Gemcitabine
Sold as Gemzar, Gemcitabine oethmaan, Gemtaz, Accord gemcitabine, Cytigem, Mylan gemcitabine, Oncogem, Gemnil, Rogem, Gemcitabine zydus, Gemcitabine pharma-q, Gemcitabine rtu fresenius, Pulmogem iv, Gemcitabine iv austell, Cerbigem, Gemtaz ready to use, * jemeta, Gemcitabine rtu accord
4-Amino-1-[(2R,4R,5R)-3,3-difluoro-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]pyrimidin-2-one
Drag to rotate. Structure from PubChem CID 60750.
Background
Registration
- Applicants
- 15
- Registrations
- 45
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Eli Lilly (S.A.) (Pty) LtdCancelled | Gemzar | 1 g, 200 mg | 290306, 290307 | S4 | None |
| Oethmaan Biosims (Pty) Ltd | Gemcitabine oethmaan | 1 g, 200 mg | 410489, 410490 | S4 | None |
| Ranbaxy Pharmaceutical (Pty) Ltd | Gemtaz, Gemtaz ready to use | 000 mg/200 ml 2, 000 mg/220 ml 2, 1 g, 200 mg, 200 mg/120 ml 1, 400 mg/140 ml 1, 500 mg/150 ml 1, 600 mg/160 ml 1, 700 mg/170 ml 1, 800 mg/180 ml 1 | 410933, 410934, 540842, 540844, 540845, 540846, 540847, 540848, 540850, 540851 | S4 | None |
| Accord Healthcare (Pty) Ltd | Accord gemcitabine, Gemcitabine rtu accord | 000 mg/10 ml 1, 000 mg/20 ml 2, 1 g, 200 mg, 200 mg/2 ml, 500 mg/15 ml 1 | 420088, 420903, 56/26/962, 560961, 560963, 560964 | S4 | None |
| Eurolab (Pty) Ltd | Cytigem | 1 g, 200 mg | 420089, 420902 | S4 | None |
| Viatris South Africa (Pty) Ltd | Mylan gemcitabine | 1 g, 200 mg | 430046, 430068 | S4 | None |
| Cipla Medpro (Pty) Ltd | Oncogem | 200, 1000 | 431171, 431172 | S4 | None |
| Safeline Pharmaceuticals (Pty) LtdCancelled | Gemnil | 1 g, 200 mg | 450548, 450549 | S4 | None |
| Zydus Healthcare (Pty) Ltd | Rogem, Gemcitabine zydus | 1 g, 200 | 460103, 460104, 460105, 460106 | S4 | None |
| Pharma-q Holdings (Pty) Ltd | Gemcitabine pharma-q | 1g, 200 mg | 480459, 480460 | S4 | None |
| Fresenius Kabi South Africa (Pty) Ltd | Gemcitabine rtu fresenius | 200 mg | 500871 | S4 | PIL |
| Austell Pharmaceuticals (Pty) LtdCancelled | Pulmogem iv, Gemcitabine iv austell | 1g/ 25ml, 1g/25ml, 2g/ 50ml, 2g/50 ml, 200 mg/5ml, 200mg/5ml | 520315, 520316, 520317, 520318, 520319, 520320 | S4 | None |
| Hetero Drugs South Africa (Pty) Ltd | Cerbigem | 1 | 520462.461 | S4 | None |
| Ranbaxy Pharmaceuticals (Pty) Ltd | Gemtaz ready to use | 900 mg/190 ml 1 | 540849 | S4 | None |
| Mc Pharma (Pty) Ltd | * jemeta | 200, 1000 | 550432, 550433 | S4 | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Gemzar 200 MG EACH VIAL CONTAINS GEMCITABINE HYDROCHLORIDE EQUIVALENT TO 200 mg GEMCITABINE | 200 mg | 29030629/26/306 | Cancelled | S4 | None |
| Gemzar 1 g EACH VIAL CONTAINS GEMCITABINE HYDROCHLORIDE 1 g | 1 g | 29030729/26/307 | Cancelled | S4 | None |
| Gemcitabine 1 g oethmaan EACH VIAL CONTAINS GEMCITABINE HYDROCHLORIDE EQUIVALENT TO GEMCITABINE 1,0 g | 1 g | 41048941/26/0489 | Registered | S4 | None |
| Gemcitabine 200 MG oethmaan EACH VIAL CONTAINS GEMCITABINE HYDROCHLORIDE EQUIVALENT TO GEMCITABINE 200,0 mg | 200 mg | 41049041/26/0490 | Registered | S4 | None |
| Gemtaz 1 g EACH 50,0 ml VIAL CONTAINS: GEMCITABINE HYDROCHLORIDE EQUIVALENT TO GEMCITABINE 1,0 g | 1 g | 41093341/26/0933 | Registered | S4 | None |
