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TAMIFLU (oseltamivir), antiviral neuraminidase inhibitor
INFECTIOUS DISEASES - New indication
Opinions on drugs -
Posted on
Nov 15 2017
Reason for request
Extension of indication
Insufficient clinical benefit in the curative treatment of influenza in infants under 1 year of age during ordinary flu epidemics
- TAMIFLU has Marketing Authorisation in the treatment of influenza in full-term newborns up to 1 year of age, with typical influenza symptoms when the virus is circulating.
- Its efficacy has not been established in children < 1 year of age. It was extrapolated from data observed in older children and adults.
- There are uncertainties as for the risk of toxicity and resistance to oseltamivir in this age range, in particular in those under 2 weeks of age.
- Flu vaccination is the most effective preventative measure against infection and its complications.
Clinical Benefit
| Insufficient |
- |
Therapeutic use
|
- |
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