Schedule 5 (S5) medicines in South Africa
Prescription-only, with tighter controls on repeats.
About S5 Drugs
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.
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.
Cited: Act s22A(5)(b), s22A(5)(c), s22A(5)(d), s22A(5)(e)
Prescription: Requires a prescription from an authorised prescriber.
Repeats: Capped at six months in total, and only if the prescriber stated in advance the number of repeats and the interval between them; the same six-month cap applies to anxiolytic, antidepressant or tranquillising use unless a registered psychiatrist has been consulted, and to analgesic use unless another medical practitioner has been consulted. The prescription must also be presented for dispensing within 30 days of issue.
Cited: reg 33(3)(i) (General Regulations, 2017)
Cited: Act s22A(6)(d), s22A(6)(g), s22A(6)(h)
Advertising: May be advertised only to health professionals, not the public.
Cited: reg 42(2), reg 42(3) (General Regulations, 2017)
Labelling: Must show the letter S and the number 5 in a square border, immediately before the product's brand name.
Cited: reg 10(1)(a) (General Regulations, 2017)
What is a Schedule 5 medicine in South Africa?
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.
Can a pharmacist sell a Schedule 5 medicine without a prescription?
A prescription is required. 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. Capped at six months in total, and only if the prescriber stated in advance the number of repeats and the interval between them; the same six-month cap applies to anxiolytic, antidepressant or tranquillising use unless a registered psychiatrist has been consulted, and to analgesic use unless another medical practitioner has been consulted. The prescription must also be presented for dispensing within 30 days of issue.
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.
Substances listed under S5
237 listed in the Consolidated Schedules, 118 with a registered medicine.
- 5-Hydroxy Tryptophan
- Acitretin1
- Agomelatine1
- Alfaxalone1
- Alprazolam1
- Amisulpride
- Amitryptyline
- Amoxapine
- Anaesthetic preparations containing pregnanedione derivatives
- Androstanolone
- Androstenediol
- Aponal
- Apronalide
- Aripriprazole
- Armodafanil
- Asenapine
- Atomoxetine1
- Azacyclonol
- Barbituric acid
- Benactyzine
- Benfluramate
- Benzoctamine
- Benzodiazepines
- Benzquinamide
- Beta-aminopropylbenzene and beta-aminoisopropylbenzene
- Bolandiol
- Bolasterone
- Boldenone
- Brexpiprazole1
- Bromazepam1
- Bromides
- Bromisovalum
- Brotizolam1
- Bupropion2
- Buspirone1
- Butriptyline
- Butyrophenones
- Carbromal
- Cariprazine1
- Chloral derivatives
- Chlordiazepoxide2
- Chlormethiazole
- Chlormezanone1
- Chloroform2
- Chlorpromazine2
- Chlorprothixene1
- Citalopram1
- Clobazam1
- Clomacran
- Clomipramine2
- Clonazepam1
- Clopenthixol
