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Community register of medicinal products for human use


Product information

Invented name: Ebilfumin   
Auth. number : EU/1/14/915
Active substance : oseltamivir
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J05 - Antivirals for systemic use
Pharmacological subgroup: J05A - Agents affecting the virus directly
Chemical subgroup: J05AH - Neuraminidase inhibitors
Chemical substance: J05AH02 - oseltamivir
(See WHO ATC Index)
Indication: Treatment of influenza
Ebilfumin is indicated in adults and children including full-term neonates who present with symptoms typical of influenza, when influenza virus is circulating in the community. Efficacy has been demonstrated when treatment is initiated within two days of first onset of symptoms.
Prevention of influenza
- Post-exposure prevention in individuals 1 year of age or older following contact with a clinically diagnosed influenza case when influenza virus is circulating in the community.
- The appropriate use of Ebilfumin for prevention of influenza should be determined on a case by case basis by the circumstances and the population requiring protection. In exceptional situations (e.g. in case of a mismatch between the circulating and vaccine virus strains, and a pandemic situation) seasonal prevention could be considered in individuals one year of age or older.
- Ebilfumin is indicated for post-exposure prevention of influenza in infants less than 1 year of age during a pandemic influenza outbreak (see section 5.2).
Ebilfumin is not a substitute for influenza vaccination.
The use of antivirals for the treatment and prevention of influenza should be determined on the basis of official recommendations. Decisions regarding the use of oseltamivir for treatment and prophylaxis should take into consideration what is known about the characteristics of the circulating influenza viruses, available information on influenza drug susceptibility patterns for each season and the impact of the disease in different geographical areas and patient populations (see section 5.1).
Marketing Authorisation Holder: Actavis Group PTC ehf.
Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
27/05/2014 Centralised - Authorisation EMEA/H/C/3717 (2014)3553 of 22/05/2014
22/10/2014 Centralised - Notification EMEA/H/C/3717/N/1
Updated with Decision(2016)2821 of 02/05/2016
10/07/2015 Centralised - Variation EMEA/H/C/3717/H/C/IB/3
Updated with Decision(2016)2821 of 02/05/2016
4/05/2016 Centralised - 2-Monthly update EMEA/H/C/3717/IB/4 (2016)2821 of 2/05/2016
10/01/2017 Centralised - Variation EMEA/H/C/3717/IB/6/G
Updated with Decision(2018) 740 of 05/02/2018
4/04/2017 Centralised - Variation EMEA/H/C/3717/IB/7/G
Updated with Decision(2018) 740 of 05/02/2018
17/05/2017 Centralised - Variation EMEA/H/C/3717/IB/8/G
Updated with Decision(2018) 740 of 05/02/2018
13/09/2017 Centralised - Variation EMEA/H/C/3717/IB/9/G
Updated with Decision(2018) 740 of 05/02/2018
7/02/2018 Centralised - Yearly update (2018) 740 of 5/02/2018