Arepanrix
pandemic influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)
Table of contents
Overview
The marketing authorisation for Arepanrix has been withdrawn at the request of the marketing authorisation holder.
Authorisation details
| Product details | |
|---|---|
| Name |
Arepanrix
|
| Agency product number |
EMEA/H/C/001201
|
| Active substance |
split influenza virus, inactivated, containing antigen*: A/California/7/2009 (H1N1)v like strain (X-179A)*propagated in eggs.
|
| International non-proprietary name (INN) or common name |
pandemic influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)
|
| Therapeutic area (MeSH) |
|
| Anatomical therapeutic chemical (ATC) code |
J07BB02
|
Conditional approval |
This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation. |
| Publication details | |
|---|---|
| Marketing-authorisation holder |
GlaxoSmithKline Biologicals S.A.
|
| Revision |
1
|
| Date of issue of marketing authorisation valid throughout the European Union |
23/03/2010
|
| Contact address |
89, rue de l'Institut
BE-1330 Rixensart Belgium |
Product information
13/08/2010 Arepanrix - EMEA/H/C/001201 - IB/0005/G
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
Therapeutic indication
Prophylaxis of influenza in an officially declared pandemic situation. Pandemic influenza vaccine should be used in accordance with official guidance