Dabigatran etexilate (Pradaxa)
Dabigatran etexilate
Ingelheim Pharmaceuticals (Pty) Ltd û Ferndale
Registration
- Applicant
- Ingelheim Pharmaceuticals (Pty) Ltd û Ferndale
- Registrations
- 3
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 |
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.
No structure available
This product's active ingredient could not be matched to a single known compound.
SAHPRA documents
SAHPRA has not published a professional information or patient information leaflet for this product.