Spain· ES:91354
EMPAGLIFLOZINA/METFORMINA KRKA 5 MG/1000 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
A medicinal product containing empagliflozina + metformina, registered in Spain by Krka D.D. Novo Mesto.
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- empagliflozina + metformina
- Manufacturer
- Krka D.D. Novo Mesto
- Country
- Spain (ES)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- AEMPS CIMA (Spain)
- Last checked
- June 22, 2026
Packs & prices · 0
No packs listed by the register for this record.
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Empagliflozina + metformina in 13 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaMEMPOGLYNKrka, d.d., Novo mesto, Novo mesto
- IcelandApprefAdalvo Limited
- United StatesSynjardyBoehringer Ingelheim Pharmaceuticals, Inc.
- SwitzerlandJardiance Met
- NetherlandsAppref 12,5 mg/1000 mg filmomhulde tablettenMeren Pharma B.V.
- IrelandEmpagliflozin/Metformin Krka 12.5 mg/1000 mg film-coated tabletsKRKA, d.d., Novo mesto
- FinlandSynjardyParanova Oy
- CanadaSYNJARDYBOEHRINGER INGELHEIM (CANADA) LTD LTEE
Authorised across Europe · EMA
The same active substance is authorised in 22 EEA countries. Names it is sold under:
- Austria · Empagliflozin/Metformin Hcs
- Belgium · Empagliflozine/Metformine Hcl Hcs
- Bulgaria · Empafel Met 5 Mg/850 Mg, Емпафел Мет
- Cyprus · Empagliflozin/Metformin Tad
- Czechia · Mempoglyn
- Denmark · Empagliflozin/Metformin Krka
- Estonia · Mempoglyn
- Greece · Mempoglyn
- Croatia · Mempoglyn
- Hungary · Mempoglyn
- Ireland · Empagliflozin/Metformin Krka
- Iceland · Appref, Empagliflozin-Metformin Adalvo
- Liechtenstein · Synjardy
- Lithuania · Mempoglyn
- Luxembourg · Empagliflozin/Metformin Hcl Ab
- Latvia · Mempoglyn
- Malta · Appref, Empagliflozin-Metformin Adalvo
- Netherlands · Appref, Empagliflozine/Metformine Hcl Hcs
- Norway · Empagliflozin/Metformin Krka, Synjardy
- Portugal · Empagliflozina + Metformina Aurobindo, Empagliflozina + Metformina Generis
- Romania · Mempoglyn
- Slovenia · Emameten, Empagliflozin/Metformin Krka
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of AEMPS CIMA (Spain). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/26752fff-5277-4426-a0e7-0cb2457f1cbb GET /v1/drugs/26752fff-5277-4426-a0e7-0cb2457f1cbb?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"cpresc": "Medicamento Sujeto A Prescripción Médica",
"estado": "{\"aut\":1781691741000}",
"nregistro": "91354",
"substance": "empagliflozina + metformina"
}See everything about empagliflozina + metformina.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.