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Pharmaceuticals - Community Register
Community register of medicinal products for human use
|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|
In patients one year of age and older 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. This indication is based on clinical studies of naturally occurring influenza in which the predominant infection was influenza A (see section 5.1).
Ebilfumin is indicated for the treatment of infants less than 1 year of age during a pandemic influenza outbreak (see section 5.2). The treating physician should take into account the pathogenicity of the circulating strain and the underlying condition of the patient to ensure there is a potential benefit to the child.
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.
Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland
|EPAR and active 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.
|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|
|10/07/2015||Centralised - Variation||EMEA/H/C/3717/H/C/IB/3|