| Gemtaz 200 MG EACH 5,0 ml VIAL CONTAINS: GEMCITABINE HYDROCHLORIDE EQUIVALENT TO GEMCITABINE 200,0 mg | 200 mg | 41093441/26/0934 | Registered | S4 | None |
| Accord gemcitabine 200 MG EACH 10,0 ml VIAL CONTAINS :GEMCITABINE HYDROCHLORIDE EQUIVALENT TO GENCITABINE 200,0 mg | 200 mg | 42008842/26/0088 | Registered | S4 | None |
| Cytigem 200 MG EACH 10,0 ml VIAL CONTAINS GEMCITABINE 200,0 mg | 200 mg | 42008942/26/0089 | Registered | S4 | None |
| Cytigem 1 g EACH 50,0 ml VIAL CONTAINS GEMCITABINE 1,0 g | 1 g | 42090242/26/0902 | Registered | S4 | None |
| Accord gemcitabine 1 g EACH 50,0 ml VIAL CONTAINS :GEMCITABINE 1,0 g | 1 g | 42090342/26/0903 | Registered | S4 | None |
| Mylan gemcitabine 1 g EACH VIAL CONTAINS GEMCITABINE HYDROCHLORIDE EQUIVALENT TO GEMCITABINE 1,0 g | 1 g | 43004643/26/0046 | Registered | S4 | None |
| Mylan gemcitabine 200 MG EACH VIAL CONTAINS GEMCITABINE HYDROCHLORIDE EQUIVALENT TO GEMCITABINE 200,0 mg | 200 mg | 43006843/26/0068 | Registered | S4 | None |
| Oncogem 200 EACH 10,0 ml VIAL CONTAINS GEMCITABINE HYDROCHLORIDE EQUIVALENT TO GEMCITABINE 200,0 mg | 200 | 43117143/26/1171 | Registered | S4 | None |
| Oncogem 1000 EACH 50,0 ml VIAL CONTAINS GEMCITABINE HYDROCHLORIDE EQUIVALENT TO GEMCITABINE 1 000,0 mg | 1000 | 43117243/26/1172 | Registered | S4 | None |
| Gemnil 200 MG EACH VIAL CONTAINS GEMCITABINE HYDROCHLORIDE EQUIVALENT TO GEMCITABINE 200,0 mg | 200 mg | 45054845/26/0548 | Cancelled | S4 | None |
| Gemnil 1 g EACH VIAL CONTAINS GEMCITABINE HYDROCHLORIDE EQUIVALENT TO GEMCITABINE 1,0 g | 1 g | 45054945/26/0549 | Cancelled | S4 | None |
| Rogem 1 EACH VIAL CONTAINS GEMCITABINE HYDROCHLORIDE EQUIVALENT TO GEMCITABINE 1 000,0 mg | 1 | 46010346/26/0103 | Registered | S4 | None |
| Rogem 200 EACH VIAL CONTAINS GEMCITABINE HYDROCHLORIDE EQUIVALENT TO GEMCITABINE 200,0 mg | 200 | 46010446/26/0104 | Registered | S4 | None |
| Gemcitabine zydus 1 g EACH VIAL CONTAINS GEMCITABINE HYDROCHLORIDE EQUIVALENT TO GEMCITABINE 1 000,0 mg | 1 g | 46010546/26/0105 | Registered | S4 | None |
| Gemcitabine zydus 200 EACH VIAL CONTAINS GEMCITABINE HYDROCHLORIDE EQUIVALENT TO GEMCITABINE 200,0 mg | 200 | 46010646/26/0106 | Registered | S4 | None |
| Gemcitabine 200 MG pharma-q EACH VIAL CONTAINS: GEMCITABINE HYDROCHLORIDE EQUIVALENT TO GEMCITABINE 200,0 mg | 200 mg | 48045948/26/0459 | Registered | S4 | None |
| Gemcitabine 1g pharma-q EACH VIAL CONTAINS: GEMCITABINE HYDROCHLORIDE EQUIVALENT TO GEMCITABINE 1000,0 mg | 1g | 48046048/26/0460 | Registered | S4 | None |
| Gemcitabine 200 MG rtu fresenius | 200 mgConcentrate for solution for infusion | 50087150/26/0871Approved 30 August 2024 | Registered | S4 | PIL |
| Pulmogem iv 200 mg/5ml EACH VIAL CONTAINS: GEMCITABINE HYDROCHLORIDE EQUIVALENT TO GEMCITABINE FREE BASE 200,0 mg | 200 mg/5ml | 52031552/26/0315 | Cancelled | S4 | None |
| Pulmogem iv 1g/ 25ml EACH VIAL CONTAINS: GEMCITABINE HYDROCHLORIDE EQUIVALENT TO GEMCITABINE FREE BASE 1,0 g | 1g/ 25ml | 52031652/26/0316 | Cancelled | S4 | None |
| Pulmogem iv 2g/ 50ml EACH VIAL CONTAINS: GEMCITABINE HYDROCHLORIDE EQUIVALENT TO GEMCITABINE FREE BASE 2,0 g | 2g/ 50ml | 52031752/26/0317 | Cancelled | S4 | None |
| Gemcitabine iv 200mg/5ml austell EACH VIAL CONTAINS: GEMCITABINE HYDROCHLORIDE EQUIVALENT TO GEMCITABINE FREE BASE 200,0 mg | 200mg/5ml | 52031852/26/0318 | Cancelled | S4 | None |
