Dinoprostone
Sold as Propess, Prostin e2, Prepidil, Prandin e2
(Z)-7-[(1R,2R,3R)-3-Hydroxy-2-[(E,3S)-3-hydroxyoct-1-enyl]-5-oxocyclopentyl]hept-5-enoic acid
Drag to rotate. Structure from PubChem CID 5280360.
Background
Registration
- Applicants
- 3
- Registrations
- 5
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Ferring (Pty) Ltd | Propess | Not stated | 330059 | S4 | None |
| Pfizer Laboratories (Pty) Ltd1 of 3 cancelled | Prostin e2, Prepidil, Prandin e2 | 0,5 mg, 1 mg | J0008, U0259, W0455 | S4 | None |
| Pharmacia South Africa (Pty) Ltd | Prandin e2 | 2 mg | W0456 | S4 | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Propess EACH PESSARY CONTAINS DINOPROSTONE 10,0 mg | Not listed | 33005933/19/0059 | Registered | S4 | None |
| Prostin e2 0,5 MG EACH TABLET CONTAINS DINOPROSTONE 0,5 mg | 0,5 mg | J0008J/19/8 | Registered | S4 | None |
| Prepidil gel 0,5 MG EACH 3 g GEL CONTAINS DINOPROSTONE 0,5 mg | 0,5 mgGel | U0259U/19/259 | Cancelled | S4 | None |
| Prandin e2 1 MG EACH 3 g VAGINAL GEL CONTAINS DINOPROSTONE 1 mg | 1 mg | W0455W/19/455 | Registered | S4 | None |
| Prandin e2 2 MG EACH 3 g VAGINAL GEL CONTAINS DINOPROSTONE 2 mg | 2 mg | W0456W/19/456 | Registered | S4 | None |
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 Dinoprostone
S4: Dinoprostone
Consolidated Schedules 06 July 2026, line 6074
Pharmacological class: Oxytocics (class 19)
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
SAHPRA has not published a professional information or patient information leaflet for this product.