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Medicines
Spain
Empagliflozin

AEMPS 2015

Empagliflozin, Metformin

Synjardy 5 MG/1000 MG Comprimidos Recubiertos con Pelicula

5 mg + 1000 mg comprimido recubierto con películaSpainMarketedAuthorised 18 Jun 2015

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.

Authorised centrally in the EU

This national listing belongs to a medicine the European Commission authorised for the whole EU.

SynjardyEuropean UnionAuthorised

SynjardyCanada · 5 MG + 1000 MG · Tablet · Boehringer Ingelheim (Canada) LTD LteeSame brand
SynjardyCanada · 12.5 MG + 1000 MG · Tablet · Boehringer Ingelheim (Canada) LTD LteeSame brand
SynjardyCanada · 5 MG + 500 MG · Tablet · Boehringer Ingelheim (Canada) LTD LteeSame brand
SynjardyEuropean Union · Boehringer IngelheimSame brand
SynjardyCroatiaSame brand
SynjardyItaly · Compressa rivestita con film · Boehringer Ingelheim International GMBHSame brand

More with the same substance on this register

Synjardy 12,5 MG/1000 MG Comprimidos Recubiertos con PeliculaEmpagliflozin + Metformin · 12,5 mg + 1000 mg · comprimido recubierto con películaSpain
Empagliflozina/Metformina Krka 12,5 MG/1000 MG Comprimidos Recubiertos con Pelicula Efg

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.

🇳🇱Synjardy 12,5 mg/1000 mg filmomhulde tablettenNetherlands · Filmomhulde tablet · Boehringer Ingelheim International GmbHSame brand

🇳🇱Synjardy 12,5 mg/850 mg filmomhulde tablettenNetherlands · Filmomhulde tablet · Boehringer Ingelheim International GmbHSame brand

🇳🇱Synjardy 5 mg/1000 mg filmomhulde tablettenNetherlands · Filmomhulde tablet · Boehringer Ingelheim International GmbHSame brand

🇷🇸Synjardy®Serbia · 1000mg+12.5mg · film tableta · Boehringer Ingelheim Serbia D.O.O. BeogradSame brand

🇷🇸Synjardy®Serbia · 1000mg+5mg · film tableta · Boehringer Ingelheim Serbia D.O.O. BeogradSame brand

🇷🇸Synjardy®Serbia · 850mg+5mg · film tableta · Boehringer Ingelheim Serbia D.O.O. BeogradSame brand

🇸🇦SYNJARDY 12.5/1000 mg Film-coated TabletSaudi Arabia · Boehringer Ingelheim Pharma GMBH & Co. KG,BiberachSame brand

🇸🇦SYNJARDY 12.5/850 mg Film-coated TabletSaudi Arabia · Boehringer Ingelheim Pharma GMBH & Co. KG,BiberachSame brand

🇸🇦SYNJARDY 5/1000 mg Film-coated TabletSaudi Arabia · Boehringer Ingelheim Pharma GMBH & Co. KG,BiberachSame brand

🇺🇸SynjardyUnited States · 12.5MG; 1GM, 12.5MG; 500MG, 5MG; 1GM … · tablet · Boehringer IngelheimSame brand

🇺🇸Synjardy XRUnited States · 10MG; 1GM, 12.5MG; 1GM, 25MG; 1GM … · tablet, extended release · Boehringer IngelheimSame brand

🇭🇷Mempoglyn 12,5 mg/1000 mg filmom obložene tableteCroatia · Filmom obložena tableta · Krka - farma d.o.o., Radnička cesta 48, Zagreb, HrvatskaSame form

🇭🇷Mempoglyn 12,5 mg/850 mg filmom obložene tableteCroatia · Filmom obložena tableta · Krka - farma d.o.o., Radnička cesta 48, Zagreb, HrvatskaSame form

🇳🇿JardiametNew Zealand · Tab 12.5 mg with 1,000 mg metformin hydrochlorideSame form

🇳🇿JardiametNew Zealand · Tab 12.5 mg with 500 mg metformin hydrochlorideSame form

🇳🇿JardiametNew Zealand · Tab 5 mg with 1,000 mg metformin hydrochlorideSame form

🇸🇬Jardiance Duo Film Coated Tablet 12.5MG/1000MGSingapore · 12.5 mg + 1000mg · tablet, film coated · Boehringer Ingelheim Singapore Pte. LTD.Same form

🇸🇬Jardiance Duo Film Coated Tablet 12.5MG/500MGSingapore · 12.5 mg + 500mg · tablet, film coated · Boehringer Ingelheim Singapore Pte. LTD.Same form

🇸🇬Jardiance Duo Film Coated Tablet 12.5MG/850MGSingapore · 12.5 mg + 850mg · tablet, film coated · Boehringer Ingelheim Singapore Pte. LTD.Same form

🇺🇸Empagliflozin and Metformin HydrochlorideUnited States · 12.5MG; 1GM, 12.5MG; 500MG, 5MG; 1GM … · tablet · Zydus PharmsSame form

🇧🇷Jardiance DuoBrazil · Boehringer Ingelheim do Brasil Química e Farmacêutica Ltda.Same substance

Packs

Pack	Code	Status
SYNJARDY 5 MG/1000 MG COMPRIMIDOS RECUBIERTOS CON PELICULA, 60 comprimidos	706806

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 substances: Empagliflozin, Metformin
Strength: 5 mg + 1000 mg
Dosage form: comprimido recubierto con película
Route: vía oral
Register: Spain (AEMPS)
Status: Marketed
Status in the register: Autorizado, comercializado
Authorised: 18 Jun 2015
Registration: 1151003014
Marketing authorisation holder: Boehringer Ingelheim International Gmbh
Procedure: EU centralised
Supply: Medicamento Sujeto A Prescripción Médica
EU number: EU/1/15/1003

Empagliflozin + Metformin · 12,50 mg + 1000 mg · comprimido recubierto con película

🇪🇸Spain

AEMPSEmpagliflozina/Metformina Krka 5 MG/1000 MG Comprimidos Recubiertos con Pelicula EfgEmpagliflozin + Metformin · 5 mg + 1000 mg · comprimido recubierto con película🇪🇸Spain

AEMPSSynjardy 12,5 MG/850 MG Comprimidos Recubiertos con PeliculaEmpagliflozin + Metformin · 12,5 mg + 850 mg · comprimido recubierto con película🇪🇸Spain

AEMPSSynjardy 5 MG/850 MG Comprimidos Recubiertos con PeliculaEmpagliflozin + Metformin · 850 mg + 5 mg · comprimido recubierto con película🇪🇸Spain