- Clorazepic acid
- Clostebol
- Clothiapine
- Clozapine1
- Corticotrophin
- Cyclobenzaprine1
- Cyproheptadine2
- Danazol1
- Dapoxetine1
- Deanol
- Dehydrochloromethyltestosterone
- Desflurane1
- Desipramine1
- Desvenlafaxine1
- Detomidine1
- Dexfenfluramine
- Dexmedetomidine1
- Dextropropoxyphene4
- Diazepam1
- Dibenzepin1
- Diprenorphine1
- Donepezil1
- Dosulepin
- Dothiepin1
- Doxepin1
- Droperidol1
- Drostanolone1
- Duloxetine1
- Ecothiopate
- Emylcamate
- Enflurane
- Epitiostanol
- Escitalopram1
- Esketamine1
- Estazolam
- Ethchlorvynol
- Ether
- Ethinamate
- Ethylestrenol1
- Etifoxine1
- Etodroxizine1
- Etomidate1
- Etretinate
- Fencamfamine
- Fenfluramine1
- Flumazenil1
- Fluoxetine1
- Fluoxymesterone1
- Flupenthixol1
- Fluphenazine1
- Flurazepam1
- Fluspirilene
- Fluvoxamine1
- Formebolone
- Furazabol
- Haloperidol1
- Halothane1
- Hedonal
- Human growth hormone (human somatotropin) - all forms
- Hydroxyzine1
- Hygromycin B
- Imipramine1
- Iproniazid
- Isoflurane1
- Isotretinoin1
- Ketamine1
- Ketazolam
- L-Tryptophan
- Lemborexant1
- Lithium salts
- Lofepramine1
- Loprazolam1
- Lorazepam1
- Lormetazepam1
- Loxapine
- Maprotiline1
- Mazindol
- Mebolazine
- Mechlorethamine
- Meclofenoxate1
- Medazepam
- Medetomidine1
- Melitracene
- Mephenoxalone
- Meprobamate4
- Mesterolone1
- Metandienone
- Metenolone
- Methandranone
- Methandriol1
- Methoxyflurane1
- Methyltestosterone1
- Metrifonate
- Mianserin1
- Mibolerone
- Midazolam1
- Milnacipran
- Mirtazapine1
- Moclobemide1
- Modafinil1
- Molindone
- Nalbuphine1
- Nandrolone
- Nefazodone
- Nitrazepam1
- Nomifensine
- Norclostebol
- Norethandronlone
- Nortriptyline
- Olanzapine1
- Oxabolone
- Oxandrolone
- Oxazepam1
- Oxymesterone
- Oxymetholone
- Oxypertine
- Paliperidone1
- Paraldehyde
- Pargyline
- Paroxetine1
- Pemoline1
- Perampanel1
- Phenazepam
- Phenethylhydrazine
- Phenothiazine
- Phentermine1
- Pimethixene
- Pimozide1
- Pipradrol
- Pizotifen
- Prasterone
- Prazepam1
- Pregabalin1
- Prochlorperazine maleate1
- Prolintane1
- Propofol1
- Protriptyline
- Quazepam
- Quetiapine1
- Quinbolone
- Quinupramine
- Reboxetine1
- Rimonabant
- Risperidone1
- Rivastigmine
- Romifidine1
- Sertindole
- Sertraline1
- Sevoflurane1
- Sibutramine
- Stanozolol
- Stenbolone
- Sulphonmethane
- Sulpiride1
- Temazepam1
- Testolactone
- Testosterone3
- Thioguanosine
- Thiopentone
- Thiothixene
- Tiapride
- Tiletamine1
- Tizanidine
- Tramadol3
- Tranylcypromine
- Trazodone1
- Trenbolone
- Tretinoin1
- Triazolam1
- Trifluoroperazine
- Trihexyphenidyl
- Trimipramine1
- Varenicline1
- Venlafaxine1
- Viloxazine
- Vortioxetine2
- Xylazine1
- Zaleplon
- Zimelidine
- Ziprasidone1
- Zolazepam1
- Zolpidem1
- Zopiclone1
- Zotepine
- Zuclopenthixol1
Registered medicines in S5
| Name | Brands | Dosages | Applicants | Registrations | Schedule |
|---|---|---|---|---|---|
