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Tacrolimus

Sold as Prograf, Prograf concentrate, Advagraf, Pangraf, Tacograf, Munograf, Tarograf, Tacrum, Tevligraf, Cleraglen, Gravtell, Tacrolimus austell, Graftac prolonged release, Limmupres, Tacrolimus ascendis, Protopic

S4

No structure available

This product's active ingredient could not be matched to a single known compound.

Background

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Registration

Applicants
11
Registrations
44
Schedule source
Consolidated Schedules 06 July 2026

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Astellas Pharma (Pty) LtdPrograf, Prograf concentrate, Advagraf0,5 mg, 1 mg, 5 mg, 5 mg/ml320559, 320560, 320561, 420786, 420787, 420788, A390647S4None
Adcock Ingram Critical Care (Pty) LtdPangraf, Tacograf0,5 mg, 1 mg, 5 mg430704, 430705, 430706, 430710, 430711, 430712S4None
Accord Healthcare (Pty) Ltd3 of 6 cancelledMunograf, Tarograf0,5, 1, 5481149, 481150, 481151, 481153, 481154, 481155S4None
Cipla Medpro (Pty) LtdTacrum0,5 mg, 1 mg, 5 mg510172, 510173, 510174S4None
Teva Pharmaceuticals (Pty) LtdTevligraf0,5 mg/ 1 mg/ 3 mg/ 5 mg520220, 520221, 520222, 520223S4PIPIL
Glenmark Pharmaceuticals South Africa (Pty) LtdCleraglen0,03 %, 0,1 %530146, 530147S4None
Austell Pharmaceuticals (Pty) LtdGravtell, Tacrolimus austell0,5 mg, 1 mg, 5 mg54/34/0445, 540444, 540446, 540447.444, 540448.0445, 540449.446S4None
Sandoz South Africa (Pty) LtdGraftac prolonged release0,5, 1, 1,5550854, 550855, 550856S4None
Lebasi Pharmaceuticals (Pty) LtdLimmupres0,5, 5560236, 560238S4None
Ascendis Pharma (Pty) LtdTacrolimus ascendis0,5 mg, 1 mg, 5 mg561226, 561227, 561228S4None
Adcock ingram limitedProtopic0,03 %, 0,1 %A400219, A400231S4None

