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zameds

Esketamine

Sold as Spravato

S5
Loading the molecular structure
C13H16ClNO237.72 g/mol

(2S)-2-(2-Chlorophenyl)-2-(methylamino)cyclohexan-1-one

Drag to rotate. Structure from PubChem CID 182137.

Background

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Registration

Applicants
1
Registrations
1
Schedule source
Consolidated Schedules 06 July 2026

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Janssen Pharmaceutica (Pty) LtdSpravato28 mg530732S5PIPIL

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Spravato

EACH NASAL SPRAY DEVICE CONTAINS ESKETAMINE HYDROCHLORIDE EQUIVALENT TO 28,0 mg

28 mgNasal spray53073253/1.2/0732Approved 24 July 2024RegisteredS5PIPIL

Regulatory status

Where S5 sits on the scale

Prescription-only, with tighter controls on repeats.

Schedule 5 medicines need a prescription, and repeat dispensing is capped at six months in total; the prescriber must state upfront how many times, and at what intervals, it may be repeated. Extra limits apply to some uses: if it is being used for its anxiolytic, antidepressant, tranquillising or analgesic properties, it cannot be prescribed for longer than six months without a further consultation. 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 S5, matched to the Consolidated Schedules by ingredient, confidence high.

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.

Consolidated Schedules listings for Esketamine hydrochloride

  • S5: Esketamine

    Consolidated Schedules 06 July 2026, line 9413

Pharmacological class: Psychoanaleptics (antidepressants). (class 1.2)

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.

Research articles

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