Pramipexole
Sold as Pexola, Pexasp, Oxpola, Pexiplan, Pramex, Sandoz pramipexole, Pexola er, Pramidas, Adco-pramipexole, Zymipex, Pramipexole zydus, Mylan pramipexole, Pazoram, Pramipexole glenmark, Pexson xr, Makprami
(6S)-6-N-Propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine
Drag to rotate. Structure from PubChem CID 119570.
Background
Registration
- Applicants
- 13
- Registrations
- 56
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Ingelheim Pharmaceuticals (Pty) Ltd û Ferndale1 of 7 cancelled | Pexola, Pexola er | 0,125 mg, 0,25 mg, 0,375 mg, 0,75 mg, 1,5 mg, 3,0 mg, 4,5 mg | 320298, 320299, 431062, 431063, 431064, 431065, 431066 | S4 | None |
| Pharmacare limited û woodmead | Pexasp | 0,125 mg, 0,25 mg, 1 mg | 421022, 421023, 421024 | S4 | None |
| Gulf Drug Company (Pty) Ltd | Oxpola | 0,125 mg, 0,25 mg, 1,0 mg | 430133, 430134, 430135 | S4 | None |
| Pharmaplan (Pty) Ltd2 of 3 cancelled | Pexiplan | 0,125, 0,25, 1 | 430397, 430398, 430399 | S4 | None |
| Ascendis Pharma (Pty) Ltd | Pramex | 0,125, 0,25, 0,5, 1,0, 1,5 | 430622, 430623, 430624, 430625, 430626 | S4 | None |
| Biotech Laboratories (Pty) Ltd | Sandoz pramipexole | 0,125, 0,25 | 430857, 430858 | S4 | None |
| Adcock ingram limited | Pramidas, Adco-pramipexole | 0,125 mg, 0,25 mg, 0,50 mg, 1,0 mg | 440987, 440988, 440989, 440990, 440991, 440992, 440993, 440994 | S4 | None |
| Zydus Healthcare (Pty) Ltd | Zymipex, Pramipexole zydus | 0,25 mg, 1 mg | 450233, 450234, 450235, 450236 | S4 | None |
| Viatris Healthcare (Pty) Ltd | Mylan pramipexole | 0,125 mg | 450254 | S4 | None |
| Viatris South Africa (Pty) Ltd | Mylan pramipexole | 0,25 mg, 1 mg | 450255, 450256 | S4 | None |
| Ranbaxy Pharmaceutical (Pty) Ltd | Pazoram | 0,125, 0,25, 1,0 | 451113, 451114, 451115 | S4 | None |
| Glenmark Pharmaceuticals South Africa (Pty) Ltd | Pramipexole glenmark | 0,125 MG, 0,25 MG, 0,5 MG, 1,0 MG, 1,5 MG | 480521, 480522, 480523, 480524, 480525 | S4 | None |
| Macleods Pharmaceuticals SA (Pty) Ltd | Pexson xr, Makprami | 0,375, 0,75, 1,5, 3, 4,5 | 580016, 580017, 580018, 580019, 580020, 580021.016, 580022.017, 580023.018, 580024.019, 580025.020 | S4 | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Pexola 0,125 MG EACH TABLET CONTAINS PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0,125 mg | 0,125 mg | 32029832/5.4.1/0298 | Registered | S4 | None |
| Pexola 0,25 MG EACH TABLET CONTAINS PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0,25 mg | 0,25 mg | 32029932/5.4.1/0299 | Registered | S4 | None |
| Pexasp 0,25 MG EACH TABLET CONTAINS PRAMIPEXOLE DIHYDROCHLORIDE 0,25 mg | 0,25 mg | 42102242/5.4.1/1022 | Registered | S4 | None |
