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Medicines
Spain
Duloxetine

AEMPS 2017

Duloxetine

Dulotex 30 MG Comprimidos Gastrorresistentes

34,36 mg comprimido gastrorresistenteSpainMarketedAuthorised 13 Nov 2017

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.

cloridrato de duloxetinaBrazil · Multilab Industria e Comercio de Produtos Farmaceuticos LtdaSame substance
cloridrato de duloxetinaBrazil · Ranbaxy Farmacêutica LtdaSame substance
cloridrato de duloxetinaBrazil · Germed Farmaceutica LtdaSame substance
Accel-DuloxetineCanada · 30 MG · Capsule (Delayed-Release) · Accel Pharma INCSame substance
Accel-DuloxetineCanada · 60 MG · Capsule (Delayed-Release) · Accel Pharma INCSame substance
AG-DuloxetineCanada · 60 MG · Capsule (Delayed-Release) · Angita Pharma INC.Same substance
CymbaltaEuropean Union · Eli Lilly Nederland B.V.Same substance

More with the same substance on this register

Cymbalta 30 MG Capsulas Duras GastrorresistentesDuloxetine · 30 mg · cápsula dura gastrorresistenteSpain
Cymbalta 30 MG Capsulas Duras GastrorresistentesDuloxetine · 30 mg · cápsula dura gastrorresistente

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.

🇪🇺Duloxetine LillyEuropean Union · Eli Lilly Nederland B.V.Same substance

🇪🇺Duloxetine Viatris (previously Duloxetine Mylan)European Union · Viatris LimitedSame substance

🇭🇷Dolyxan 30 mg tvrde želučanootporne kapsuleCroatia · želučanootporna kapsula, tvrda · Belupo lijekovi i kozmetika d.d., Ulica Danica 5, Koprivnica, HrvatskaSame substance

🇭🇷Dolyxan 60 mg tvrde želučanootporne kapsuleCroatia · želučanootporna kapsula, tvrda · Belupo lijekovi i kozmetika d.d., Ulica Danica 5, Koprivnica, HrvatskaSame substance

🇭🇷Duloksetin Pliva 30 mg želučanootporne tvrde kapsuleCroatia · želučanootporna kapsula, tvrda · Pliva Hrvatska d.o.o., Prilaz baruna Filipovića 25, Zagreb, HrvatskaSame substance

🇮🇹AlikresItaly · Capsula rigida gastroresistente · Laboratorio Farmaceutico C.T. S.R.L.Same substance

🇮🇹CymbaltaItaly · Capsula rigida gastroresistente · Farmed S.R.L.Same substance

🇮🇹CymbaltaItaly · Capsula rigida gastroresistente · GMM Farma S.R.L.Same substance

🇳🇱Cymbalta 30 mg, maagsapresistente capsule, hardNetherlands · Maagsapresistente capsule, hard · Eli Lilly Nederland BVSame substance

🇳🇱Cymbalta 60 mg, maagsapresistente capsules, hardNetherlands · Maagsapresistente capsule, hard · Eli Lilly Nederland BVSame substance

🇳🇱Dulasolan 30 mg harde maagsapresistente capsulesNetherlands · Maagsapresistente capsule, hard · G.L. Pharma GmbHSame substance

🇷🇴CYMBALTA 30mgRomania · 30mg · caps. gastrorez. · Eli Lilly Nederland BVSame substance

🇷🇴CYMBALTA 60mgRomania · 60mg · caps. gastrorez. · Eli Lilly Nederland BVSame substance

🇷🇴DOZZEX 30 mgRomania · 30mg · caps. gastrorez. · Terapia S.A.Same substance

🇷🇸Dulsevia®Serbia · 90mg · gastrorezistentna kapsula, tvrda · Krka-Farma D.O.O. BeogradSame substance

🇷🇸Dulsevia®Serbia · 60mg · gastrorezistentna kapsula, tvrda · Krka-Farma D.O.O. BeogradSame substance

🇷🇸Dulsevia®Serbia · 30mg · gastrorezistentna kapsula, tvrda · Krka-Farma D.O.O. BeogradSame substance

🇸🇦Cymbalta 30MG Hard Gastro-Resistant Cap.Saudi Arabia · Lilly Del Caribe, Inc.Same substance

🇸🇦Cymbalta 30MG Hard Gastro-Resistant Cap.Saudi Arabia · Eli LillySame substance

🇸🇦Cymbalta 60MG Hard Gastro-Resistant CapSaudi Arabia · Lilly Del Caribe, Inc.Same substance

🇹🇼Dulox 60Taiwan · 膠囊劑 · 台灣諾華股份有限公司Same substance

🇺🇸CymbaltaUnited States · 20MG BASE, 30MG BASE, 60MG BASE · capsule, delayed rel pellets · LillySame substance

🇺🇸Duloxetine HydrochlorideUnited States · 120MG BASE, 20MG BASE, 30MG BASE … · capsule, delayed rel pellets · Sun PharmSame substance

🇺🇸Drizalma SprinkleUnited States · 20MG BASE, 30MG BASE, 40MG BASE … · capsule, delayed rel pellets · Sun PharmSame substance

Packs

Pack	Code	Status
DULOTEX 30 MG COMPRIMIDOS GASTRORRESISTENTES, 28 comprimidos	719726

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: Duloxetine
Strength: 34,36 mg
Dosage form: comprimido gastrorresistente
Route: vía oral
Register: Spain (AEMPS)
Status: Marketed
Status in the register: Autorizado, comercializado
Authorised: 13 Nov 2017
Registration: 82593
Marketing authorisation holder: Neuraxpharm Spain S.L.
Procedure: National, MRP or DCP
Supply: Medicamento Sujeto A Prescripción Médica

🇪🇸Spain

AEMPSCymbalta 30 MG Capsulas Duras GastrorresistentesDuloxetine · 30 mg · cápsula dura gastrorresistente🇪🇸Spain

AEMPSCymbalta 60 MG Capsulas Duras GastrorresistentesDuloxetine · 60 mg · cápsula dura gastrorresistente🇪🇸Spain

AEMPSCymbalta 60 MG Capsulas Duras GastrorresistentesDuloxetine · 60 mg · cápsula dura gastrorresistente🇪🇸Spain

AEMPSCymbalta 60 MG Capsulas Duras GastrorresistentesDuloxetine · 60 mg · cápsula dura gastrorresistente🇪🇸Spain

AEMPSCymbalta 60 MG Capsulas Duras GastrorresistentesDuloxetine · 60 mg · cápsula dura gastrorresistente🇪🇸Spain

AEMPSCymbalta 60 MG Capsulas Duras GastrorresistentesDuloxetine · 60 mg · cápsula dura gastrorresistente🇪🇸Spain

AEMPSDulotex 120 MG Capsulas Duras GastrorresistentesDuloxetine · 134,716 mg · cápsula dura gastrorresistente🇪🇸Spain

AEMPSDulotex 30 MG Capsulas Duras Gastrorresistentes EfgDuloxetine · 33,68 mg · cápsula dura gastrorresistente🇪🇸Spain

AEMPSDulotex 60 MG Capsulas Duras Gastrorresistentes EfgDuloxetine · 67,36 mg · cápsula dura gastrorresistente🇪🇸Spain

AEMPSDulotex 60 MG Comprimidos GastrorresistentesDuloxetine · 68,72 mg · comprimido gastrorresistente🇪🇸Spain