Levonorgestrel (Hy-an, Microval)
Levonorgestrel
Pharmacare limited û woodmead
Registration
- Applicant
- Pharmacare limited û woodmead
- Certificate holder
- Mylan (Pty) Ltd
- Registrations
- 2
- Schedule source
- SAHPRA documentation
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Hy-an EACH TABLET CONTAINS: LEVONORGESTREL 0,03 mg | 0,03 mgTablets. | A400747A40/18.8/0747Approved 11 November 2022 | Registered | Not determined | PIPIL |
| Microval EACH TABLET CONTAINS LEVONORGESTREL 0,03 mg | 0,03 mgSugar-coated tablets. | E0058E/18.8/58Approved 20 May 2023 | Registered | S3 | PIL |
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.
The Consolidated Schedules list this ingredient up to S4; the leaflet's S3 applies to this product.
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.
Consolidated Schedules listings for Levonorgestrel
S4: Levonorgestrel
- when administered via an Intra Uterine System;
- except when intended for oral contraception; (S3)
- except when intended for emergency post coital contraception. (S2)
Consolidated Schedules 06 July 2026, lines 6911 to 6917
S3: Levonorgestrel
- when intended for oral contraception
- except when intended for emergency post coital contraception; (S2)
- except when administered via an Inta-Uterine System. (S4)
Consolidated Schedules 06 July 2026, lines 3880 to 3886
S2: Levonorgestrel
- when intended for emergency post coital contraception;
- except when intended for oral contraception; (S3)
- except when administered via an Intra Uterine System. (S4)
Consolidated Schedules 06 July 2026, lines 2234 to 2240
Pharmacological class: Ovulation controlling agents. (class 18.8)
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.
(8R,9S,10R,13S,14S,17R)-13-Ethyl-17-ethynyl-17-hydroxy-1,2,6,7,8,9,10,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-3-one
Drag to rotate. Structure from PubChem CID 13109.
SAHPRA documents
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.