| Pexasp 0,125 MG EACH TABLET CONTAINS PRAMIPEXOLE DIHYDROCHLORIDE 0,125 mg | 0,125 mg | 42102342/5.4.1/1023 | Registered | S4 | None |
| Pexasp 1 MG EACH TABLET CONTAINS PRAMIPEXOLE DIHYDROCHLORIDE 1,0 mg | 1 mg | 42102442/5.4.1/1024 | Registered | S4 | None |
| Oxpola 0,25 MG EACH TABLET CONTAINS PRAMIPEXOLE DIHYDROCHLORIDE 0,25 mg | 0,25 mg | 43013343/5.4.1/0133 | Registered | S4 | None |
| Oxpola 0,125 MG EACH TABLET CONTAINS PRAMIPEXOLE DIHYDROCHLORIDE 0,125 mg | 0,125 mg | 43013443/5.4.1/0134 | Registered | S4 | None |
| Oxpola 1,0 MG EACH TABLET CONTAINS PRAMIPEXOLE DIHYDROCHLORIDE 1,0 mg | 1,0 mg | 43013543/5.4.1/0135 | Registered | S4 | None |
| Pexiplan 0,25 EACH TABLET CONTAINS PRAMIPEXOLE DIHYDROCHLORIDE 0,25 mg | 0,25 | 43039743/5.4.1/0397 | Registered | S4 | None |
| Pexiplan 0,125 EACH TABLET CONTAINS PRAMIPEXOLE DIHYDROCHLORIDE 0,125 mg | 0,125 | 43039843/5.4.1/0398 | Cancelled | S4 | None |
| Pexiplan 1 EACH TABLET CONTAINS PRAMIPEXOLE DIHYDROCHLORIDE 1,0 mg | 1 | 43039943/5.4.1/0399 | Cancelled | S4 | None |
| Pramex 0,5 EACH TABLET CONTAINS PRAMIPEXOLE DIHYDROCHLORIDE 0,5 mg | 0,5 | 43062243/5.4.1/0622 | Registered | S4 | None |
| Pramex 0,25 EACH TABLET CONTAINS PRAMIPEXOLE DIHYDROCHLORIDE 0,25 mg | 0,25 | 43062343/5.4.1/0623 | Registered | S4 | None |
| Pramex 0,125 EACH TABLET CONTAINS PRAMIPEXOLE DIHYDROCHLORIDE 0,125 mg | 0,125 | 43062443/5.4.1/0624 | Registered | S4 | None |
| Pramex 1,0 EACH TABLET CONTAINS PRAMIPEXOLE DIHYDROCHLORIDE 1,0 mg | 1,0 | 43062543/5.4.1/0625 | Registered | S4 | None |
| Pramex 1,5 EACH TABLET CONTAINS PRAMIPEXOLE DIHYDROCHLORIDE 1,5 mg | 1,5 | 43062643/5.4.1/0626 | Registered | S4 | None |
| Sandoz pramipexole 0,25 EACH TABLET CONTAINS PRAMIPEXOLE DIHYDROCHLORIDE 0,25 mg | 0,25 | 43085743/5.4.1/0857 | Registered | S4 | None |
| Sandoz pramipexole 0,125 EACH TABLET CONTAINS PRAMIPEXOLE DIHYDROCHLORIDE 0,125 mg | 0,125 | 43085843/5.4.1/0858 | Registered | S4 | None |
| Pexola er 0,375 MG EACH TABLET CONTAINS PRAMIPEXOLE DIHYDROCHLORIDE 0,375 mg | 0,375 mg | 43106243/5.4.1/1062 | Registered | S4 | None |
| Pexola er 0,75 MG EACH TABLET CONTAINS PRAMIPEXOLE DIHYDROCHLORIDE 0,75 mg | 0,75 mg | 43106343/5.4.1/1063 | Registered | S4 | None |
| Pexola er 1,5 MG EACH TABLET CONTAINS PRAMIPEXOLE DIHYDROCHLORIDE 1,5 mg | 1,5 mg | 43106443/5.4.1/1064 | Registered | S4 | None |
| Pexola er 3,0 MG EACH TABLET CONTAINS PRAMIPEXOLE DIHYDROCHLORIDE 3,0 mg | 3,0 mg | 43106543/5.4.1/1065 | Registered | S4 | None |
| Pexola er 4,5 MG EACH TABLET CONTAINS PRAMIPEXOLE DIHYDROCHLORIDE 4,5 mg | 4,5 mg | 43106643/5.4.1/1066 | Cancelled | S4 | None |
