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Testosterone undecanoate (Testosterone PD)

Testosterone undecanoate

Pharma Dynamics (Pty) Ltd

S5Read from the PI-PIL document and verified

Registration

Applicant
Pharma Dynamics (Pty) Ltd
Certificate holder
Pharma Dynamics (Pty) Ltd
Registrations
1
Schedule source
SAHPRA documentation

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Testosterone PD

Each Ampoule/vial contains: Testosterone Undecanoate 1000,0 mg

1000 mg/ 4 mLSolution for injection.57045257/21.7/0452Approved 24 June 2024RegisteredS5PIPIL

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, read from the product's PI-PIL leaflet.

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.

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.

C30H48O3456.70 g/mol

[(8R,9S,10R,13S,14S,17S)-10,13-Dimethyl-3-oxo-1,2,6,7,8,9,11,12,14,15,16,17-dodecahydrocyclopenta[a]phenanthren-17-yl] undecanoate

Drag to rotate. Structure from PubChem CID 65157.

SAHPRA documents

Schedule verified from official documents

Schedule Verification

This medication's schedule (S5) has been verified from official SAHPRA documents with 90% confidence.

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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