Human coagulation factor ii 14, human coagulation factor ix 20, human coagulation factor vii 9, human coagulation factor x 18, protien c 13, protien s 12, total protien 31
Sold as Octaplex
Combination product
This product contains more than one active ingredient, so it has no single molecular structure.
Background
Registration
- Applicants
- 1
- Registrations
- 1
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Octapharma South Africa (Pty) Ltd | Octaplex | 500 IU | 520357 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Octaplex 500 IU EACH 1,0 ml SOLUTION CONTAINS: HUMAN COAGULATION FACTOR II 14 – 38 IU HUMAN COAGULATION FACTOR VII 9 – 24 IU HUMAN COAGULATION FACTOR IX 20 – 31 IU HUMAN COAGULATION FACTOR X 18 – 30 IU PROTIEN C 13 – 31 IU PROTIEN S 12 – 32 IU TOTAL PROTIEN 31 – 41 mg | 500 IU | 52035752/30.3/0357 | 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.