Spain· ES:90578
DAPAGLIFLOZINA/METFORMINA KRKA 5 MG/850 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
A medicinal product containing dapagliflozina + 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
- dapagliflozina + 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 3, 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
Dapagliflozina + metformina in 12 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United Statesdapagliflozin and metformin hydrochlorideAscend Laboratories, LLC
- CzechiaDAPAGLIFLOZIN/METFORMIN POLPHARMAZaklady Farmaceutyczne Polpharma SA, Starogard Gdański
- SwedenDapagliflozin/Metformin ELPEN 5 mg/1000 mg Filmdragerad tablettElpen Pharmaceutical Co. Inc
- United KingdomDapagliflozin 5mg / Metformin 1g tabletsCelix Pharma Ltd
- SwitzerlandXigduo XR 10 mg / 1000 mg, FilmtablettenAstraZeneca AG
- PolandDiaflix ComboZakłady Farmaceutyczne POLPHARMA S.A.
- NetherlandsDapaglozamet 5 mg/1000 mg, filmomhulde tablettenMaddox Pharma Swiss B.V.
- CanadaAPO-DAPAGLIFLOZIN-METFORMINAPOTEX INC
Authorised across Europe · EMA
The same active substance is authorised in 27 EEA countries. Names it is sold under:
- Austria · Dapagliflozin/Metformin Hcs, Dapagliflozin/Metformin Reddy
- Bulgaria · Dapagliflozin/Metformin Tchaikapharma, Дапаглифлозин/Метформин Полфарма
- Cyprus · Mexdagry
- Czechia · Dapagliflozin/Metformin Polpharma, Mexdagry
- Germany · Dapagliflozin/Metformin 089pharm, Dapagliflozin/Metformin 123 Acurae Pharma
- Denmark · Dapagliflozin/Metformin Hydrochloride Juta, Dapagliflozin/Metformin Krka
- Estonia · Mexdagry
- Finland · Dapagliflozin/Metformin Krka
- France · Dapagliflozine/Chlorhydrate De Metformine Arrow, Dapagliflozine/Chlorhydrate De Metformine Krka
- United Kingdom (Northern Ireland) · Dapagliflozin And Metformin Hydrochloride Milpharm, Dapagliflozin/Metformin Hydrochloride Torrent
- Greece · Dapimefa, Mexdagry
- Croatia · Dapagliflozin/Metforminklorid Krka, Dapagliflozin/Metforminklorid Krka D.D.
- Hungary · Dapagliflozin/Metformin Pharmapath, Dapagliflozin/Metformin Polpharma
- Ireland · Dapagliflozin/Metformin Krka
- Iceland · Ebymect, Xigduo
- Italy · Dapagliflozin E Metformina Aurobindo
- Liechtenstein · Ebymect, Xigduo
- Lithuania · Dapagliflozin/Metformin Polpharma, Mexdagry
- Latvia · Dapagliflozin/Metformin Polpharma, Mexdagry
- Malta · Dapagliflozin/Metformin Hydrochloride Aurobindo, Dapagliflozin/Metformin Hydrochloride Aurobindo Pharma
- Netherlands · Dapaglozamet
- Norway · Dapagliflozin/Metformin Krka, Ebymect
- Poland · Diaflix Combo, Mexdagry
- Portugal · Dapagliflozina + Metformina Farmoz, Dapagliflozina + Metformina Krka
- Romania · Mexdagry
- Sweden · Dapagliflozin/Metformin Elpen, Dapagliflozin/Metformin Krka
- Slovenia · Mexdagry
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/f01186bc-05b3-40b6-b630-47c058dc5b2f GET /v1/drugs/f01186bc-05b3-40b6-b630-47c058dc5b2f?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\":1758795961000}",
"nregistro": "90578",
"substance": "dapagliflozina + metformina"
}See everything about dapagliflozina + 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.