In other countries
The same active substances on other registers, the same brand first.
- Apo-DabigatranCanada · 110 MG · Capsule · Apotex INCSame form
- Apo-DabigatranCanada · 150 MG · Capsule · Apotex INCSame form
- Apo-DabigatranCanada · 75 MG · Capsule · Apotex INCSame form
- Dabigatran Etexilato Alter Genericos 110 MG Capsulas Duras EfgSpain · 126,83 mg · cápsula dura · Laboratorios Alter S.A.Same form
- Dabigatran Etexilato Alter Genericos 150 MG Capsulas Duras EfgSpain · 172,95 mg · cápsula dura · Laboratorios Alter S.A.Same form
- Dabigatran Etexilato Cinfa 110 MG Capsulas Duras EfgSpain · 126,84 mg · cápsula dura · Laboratorios Cinfa S.A.Same form
- AndabraItaly · Capsula rigida · Pharmathen S.A.Same form
- AuralganItaly · Capsula rigida · Pharmacare S.R.L.Same form
- Dabigatran Etexilato AbdiItaly · Capsula rigida · Abdi Farma GmbHSame form
- Dabigatran etexilaat Accord 110 mg harde capsulesNetherlands · Capsule, hard · Accord Healthcare S.L.U.Same form
- Dabigatran etexilaat Accord 150 mg harde capsulesNetherlands · Capsule, hard · Accord Healthcare S.L.U.Same form
- Dabigatran etexilaat Accord 75 mg harde capsulesNetherlands · Capsule, hard · Accord Healthcare S.L.U.Same form
- PRADAXA 110mgRomania · 110mg · caps. · Boehringer Ingelheim International GMBHSame form
- PRADAXA 150mgRomania · 150mg · caps. · Boehringer Ingelheim International GMBHSame form
- PRADAXA 75mgRomania · 75mg · caps. · Boehringer Ingelheim International GMBHSame form
- Berevin®Serbia · 150mg · kapsula, tvrda · PredstavniŠTvo Richter Gedeon NyrtSame form
- Berevin®Serbia · 110mg · kapsula, tvrda · PredstavniŠTvo Richter Gedeon NyrtSame form
- Berevin®Serbia · 150mg · kapsula, tvrda · PredstavniŠTvo Richter Gedeon NyrtSame form
- Pradaxa 110MG CapsulesSaudi Arabia · Boehringer IngelheimSame form
- Pradaxa 150MG CapsulesSaudi Arabia · Boehringer IngelheimSame form
- Pradaxa 75MG CapsulesSaudi Arabia · Boehringer IngelheimSame form
- LEAXOLAR CAPSULES 110 mgSingapore · 110 mg · capsule · Lotus International Pte. LTD.Same form
- LEAXOLAR CAPSULES 150 mgSingapore · 150 mg · capsule · Lotus International Pte. LTD.Same form
- LEAXOLAR CAPSULES 75 mgSingapore · 75 mg · capsule · Lotus International Pte. LTD.Same form
- Dabigatran Etexilate MesylateUnited States · 110MG BASE, 150MG BASE, 75MG BASE · capsule · ApotexSame form
- PradaxaUnited States · 110MG BASE, 150MG BASE, 75MG BASE · capsule · Boehringer IngelheimSame form
- DabgamBrazil · Cosmed Industria de Cosmeticos e Medicamentos S.A.Same substance
- etexilato de dabigatranaBrazil · Brainfarma Indústria Química e Farmacêutica S.ASame substance
- PradaxaBrazil · Boehringer Ingelheim do Brasil Química e Farmacêutica Ltda.Same substance
- Dabigatran Etexilate AccordEuropean Union · Accord Healthcare S.L.U.Same substance
- Dabigatran etexilate Teva (previously Dabigatran etexilate Leon Farma)European Union · Teva GmbHSame substance
- PradaxaEuropean Union · Boehringer Ingelheim International GmbHSame substance
- PradaxaUnited States · 110MG BASE/PACKET, 150MG BASE/PACKET, 20MG BASE/PACKET … · pellets · Boehringer IngelheimSame substance
Packs
| Pack | Code | Status |
|---|---|---|
| 60 kapsula u bočici, u kutiji | HR-H-484695518-01 | |
| 10 kapsula u blisteru, u kutiji | HR-H-484695518-02 | |
| 30 kapsula u blisteru, u kutiji | HR-H-484695518-03 | |
| 60 kapsula u blisteru, u kutiji | HR-H-484695518-04 | stavljeno u promet |
| 100 kapsula (2 pakiranja sa 50 kapsula u blisteru), u kutiji | HR-H-484695518-05 | |
| 180 kapsula (3 pakiranja sa po 60 kapsula u blisteru), u kutiji | HR-H-484695518-06 |
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
- Dabigatran etexilate
- Dosage form
- Kapsula, tvrda
- Register
- Croatia (HALMED)
- Status
- Marketed
- Status in the register
- stavljeno u promet; nema nestašice
- Authorised
- 23 Nov 2022
- Registration
- HR-H-484695518
- Marketing authorisation holder
- Genericon Pharma Gesellschaft m.b.H., Hafnerstraße 211, Graz, Austrija
- Manufacturer
- Towa Pharmaceutical Europe S.L., Barcelona, Španjolska Pharmadox Healthcare Limited, Paola PLA, Malta
- ATC code
- B01AE07
- Procedure
- National, MRP or DCP
- Supply
- na recept; u ljekarni