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Mylan-pantoprazole

Pantoprazole

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C16H15F2N3O4S383.40 g/mol

6-(Difluoromethoxy)-2-[(3,4-dimethoxy-2-pyridinyl)methylsulfinyl]-1H-benzimidazole

Drag to rotate; arrow keys step through the atoms. Structure from PubChem CID 4679.

Registration

Applicants
1
Registrations
2

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Viatris South Africa (Pty) LtdMylan-pantoprazole20 mg, 40 mg430843, 430844Not determinedPIPIL

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Mylan-pantoprazole 20 MG

EACH TABLET CONTAINS PANTOPRAZOLE 20,0 mg

20 mg43084343/11.4.3/0843RegisteredNot determinedPIPIL
Mylan-pantoprazole 40 MG

EACH TABLET CONTAINS PANTOPRAZOLE 40,0 mg

40 mg43084443/11.4.3/0844RegisteredNot determinedPIPIL

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

  • S4: Pantoprazole

    • except when intended for the temporary short-term relief of heartburn and hyperacidity, subject to:
    • a maximum daily dose of 20 milligrams (S2); and
    • a maximum treatment period of 14 days. (S2)

    Consolidated Schedules 06 July 2026, lines 7479 to 7482

  • S2: Pantoprazole

    • when intended for the temporary short-term relief of heartburn and hyperacidity, subject to:
    • maximum daily dose of 20 milligrams
    • maximum treatment period of 14 days. (S4)

    Consolidated Schedules 06 July 2026, lines 2482 to 2486

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

Professional information (PI)For healthcare professionalsMylan-pantoprazole 20 MG, Viatris South Africa (Pty) Ltd. SAHPRA's document for Mylan pantoprazolePatient information leaflet (PIL)For patients and carersMylan-pantoprazole 20 MG, Viatris South Africa (Pty) Ltd. SAHPRA's document for Mylan pantoprazole

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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