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Promethazine (Promethazine Hcl-fresenius)

Promethazine

Fresenius Medical Care South Africa (Pty) Ltd

Registration

Applicant
Fresenius Medical Care South Africa (Pty) Ltd
Registrations
2

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Promethazine hcl-fresenius 25 MG

EACH 1,0 ml SOLUTION CONTAINS PROMETHAZINE HYDROCHLORIDE A 25,0 mg

25 mgB1450Old MedicineNot determinedNone
Promethazine hcl-fresenius 50 mg/2 ML

EACH 2,0 ml SOLUTION CONTAINS PROMETHAZINE HYDROCHLORIDE A 50,0 mg

50 mg/2 mlB1637Old MedicineNot determinedNone

Regulatory status

This product is still scheduled by law even when this site could not determine which tier it falls under. The label carries the S number in a square border; ask a pharmacist if you need to know its schedule.

Listings for this ingredient that could not be applied to this product

  • S2: Promethazine

    • when intended for use as an antihistamine, and
    • when intended for application to the skin, and
    • when intended specifically for the treatment of travel sickness. (S5)

    Consolidated Schedules 06 July 2026, lines 2586 to 2592

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.

C17H20N2S284.40 g/mol

N,N-Dimethyl-1-phenothiazin-10-ylpropan-2-amine

Drag to rotate. Structure from PubChem CID 4927.

SAHPRA documents

SAHPRA has not published a professional information or patient information leaflet for this product.

Background

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Research articles

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