In other countries
The same active substances on other registers, the same brand first.
- Daforbis 10 MG Comprimidos Recubiertos con Pelicula EfgSpain · 10 mg · comprimido recubierto con película · Viatris LimitedSame brand
- Daforbis 5 MG Comprimidos Recubiertos con Pelicula EfgSpain · 5 mg · comprimido recubierto con película · Viatris LimitedSame brand
- Accel-DapagliflozinCanada · 5 MG · Tablet · Accel Pharma INCSame form
- Accel-DapagliflozinCanada · 10 MG · Tablet · Accel Pharma INCSame form
- AG-DapagliflozinCanada · 10 MG · Tablet · Angita Pharma INC.Same form
- Edistride 10 MG Comprimidos Recubiertos con PeliculaSpain · 10 mg · comprimido recubierto con película · Astrazeneca AbSame form
- Dapagliflozin AurobindoItaly · Compressa rivestita con film · Aurobindo Pharma (Italia) S.R.L.Same form
- Dapagliflozin DocItaly · Compressa rivestita con film · Doc Generici SRLSame form
- Dapagliflozin DR. Reddy?SItaly · Compressa rivestita con film · DR. Reddy'S S.R.L.Same form
- Dapagliflozine Accord 10 mg filmomhulde tablettenNetherlands · Filmomhulde tablet · Accord Healthcare B.V.Same form
- Dapagliflozine Accord 5 mg filmomhulde tablettenNetherlands · Filmomhulde tablet · Accord Healthcare B.V.Same form
- Dapagliflozine Alembic 10 mg, filmomhulde tablettenNetherlands · Filmomhulde tablet · Alembic Pharmaceuticals Europe LimitedSame form
- Dagrafors®Serbia · 5mg · film tableta · Krka-Farma D.O.O. BeogradSame form
- Dagrafors®Serbia · 10mg · film tableta · Krka-Farma D.O.O. BeogradSame form
- DapiraSerbia · 5mg · film tableta · Galenika Ad BeogradSame form
- DIVINUS 10 mg film-coated tabletSaudi Arabia · Jazeera Pharmaceutical Industries (JPI)Same form
- DIVINUS 5 mg film-coated tabletSaudi Arabia · Jazeera Pharmaceutical Industries (JPI)Same form
- FORXIGA 10 mg film-coated tabletSaudi Arabia · AstraZeneca Pharmaceuticals LPSame form
- Dafasglit 10 Film-Coated Tablets 10MGSingapore · 10.000 mg · tablet, film coated · Apotheca Marketing Pte LTDSame form
- Dapagliflozin Sandoz Film Coated Tablet 10MGSingapore · 10.000mg · tablet, film coated · Sandoz Singapore Pte. LTD.Same form
- Dapavid Film-Coated Tablets 10mgSingapore · 10.000 mg · tablet, film coated · Hovid Pte. LTD.Same form
- DapagliflozinUnited States · 10MG, 5MG · tablet · Jiangsu Hansoh PharmSame form
- FarxigaUnited States · 10MG, 5MG · tablet · Astrazeneca ABSame form
- DapagliflozinUnited States · 10MG, 5MG · tablet · Centaur Pharmaceuticals Private LimitedSame form
- dapagliflozinaBrazil · Geolab Indústria Farmacêutica S/ASame substance
- dapagliflozinaBrazil · Germed Farmaceutica LtdaSame substance
- dapagliflozinaBrazil · Legrand Pharma Indústria Farmacêutica LtdaSame substance
- Dapagliflozin ViatrisEuropean Union · Viatris LimitedSame substance
- EdistrideEuropean Union · AstraZeneca ABSame substance
- ForxigaEuropean Union · AstraZeneca ABSame substance
Packs
| Pack | Code | Status |
|---|---|---|
| 14 tableta u blisteru, u kutiji | HR-H-544705771-01 | nije stavljeno u promet |
| 28 tableta u blisteru, u kutiji | HR-H-544705771-02 | |
| 30 tableta u blisteru, u kutiji | HR-H-544705771-03 | |
| 98 tableta u blisteru, u kutiji | HR-H-544705771-04 | |
| 14 tableta u blisteru s jediničnom dozom, u kutiji | HR-H-544705771-05 | |
| 28 tableta u blisteru s jediničnom dozom, u kutiji | HR-H-544705771-06 | nije stavljeno u promet |
| 30 tableta u blisteru s jediničnom dozom, u kutiji | HR-H-544705771-07 | nije stavljeno u promet |
| 98 tableta u blisteru s jediničnom dozom, u kutiji | HR-H-544705771-08 | nije stavljeno u promet |
| 30 tableta u bočici, u kutiji | HR-H-544705771-09 | |
| 90 tableta u bočici, u kutiji | HR-H-544705771-10 | nije stavljeno u promet |
Sources and licences
Compiled by Prognia from the public register below; the register’s text is the official one.
HALMED — Agencija za lijekove i medicinske proizvode RH
HALMED, Baza lijekova, source export 08.10.2026., acquired 2026-10-08; factual structured adaptation; Otvorena dozvola RH, NN 67/2017.
Licence: Otvorena dozvola RH NN 67/2017 · Added 8 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
- Dapagliflozin
- Dosage form
- Filmom obložena tableta
- Register
- Croatia (HALMED)
- Status
- Not marketed
- Status in the register
- nije stavljeno u promet
- Authorised
- 15 Nov 2023
- Registration
- HR-H-544705771
- Marketing authorisation holder
- Viatris Limited, Damastown Industrial Park, Mulhuddart, Dublin, Irska
- Manufacturer
- Mylan Hungary Kft, Komárom, Mađarska<br/>Mylan Germany GmbH , Bad Homburg, Hesse, Njemačka
- ATC code
- A10BK01
- Procedure
- National, MRP or DCP
- Supply
- na recept; u ljekarni