Ganaxolone

ZTALMY 50 mg/ml orale suspensie

Suspensie voor oraal gebruikNetherlandsAuthorisedAuthorised 26 Jul 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.

ZtalmyEuropean 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.

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Ganaxolone

ZTALMY 50 mg/ml orale suspensie

Suspensie voor oraal gebruikNetherlandsAuthorisedAuthorised 26 Jul 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.

ZtalmyEuropean 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: Ganaxolone
Dosage form: Suspensie voor oraal gebruik
Route: Oraal gebruik
Register: Netherlands (CBG-MEB)
Status: Authorised
Status in the register: Ingeschreven
Authorised: 26 Jul 2023
Registration: EU/1/23/1743
Marketing authorisation holder: Immedica Pharma AB
ATC code: N03AX27
Group: Nervous system
Procedure: EU centralised
Supply: Uitsluitend recept
EMA product number: EMEA/H/C/005825
EU number: EU/1/23/1743