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The EMA has issued an opinion that endorses the use of the Dengue Tetravalent Vaccine outside the EU for individuals aged 4 to 60, marking a significant regulatory position.
This opinion affects regulatory protocols concerning the vaccine, particularly in terms of compliance and safety assessments for its administration in non-EU countries.
Regulatory compliance workflows involving the Dengue Tetravalent Vaccine outside the EU need to incorporate the EMA's positive opinion concerning its use in individuals aged 4 to 60.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
Regulatory compliance workflows involving the Dengue Tetravalent Vaccine outside the EU need to incorporate the EMA's positive opinion concerning its use in individuals aged 4 to 60.
The European Medicines Agency (EMA) has posited an opinion for the Dengue Tetravalent Vaccine (Live, Attenuated) Takeda, indicating its use for the prevention of dengue disease in individuals aged 4 to 60 outside the EU. This positive opinion, stemming from an assessment conducted under Regulation (EC) No 726/2004, may influence compliance evaluations and safety assessments regarding the vaccine's deployment.
What changed: The EMA has issued an opinion that endorses the use of the Dengue Tetravalent Vaccine outside the EU for individuals aged 4 to 60, marking a significant regulatory position.
Why it matters: This opinion affects regulatory protocols concerning the vaccine, particularly in terms of compliance and safety assessments for its administration in non-EU countries.
Practical implication: Regulatory compliance workflows involving the Dengue Tetravalent Vaccine outside the EU need to incorporate the EMA's positive opinion concerning its use in individuals aged 4 to 60.
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