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Kyleena

Levonorgestrel

S4Read from the PI-PIL document and verified
Loading the molecular structure
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; arrow keys step through the atoms. Structure from PubChem CID 13109.

Registration

Applicants
1
Registrations
1
Schedule source
SAHPRA documentation

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Bayer (Pty) Ltd û IsandoCertificate held by Bayer (Pty) LtdKyleena19,5 mg470037S4PIPIL

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Kyleena

EACH IUD SYSTEM CONTAINS LEVONORGESTREL 19,5 mg

19,5 mgIntrauterine devices.47003747/32.9/0037Approved 23 November 2017RegisteredS4PIPIL

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.

Background

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SAHPRA documents

Schedule verified from official documents

Schedule Verification

Kyleena, Bayer (Pty) Ltd û Isando is scheduled S4 in its official SAHPRA documents, read with 90% confidence.

These documents come from SAHPRA's PI-PIL repository unless the line under a document says otherwise. Always consult with a healthcare professional for medical advice.

Research articles

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