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
- Dabigatraneteksilat Genericon 110 mg tvrde kapsuleCroatia · Kapsula, tvrda · Genericon Pharma Gesellschaft m.b.H., Hafnerstraße 211, Graz, AustrijaSame form
- Dabigatraneteksilat Genericon 150 mg tvrde kapsuleCroatia · Kapsula, tvrda · Genericon Pharma Gesellschaft m.b.H., Hafnerstraße 211, Graz, AustrijaSame form
- Dabigatraneteksilat STADA 110 mg tvrde kapsuleCroatia · Kapsula, tvrda · Stada d.o.o., Hercegovačka 14, Zagreb, HrvatskaSame 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 · 110mg · 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 |
|---|---|---|
| 75 mg - Capsula rigida - Uso orale - blister (OPA/Alu/essiccante PEPET/Alu/PE) - 10 capsule | 050696018 | Autorizzata |
| 75 mg - Capsula rigida - Uso orale - blister (OPA/Alu/essiccante PEPET/Alu/PE) - 30 capsule | 050696020 | Autorizzata |
| 75 mg - Capsula rigida - Uso orale - blister (OPA/Alu/essiccante PEPET/Alu/PE) - 60 capsule | 050696032 | Autorizzata |
| 75 mg - Capsula rigida - Uso orale - blister (OPA/Alu/essiccante PEPET/Alu/PE) - 10 x 1 capsule (dose unitaria) | 050696044 | Autorizzata |
| 75 mg - Capsula rigida - Uso orale - blister (OPA/Alu/essiccante PEPET/Alu/PE) - 30 x 1 capsule (dose unitaria) | 050696057 | Autorizzata |
| 75 mg - Capsula rigida - Uso orale - blister (OPA/Alu/essiccante PEPET/Alu/PE) - 60 x 1 capsule (dose unitaria) | 050696069 | Autorizzata |
| 110 mg - Capsula rigida - Uso orale - blister (OPA/Alu/essiccante PEPET/Alu/PE) - 10 capsule | 050696071 | Autorizzata |
| 110 mg - Capsula rigida - Uso orale - blister (OPA/Alu/essiccante PEPET/Alu/PE) - 30 capsule | 050696083 | Autorizzata |
| 110 mg - Capsula rigida - Uso orale - blister (OPA/Alu/essiccante PEPET/Alu/PE) - 60 capsule | 050696095 | Autorizzata |
| 110 mg - Capsula rigida - Uso orale - blister (OPA/Alu/essiccante PEPET/Alu/PE) - 100 capsule | 050696107 | Autorizzata |
| 110 mg - Capsula rigida - Uso orale - blister (OPA/Alu/essiccante PEPET/Alu/PE) - 180 capsule | 050696119 | Autorizzata |
| 110 mg - Capsula rigida - Uso orale - blister (OPA/Alu/essiccante PEPET/Alu/PE) - 10 x 1 capsule (dose unitaria) | 050696121 | Autorizzata |
| 110 mg - Capsula rigida - Uso orale - blister (OPA/Alu/essiccante PEPET/Alu/PE) - 30 x 1 capsule (dose unitaria) | 050696133 | Autorizzata |
| 110 mg - Capsula rigida - Uso orale - blister (OPA/Alu/essiccante PEPET/Alu/PE) - 60 x 1 capsule (dose unitaria) | 050696145 | Autorizzata |
| 110 mg - Capsula rigida - Uso orale - blister (OPA/Alu/essiccante PEPET/Alu/PE) - 100 x 1 capsule (dose unitaria) | 050696158 | Autorizzata |
| 110 mg - Capsula rigida - Uso orale - blister (OPA/Alu/essiccante PEPET/Alu/PE) - 180 x 1 capsule (dose unitaria) | 050696160 | Autorizzata |
| 150 mg - Capsula rigida - Uso orale - blister (OPA/Alu/essiccante PEPET/Alu/PE) - 10 capsule | 050696172 | Autorizzata |
| 150 mg - Capsula rigida - Uso orale - blister (OPA/Alu/essiccante PEPET/Alu/PE) - 30 capsule | 050696184 | Autorizzata |
| 150 mg - Capsula rigida - Uso orale - blister (OPA/Alu/essiccante PEPET/Alu/PE) - 60 capsule | 050696196 | Autorizzata |
| 150 mg - Capsula rigida - Uso orale - blister (OPA/Alu/essiccante PEPET/Alu/PE) - 180 capsule | 050696208 | Autorizzata |
| 150 mg - Capsula rigida - Uso orale - blister (OPA/Alu/essiccante PEPET/Alu/PE) - 10 x 1 capsule (dose unitaria) | 050696210 | Autorizzata |
| 150 mg - Capsula rigida - Uso orale - blister (OPA/Alu/essiccante PEPET/Alu/PE) - 30 x 1 capsule (dose unitaria) | 050696222 | Autorizzata |
| 150 mg - Capsula rigida - Uso orale - blister (OPA/Alu/essiccante PEPET/Alu/PE) - 60 x 1 capsule (dose unitaria) | 050696234 | Autorizzata |
| 150 mg - Capsula rigida - Uso orale - blister (OPA/Alu/essiccante PEPET/Alu/PE) - 180 x 1 capsule (dose unitaria) | 050696246 | Autorizzata |
| 75 mg - Capsula rigida - Uso orale - flacone (PP) - 60 capsule | 050696259 | Autorizzata |
| 110 mg - Capsula rigida - Uso orale - flacone (PP) - 60 capsule | 050696261 | Autorizzata |
| 150 mg - Capsula rigida - Uso orale - flacone (PP) - 60 capsule | 050696273 | Autorizzata |
Documents
The official texts, at the regulator.
Sources and licences
Compiled by Prognia from the public register below; the register’s text is the official one.
Agenzia Italiana del Farmaco (AIFA), Italy
Agenzia Italiana del Farmaco (AIFA); https://drive.aifa.gov.it/farmaci/confezioni_fornitura.csv; HTTP Last-Modified Mon, 12 Oct 2026 23:02:44 GMT; acquired 2026-10-13T17:21:16.224007+00:00; native fields retained, source identifier and role projections are adaptations.
Licence: CC BY 4.0; AIFA published open-data catalog · Added 13 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
- Capsula rigida
- Register
- Italy (AIFA)
- Status
- Authorised
- Status in the register
- Autorizzata
- Registration
- AIC 050696
- Marketing authorisation holder
- Accord Healthcare, S.L.U.
- ATC code
- B01AE07
- Procedure
- Procedura Centralizzata
- Supply
- Medicinali soggetti a prescrizione medica limitativa, vendibili al pubblico su prescrizione di centri ospedalieri o di specialisti