Teduglutide

Revestive 5 MG Polvo y Disolvente Para Solucion Inyectable

5 mg polvo y disolvente para solución inyectableSpainMarketedAuthorised 27 May 2013

In other countries

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

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

Teduglutide

Revestive 5 MG Polvo y Disolvente Para Solucion Inyectable

5 mg polvo y disolvente para solución inyectableSpainMarketedAuthorised 27 May 2013

Product informationAsk Osler about it

In other countries

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

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

Revestive 1.25 mg, poeder en oplossing voor injectieNetherlands · Poeder en oplosmiddel voor oplossing voor injectie · Takeda Pharmaceuticals International AG Ireland Branch

Revestive 5 mg, poeder en oplosmiddel voor oplossing voor injectieNetherlands · Poeder en oplosmiddel voor oplossing voor injectie · Takeda Pharmaceuticals International AG Ireland Branch

Teduglutide ViatrisItaly · Polvere e solvente per soluzione iniettabile · Viatris Limited

Teduglutide Viatris 5 mg, poeder en oplosmiddel voor oplossing voor injectieNetherlands · Poeder en oplosmiddel voor oplossing voor injectie · Viatris Limited

Teduglutide ViatrisEuropean Union · Viatris Limited

Teduglutid ViatrisCroatia

Gattex KitUnited States · 5MG/VIAL · powder · Takeda Pharms USA

Packs

Pack	Code	Status
REVESTIVE 5 MG POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE, 28 viales + 28 jeringas precargadas de disolvente	698188

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: Teduglutide
Strength: 5 mg
Dosage form: polvo y disolvente para solución inyectable
Route: vía subcutánea
Register: Spain (AEMPS)
Status: Marketed
Status in the register: Autorizado, comercializado
Authorised: 27 May 2013
Registration: 12787001
Marketing authorisation holder: Takeda Pharmaceuticals International Ag Ireland Branch
Procedure: EU centralised
Supply: Uso Hospitalario

Spain