Ethinylestradiol, levonorgestrel
Sold as Levette, Lexilev, Oralcon, Nordiol, Nordette
Combination product
This product contains more than one active ingredient, so it has no single molecular structure.
Background
Registration
- Applicants
- 4
- Registrations
- 5
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Cipla Medpro (Pty) LtdCertificate held by Actorpharma | Levette | 0.03mg, 0.15mg | 470525 | Not determined | PIPIL |
| Pharma Dynamics (Pty) Ltd | Lexilev | 0,15 mg/0.03 mg | 521022 | S3 | PIPIL |
| Pharmacare limited û woodmeadCertificate held by Mylan (Pty) Ltd, Pharmacare limited | Oralcon, Nordette | 0,15 mg/0,03 mg, 150 ug/30 ug | A400693, F0229 | S3 | PIPIL |
| Akromed Products (Pty) LtdCertificate held by Pharmacare limited | Nordiol | 250 _g / 50 _g | C0197 | Not determined | PIPIL |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Levette EACH TABLET CONTAINS ETHINYLESTRADIOL 0,03 mg LEVONORGESTREL 0,15 mg | 0.15mg. 0.03mgTablets | 47052547/18.8/0525 | Registered | Not determined | PIPIL |
| Lexilev Each active tablet contains LEVONORGESTREL 0,15 mg and ETHINYLESTRADIOL 0,03 mg | 0,15 mg/0.03 mgFilm-coated tablets | 52102252/18.8/1022Approved 27 February 2025 | Registered | S3 | PIPIL |
| Oralcon EACH TABLET CONTAINS: LEVONORGESTREL 0,15 mg ETHINYLESTRADIOL 0,03 mg | 0,15 mg/0,03 mgTablets. | A400693A40/18.8/0693Approved 18 November 2022 | Registered | Not determined | PIL |
| Nordiol EACH TABLET CONTAINS ETHINYLESTRADIOL 0,05 mg LEVONORGESTREL 0,25 mg | 250 _g / 50 _gTablet | C0197C/18.8/197Approved 13 July 2021 | Registered | Not determined | PIPIL |
| Nordette* EACH TABLET CONTAINS ETHINYLESTRADIOL 0,03 mg LEVONORGESTREL 0,15 mg | 150 ug/30 ugSugar-coated tablets | F0229F/18.8/229Approved 3 June 2023 | Registered | S3 | PIPIL |
Regulatory status
Where S3 sits on the scale
Needs a doctor's prescription, dispensed by a pharmacist.
Schedule 3 medicines can only be sold on a prescription from an authorised prescriber, such as a doctor or dentist. A pharmacist dispenses the medicine once they have the written prescription, or a verbal instruction from a prescriber they know. 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 S3, 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
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.