Drospirenone, ethinylestradiol
Sold as Yasmin, Yaz, Ruby, Jarina, Ynez, Cloelle, Eloine, Maya, Yade, Drasira, Drospirenone/ethinylestradiol adco, Ethodros, Nezdropaz, Uvisma forte, Uvisma, Debigen, Ginorelle, Contrez, Contrezin, Rubaz, Esdopil
Combination product
This product contains more than one active ingredient, so it has no single molecular structure.
Background
Registration
- Applicants
- 9
- Registrations
- 21
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Bayer (Pty) Ltd û IsandoCertificate held by Bayer (Pty) Ltd, Bayer | Yasmin, Yaz, Jarina, Eloine | 3mg, 3 mg/0,03 mg, 3 mg | 340494, 410842, 430782, 440957 | S4S3 to S4 by pack | PIPIL |
| Pharma Dynamics (Pty) Ltd | Ruby, Rubaz | 3 mg/0,03 mg, 3 mg / 0,02 mg | 430648, 50342 | S4S3 to S4 by pack | PIPIL |
| Adcock ingram limited3 of 5 cancelled | Ynez, Cloelle, Drospirenone/ethinylestradiol adco, Ethodros, Nezdropaz | 3/0,02 MG | 440397, 440398, 470702, 470704, 470705 | Not determined | None |
| Teva Pharmaceuticals (Pty) LtdCancelled | Maya, Yade | Not stated | 470024, 470025 | Not determined | None |
| Cipla Medpro (Pty) Ltd | Drasira, Ginorelle | Not stated | 470141, 500343 | Not determined | None |
| Ranbaxy (SA) (Pty) LtdCancelled | Uvisma forte, Uvisma | Not stated | 481025, 481026 | Not determined | None |
| Viatris South Africa (Pty) Ltd | Debigen | Not stated | 481252 | Not determined | None |
| Innovata pharmaceuticalsCertificate held by Innovata Pharmaceuticals (Pty) Ltd | Contrez, Contrezin | 0,02 mg, 3,0 mg, 0,03 mg, 3,0 mg | 500517, 500590 | Not determined | PIPIL |
| Austell Pharmaceuticals (Pty) Ltd | Esdopil | 0,03 mg 3/0, | 550861 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Yasmin EACH TABLET CONTAINS DROSPIRENONE 3,0 mg ETHINYLESTRADIOL 0,03 mg | 3mgTablet | 34049434/18.8/0494Approved 11 July 2024 | Registered | S3 | PIPIL |
| Yaz EACH PACK CONTAINS DROSPIRENONE 3,0 mg ETHINYLESTRADIOL 0,02 mg | 3mgTablet | 41084241/21.8.2/0842Approved 11 October 2013 | Registered | S4 | PIPIL |
| Ruby EACH TABLET CONTAINS DROSPIRENONE 3.0 mg ETHINYLESTRADIOL 0,03 mg | 3 mg/0,03 mgFilm-coated tablets | 43064843/18.8/0648Approved 18 October 2024 | Registered | S3 | PIPIL |
| Jarina EACH TABLET CONTAINS DROSPIRENONE 3,0 mg ETHINYLESTRADIOL 0,03 mg | 3 mg/0,03 mgFilm-coated tablets. | 43078243/18.8/0782Approved 11 July 2024 | Registered | S3 | PIPIL |
| Ynez EACH TABLET CONTAINS DROSPIRENONE 3,0 mg ETHINYLESTRADIOL 0,03 mg | Not listed | 44039744/18.8/0397 | Registered | Not determined | None |
| Cloelle EACH TABLET CONTAINS DROSPIRENONE 3,0 mgETHINYLESTRADIOL 0,03 mg | Not listed | 44039844/18.8/0398 | Cancelled | Not determined | None |
| Eloine EACH TABLET CONTAINS DROSPIRENONE 3,0 mg ETHINYLESTRADIOL 0,02 mg | 3 mgFilm-coated tablets | 44095744/21.8.2/0957Approved 10 October 2023 | Registered | S4 | PIPIL |
| Maya EACH TABLET CONTAINS : DROSPIRENONE 3,0 mg ETHINYLESTRADIOL 0,03 mg | Not listed | 47002447/21.8.2/0024 | Cancelled | Not determined | None |
| Yade EACH TABLET CONTAINS : DROSPIRENONE 3,0 mg ETHINYLESTRADIOL 0,02 mg | Not listed | 47002547/21.8.2/0025 | Cancelled | Not determined | None |
