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Mirtazapine

Sold as Remeron, Aspen mirtazapine, Mirtazapine viatris, Ramure, Mirtaneo, Miradep, Uplivixa, Adco-mirteron, Tazeron, Beron, Zapamirt, Mytra

S5
Loading the molecular structure
C17H19N3265.35 g/mol

5-Methyl-2,5,19-triazatetracyclo[13.4.0.02,7.08,13]nonadeca-1(15),8,10,12,16,18-hexaene

Drag to rotate. Structure from PubChem CID 4205.

Background

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Registration

Applicants
12
Registrations
26
Schedule source
Consolidated Schedules 06 July 2026

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Organon South Africa (Pty) LtdCancelledRemeron15 mg, 30 mg320481, 320482S5None
Pharmacare limited û woodmeadAspen mirtazapine15 mg, 30 mg410142, 410143S5None
Viatris South Africa (Pty) LtdMirtazapine viatris15, 30410367, 410368S5None
Pharmacia South Africa (Pty) LtdRamure15 mg, 30 mg410529, 410530S5None
Zydus Healthcare (Pty) LtdMirtaneo, Miradep15 mg, 30 mg441005, 441006, 441007, 441008S5None
Austell Pharmaceuticals (Pty) LtdUplivixa15 mg, 30 mg590526, 590527S5None
Aurobindo Pharma (Pty) LtdUplivixa45 mg590528S5None
Adcock ingram limitedAdco-mirteron15, 30, 45A390217, A390218, A390219S5PIPIL
Pharmaplan (Pty) LtdTazeron15 mg, 30 mgA390500, A390501S5None
Aurogen South Africa (Pty) LtdBeron15 mg / 30 mgA400366, A400367S5PIPIL
Sandoz South Africa (Pty) LtdZapamirt15, 30A400584, A400585S5None
Novagen Pharma (Pty) LtdCertificate held by Novagen Pharma (Pty) Ltd.Mytra15, 30A400652, A400653S5PIPIL

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Remeron 15 MG

EACH TABLET CONTAINS MIRTAZAPINE 15,0 mg

15 mg32048132/1.2/0481CancelledS5None
Remeron 30 MG

EACH TABLET CONTAINS MIRTAZAPINE 30,0 mg

30 mg32048232/1.2/0482CancelledS5None
Aspen mirtazapine 15 MG

EACH TABLET CONTAINS MIRTAZAPINE 15,0 mg

15 mg41014241/1.2/0142RegisteredS5None
Aspen mirtazapine 30 MG

EACH TABLET CONTAINS MIRTAZAPINE 30,0 mg

30 mg41014341/1.2/0143RegisteredS5None
Mirtazapine 15 viatris

EACH TABLET CONTAINS:MIRTAZAPINE 15,0 mg

1541036741/1.2/0367RegisteredS5None
Mirtazapine 30 viatris

EACH TABLET CONTAINS MIRTAZAPINE 30,0 mg

3041036841/1.2/0368RegisteredS5None
Ramure 15 MG

EACH TABLET CONTAINS MIRTAZAPINE 15,0 mg

15 mg41052941/1.2/0529RegisteredS5None
Ramure 30 MG

EACH TABLET CONTAINS MIRTAZAPINE 30,0 mg

30 mg41053041/1.2/0530RegisteredS5None
Mirtaneo 15

EACH TABLET CONTAINS MIRTAZAPINE 15,0 mg

1544100544/1.2/1005RegisteredS5None
Mirtaneo 30

EACH TABLET CONTAINS MIRTAZAPINE 30,0 mg

3044100644/1.2/1006RegisteredS5None
Miradep 15 MG

EACH TABLET CONTAINS MIRTAZAPINE 15,0 mg

15 mg44100744/1.2/1007RegisteredS5None
Miradep 30 MG

EACH TABLET CONTAINS MIRTAZAPINE 30,0 mg

30 mg44100844/1.2/1008RegisteredS5None
Uplivixa 15 MG

EACH TABLET CONTAINS: MIRTAZAPINE 15,0 mg

15 mg59052659/1.2/0526RegisteredS5None
Uplivixa 30 MG

EACH TABLET CONTAINS: MIRTAZAPINE 30,0 mg

30 mg59052759/1.2/0527RegisteredS5None
Uplivixa 45 MG

EACH TABLET CONTAINS: MIRTAZAPINE 45,0 mg

45 mg59052859/1.2/0528RegisteredS5None
Adco-mirteron 15

EACH TABLET CONTAINS MIRTAZAPINE 15,0 mg

15Film-coated tabletsA390217A39/1.2/0217Approved 12 January 2026RegisteredS5PIPIL
Adco-mirteron 30

EACH TABLET CONTAINS MIRTAZAPINE 30,0 mg

30Film-coated tabletsA390218A39/1.2/0218Approved 12 January 2026RegisteredS5PIPIL
Adco-mirteron 45

EACH TABLET CONTAINS MIRTAZAPINE 45,0 mg

45Film-coated tabletsA390219A39/1.2/0219Approved 12 January 2026RegisteredS5PIPIL
Tazeron 15 MG

EACH TABLET CONTAINS MIRTAZAPINE 15,0 mg

15 mgA390500A39/1.2/0500RegisteredS5None
Tazeron 30 MG

EACH TABLET CONTAINS MIRTAZAPINE 30,0 mg

30 mgA390501A39/1.2/0501RegisteredS5None
Beron 15

EACH TABLET CONTAINS MIRTAZAPINE 15,0 mg

15 mg / 30 mgFilm-coated tabletsA400366A40/1.2/0366Approved 11 November 2022RegisteredS5PIPIL
Beron 30

EACH TABLET CONTAINS MIRTAZAPINE 30,0 mg

15 mg / 30 mgFilm-coated tabletsA400367A40/1.2/0367Approved 11 November 2022RegisteredS5PIPIL
Zapamirt 15

EACH TABLET CONTAINS MIRTAZAPINE 15,0 mg

15A400584A40/1.2/0584RegisteredS5None
Zapamirt 30

EACH TABLET CONTAINS MIRTAZAPINE 30,0 mg

30A400585A40/1.2/0585RegisteredS5None
Mytra 15

EACH TABLET CONTAINS MIRTAZAPINE 15,0 mg

15Film-coated tablets.A400652A40/1.2/0652Approved 27 August 2021RegisteredS5PIPIL
Mytra 30

EACH TABLET CONTAINS MIRTAZAPINE 30,0 mg

30Film-coated tablets.A400653A40/1.2/0653Approved 27 August 2021RegisteredS5PIPIL

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 Mirtazapine

  • S5: Mirtazapine

    Consolidated Schedules 06 July 2026, line 9570

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

Professional information (PI)For healthcare professionalsAdco-mirteron 15, Adcock ingram limitedPatient information leaflet (PIL)For patients and carersAdco-mirteron 15, Adcock ingram limited

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

Research articles

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