Levonorgestrel (Mirena, Kyleena, Jadelle)
Levonorgestrel
Bayer (Pty) Ltd û Isando
Registration
- Applicant
- Bayer (Pty) Ltd û Isando
- Certificate holder
- Bayer (Pty) Ltd
- Registrations
- 3
- Schedule source
- SAHPRA documentation
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Mirena EACH INTRAUTERINE SYSTEM CONTAINS LEVONORGESTREL 52,0 mg | 52 mgIntrauterine delivery system (ius) | 32033232/34/0332Approved 9 September 2025 | Registered | Not determined | PIPIL |
| Kyleena EACH IUD SYSTEM CONTAINS LEVONORGESTREL 19,5 mg | 19,5 mgIntrauterine devices. | 47003747/32.9/0037Approved 23 November 2017 | Registered | S4 | PIPIL |
| Jadelle EACH IMPLANT CONTAINS LEVONORGESTREL 75,0 mg | 2 X 75 mgImplants | A400138A40/18.1/0138Approved 23 May 2025 | Registered | S4 | PIPIL |
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.
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: Intra-uterine devices. (class 32.9)
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.