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Prograf 1 MG

EACH CAPSULE CONTAINS :TACROLIMUS INTERMEDIATE GRANULES EQUIVALENT TO TACROLIMUS 1,0 mg

1 mg32055932/34/0559RegisteredS4None
Prograf 5 MG

EACH CAPSULE CONTAINS TACROLIMUS INTERMEDIATE GRANULES EQUIVALENT TO TACROLIMUS 5,0 mg

5 mg32056032/34/0560RegisteredS4None
Prograf concentrate for infusion 5 mg/ml

EACH 1,0 ml INFUSION CONTAINS TACROLIMUS 5,0 mg

5 mg/mlFor infusion32056132/34/0561RegisteredS4None
Advagraf 0,5 MG

EACH CAPSULE CONTAINS TACROLIMUS 0,5 mg

0,5 mg42078642/34/0786RegisteredS4None
Advagraf 1 MG

EACH CAPSULE CONTAINS TACROLIMUS 1,0 mg

1 mg42078742/34/0787RegisteredS4None
Advagraf 5 MG

EACH CAPSULE CONTAINS TACROLIMUS 5,0 mg

5 mg42078842/34/0788RegisteredS4None
Pangraf 0,5 MG

EACH CAPSULE CONTAINS TACROLIMUS 0,5 mg

0,5 mg43070443/32.2/0704RegisteredS4None
Pangraf 1 MG

EACH CAPSULE CONTAINS TACROLIMUS 1,0 mg

1 mg43070543/32.2/0705RegisteredS4None
Pangraf 5 MG

EACH CAPSULE CONTAINS TACROLIMUS 5,0 mg

5 mg43070643/32.2/0706RegisteredS4None
Tacograf 0,5 MG

EACH CAPSULE CONTAINS TACROLIMUS 0,5 mg

0,5 mg43071043/32.2/0710RegisteredS4None
Tacograf 1 MG

EACH CAPSULE CONTAINS TACROLIMUS 1,0 mg

1 mg43071143/32.2/0711RegisteredS4None
Tacograf 5 MG

EACH CAPSULE CONTAINS TACROLIMUS 5,0 mg

5 mg43071243/32.2/0712RegisteredS4None
Munograf 0,5

EACH CAPSULE CONTAINS TACROLIMUS 0,5 mg

0,548114948/34/1149CancelledS4None
Munograf 1

EACH CAPSULE CONTAINS :TACROLIMUS 1,0 mg

148115048/34/1150CancelledS4None
Munograf 5

EACH CAPSULE CONTAINS : TACROLIMUS 5,0 mg

548115148/34/1151CancelledS4None
Tarograf 0,5

EACH CAPSULE CONTAINS :TACROLIMUS 0,5 mg

0,548115348/34/1153RegisteredS4None
Tarograf 1

EACH CAPSULE CONTAINS :TACROLIMUS 1,0 mg

148115448/34/1154RegisteredS4None
Tarograf 5

EACH CAPSULE CONTAINS :TACROLIMUS 5,0 mg

548115548/34/1155RegisteredS4None
Tacrum 0,5 MG

EACH CAPSULE CONTAINS: TACROLIMUS 0,5 mg

0,5 mg51017251/32.16/0172RegisteredS4None
Tacrum 1 MG

EACH CAPSULE CONTAINS: TACROLIMUS 1,0 mg

1 mg51017351/32.16/0173RegisteredS4None
Tacrum 5 MG

EACH CAPSULE CONTAINS: TACROLIMUS 5,0 mg

5 mg51017451/32.16/0174RegisteredS4None
Tevligraf 0,50,5 mg/ 1 mg/ 3 mg/ 5 mgProlonged-release hard capsules.52022052/34/0220Approved 10 November 2022RegisteredS4PIPIL
Tevligraf 10,5 mg/ 1 mg/ 3 mg/ 5 mgProlonged-release hard capsules.52022152/34/0221Approved 10 November 2022RegisteredS4PIPIL
Tevligraf 30,5 mg/ 1 mg/ 3 mg/ 5 mgProlonged-release hard capsules.52022252/34/0222Approved 10 November 2022RegisteredS4PIPIL
Tevligraf 50,5 mg/ 1 mg/ 3 mg/ 5 mgProlonged-release hard capsules.52022352/34/0223Approved 10 November 2022RegisteredS4PIPIL
Cleraglen 0,03 %

EACH 1,0 g OINTMENT CONTAINS TACROLIMUS MONOHYDRATE EQUIVALENT TO TACROLIMUS 0,03 % m/m

0,03 %53014653/13.12/0146RegisteredS4None
Cleraglen 0,1 %

EACH 1,0 g OINTMENT CONTAINS TACROLIMUS MONOHYDRATE EQUIVALENT TO TACROLIMUS 0,1 % m/m

0,1 %53014753/13.12/0147RegisteredS4None
Gravtell 1 MG

EACH CAPSULE CONTAINS TACROLIMUS MONOHYDRATE EQUIVALENT TO TACROLIMUS 1,0 mg

1 mg54/34/0445RegisteredS4None
Gravtell 0,5 MG

EACH CAPSULE CONTAINS TACROLIMUS MONOHYDRATE EQUIVALENT TO TACROLIMUS 0,5 mg

0,5 mg54044454/34/0444RegisteredS4None
Gravtell 5 MG

EACH CAPSULE CONTAINS TACROLIMUS MONOHYDRATE EQUIVALENT TO TACROLIMUS 5,0 mg

5 mg54044654/34/0446RegisteredS4None
Tacrolimus 0,5 MG austell

EACH CAPSULE CONTAINS TACROLIMUS MONOHYDRATE EQUIVALENT TO TACROLIMUS 0,5 mg

0,5 mg540447.44454/34/0447.444RegisteredS4None
Tacrolimus 1 MG austell

EACH CAPSULE CONTAINS TACROLIMUS MONOHYDRATE EQUIVALENT TO TACROLIMUS 1,0 mg

1 mg540448.044554/34/0448.445RegisteredS4None
Tacrolimus 5 MG austell

EACH CAPSULE CONTAINS TACROLIMUS MONOHYDRATE EQUIVALENT TO TACROLIMUS 5,0 mg

5 mg540449.44654/34/0449.446RegisteredS4None
Graftac 0,5 prolonged release

EACH CAPSULE CONTAINS TACROLIMUS 0,5 mg

0,555085455/34/0854RegisteredS4None
Graftac 1 prolonged release

EACH CAPSULE CONTAINS TACROLIMUS 1,0 mg

155085555/34/0855RegisteredS4None
Graftac 1,5 prolonged release

EACH CAPSULE CONTAINS TACROLIMUS 1,5 mg

1,555085655/34/0856RegisteredS4None
Limmupres 0,5

EACH CAPSULE CONTAINS TACROLIMUS 0,5 mg

0,556023656/34/0236RegisteredS4None
Limmupres 5

EACH CAPSULE CONTAINS TACROLIMUS 5,0 mg

556023856/34/0238RegisteredS4None
Tacrolimus 0,5 MG ascendis

EACH CAPSULE CONTAINS: TACROLIMUS 0,5 mg

0,5 mg56122656/32.16/1226RegisteredS4None
Tacrolimus 1 MG ascendis

EACH CAPSULE CONTAINS: TACROLIMUS 1,0 mg

1 mg561227TACROLIMUS 1 mg ASCENDISRegisteredS4None
Tacrolimus 5 MG ascendis

EACH CAPSULE CONTAINS: TACROLIMUS 5,0 mg

5 mg56122856/32.16/1228RegisteredS4None
Prograf 0,5 MG

EACH CAPSULE CONTAINS TACROLIMUS 0,5 mg

0,5 mgA390647A39/34/0647RegisteredS4None
Protopic 0,03 % ointment

EACH 1,0 g OINTMENT CONTAINS TACROLIMUS 0,3 mg

0,03 %OintmentA400219A40/13.12./0219RegisteredS4None
Protopic 0,1 % ointment

EACH 1,0 g OINTMENT CONTAINS TACROLIMUS 1,0 mg

0,1 %OintmentA400231A40/13.12/0231RegisteredS4None

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 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; and, for animal treatment, a person practising a para-veterinary profession, on a veterinarian's written or verbal instruction.

Consolidated Schedules listings for Tacrolimus

  • S4: Tacrolimus

    Consolidated Schedules 06 July 2026, line 8084

Pharmacological class: Complementary Medicines: Health Supplements (class 34)

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

Schedule verified from official documents

Schedule Verification

Tevligraf 0,5, Teva Pharmaceuticals (Pty) Ltd is scheduled S4 in its official SAHPRA documents, read with 90% confidence.

Professional information (PI)For healthcare professionalsTevligraf 0,5, Teva Pharmaceuticals (Pty) LtdPatient information leaflet (PIL)For patients and carersTevligraf 0,5, Teva Pharmaceuticals (Pty) Ltd

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

Research articles

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