Drospirenone, ethinyl estradiol
Sold as Ocaz, Leyla, Drosmyl, Spirenyl, Drostra
Combination product
This product contains more than one active ingredient, so it has no single molecular structure.
Background
Registration
- Applicants
- 4
- Registrations
- 5
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Unicorn Pharmaceuticals (Pty) Ltd | Ocaz | Not stated | 470159 | Not determined | None |
| Austell Pharmaceuticals (Pty) Ltd | Leyla | Not stated | 470333 | Not determined | None |
| Viatris South Africa (Pty) Ltd | Drosmyl | Not stated | 481253 | Not determined | None |
| Activo Health (Pty) Ltd | Spirenyl, Drostra | Not stated | 501175, 510234 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Ocaz Each active tablet contains DROSPIRENONE 3,0 mg ETHINYL ESTRADIOL 0,03 mg | Not listed | 47015947/18.8/0159 | Registered | Not determined | None |
| Leyla Each active tablet contains DROSPIRENONE 3,0 mg and ETHINYL ESTRADIOL 0,02 mg | Not listed | 47033347/21.8.2/0333 | Registered | Not determined | None |
| Drosmyl Each active tablet contains DROSPIRENONE 3,0 mg ETHINYL ESTRADIOL 0,03 mg | Not listed | 48125348/18.8/1253 | Registered | Not determined | None |
| Spirenyl Each active tablet contains DROSPIRENONE 3,0 mg and ETHINYL ESTRADIOL 0,02 mg | Not listed | 50117550/21.8.2/1175 | Registered | Not determined | None |
| Drostra Each active tablet contains DROSPIRENONE 3,0 mg and ETHINYL ESTRADIOL 0,03 mg | Not listed | 51023451/18.8/0234 | 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.