Elasomeran

Spikevax, 0,2 mg/ml dispersie voor injectie

Suspensie voor injectieNetherlandsAuthorisedAuthorised 6 Jan 2021

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.

Spikevax (previously COVID-19 Vaccine Moderna)European UnionAuthorised

SpikevaxCanada · 0.1 MG / ML · Dispersion · Moderna Biopharma Canada CorporationSame brand
SpikevaxCanada · 0.2 MG / ML · Dispersion · Moderna Biopharma Canada CorporationSame brand
Spikevax, Dispersion InyectableSpain · 1,26 mg · dispersión inyectable · Moderna Biotech Spain S.L.Same brand
Spikevax (Ex Covid-19 Vaccine Moderna)Italy · Dispersione per preparazione iniettabile · Moderna Biotech Spain, S.L.Same brand

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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Elasomeran

Spikevax, 0,2 mg/ml dispersie voor injectie

Suspensie voor injectieNetherlandsAuthorisedAuthorised 6 Jan 2021

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.

Spikevax (previously COVID-19 Vaccine Moderna)European UnionAuthorised

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 characteristicsCBG-MEB

Register entryCBG-MEB

Sources and licences

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

College ter Beoordeling van Geneesmiddelen

College ter Beoordeling van Geneesmiddelen, Geneesmiddeleninformatiebank metadata, source update 07-10-2026; downloaded 08-10-2026; factual adaptation.

Licence: Conditional noncreative administrative factual metadata; no dataset-wide CC0 claim · Added 8 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: Elasomeran
Dosage form: Suspensie voor injectie
Route: Intramusculair gebruik
Register: Netherlands (CBG-MEB)
Status: Authorised
Status in the register: Ingeschreven
Authorised: 6 Jan 2021
Registration: EU/1/20/1507
Marketing authorisation holder: Moderna Biotech Spain, S.L
ATC code: J07BN01
Group: Anti-infectives for systemic use
Procedure: EU centralised
Supply: Uitsluitend recept
EMA product number: EMEA/H/C/005791
EU number: EU/1/20/1507

Netherlands

Spikevax XBB.1.5 25 mcg dispergie voor injectie in een voorgevulde spuitElasomeran · Dispersie voor injectieNetherlands