Toxóide diftérico, Toxóide tetânico, Bordetella pertussis toxoide, Bordetella pertussis hemaglutinina filamentosa, Bordetella pertussis pertactina, Aglutinogeno fimbrias toxoide pertussis, Poliovirus inactivado tipo producido en celulas vero, Poliovirus inactivado tipo (saukett producido en celulas vero, Antigeno superficie hepatitis b, Conjugado haemophilus influenzae prp-neisseria meningitidis ompc

Vaxelis Suspension Inyectable en Jeringa Precargada

Mayor o igual a 20 UI + Mayor o igual a 40 UI + 20 µg + 20 µg + 3 µg + 5 µg + 29 U.D. (UNIDADES ANTIGENICAS D) + 7 U.D. (UNIDADES ANTIGENICAS D) + 26 U.D. (UNIDADES ANTIGENICAS D) + 10 µg + 3 µg suspensión inyectable en jeringa precargadaSpainMarketedAuthorised 16 Dec 2016

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In other countries

The same active substances on other registers, the same brand first.

Authorised centrally in the EU

This national listing belongs to a medicine the European Commission authorised for the whole EU.

VaxelisEuropean UnionAuthorised

Packs

Pack	Code	Status
VAXELIS SUSPENSION INYECTABLE EN JERINGA PRECARGADA, 10 jeringa precargada + 20 agujas	606933
VAXELIS SUSPENSION INYECTABLE EN JERINGA PRECARGADA, 1 jeringa precargada + 2 agujas	714004
VAXELIS SUSPENSION INYECTABLE EN JERINGA PRECARGADA, 10 jeringa precargada + 20 agujas	721440
VAXELIS SUSPENSION INYECTABLE EN JERINGA PRECARGADA, 1 jeringa precargada + 1 aguja	768257
VAXELIS SUSPENSION INYECTABLE EN JERINGA PRECARGADA, 10 jeringas precargadas + 10 agujas	768258

Documents

The official texts, at the regulator.

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Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

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Toxóide diftérico, Toxóide tetânico, Bordetella pertussis toxoide, Bordetella pertussis hemaglutinina filamentosa, Bordetella pertussis pertactina, Aglutinogeno fimbrias toxoide pertussis, Poliovirus inactivado tipo producido en celulas vero, Poliovirus inactivado tipo (saukett producido en celulas vero, Antigeno superficie hepatitis b, Conjugado haemophilus influenzae prp-neisseria meningitidis ompc

Vaxelis Suspension Inyectable en Jeringa Precargada

Mayor o igual a 20 UI + Mayor o igual a 40 UI + 20 µg + 20 µg + 3 µg + 5 µg + 29 U.D. (UNIDADES ANTIGENICAS D) + 7 U.D. (UNIDADES ANTIGENICAS D) + 26 U.D. (UNIDADES ANTIGENICAS D) + 10 µg + 3 µg suspensión inyectable en jeringa precargadaSpainMarketedAuthorised 16 Dec 2016

Product informationAsk Osler about it

In other countries

The same active substances on other registers, the same brand first.

Authorised centrally in the EU

This national listing belongs to a medicine the European Commission authorised for the whole EU.

VaxelisEuropean UnionAuthorised

Packs

Pack	Code	Status
VAXELIS SUSPENSION INYECTABLE EN JERINGA PRECARGADA, 10 jeringa precargada + 20 agujas	606933
VAXELIS SUSPENSION INYECTABLE EN JERINGA PRECARGADA, 1 jeringa precargada + 2 agujas	714004
VAXELIS SUSPENSION INYECTABLE EN JERINGA PRECARGADA, 10 jeringa precargada + 20 agujas	721440
VAXELIS SUSPENSION INYECTABLE EN JERINGA PRECARGADA, 1 jeringa precargada + 1 aguja	768257
VAXELIS SUSPENSION INYECTABLE EN JERINGA PRECARGADA, 10 jeringas precargadas + 10 agujas	768258

Documents

The official texts, at the regulator.

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

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Summary of product characteristics

AEMPS

Package leafletAEMPS

Register entryAEMPS

Sources and licences

Compiled by Prognia from the public register below; the register’s text is the official one.

Agencia Española de Medicamentos y Productos Sanitarios

Fuente de la información: Agencia Española de Medicamentos y Productos Sanitarios www.aemps.gob.es; CIMA medicamentos, acquired 11 October 2026 UTC; each source response/update date retained.

Licence: AEMPS explicit public open-data reuse for citizens and companies; source attribution and update date required · Added 12 Oct 2026

Report an error or request removalCorrections from the holder or the register are welcome.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Active substances: Toxóide diftérico, Toxóide tetânico, Bordetella pertussis toxoide, Bordetella pertussis hemaglutinina filamentosa, Bordetella pertussis pertactina, Aglutinogeno fimbrias toxoide pertussis, Poliovirus inactivado tipo producido en celulas vero, Poliovirus inactivado tipo (saukett producido en celulas vero, Antigeno superficie hepatitis b, Conjugado haemophilus influenzae prp-neisseria meningitidis ompc
Strength: Mayor o igual a 20 UI + Mayor o igual a 40 UI + 20 µg + 20 µg + 3 µg + 5 µg + 29 U.D. (UNIDADES ANTIGENICAS D) + 7 U.D. (UNIDADES ANTIGENICAS D) + 26 U.D. (UNIDADES ANTIGENICAS D) + 10 µg + 3 µg
Dosage form: suspensión inyectable en jeringa precargada
Route: vía intramuscular
Register: Spain (AEMPS)
Status: Marketed
Status in the register: Autorizado, comercializado
Authorised: 16 Dec 2016
Registration: 1151079004
Marketing authorisation holder: Mcm Vaccine B.V.
Procedure: EU centralised
Supply: Medicamento Sujeto A Prescripción Médica
EU number: EU/1/15/1079