| Acitretin | Acitretin PHARMC, Neotigason | 10 mg, 25 mg | 2 applicants | 4 registrations | S5 |
| Agomelatine | Valdoxane | 25 mg | Servier Laboratories South Africa (Pty) Ltd | A400347 | S5 |
| Alfaxalone | Alfaxan-cd rtu anaesthetic, Alfaxan multidose | injection, 10mg | 2 applicants | 2 registrations | S5 |
| Alprazolam | Xanor, Biozane, Anxirid, +13 more | 0,25 mg, 0,5 mg, 1 mg, 1,0 mg, +2 more | 10 applicants | 39 registrations | S5 |
| Amitriptyline | Trepiline | 10 mg, 25 mg | Pharmacare limited û woodmead | 2 registrations | S5 |
| Aripiprazole | Apize, Ariphrenz, Aripiprazole alkem | 5 mg, 10 mg, 15 mg, 30 mg | Ascend Laboratories (Pty) Ltd | 12 registrations | S5 |
| Atomoxetine | Strattera, Inir, Attentra, +10 more | 10 mg, 18 mg, 25 mg, 40 mg, +3 more | 10 applicants | 68 registrations | S5 |
| Brexpiprazole | Rexulti | 0,25 mg, 0,5 mg, 1 mg, 2 mg, +2 more | H. Lundbeck (Pty) Ltd | 6 registrations | S5 |
| Bromazepam | Bromaze, Lexotan, Bromazepam kiara, +1 more | 3, 6 | 4 applicants | 7 registrations | S5 |
| Brotizolam Cancelled | Mederantil | 10 ml, 50 ml | Boehringer Ingelheim Animal Health South Africa (Pty) Ltd | 2 registrations | S5 |
| Bupropion | Wellbutrin xl, Voxra xl, Nicolift, +12 more | 150 mg, 300 mg | 10 applicants | 23 registrations | S5 |
| Buspirone | Astrid, Pasrin | 10 mg | 2 applicants | 2 registrations | S5 |
| Caffeine | Stilpane | 150 mg | Pharmacare limited û woodmead | M0002 | S5 |
| Cariprazine | Reagila | 1,5 mg, 3,0 mg, 4,5 mg, 6,0 mg | Adcock ingram limited | 4 registrations | S5 |
| Chlordiazepoxide | Librium, Medchlor | 5, 10, 25 | 3 applicants | 6 registrations | S5 |
| Chlorpromazine | Chlorpromazine unimed, Largactil, Klorazin, +5 more | 10 MG, 25 MG, 25MG/ML, 25 mg/1 ml, +4 more | 8 applicants | 23 registrations | S5 |
| Chlorprothixene Cancelled | Truxal paediatric | syrup | Scp Pharmaceuticals (Pty) Ltd | B0716 | S5 |
| Citalopram | Cipramil, Adco-talomil, Cilift, +25 more | 10mg/20mg/40 mg, 10 mg, 20 mg, 30 mg, +1 more | 21 applicants | 55 registrations | S5 |
| Clobazam | Qlocam, Clobazam adco, Clozoby, +5 more | 5 mg, 10 mg, 20 mg | 9 applicants | 16 registrations | S5 |
| Clomipramine | Apotex-clomipramine, Xixia-clomipramine hydrochloride, Companil, +7 more | 5 mg, 10 mg, 20 mg, 25 mg, +4 more | 12 applicants | 19 registrations | S5 |
| Clomipramine hydrochloride a | Anafranil | 25 | Equity Pharmaceutical (Pty) Ltd | B1532 | S5 |
| Clonazepam | Clonam, Clonazepam ascendis, Remialz, +2 more | 0,5 mg, 1 mg, 1 mg/ml, 2 mg, +1 more | 6 applicants | 11 registrations | S5 |
| Clozapine | Cloment, Clozapine oethmaan, Clozapine-hexal, +2 more | 25 mg, 100 mg, suspension, 25 mg/50 mg/100 mg, +1 more | 4 applicants | 10 registrations | S5 |
| Codeine | Stilpane | 10 mg/200 mg/350 mg, 150 mg/8 mg/320 mg | Pharmacare limited û woodmead | 2 registrations | S5 |
