Label Changes for:

Tamiflu (Oseltamivir Phosphate) Capsules and Oral Suspension

December 2012

Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) 

 

December 2012

 

WARNINGS AND PRECAUTIONS

Limitations of Populations Studied
  • Safety and efficacy of TAMIFLU for treatment of influenza in pediatric patients less than 2 weeks of age have not been established. Safety and efficacy of TAMIFLU for prophylaxis of influenza have not been established for pediatric patients less than 1 year of age.

 

December 2010

 

DRUG INTERACTIONS

  • Proposed update on Aspirin/Tamiflu Drug-Drug Interaction

 

November 2010

ADVERSE REACTIONS

Postmarketing Experience
  • Hypothermia

 

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