| Gemcitabine iv 1g/25ml austell EACH VIAL CONTAINS: GEMCITABINE HYDROCHLORIDE EQUIVALENT TO GEMCITABINE FREE BASE 1,0 g | 1g/25ml | 52031952/26/0319 | Cancelled | S4 | None |
| Gemcitabine iv 2g/50 ML austell EACH VIAL CONTAINS: GEMCITABINE HYDROCHLORIDE EQUIVALENT TO GEMCITABINE FREE BASE 2,0 g | 2g/50 ml | 52032052/26/0320 | Cancelled | S4 | None |
| Cerbigem 1 EACH 50 mL VIAL CONTAINS GEMCITABINE HYDROCHLORIDE EQUIVALENT TO GEMCITABINE 1,0 g | 1 | 520462.46152/26/0462.461 | Registered | S4 | None |
| Gemtaz 1 200 mg/120 ML ready to use EACH 120,0 ml SOLUTION CONTAINS GEMCITABINE HYDROCHLORIDE 1 200,0 mg | 200 mg/120 ml 1 | 54084254/26/0842 | Registered | S4 | None |
| Gemtaz 1 400 mg/140 ML ready to use EACH 140,0 ml SOLUTION CONATAINS GEMCITABINE HYDROCHLORIDE 1 400,0 mg | 400 mg/140 ml 1 | 54084454/26/0844 | Registered | S4 | None |
| Gemtaz 1 500 mg/150 ML ready to use EACH 150,0 ml SOLUTION CONTAINS GEMCITABINE HYDROCHLORIDE 1 500,0 mg | 500 mg/150 ml 1 | 54084554/26/0845 | Registered | S4 | None |
| Gemtaz 1 600 mg/160 ML ready to use EACH 160,0 ml SOLUTION CONTAINS GEMCITABINE HYDROCHLORIDE 1 600,0 mg | 600 mg/160 ml 1 | 54084654/26/0846 | Old Medicine | S4 | None |
| Gemtaz 1 700 mg/170 ML ready to use EACH 170,0 ml SOLUTION CONTAINS GEMCITABINE HYDROCHLORIDE 1 700,0 mg | 700 mg/170 ml 1 | 54084754/26/0847 | Registered | S4 | None |
| Gemtaz 1 800 mg/180 ML ready to use EACH 180,0 ml SOLUTION CONTAINS GEMCITABINE HYDROCHLORIDE 1 800,0 mg | 800 mg/180 ml 1 | 54084854/26/0848 | Registered | S4 | None |
| Gemtaz 1 900 mg/190 ML ready to use EACH 190,0 ml SOLUTION CONTAINS GEMCITABINE HYDROCHLORIDE 1 900,0 mg | 900 mg/190 ml 1 | 54084954/26/0849 | Registered | S4 | None |
| Gemtaz 2 000 mg/200 ML ready to use EACH 200,0 ml SOLUTION CONTAINS GEMCITABINE HYDROCHLORIDE 2000,0 mg | 000 mg/200 ml 2 | 54085054/26/0850 | Registered | S4 | None |
| Gemtaz 2 000 mg/220 ML ready to use EACH 220,0 ml SOLUTION CONTAINS GEMCITABINE HYDROCHLORIDE 2 200,0 mg | 000 mg/220 ml 2 | 54085154/26/0851 | Registered | S4 | None |
| * jemeta 200 EACH VIAL CONTAINS: GEMCITABINE HYDROCHLORIDE EQUIVALENT TO GEMCITABINE 200,0 mg | 200 | 55043255/26/0432 | Registered | S4 | None |
| * jemeta 1000 EACH VIAL CONTAINS: GEMCITABINE HYDROCHLORIDE EQUIVALENT TO GEMCITABINE 1 000,0 mg | 1000 | 55043355/26/0433 | Registered | S4 | None |
| Gemcitabine 1 000 mg/10 ML rtu accord EACH VIAL CONTAINS GEMCITABINE 1 000,0 mg | 000 mg/10 ml 1 | 56/26/96256/26/0962 | Registered | S4 | None |
| Gemcitabine 200 mg/2 ML rtu accord EACH VIAL CONTAINS GEMCITABINE 200,0 mg | 200 mg/2 ml | 56096156/26/0961 | Registered | S4 | None |
| Gemcitabine 1 500 mg/15 ML rtu accord EACH VIAL CONTAINS GEMCITABINE 1 500,0 mg | 500 mg/15 ml 1 | 56096356/26/0963 | Registered | S4 | None |
| Gemcitabine 2 000 mg/20 ML rtu accord EACH VIAL CONTAINS GEMCITABINE 2000,0 mg | 000 mg/20 ml 2 | 56096456/26/0964 | 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 Gemcitabine hydrochloride equivalent to gemcitabine
S4: Gemcitabine
Consolidated Schedules 06 July 2026, line 6511
Pharmacological class: Cytostatic agents (class 26)
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
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.