Tamiflu (oseltamivir)
- Region
- 🇪🇺 EU
- Active substance
- oseltamivir
- Company
- Roche Registration GmbH
- Status
- Authorised
- Therapeutic area
- Influenza, Human
- CHMP opinion
- Thu 21 Mar 2002
- EU approval
- Thu 20 Jun 2002
- Application
- EMEA/H/C/000402
- ATC
- J05AH02
- Official record
- www.ema.europa.eu
Indication
Treatment of influenza Tamiflu 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 one 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 Tamiflu 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. Tamiflu is indicated for post-exposure prevention of influenza in infants less than 1 year of age during a pandemic-influenza outbreak. Tamiflu 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.
Regulatory milestones
No milestones recorded in the last year.
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