| Drasira Each tablet contains DROSPIRENONE 3,0 mg and ETHINYLESTRADIOL 0,02 mg | Not listed | 47014147/21.8.2/0141 | Registered | Not determined | None |
| Drospirenone/ethinylestradiol 3/0,02 MG adco Each active tablet contains DROSPIRENONE 3,0 mg AND ETHINYLESTRADIOL 0,02 mg | 3/0,02 MG | 47070247/21.8.2/0702 | Cancelled | Not determined | None |
| Ethodros Each active tablet contains DROSPIRENONE 3,0 mg AND ETHINYLESTRADIOL 0,02 mg | Not listed | 47070447/21.8.2/0704 | Registered | Not determined | None |
| Nezdropaz Each active tablet contains DROSPIRENONE 3,0 mg AND ETHINYLESTRADIOL 0,02 mg | Not listed | 47070547/21.8.2/0705 | Cancelled | Not determined | None |
| Uvisma forte Each active tablet contains DROSPIRENONE 3,0 mg and ETHINYLESTRADIOL 0,03 mg | Not listed | 48102548/18.8/1025 | Cancelled | Not determined | None |
| Uvisma Each active tablet contains DROSPIRENONE 3,0 mg and ETHINYLESTRADIOL 0,02 mg | Not listed | 48102648/21.8.2/1026 | Cancelled | Not determined | None |
| Debigen Each active tablet contains DROSPIRENONE 3,0 mg ETHINYLESTRADIOL 0,02 mg | Not listed | 48125248/21.18.2/1252 | Registered | Not determined | None |
| Ginorelle Each active tablet contains DROSPIRENONE 3,0 mg and ETHINYLESTRADIOL 0,03 mg | Not listed | 50034350/18.8/0343 | Registered | Not determined | None |
| Contrez EACH TABLET CONTAINS ETHINYLESTRADIOL 0.02 mg and DROSPIRENONE 3,0 mg | 0,02 mg, 3,0 mgTablet | 50051750/21.8.2/0517Approved 25 October 2022 | Registered | Not determined | PIPIL |
| Contrezin ETHINYLESTRADIOL & DROSPIRENONE | 0,03 mg, 3,0 mgTablet | 50059050/21.8.2/0590Approved 2 September 2025 | Registered | Not determined | PIPIL |
| Rubaz Each active tablet contains DROSPIRENONE 3,00 mg ETHINYLESTRADIOL 0,02 mg | 3 mg / 0,02 mgFilm-coated tablets | 5034250/21.8.2/0342Approved 21 January 2025 | Registered | S4 | PIPIL |
| Esdopil 3/0,0,03 MG EACH TABLET CONTAINS DROSPIRENONE 3,0 mg ETHINYLESTRADIOL 0,03 mg | 0,03 mg 3/0, | 55086155/18.8/0861 | Registered | Not determined | None |
Regulatory status
Where S4 sits on the scale
Prescription-only medicine.
Schedule 4 covers most ordinary prescription medicines. You need a prescription from an authorised prescriber, such as a doctor or dentist, and a pharmacist dispenses it. Its price, name, pack size and strength can still be told to the public, as long as nothing links it to what it treats.
Schedule S4, read from the product's PI-PIL leaflet.
Who may supply: A pharmacist dispensing against a written or verbal prescription from an authorised prescriber; a veterinarian, who may also prescribe, compound or dispense it directly; a medical practitioner or dentist, who may prescribe it and may compound or dispense it directly only if licensed under section 22C(1)(a); manufacturers and wholesalers may supply people who may lawfully possess it; and, for animal treatment, a person practising a para-veterinary profession, on a veterinarian's written or verbal instruction.
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
Schedule Verification
Yasmin, Bayer (Pty) Ltd û Isando is scheduled S3 in its official SAHPRA documents, read with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.