Pradaxa
3-[[2-[(4-Carbamimidoylanilino)methyl]-1-methylbenzimidazole-5-carbonyl]-pyridin-2-ylamino]propanoic acid
Drag to rotate; arrow keys step through the atoms. Structure from PubChem CID 216210.
Registration
- Applicants
- 1
- Registrations
- 3
Applicants and registrations
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 | PIPIL |
| 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 | PIPIL |
| 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 | PIPIL |
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.
Background
SAHPRA documents
These documents come from SAHPRA's PI-PIL repository unless the line under a document says otherwise. Always consult with a healthcare professional for medical advice.