Dabigatran etexilate
Sold as Pradaxa, Dabiklot, Darbaga, Dabitrin, Anodabi, Dabigatran DRL
3-[[2-[(4-Carbamimidoylanilino)methyl]-1-methylbenzimidazole-5-carbonyl]-pyridin-2-ylamino]propanoic acid
Drag to rotate. Structure from PubChem CID 216210.
Background
Registration
- Applicants
- 4
- Registrations
- 18
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Ingelheim Pharmaceuticals (Pty) Ltd û Ferndale | Pradaxa | 75 mg, 110 mg, 150 mg | 420130, 420131, 450162 | Not determined | None |
| Pharma Dynamics (Pty) Ltd | Dabiklot | 75 mg, 110 mg, 150 mg | 550325, 550326, 550327 | Not determined | None |
| Hetero Drugs South Africa (Pty) Ltd | Darbaga, Dabitrin, Anodabi | 75 mg, 110 mg, 150 mg | 560686, 560687, 560688, 560689.686, 560690.687, 560691.688, 560692.686, 560693.687, 560694.688 | Not determined | None |
| Dr Reddyæs Laboratories (Pty) Ltd | Dabigatran DRL | 75, 110, 150 | 560695, 560696, 560697 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Pradaxa 75 MG EACH CAPSULE CONTAINS DABIGATRAN ETEXILATE MESILATE EQUIVALENT TO DABIGATRAN ETEXILATE 75,0 mg | 75 mg | 42013042/8.2/0130 | Registered | Not determined | None |
| Pradaxa 110 MG EACH CAPSULE CONTAINS DABIGATRAN ETEXILATE MESILATE EQUIVALENT TO DABIGATRAN ETEXILATE 110,0 mg | 110 mg | 42013142/8.2/0131 | Registered | Not determined | None |
| Pradaxa 150 MG EACH CAPSULE CONTAINS DABIGATRAN ETEXILATE MESILATE EQUIVALENT TO DABIGATRAN ETEXILATE 150,0 mg | 150 mg | 45016245/8.2/0162 | Registered | Not determined | None |
| Dabiklot 75 MG EACH CAPSULE CONTAINS DABIGATRAN ETEXILATE MESYLATE 75,0 mg | 75 mg | 55032555/8.2/0325 | Registered | Not determined | None |
| Dabiklot 110 MG EACH CAPSULE CONTAINS DABIGATRAN ETEXILATE MESYLATE 110,0 mg | 110 mg | 55032655/8.2/0326 | Registered | Not determined | None |
| Dabiklot 150 MG EACH CAPSULE CONTAINS DABIGATRAN ETEXILATE MESYLATE 150,0 mg | 150 mg | 55032755/8.2/0327 | Registered | Not determined | None |
| Darbaga 75 MG EACH CAPSULE CONTAINS DABIGATRAN ETEXILATE MESILYTE EQUIVALENT TO DABIGATRAN ETEXILATE 75,0 mg | 75 mg | 56068656/8.2/0686 | Registered | Not determined | None |
| Darbaga 110 MG EACH CAPSULE CONTAINS DABIGATRAN ETEXILATE MESYLATE EQUIVALENT TO DABIGATRAN ETEXILATE 110,0 mg | 110 mg | 56068756/8.2/0687 | Registered | Not determined | None |
| Darbaga 150 MG EACH CAPSULE CONTAINS DABIGATRAN ETEXILATE MESYLATE EQUIVALENT TO DABIGATRAN ETEXILATE 150,0 mg | 150 mg | 56068856/8.2/0688 | Registered | Not determined | None |
| Dabitrin 75 MG EACH CAPSULE CONTAINS DABIGATRAN ETEXILATE MESYLATE EQUIVALENT TO DABIGATRAN ETEXILATE 75,0 mg | 75 mg | 560689.68656/8.2/0689.686 | Registered | Not determined | None |
| Dabitrin 110 MG EACH CAPSULE CONTAINS DABIGATRAN ETEXILATE MESYLATE EQUIVALENT TO DABIGATRAN ETEXILATE 110,0 mg | 110 mg | 560690.68756/8.2/0690.687 | Registered | Not determined | None |
| Dabitrin 150 MG EACH CAPSULE CONTAINS DABIGATRAN ETEXILATE MESYLATE EQUIVALENT TO DABIGATRAN ETEXILATE 150,0 mg | 150 mg | 560691.68856/8.2/0691.688 | Registered | Not determined | None |
| Anodabi 75 MG EACH CAPSULE CONTAINS DABIGATRAN ETEXILATE MESYLATE EQUIVALENT TO DABIGATRAN ETEXILATE 75,0 mg | 75 mg | 560692.68656/8.2/0692.686 | Registered | Not determined | None |
| Anodabi 110 MG EACH CAPSULE CONTAINS DABIGATRAN ETEXILATE MESYLATE EQUIVALENT TO DABIGATRAN ETEXILATE 110,0 mg | 110 mg | 560693.68756/8.2/0693.687 | Registered | Not determined | None |
| Anodabi 150 MG EACH CAPSULE CONTAINS DABIGATRAN ETEXILATE MESYLATE EQUIVALENT TO DABIGATRAN ETEXILATE 150,0 mg | 150 mg | 560694.68856/8.2/0694.688 | Registered | Not determined | None |
| Dabigatran 75 DRL EACH CAPSULE CONTAINS DABIGATRAN ETEXILATE MESILATE EQUIVALENT TO DABIGATRAN ETEXILATE 75,0 mg | 75 | 56069556/8.2/0695 | Registered | Not determined | None |
| Dabigatran 110 DRL EACH CAPSULE CONTAINS DABIGATRAN ETEXILATE MESILATE EQUIVALENT TO DABIGATRAN ETEXILATE 110,0 mg | 110 | 56069656/8.2/0696 | Registered | Not determined | None |
| Dabigatran 150 DRL EACH CAPSULE CONTAINS DABIGATRAN ETEXILATE MESYLATE 150,0 mg | 150 | 56069756/8.2/0697 | Registered | Not determined | None |
Regulatory status
This product is still scheduled by law even when this site could not determine which tier it falls under. The label carries the S number in a square border; ask a pharmacist if you need to know its schedule.
This is an informational summary of the Medicines and Related Substances Act 101 of 1965 and its 2017 General Regulations. It is not medical advice and not legal advice. Always check the medicine's label, which carries the schedule number inside a square border, or ask a pharmacist if you are unsure.
SAHPRA documents
SAHPRA has not published a professional information or patient information leaflet for this product.