Raxtozinameran

Comirnaty Omicron XBB.1.5 (30 Microgramos)/Dosis Dispersion Inyectable

0,1 mg/ml dispersión inyectableSpainAuthorisedAuthorised 4 Sept 2023

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.

ComirnatyEuropean UnionAuthorised

Comirnaty Omicron XBB.1.5Canada · 10 MCG / 0.2 ML · Suspension · Biontech Manufacturing GMBHSame brand
Comirnaty Omicron XBB.1.5Canada · 3 MCG / 0.2 ML · Suspension · Biontech Manufacturing GMBHSame brand
Comirnaty Omicron XBB.1.5Italy · Dispersione per preparazione iniettabile · Biontech Manufacturing GMBHSame brand

Packs

Pack	Code	Status
COMIRNATY OMICRON XBB.1.5 (30 MICROGRAMOS)/DOSIS DISPERSION INYECTABLE, 10 viales multidosis	763234

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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Raxtozinameran

Comirnaty Omicron XBB.1.5 (30 Microgramos)/Dosis Dispersion Inyectable

0,1 mg/ml dispersión inyectableSpainAuthorisedAuthorised 4 Sept 2023

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.

ComirnatyEuropean UnionAuthorised

Packs

Pack	Code	Status
COMIRNATY OMICRON XBB.1.5 (30 MICROGRAMOS)/DOSIS DISPERSION INYECTABLE, 10 viales multidosis	763234

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.

Discover Osler

Summary of product characteristicsAEMPS

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 substance: Raxtozinameran
Strength: 0,1 mg/ml
Dosage form: dispersión inyectable
Route: vía intramuscular
Register: Spain (AEMPS)
Status: Authorised
Status in the register: Autorizado, no comercializado
Authorised: 4 Sept 2023
Registration: 1201528019
Marketing authorisation holder: Biontech Manufacturing Gmbh
Procedure: EU centralised
Supply: Medicamento Sujeto A Prescripción Médica
EU number: EU/1/20/1528

Spain