Levonorgestrel

Sold as Mirena, Norlevo, Medilevo, Levonor, Plan b, Escapelle, Medinor, Kyleena, Ekuvor, Vonel, Levonorgestrel unicorn, Avibela, Lornestin, Trinestin, Lendemain, Jadelle, Hy-an, Microval

S4Read from the PI-PIL document and verified

C₂₁H₂₈O₂312.40 g/mol

(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.

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Registration

Applicants: 11
Registrations: 20
Schedule source: SAHPRA documentation

Applicants and registrations

Applicant	Brands	Dosages	Registrations	Schedule	Leaflets
Bayer (Pty) Ltd û IsandoCertificate held by Bayer (Pty) Ltd	Mirena, Kyleena, Jadelle	2 X 75 mg, 19,5 mg, 52 mg	320332, 470037, A400138	S4	PI PIL
Cipla Medpro (Pty) Ltd	Norlevo, Medilevo, Levonor, Medinor	0,75 mg, 1,5 mg	330471, 360168, 360169, 440808, 440809, 440810	Not determined	None
Elttab Pharmaceuticals CC	Plan b	Not stated	360212	Not determined	None
Acino Pharma (Pty) Ltd	Escapelle	Not stated	410021	Not determined	None
Viatris South Africa (Pty) Ltd	Ekuvor	Not stated	481254	Not determined	None
Ranbaxy Pharmaceutical (Pty) Ltd	Vonel	Not stated	490574	Not determined	None
Unicorn Pharmaceuticals (Pty) Ltd	Levonorgestrel unicorn	1,5 mg	530608	S2	PI PIL
Pharma Dynamics (Pty) Ltd	Avibela	52 mg	561048	S4	PI PIL
Trinity Pharma (Pty) Ltd	Lornestin, Trinestin	1,50 mg	561194, 561195.1194	S2	PI PIL
Cospharm Investments (Pty) Ltd	Lendemain	1,5 mg	580208	Not determined	None
Pharmacare limited û woodmeadCertificate held by Mylan (Pty) Ltd, Pharmacare limited	Hy-an, Microval	0,03 mg	A400747, E0058	S3	PI PIL

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	PI PIL
Norlevo EACH TABLET CONTAINS LEVONORGESTREL 0,75 mg	Not listed	33047133/21.8.2/0471	Registered	Not determined	None
Medilevo 0,75 MG EACH TABLET CONTAINS LEVONORGESTREL 0,75 mg	0,75 mg	36016836/21.8.2/0168	Registered	Not determined	None
Levonor EACH TABLET CONTAINS LEVONORGESTREL 0,75 mg	Not listed	36016936/21.8.2/0169	Registered	Not determined	None
Plan b EACH TABLET CONTAINS LEVONORGESTREL 0,75 mg	Not listed	36021236/21.8.2/0212	Registered	Not determined	None
Escapelle EACH TABLET CONTAINS LEVONORGESTREL 1,5 mg	Not listed	41002141/21.8.2/0021	Registered	Not determined	None
Medilevo 1,5 MG EACH TABLET CONTAINS LEVONORGESTREL 1,5 mg	1,5 mg	44080844/21.8.2/0808	Registered	Not determined	None
Norlevo 1,5 MG EACH TABLET CONTAINS LEVONORGESTREL 1,5 mg	1,5 mg	44080944/21.8.2/0809	Registered	Not determined	None
Medinor 1,5 MG EACH TABLET CONTAINS LEVONORGESTREL 1,5 mg	1,5 mg	44081044/21.8.2/0810	Registered	Not determined	None
Kyleena EACH IUD SYSTEM CONTAINS LEVONORGESTREL 19,5 mg	19,5 mgIntrauterine devices.	47003747/32.9/0037Approved 23 November 2017	Registered	S4	PI PIL
Ekuvor Each tablet contains LEVONORGESTREL 1,50 mg	Not listed	48125448/21.8.2/1254	Registered	Not determined	None
Vonel EACH TABLET CONTAINS :LEVONORGESTREL 0,75 mg	Not listed	49057449/21.8.2/0574	Registered	Not determined	None
Levonorgestrel 1,5 unicorn EACH TABLET CONTAINS LEVONORGESTREL 1,5 mg	1,5 mgTablet	53060853/18.7/0608Approved 24 October 2023	Registered	S2	PI PIL
Avibela EACH SYSTEM CONTAINS LEVONORGESTREL 52,0 mg	52 mgIntrauterine system/device	56104856/32.9/1048Approved 18 March 2026	Registered	S4	PI PIL
Lornestin Each Tablet contains: Levonorgestrel 1,5 mg	1,50 mgTablet	56119456/21.8.2/1194Approved 2 July 2025	Registered	S2	PI PIL
Trinestin Each Tablet contains: Levonorgestrel 1,5 mg	Not listed	561195.119456/21.8.2/1195.1194	Registered	Not determined	None
Lendemain 1,5 MG EACH TABLET CONTAINS: LEVONORGESTREL 1,5 mg	1,5 mg	58020858/21.8.2/0208	Registered	Not determined	None
Jadelle EACH IMPLANT CONTAINS LEVONORGESTREL 75,0 mg	2 X 75 mgImplants	A400138A40/18.1/0138Approved 23 May 2025	Registered	S4	PI PIL
Hy-an EACH TABLET CONTAINS: LEVONORGESTREL 0,03 mg	0,03 mgTablets.	A400747A40/18.8/0747Approved 11 November 2022	Registered	Not determined	PI PIL
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 S4 sits on the scale

S0S1S2S3S4S5S6S7S8

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.

SAHPRA documents

Professional information (PI)For healthcare professionalsMirena, Bayer (Pty) Ltd û Isando Patient information leaflet (PIL)For patients and carersMirena, Bayer (Pty) Ltd û Isando

These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.

Research articles

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