccine H5N1 Baxter has been withdrawn at the request of the marketing-authorisation holder.
Authorisation details
| Product details | |
|---|---|
| Name |
Pandemic Influenza Vaccine H5N1 Baxter AG
|
| Agency product number |
EMEA/H/C/001200
|
| Active substance |
influenza vaccine (whole virion, inactivated) containing antigen of: A/Vietnam/1203/2004 (H5N1)
|
| International non-proprietary name (INN) or common name |
pandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture)
|
| Therapeutic area (MeSH) |
|
| Anatomical therapeutic chemical (ATC) code |
J07BB01
|
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 |
Resilience Biomanufacturing Ireland Limited
|
| Revision |
8
|
| Date of issue of marketing authorisation valid throughout the European Union |
16/10/2009
|
| Contact address |
Resilience Biomanufacturing Ireland Limited |
Product information
01/02/2023 Pandemic Influenza Vaccine H5N1 Baxter AG - EMEA/H/C/001200 - IAIN/0032
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.