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Medicines
Spain
Tetrabenazine

AEMPS 2019

Tetrabenazine

Tetrabenazina Aristo 25 MG Comprimidos Efg

25 mg comprimidoSpainMarketedAuthorised 24 May 2019

Product informationAsk Osler about it

On this page

In other countries
Packs
Documents
Sources and licences

In other countries

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

Apo-TetrabenazineCanada · 25 MG · Tablet · Apotex INCSame form
NitomanCanada · 25 MG · Tablet · Bausch Health, Canada INC.Same form
PMS-TetrabenazineCanada · 25 MG · Tablet · Pharmascience INCSame form
Tetmodis 25 mg tableteCroatia · Tableta · Walter Ritter GmbH + Co. KG, Spaldingstraße 110B, Hamburg, NjemačkaSame form
Tetrabenazina AristoItaly · Compressa · Aristo Pharma GMBHSame form
Tetrabenazina SunItaly · Compressa · Sun Pharmaceutical Industries (Europe) B.V.Same form
XenazinaItaly · Compressa · Bausch Health Ireland LimitedSame form

More with the same substance on this register

NITOMAN 25 mg COMPRIMIDOSTetrabenazine · 25,00 mg · comprimidoSpain
Tetrabenazina Sun 25 MG Comprimidos EfgTetrabenazine · 25 mg · comprimidoSpain

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.

🇳🇱

Tetmodis 25 mg, tablettenNetherlands · Tablet · Euro Registratie Collectief B.V.

Same form

🇳🇱Tetmodis 25 mg, tablettenNetherlands · Tablet · Walter Ritter GmbH & Co. KGSame form

🇳🇱Tetmodis 25 mg tablettenNetherlands · Tablet · BModesto B.V.Same form

🇳🇿MotetisNew Zealand · Tab 25 mgSame form

🇺🇸TetrabenazineUnited States · 12.5MG, 25MG · tablet · ApotexSame form

🇺🇸XenazineUnited States · 12.5MG, 25MG · tablet · BauschSame form

🇷🇴ARTESYD 25 mgRomania · 25mg · compr. · Aop Orphan Pharmaceuticals AGSame substance

🇷🇴TETMODIS 25mgRomania · 25mg · compr. · Aop Orphan Pharmaceuticals AGSame substance

Packs

Pack	Code	Status
TETRABENAZINA ARISTO 25 MG COMPRIMIDOS EFG, 112 comprimidos	725864

Documents

The official texts, at the regulator.

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: Tetrabenazine
Strength: 25 mg
Dosage form: comprimido
Route: vía oral
Register: Spain (AEMPS)
Status: Marketed
Status in the register: Autorizado, comercializado
Authorised: 24 May 2019
Registration: 84164
Marketing authorisation holder: Aristo Pharma Gmbh
Procedure: National, MRP or DCP
Supply: Medicamento Sujeto A Prescripción Médica

AEMPSTETMODIS 25 mg COMPRIMIDOS EFGTetrabenazine · 25 mg · comprimido🇪🇸Spain