| Cyclobenzaprine | Myprocam, Pribemak, Tanzof | 15 mg, 30 mg | 3 applicants | 6 registrations | S5 |
| Danazol | Danogen | 100, 200 | Cipla Medpro (Pty) Ltd | 2 registrations | S5 |
| Dapoxetine | Priligy | 30 mg, 60 mg | Lebasi Pharmaceuticals (Pty) Ltd | 2 registrations | S5 |
| Desflurane | Suprane, Torrane | 240 ml | 2 applicants | 2 registrations | S5 |
| Desipramine Cancelled | Pertofan | 25 | Ciba-geigy (Pty) Ltd | B1534 | S5 |
| Desvenlafaxine | Exsira, Voloxin, Depven xl, +6 more | 50 mg, 50mg, 50/100 mg, 100 mg | 7 applicants | 18 registrations | S5 |
| Detomidine | Equidine, Equisedan, Domosedan | Not stated | 3 applicants | 3 registrations | S5 |
| Dexketoprofen | Skudexa, Lenizak | 75 mg, granules | 2 applicants | 4 registrations | S5 |
| Dexmedetomidine | Dexdomitor, Precedex, Sedalpha, +15 more | 000 μg 1, 1 mL, 4 μg, 50 ml, +15 more | 14 applicants | 28 registrations | S5 |
| Diazepam | Dynapam, Tranject, Diazepam pharm c, +14 more | ampoules, 10 mg/2 ml, injection, tablets, +3 more | 17 applicants | 37 registrations | S5 |
| Dibenzepin | Noveril | 40 MG | Sandoz South Africa (Pty) Ltd | 2 registrations | S5 |
| Diprenorphine | M5050, Activon | 98 | 2 applicants | 2 registrations | S5 |
| Donepezil | Aricept, Ariknow, Ran-donepezil, +17 more | 5 mg, 10 mg | 15 applicants | 40 registrations | S5 |
| Dothiepin | Prothiaden, Dosulepin biotech, Thaden | 25 mg, 75 mg | 3 applicants | 6 registrations | S5 |
| Droperidol | Pharma-q droperidol, Droperidol equity, Inapsin | 1,25 mg/mL, 5 mg/2 ml | 3 applicants | 3 registrations | S5 |
| Drostanolone propionate Cancelled | Masteril | Not stated | Adcock ingram limited | G3078 | S5 |
| Duloxetine | Cymbalta, Cymgen, Yelate, +11 more | 20, 30 mg, 30 mg/ 60 mg, 60 mg | 12 applicants | 28 registrations | S5 |
| Escitalopram | Cipralex, Lexamil, Escitalopram be-tabs, +24 more | 5 mg, 5 mg/ 10mg / 20mg, 10 mg, 15 mg, +1 more | 21 applicants | 67 registrations | S5 |
| Esketamine | Spravato | 28 mg | Janssen Pharmaceutica (Pty) Ltd | 530732 | S5 |
| Ethylestrenol Cancelled | Orabolin | Not stated | Donmed Pharmaceuticals (Pty) Ltd | G3193 | S5 |
| Etifoxine | Stresigen, Neusera, Kalmexan, +6 more | 50 mg | 6 applicants | 9 registrations | S5 |
| Etomidate | B. Braun etomidate, Etomidate RBC, Hypnomidate | 2 mg/ml | 3 applicants | 3 registrations | S5 |
| Fenfluramine | Ponderax | Not stated | Servier Laboratories South Africa (Pty) Ltd | C0518 | S5 |
| Flumazenil | Flumazenil fresenius, Flumazenil b braun, Anexate | 0,5 MG/ 5 ML, 0,5 mg, 1,0 MG/ 10 ML, 1,0 MG, +2 more | 4 applicants | 7 registrations | S5 |
| Fluoxetine | Lilly-fluoxetine, Lorien, Fluoxetine biotech, +17 more | 20 mg, tablets, 40, oral solution, +1 more | 15 applicants | 24 registrations | S5 |
| Fluoxymesterone | Halotestin | 5 MG | Upjohn South Africa (Pty) Ltd | G3216 | S5 |
| Flupenthixol | Fluanxol | 1 mg | Adcock ingram limited | B1380 | S5 |
