Revised SPC: Tamiflu (oseltamivir) preparations

Tamiflu is licensed in adults and children including full term neonates who present with symptoms typical of influenza, when influenza virus is circulating in the community (previously only indicated for use in those <1 year old during a pandemic influenza outbreak).

Additional changes include:

• The dose for infants aged >1 year is 3mg/kg twice daily (was previously between 2mg/kg and 3mg/kg twice daily) (section 4.2)

 

• Reference to a commercially manufactured Tamiflu powder for oral suspension (6 mg/ml) as the preferred product for paediatric and adult patients who have difficulties swallowing capsules or where lower doses are needed (section 4.2 of the capsule SPCs)

 

• A new table to aid dosing for treatment according to weight (from 3-10kg) – the previous table grouped by age (0-12 months)

 

• Updated information in sections 4.8 and 5.1 on studies in children less than one year of age