| Pramidas 0,125 MG EACH TABLET CONTAINS PRAMIPEXOLE DIHYDROCHLORIDE 0,125 mg | 0,125 mg | 44098744/5.4.1/0987 | Registered | S4 | None |
| Pramidas 0,25 MG EACH TABLET CONTAINS PRAMIPEXOLE DIHYDROCHLORIDE 0,25 mg | 0,25 mg | 44098844/5.4.1/0988 | Registered | S4 | None |
| Pramidas 0,50 MG EACH TABLET CONTAINS PRAMIPEXOLE DIHYDROCHLORIDE 0,50 mg | 0,50 mg | 44098944/5.4.1/0989 | Registered | S4 | None |
| Pramidas 1,0 MG EACH TABLET CONTAINS PRAMIPEXOLE DIHYDROCHLORIDE 1,0 mg | 1,0 mg | 44099044/5.4.1/0990 | Registered | S4 | None |
| Adco-pramipexole 0,125 MG EACH TABLET CONTAINS PRAMIPEXOLE DIHYDROCHLORIDE 0,125 mg | 0,125 mg | 44099144/5.4.1/0991 | Registered | S4 | None |
| Adco-pramipexole 0,25 MG EACH TABLET CONTAINS PRAMIPEXOLE DIHYDROCHLORIDE 0,25 mg | 0,25 mg | 44099244/5.4.1/0992 | Registered | S4 | None |
| Adco-pramipexole 0,50 MG EACH TABLET CONTAINS PRAMIPEXOLE DIHYDROCHLORIDE 0,50 mg | 0,50 mg | 44099344/5.4.1/0993 | Registered | S4 | None |
| Adco-pramipexole 1,0 MG EACH TABLET CONTAINS PRAMIPEXOLE DIHYDROCHLORIDE 1,0 mg | 1,0 mg | 44099444/5.4.1/0994 | Registered | S4 | None |
| Zymipex 0,25 MG EACH TABLET CONTAINS PRAMIPEXOLE DIHYDROCHLORIDE 0,25 mg | 0,25 mg | 45023345/5.4.1/0233 | Registered | S4 | None |
| Zymipex 1 MG EACH TABLET CONTAINS PRAMIPEXOLE DIHYDROCHLORIDE 1,0 mg | 1 mg | 45023445/5.4.1/0234 | Registered | S4 | None |
| Pramipexole zydus 0,25 MG EACH TABLET CONTAINS PRAMIPEXOLE DIHYDROCHLORIDE 0,25 mg | 0,25 mg | 45023545/5.4.1/0235 | Registered | S4 | None |
| Pramipexole zydus 1 MG EACH TABLET CONTAINS PRAMIPEXOLE DIHYDROCHLORIDE 1,0 mg | 1 mg | 45023645/5.4.1/0236 | Registered | S4 | None |
| Mylan pramipexole 0,125 MG EACH TABLET CONTAINS PRAMIPEXOLE DIHYDROCHLORIDE EQUIVALENT TO PRAMIPEXOLE 0,088 mg | 0,125 mg | 45025445/5.4.1/0254 | Registered | S4 | None |
| Mylan pramipexole 0,25 MG EACH TABLET CONTAINS PRAMIPEXOLE DIHYDROCHLORIDE EQUIVALENT TO PRAMIPEXOLE 0,18 mg | 0,25 mg | 45025545/5.4.1/0255 | Registered | S4 | None |
| Mylan pramipexole 1 MG EACH TABLET CONTAINS PRAMIPEXOLE DIHYDROCHLORIDE EQUIVALENT TO PRAMIPEXOLE 0,7 mg | 1 mg | 45025645/5.4.1/0256 | Registered | S4 | None |
| Pazoram 0,125 EACH TABLET CONTAINS PRAMIPEXOLE DIHYDROCHLORIDE EQUIVALENT TO PRAMIPEXOLE 0,125 mg | 0,125 | 45111345/5.4.1/1113 | Registered | S4 | None |
| Pazoram 0,25 EACH TABLET CONTAINS PRAMIPEXOLE DIHYDROCHLORIDE EQUIVALENT TO PRAMIPEXOLE 0,25 mg | 0,25 | 45111445/5.4.1/1114 | Registered | S4 | None |
| Pazoram 1,0 EACH TABLET CONTAINS PRAMIPEXOLE DIHYDROCHLORIDE EQUIVALENT TO PRAMIPEXOLE 1,0 mg | 1,0 | 45111545/5.4.1/1115 | Registered | S4 | None |