| Fluphenazine Cancelled | Pheracarm rapid ( ), Anatensol | 1 MG, 2 MG, 2,5 mg/ml 10 ml, 5 MG | 2 applicants | 4 registrations | S5 |
| Flurazepam | Dalmadorm, Flurazepam | 15 mg, 30 mg | 3 applicants | 5 registrations | S5 |
| Fluvoxamine | Faverin, Fluvoxamine oethmaan, Fluvoxamine-hexal, +1 more | 50, 100 mg | 3 applicants | 6 registrations | S5 |
| Haloperidol | Haloperidol GDC, Haloject, Haloperidol cipla, +6 more | 1, 1,5, 5 mg, 5 mg/ml | 8 applicants | 12 registrations | S5 |
| Halothane | Fluothane, Halothane m&b, Fluopan | Not stated | 3 applicants | 3 registrations | S5 |
| Hydroxyzine | Neurax, Pharma-q hydroxyzine, Hydroxyzine equity, +1 more | 10MG, 25 mg, 100 mg/2 ml, syrup, +2 more | 5 applicants | 9 registrations | S5 |
| Imipramine | Ethipramine, Imipramine HCL, Imipramine bp, +5 more | 10 mg, 25 mg, 25MG | 4 applicants | 14 registrations | S5 |
| Isoflurane | Isofor, Terrell, Pe-isoflurane | Not stated | 2 applicants | 3 registrations | S5 |
| Isotretinoin | Acnetane, Oratane, Acnetret, +2 more | 5 mg, 8 mg, 10 mg, 16 mg, +2 more | 5 applicants | 12 registrations | S5 |
| Ketamine | Pharma-q ketamine, Zenziket, Ketamine equity, +2 more | 1 mg, 10 mg/ml, 10, 10 mg/1 ml, +5 more | 5 applicants | 12 registrations | S5 |
| Lemborexant | Dayvigo | 5, 10 | Eisai pharmaceuticals | 2 registrations | S5 |
| Lithium carbonate | Camcolit | 250, 400 | Pharmacare limited û woodmead | 2 registrations | S5 |
| Lofepramine Cancelled | Emdalen hs | Not stated | Merck (Pty) Ltd | N0204 | S5 |
| Loprazolam | Dormonoct | 2 mg | Sanofi-aventis South Africa (Pty) Ltd | Q0355 | S5 |
| Lorazepam | Ativan, Ativan sl, Tranqipam | 0,5 mg, 0,5 mg/1 mg/2,5 mg, 1 mg, 1 ml, +2 more | 2 applicants | 8 registrations | S5 |
| Lormetazepam | Genoct, Loramet | 0,5 mg, 1 mg, 2 mg | 2 applicants | 6 registrations | S5 |
| Lurasidone | Latumak | 20 mg, 40 mg, 60 mg, 80 mg, +1 more | Macleods Pharmaceuticals SA (Pty) Ltd | 5 registrations | S5 |
| Maprotiline Cancelled | Luprodil, Ludiomil | 10, 25, 50, 75 | 2 applicants | 5 registrations | S5 |
| Meclofenoxate Cancelled | Lucidril | Not stated | Keatings | B1543 | S5 |
| Medetomidine | Domivet, Dorbene, Domitor | Not stated | 2 applicants | 3 registrations | S5 |
| Meprobamate | Meprepose, Meprobamate, Genprobamate, +2 more | 400 MG | 4 applicants | 5 registrations | S5 |
| Mesterolone | Proviron | Not stated | Bayer (Pty) Ltd û Isando | B0137 | S5 |
| Methandriol Cancelled | Depahor, Oraject orabol h | Not stated | Rhone-poulenc Animal Health SA (Pty) Ltd | 2 registrations | S5 |
| Methoxyflurane | Penthrop | Not stated | Equity Pharmaceutical (Pty) Ltd | 451118 | S5 |
| Methyltestosterone Cancelled | Lennon methyltestosterone | 5 mg | Pharmacare limited û woodmead | G2966 | S5 |
| Mianserin | Lantanon, Aspen mianserin ( ), Mianserin hydrochloride (lennon) | 10 mg, 30 mg | 2 applicants | 4 registrations | S5 |
