🇪🇺 Infanrix® Penta in European Union

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

EMA authorised Infanrix® Penta on 23 October 2000

Marketing authorisation

EMA — authorised 23 October 2000

Application: EMEA/H/C/000295
Marketing authorisation holder: GlaxoSmithKline Biologicals S.A.
Local brand name: Infanrix Penta
Indication: Infanrix Penta is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis B and poliomyelitis.
Status: withdrawn

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Frequently asked questions

Is Infanrix® Penta approved in European Union?

Yes. EMA authorised it on 23 October 2000.

Who is the marketing authorisation holder for Infanrix® Penta in European Union?

GlaxoSmithKline Biologicals S.A. holds the EU marketing authorisation.