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Sandoz Zopiclone

Zopiclone

S5Read from the PI-PIL document and verified
Loading the molecular structure
C17H17ClN6O3388.80 g/mol

[6-(5-Chloro-2-pyridinyl)-5-oxo-7H-pyrrolo[3,4-b]pyrazin-7-yl] 4-methylpiperazine-1-carboxylate

Drag to rotate; arrow keys step through the atoms. Structure from PubChem CID 5735.

Registration

Applicants
1
Registrations
1
Schedule source
SAHPRA documentation

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Sandoz South Africa (Pty) LtdCertificate held by Sandoz SA (Pty) LtdSandoz zopiclone7,5 mg320487S5PIPIL

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Sandoz zopiclone 7,5

EACH TABLET CONTAINS ZOPICLONE 7,5 mg

7,5 mgFilm-coated tablets32048732/2.2/0487Approved 22 June 2022RegisteredS5PIPIL

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, 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.

Consolidated Schedules listings for Zopiclone

  • S5: Zopiclone

    Consolidated Schedules 06 July 2026, line 9779

Pharmacological class: Sedatives, hypnotics. (class 2.2)

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.

Background

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SAHPRA documents

Schedule verified from official documents

Schedule Verification

Sandoz zopiclone 7,5, Sandoz South Africa (Pty) Ltd is scheduled S5 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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