| Pramipexole 0,125 MG glenmark Each tablet contains 0,125 mg PRAMIPEXOLE DIHYDROCHLORIDE EQUIVALENT TO PRAMIPEXOLE 0,088 mg | 0,125 MG | 48052148/5.4.1/0521 | Registered | S4 | None |
| Pramipexole 0,25 MG glenmark Each tablet contains 0,25 mg PRAMIPEXOLE DIHYDROCHLORIDE EQUIVALENT TO PRAMIPEXOLE 0,18 mg | 0,25 MG | 48052248/5.4.1/0522 | Registered | S4 | None |
| Pramipexole 0,5 MG glenmark Each tablet contains 0,5 mg PRAMIPEXOLE DIHYDROCHLORIDE EQUIVALENT TO PRAMIPEXOLE 0,35 mg | 0,5 MG | 48052348/5.4.1/0523 | Registered | S4 | None |
| Pramipexole 1,0 MG glenmark Each tablet contains 1,0 mg PRAMIPEXOLE DIHYDROCHLORIDE EQUIVALENT TO PRAMIPEXOLE 0,70 mg | 1,0 MG | 48052448/5.4.1/0524 | Registered | S4 | None |
| Pramipexole 1,5 MG glenmark Each tablet contains 1,5 mg PRAMIPEXOLE DIHYDROCHLORIDE EQUIVALENT TO PRAMIPEXOLE 1,050 mg | 1,5 MG | 48052548/5.4.1/0525 | Registered | S4 | None |
| Pexson 0,375 xr EACH TABLET CONTAINS: PRAMIPEXOLE DIHYDROCHLORIDE 0,375 mg | 0,375 | 58001658/5.4.1/0016 | Registered | S4 | None |
| Pexson 0,75 xr EACH TABLET CONTAINS: PRAMIPEXOLE DIHYDROCHLORIDE 0,75 mg | 0,75 | 58001758/5.4.1/0017 | Registered | S4 | None |
| Pexson 1,5 xr EACH TABLET CONTAINS: PRAMIPEXOLE DIHYDROCHLORIDE 1,5 mg | 1,5 | 58001858/5.4.1/0018 | Registered | S4 | None |
| Pexson 3 xr EACH TABLET CONTAINS: PRAMIPEXOLE DIHYDROCHLORIDE 3,0 mg | 3 | 58001958/5.4.1/0019 3 | Registered | S4 | None |
| Pexson 4,5 xr EACH TABLET CONTAINS: PRAMIPEXOLE DIHYDROCHLORIDE 4,5 mg | 4,5 | 58002058/5.4.1/0020 | Registered | S4 | None |
| Makprami 0,375 EACH TABLET CONTAINS: PRAMIPEXOLE DIHYDROCHLORIDE 0,375 mg | 0,375 | 580021.01658/5.4.1/0021.016 | Registered | S4 | None |
| Makprami 0,75 EACH TABLET CONTAINS: PRAMIPEXOLE DIHYDROCHLORIDE 0,75 mg | 0,75 | 580022.01758/5.4.1/0022.017 | Registered | S4 | None |
| Makprami 1,5 EACH TABLET CONTAINS: PRAMIPEXOLE DIHYDROCHLORIDE 1,5 mg | 1,5 | 580023.01858/5.4.1/0023.018 | Registered | S4 | None |
| Makprami 3 EACH TABLET CONTAINS: PRAMIPEXOLE DIHYDROCHLORIDE 3,0 mg | 3 | 580024.01958/5.4.1/0024.019 | Registered | S4 | None |
| Makprami 4,5 EACH TABLET CONTAINS: PRAMIPEXOLE DIHYDROCHLORIDE 4,5 mg | 4,5 | 580025.02058/5.4.1/0025.020 | 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 medium.
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 Pramipexole dihydrochloride monohydrate
S4: Pramipexole
Consolidated Schedules 06 July 2026, line 7626
Pharmacological class: Anti-Parkinsonism preparations. (class 5.4.1)
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.