Overview
The marketing authorisation for Infergen has been withdrawn at the request of the marketing authorisation holder.
Authorisation details
| Product details | |
|---|---|
| Name |
Infergen
|
| Agency product number |
EMEA/H/C/000186
|
| Active substance |
interferon alfacon-1
|
| International non-proprietary name (INN) or common name |
interferon alfacon-1
|
| Therapeutic area (MeSH) |
Hepatitis C, Chronic
|
| Anatomical therapeutic chemical (ATC) code |
L03AB09
|
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Astellas Pharma Europe B.V.
|
| Revision |
8
|
| Date of issue of marketing authorisation valid throughout the European Union |
01/02/1999
|
| Contact address |
Elisabethhof 19
NL-2350 AC Leiderdorp The Netherlands |
Product information
05/05/2006 Infergen - EMEA/H/C/000186 -
This medicine’s product information is available in all official EU languages.
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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
Immunostimulants
Therapeutic indication
Treatment of patients of 18 years and older with chronic hepatitis and serum markers for hepatitis C virus (HCV) infection e.g. those who have elevated serum transaminase levels without decompensated liver disease and who are positive for serum HCV-RNA (see section 4.4). Consideration should be given to current official guidance on the appropriate use of interferons for the treatment of patients with chronic hepatitis C.
Interferon alfacon-1 should be given alone mainly in case of intolerance or contraindication to ribavirin.