Gemcitabine (Gemtaz, Gemtaz Ready To Use)
Gemcitabine
Ranbaxy Pharmaceutical (Pty) Ltd
Registration
- Applicant
- Ranbaxy Pharmaceutical (Pty) Ltd
- Registrations
- 10
- Schedule source
- Consolidated Schedules 06 July 2026
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| 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 |
| 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 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 |
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.
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.
SAHPRA documents
SAHPRA has not published a professional information or patient information leaflet for this product.