Germany· DE-A57-a6abf207d01a42b7
Dapagliflozin/Metformin 089pharm
A medicinal product containing metformin hydrochloride, dapagliflozin, registered in Germany by 089pharm Gmbh.
Checked against EMA Article 57 (European Union) on
Informational only — not a medical device.
The record
At a glance
EMA Article 57 (European Union)- Active substance
- Metformin Hydrochloride, Dapagliflozin
- Manufacturer
- 089pharm Gmbh
- Country
- Germany (DE)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- EMA Article 57 (European Union)
- Last checked
- September 30, 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
Metformin hydrochloride, dapagliflozin 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
- SpainDAPAGLIFLOZINA/METFORMINA AUROVITAS 5 MG/1 000 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFGAurovitas Spain, S.A.U.
- SwedenDapagliflozin/Metformin ELPEN 5 mg/1000 mg Filmdragerad tablettElpen Pharmaceutical Co. Inc
- United KingdomDapagliflozin 5mg / Metformin 1g tabletsAlliance Healthcare (Distribution) 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.
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
- Denmark · Dapagliflozin/Metformin Hydrochloride Juta, Dapagliflozin/Metformin Krka
- Estonia · Mexdagry
- Spain · Dapagliflozina/Metformina Aurovitas, Dapagliflozina/Metformina Krka
- 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 EMA Article 57 (European Union). 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/2519b9ac-a957-47dc-95a8-6c109f20b4be GET /v1/drugs/2519b9ac-a957-47dc-95a8-6c109f20b4be?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.
{
"pzn": null,
"route": "Oral Use",
"source": "ema_art57_de",
"ma_number": null,
"substance": "Metformin Hydrochloride, Dapagliflozin",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about metformin hydrochloride, dapagliflozin.
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.