| Midazolam | Sedolam, Dormicum, Midazolam hexal biotech, +18 more | 1 mg/ml, 1 mg/ml 5 ml, 1,0 mg, 5 mg/5 ml, +12 more | 15 applicants | 49 registrations | S5 |
| Mirtazapine | Remeron, Aspen mirtazapine, Mirtazapine viatris, +9 more | 15 mg, 15 mg / 30 mg, 30 mg, 45 mg | 12 applicants | 26 registrations | S5 |
| Moclobemide | Adco-moclobemide, Depnil, Moclobix | 150 mg, 300 mg | 2 applicants | 4 registrations | S5 |
| Modafinil | Provigil, Modalert, Modafinil ipharma, +2 more | 100mg, 100 mg, 200 | 4 applicants | 8 registrations | S5 |
| Nalbuphine | Lanphi, Nalbain, Nalbuphine hydrochloride dihydrate equivalent to nalbuphine hydrochloride anhydrous, +1 more | 10 MG/ML, 10,0 mg, 20 MG/ML | 3 applicants | 6 registrations | S5 |
| Nitrazepam | Lyladorm, Ormodon, Arem, +3 more | 5 mg, 10 mg | 4 applicants | 7 registrations | S5 |
| Olanzapine | Zyprexa, Zyprexa im, Olexar, +24 more | 2,5 mg, 5 mg, 10.0 mg, 10 mg, +2 more | 17 applicants | 74 registrations | S5 |
| Oxazepam | Serepax forte, Serepax, Purata, +4 more | 10 mg, 15 mg, 30 mg | 5 applicants | 17 registrations | S5 |
| Paliperidone | Invega, Xeplion | 3 mg, 6 mg, 9 mg, 12 mg, +5 more | Janssen Pharmaceutica (Pty) Ltd | 9 registrations | S5 |
| Paracetamol | Tramacet, Tramaspen co, Ultracet, +9 more | 37.5 mg / 25 mg, 37,5 mg/325 mg, 37,5 mg, 37,5 mg and 325 mg, +3 more | 8 applicants | 12 registrations | S5 |
| Paroxetine | Xixia paroxetine, Adco-paroxetine, Paroxetine oethmaan, +13 more | 12,5, 20 mg, 20 mg -, 25, +2 more | 13 applicants | 21 registrations | S5 |
| Pemoline | Dynalert | Not stated | Adcock ingram limited | B1497 | S5 |
| Perampanel | Fycompa | 0,5 mg/ml, 2 mg, 4 mg, 6 mg, +3 more | 2 applicants | 7 registrations | S5 |
| Phentermine | Phentolene, Musalos, Minex, +3 more | 15 mg, 30 mg | 4 applicants | 11 registrations | S5 |
| Pimozide | Orap | 1 mg, 4 mg | Lebasi Pharmaceuticals (Pty) Ltd | 2 registrations | S5 |
| Prazepam Cancelled | Demetrin | 10 mg | Pfizer Laboratories (Pty) Ltd | G0188 | S5 |
| Pregabalin | Alond, Pregabalin viatris, Pregabalin ivax, +29 more | 25 mg, 25/50/75/150 mg, 25 mg/ 75 mg /150 mg, 25 / 75 / 150, +5 more | 19 applicants | 106 registrations | S5 |
| Prochlorperazine | Allmetic, Stemetil, Mitil | 5 mg, tablets | 3 applicants | 3 registrations | S5 |
| Prolintane | Catovit-n | Not stated | Ingelheim Pharmaceuticals (Pty) Ltd û Ferndale | G2697 | S5 |
| Propofo | Propofol ps fresenius | 10 mg per mL | Fresenius Kabi South Africa (Pty) Ltd | 491233 | S5 |
| Propofol | Diprivan pfs, Propofol fresenius, Recofol, +11 more | 1 % 20 ml, 1 % 50 ml, 1 %, 1 % 100 ml, +13 more | 11 applicants | 36 registrations | S5 |
| Quetiapine | Seroquel, Quetiapine viatris, Seroquel xr, +27 more | 25 mg, 25 mg / 100 mg / 200 mg / 300mg, 25mg / 100mg / 200mg / 300mg, 50 mg, +5 more | 21 applicants | 126 registrations | S5 |
