Ofloxacine
Sold as Zanocin, Adco-ofloxacin, Tafloc, Garec-ofloxacin, Octin, Ofloxacin austell, Exocin
7-Fluoro-2-methyl-6-(4-methylpiperazin-1-yl)-10-oxo-4-oxa-1-azatricyclo[7.3.1.05,13]trideca-5(13),6,8,11-tetraene-11-carboxylic acid
Drag to rotate. Structure from PubChem CID 4583.
Background
Registration
- Applicants
- 6
- Registrations
- 12
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Unimed Healthcare (Pty) Ltd | Zanocin | 200, 400 | 340209, 340210 | Not determined | None |
| MSQ Pharma (Pty) Ltd | Adco-ofloxacin | 200 mg, 400 mg | 340211, 340212 | Not determined | None |
| Pharmacare limited û woodmead2 of 4 cancelled | Tafloc, Garec-ofloxacin | 200 mg, 400 mg | 350174, 350175, 350176, 350177 | Not determined | None |
| Cipla Medpro (Pty) Ltd | Octin | Not stated | 360002 | Not determined | None |
| Austell Pharmaceuticals (Pty) Ltd | Ofloxacin austell | 200 mg, 400 mg | A390149, A390150 | Not determined | None |
| Abbvie (Pty) Ltd | Exocin | 3,0 mg/ml | Z0347 | S4 | PIPIL |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Zanocin 200 tablets EACH TABLET CONTAINS OFLOXACINE 200,0 mg | 200Tablets | 34020934/20.1.1/0209 | Registered | Not determined | None |
| Zanocin 400 tablets EACH TABLET CONTAINS OFLOXACINE 400,0 mg | 400Tablets | 34021034/20.1.1/0210 | Registered | Not determined | None |
| Adco-ofloxacin 200 MG EACH TABLET CONTAINS OFLOXACINE 200,0 mg | 200 mg | 34021134/20.1.1/0211 | Registered | Not determined | None |
| Adco-ofloxacin 400 MG EACH TABLET CONTAINS OFLOXACINE 400,0 mg | 400 mg | 34021234/20.1.1/0212 | Registered | Not determined | None |
| Tafloc 200 MG EACH TABLET CONTAINS OFLOXACINE 200,0 mg | 200 mg | 35017435/20.1.1/0174 | Registered | Not determined | None |
| Tafloc 400 MG EACH TABLET CONTAINS OFLOXACINE 400,0 mg | 400 mg | 35017535/20.1.1/0175 | Registered | Not determined | None |
| Garec-ofloxacin 200 MG Each Tablet Contains: Ofloxacine 200 mg | 200 mg | 35017635/20.2.2/0176 | Cancelled | Not determined | None |
| Garec-ofloxacin 400 MG Each Tablet Contains: Ofloxacine 400 mg | 400 mg | 35017735/20.2.2/0177 | Cancelled | Not determined | None |
| Octin EACH 5,0 ml SOLUTION CONTAINS:OFLOXACINE 15,0 mg | Not listed | 36000236/15.1/0002 | Registered | Not determined | None |
| Ofloxacin 200 MG austell EACH TABLET CONTAINS OFLOXACINE 200,0 mg | 200 mg | A390149A39/20.1.1/0149 | Registered | Not determined | None |
| Ofloxacin 400 MG austell EACH TABLET CONTAINS OFLOXACINE 400,0 mg | 400 mg | A390150A39/20.1.1/0150 | Registered | Not determined | None |
| Exocin EACH 1 ml SOLUTION CONTAINS OFLOXACINE 3 mg | 3,0 mg/mlOphthalmic solution (eye drops) | Z0347Z/15.1/347Approved 21 April 2023 | Registered | S4 | PIPIL |
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, read from the product's PI-PIL leaflet.
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.
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
Schedule Verification
Exocin, Abbvie (Pty) Ltd is scheduled S4 in its official SAHPRA documents, read with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.