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Carbidopa, entacapone, levodopa (Stalevo)

Carbidopa, entacapone, levodopa

Equity Pharmaceutical (Pty) Ltd

S4

Registration

Applicant
Equity Pharmaceutical (Pty) Ltd
Certificate holder
Equity Pharmaceuticals (Pty) Ltd
Registrations
3
Schedule source
Consolidated Schedules 06 July 2026

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Stalevo 50/12,5

EACH TABLET CONTAINS CARBIDOPA 12,5 mg ENTACAPONE 200,0 mg LEVODOPA 50,0 mg

50/12,5Tablet38006738/5.4.1/0067Approved 28 February 2021RegisteredS4PIPIL
Stalevo 150/37,5

EACH TABLET CONTAINS CARBIDOPA 37,5 mg ENTACAPONE 200,0 mg LEVODOPA 150,0 mg

150/37,5Tablet38013738/5.4.1/0137Approved 28 February 2021RegisteredS4PIPIL
Stalevo 100/25

EACH TABLET CONTAINS CARBIDOPA 27,0 mg ENTACAPONE 200,0 mg LEVODOPA 100,0 mg

100/25Tablet38013838/5.4.1/0138Approved 28 February 2021RegisteredS4PIPIL

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, matched to the Consolidated Schedules by ingredient, confidence medium.

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 Carbidopa, entacapone, levodopa

  • S4: Carbidopa

    Consolidated Schedules 06 July 2026, line 5661

  • S4: Entacapone

    Consolidated Schedules 06 July 2026, line 6193

  • S4: Levodopa

    Consolidated Schedules 06 July 2026, line 6907

Pharmacological class: Anti-Parkinsonism preparations. (class 5.4.1)

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.

Combination product

This product contains more than one active ingredient, so it has no single molecular structure.

SAHPRA documents

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

Background

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Research articles

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