Fluad Tetra - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation.

influenza vaccine (surface antigen, inactivated, adjuvanted)

Opinion

On 9 November 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Fluad Tetra. The marketing authorisation holder for this medicinal product is Seqirus Netherlands B.V.

The CHMP adopted a change to the existing indication to include prophylaxis of influenza in adults from 50 years of age. For information, the full indication for Fluad Tetra will therefore be as follows:¹

Prophylaxis of influenza in adultsthe elderly (6550 years of age and older).

Fluad Tetra should be used in accordance with official recommendations.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

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¹New text in bold, removed text as strikethrough

CHMP summary of positive opinion for Fluad Tetra (II-43)

AdoptedReference Number: EMA/CHMP/492465/2023

Key facts

• Name of medicine:
  Fluad Tetra
• EMA product number:
  EMEA/H/C/004993
• Active substance:
  A/Victoria/4897/2022 (H1N1)pdm09-like strain (A/Victoria/4897/2022, IVR-238) / A/Thailand/8/2022 (H3N2)-like strain (A/Thailand/8/2022 IVR-237) / B/Austria/1359417/2021-like strain (B/Austria/1359417/2021, BVR-26) / B/Phuket/3073/2013-like strain (B/Phuket/3073/2013, BVR-1B) influenza virus
• International non-proprietary name (INN) or common name:
  influenza vaccine (surface antigen, inactivated, adjuvanted)
• Therapeutic area (MeSH):
  Influenza, Human
• Anatomical therapeutical chemical (ATC) code:
  J07BB02
• Marketing authorisation holder:
  Seqirus Netherlands B.V.
• Date of opinion:
  10/11/2023
• Status:
  Positive