Cannabidiol

Epidyolex 100 MG/ML Solucion Oral

100 mg/ml solución oralSpainMarketedAuthorised 5 Dec 2019

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.

EpidyolexEuropean UnionAuthorised

EpidyolexEuropean Union · Jazz Pharmaceuticals Ireland LimitedSame brand
EpidyolexCroatiaSame brand
EpidyolexItaly · Soluzione orale · Jazz Pharmaceuticals Ireland LimitedSame brand
Epidyolex 100 mg/ml, drankNetherlands · Drank · Jazz Pharmaceuticals Ireland LimitedSame brand
EpidiolexCanada · 100 MG / ML · Solution · Jazz Pharmaceuticals Research UK LimitedSame strength and form
EpidiolexUnited States · 100MG/ML · solution · Jazz Pharms ResSame strength and form

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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Cannabidiol

Epidyolex 100 MG/ML Solucion Oral

100 mg/ml solución oralSpainMarketedAuthorised 5 Dec 2019

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.

EpidyolexEuropean UnionAuthorised

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

Packs

Pack	Code	Status
EPIDYOLEX 100 MG/ML SOLUCION ORAL, 1 frasco de 100 ml	727061

Documents

The official texts, at the regulator.

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: Cannabidiol
Strength: 100 mg/ml
Dosage form: solución oral
Route: vía oral
Register: Spain (AEMPS)
Status: Marketed
Status in the register: Autorizado, comercializado
Authorised: 5 Dec 2019
Registration: 1191389001
Marketing authorisation holder: Jazz Pharmaceuticals Ireland Limited
Procedure: EU centralised
Supply: Diagnóstico Hospitalario
EU number: EU/1/19/1389