| Reboxetine Cancelled | Edronax | 4 mg | Pfizer Laboratories (Pty) Ltd | 330246 | S5 |
| Risperidone | Risperdal, Risperdal consta, Rutra, +31 more | 0,25 mg, 0,5 mg, 0,50 mg/ 1mg/ 3mg, 1 mg, +19 more | 23 applicants | 136 registrations | S5 |
| Romifidine | Sedivet | 1 % | Boehringer Ingelheim Animal Health South Africa (Pty) Ltd | 97/2 | S5 |
| Sertraline | Zoloft, Serlife, Tralidep, +17 more | 50 mg, 100 mg | 16 applicants | 33 registrations | S5 |
| Sevoflurane | Ultane, Sojourn, Sevoflurane baxter | breathed in (inhalation) Liquid, 100 mg | 3 applicants | 3 registrations | S5 |
| Sulpiride | Prem-sulpiride, Sulpiride biotech, Endepex, +2 more | 5 ml, 50, 200, elixir | 4 applicants | 6 registrations | S5 |
| Temazepam | Vernison, Normison, Temazepam oethmaan | 10 mg, 20 mg | 4 applicants | 4 registrations | S5 |
| Testosterone | Testogel, Testafeme, Testaforte, +2 more | 10 mg, 50 mg/5 g, 50 mg in 1 ml or 100 mg in 2 ml, 1000 mg | 3 applicants | 5 registrations | S5 |
| Testosterone propionate | Testosterone propionate, Pasuma | 50 MG/ ML 10 ML, ampoule | 2 applicants | 2 registrations | S5 |
| Testosterone undecanoate | Testosterone PD, Nebido | 1000 mg/ 4 mL, 1000 mg / 4 ml | 2 applicants | 2 registrations | S5 |
| Tramadol | Nobligan, Tramal sr, Tramahexal, +16 more | 50 mg, 50 mg/100 mg, 50mg, 100 mg, +6 more | 14 applicants | 38 registrations | S5 |
| Trazodone | Aspen trazodone, Bio-trazodone, Zadopax, +3 more | 50 mg, 100 mg | 5 applicants | 12 registrations | S5 |
| Triazolam | Halcion | 0,125, 0,25 | Pfizer Laboratories (Pty) Ltd | 2 registrations | S5 |
| Trimipramine | Trimipramine bliss, Tydamine | 10 mg, 25 mg, 50 | 2 applicants | 3 registrations | S5 |
| Varenicline | Champix, Nikabex, Cabrexxa, +5 more | 0,5 mg, 1 mg | 6 applicants | 16 registrations | S5 |
| Venlafaxine | Efexor xr, Venlor, Odiven, +20 more | 37,5 mg, 50, 75 mg, 150 mg, +2 more | 13 applicants | 56 registrations | S5 |
| Vortioxetine | Brintellix, Vorellix, Vortioxetine cipla, +13 more | 2,4 mg, 5 mg, 5 mg/ 10 mg/ 20 mg, 5,10,15,20 mg, +3 more | 10 applicants | 50 registrations | S5 |
| Vortioxetine hydrobromide to vortioxetine | Elibrin | 5 | Zydus Healthcare (Pty) Ltd | 550791 | S5 |
| Xylazine | Xylavet, Xylavet for horses, Rompun, +1 more | 2 %, 10 % | 3 applicants | 4 registrations | S5 |
| Ziprasidone | Geodon, Geodon im, Zipsid, +3 more | 20 mg, 20 mg/ml, 40 mg, 60 mg, +1 more | 4 applicants | 18 registrations | S5 |
| Zolpidem | Stilnox, Noxidem, Zolpihexal, +18 more | 5 mg, 10 mg, 12,5 mg | 14 applicants | 28 registrations | S5 |
| Zopiclone | Sandoz zopiclone, Alchera, Adco zopimed, +12 more | 3,75 mg, 7,5 mg, 7.5 mg | 11 applicants | 17 registrations | S5 |
| Zuclopenthixol | Clopixol, Clopixol acuphase | 2 mg, 10 mg, 50 mg/ml | Adcock ingram limited | 3 registrations | S5 |