Somatropin
Sold as Humatrope, *Norditropin, Norditropin, Nomazac, Omnitrope, Saizen, Genotropin ( )
No structure available
This product's active ingredient could not be matched to a single known compound.
Background
Registration
- Applicants
- 5
- Registrations
- 14
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Eli Lilly (S.A.) (Pty) LtdCancelled | Humatrope | 6 mg, 12 mg | 320673, 330310 | Not determined | None |
| Novo Nordisk (Pty) Ltd û (Rivonia) | *Norditropin, Norditropin | 5 mg, 10 mg, 15 mg | 330420, 330421, 330422 | Not determined | None |
| Sandoz South Africa (Pty) Ltd | Nomazac, Omnitrope | 5 mg/1,5 ml, 10 mg/1,5 ml, 15 mg/1,5 ml | 490732, 490733, 490734, 490735.732, 490736.733, 490737.734 | Not determined | None |
| Merck (Pty) LtdCancelled | Saizen | 5,83 mg/ml, 8 mg/ml | 530523, 530524 | Not determined | None |
| Pfizer Laboratories (Pty) Ltd | Genotropin ( ) | 5,3 mg, 16 I.U | X0214 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Humatrope 6 MG EACH CARTRIDGE CONTAINS SOMATROPIN 6,0 mg | 6 mg | 32067332/21.10/0673 | Cancelled | Not determined | None |
| Humatrope 12 MG EACH CARTRIDGE CONTAINS SOMATROPIN 36,0 iu | 12 mg | 33031033/21.10/0310 | Cancelled | Not determined | None |
| *Norditropin 5 MG EACH 1,5 ml SOLUTION CONTAINS: SOMATROPIN 5,0 mg | 5 mg | 33042033/21.10/0420 | Registered | Not determined | None |
| Norditropin 10 MG EACH 1,5 ml SOLUTION CONTAINS: SOMATROPIN 10,0 mg | 10 mg | 33042133/21.10/0421 | Registered | Not determined | None |
| Norditropin 15 MG EACH 1,5 ml SOLUTION CONTAINS: SOMATROPIN 15,0 mg | 15 mg | 33042233/21.10/0422 | Registered | Not determined | None |
| Nomazac 5 mg/1,5 ML EACH 1,5 ml SOLUTION CONTAINS: SOMATROPIN 5,0 mg | 5 mg/1,5 ml | 49073249/21.10/0732 | Registered | Not determined | None |
| Nomazac 10 mg/1,5 ML EACH 1,5 mL SOLUTION CONTAINS :SOMATROPIN 10,0 mg | 10 mg/1,5 ml | 49073349/21.10/0733 | Registered | Not determined | None |
| Nomazac 15 mg/1,5 ML EACH 1,5 mL SOLUTION CONTAINS :SOMATROPIN 15,0 mg | 15 mg/1,5 ml | 49073449/21.10/0734 | Registered | Not determined | None |
| Omnitrope 5 mg/1,5 ML EACH 1,5 mL SOLUTION CONTAINS :SOMATROPIN 5,0 mg | 5 mg/1,5 ml | 490735.73249/21.10/0735.732 | Registered | Not determined | None |
| Omnitrope 10 mg/1,5 ML EACH 1,5 mL SOLUTION CONTAINS :SOMATROPIN 10,0 mg | 10 mg/1,5 ml | 490736.73349/21.10/0736.733 | Registered | Not determined | None |
| Omnitrope 15 mg/1,5 ML EACH 1,5 mL SOLUTION CONTAINS :SOMATROPIN 15,0 mg | 15 mg/1,5 ml | 490737.73449/21.10/0737.734 | Registered | Not determined | None |
| Saizen 5,83 mg/ml EACH 1,0 ml SOLUTION CONTAINS SOMATROPIN 5,83 mg (Recombinant Human Growth Hormone) | 5,83 mg/ml | 53052353/21.10/0523 | Cancelled | Not determined | None |
| Saizen 8 mg/ml EACH 1,0 ml SOLUTION CONTAINS SOMATROPIN 8,0 mg (Recombinant Human Growth Hormone) | 8 mg/ml | 53052453/21.10/0524 | Cancelled | Not determined | None |
| Genotropin 16 I.U. (5,3 mg) EACH 1 ml SOLUTION CONTAINS SOMATROPIN 16 IU | 16 I.U. 5,3 mg | X0214X/21.10/214 | 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.