Latanoprost, timolol
Sold as Xalacom, Co-atana ophthalmic, Oculatim, Latanoprost and timolol cipla, Comixol, Aglatan, Xoptolat ophthalmic, Trinopthal co, Tanotrin co, Trinlotan co, Latanoprost/timolol eye, Vistrolet
(2S)-1-(tert-Butylamino)-3-[(4-morpholin-4-yl-1,2,5-thiadiazol-3-yl)oxy]propan-2-ol
Drag to rotate. Structure from PubChem CID 33624.
Background
Registration
- Applicants
- 8
- Registrations
- 12
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Viatris Healthcare (Pty) Ltd | Xalacom | 5 mg/mL | 360043 | S4 | PIPIL |
| Gen-eye (Pty) Ltd | Co-atana ophthalmic | solution | 470528 | Not determined | None |
| Activo Health (Pty) Ltd | Oculatim | Not stated | 500403 | Not determined | None |
| Cipla Medpro (Pty) LtdCancelled | Latanoprost and timolol cipla, Comixol | Not stated | 500862, 500863.862 | Not determined | None |
| Austell Pharmaceuticals (Pty) Ltd | Aglatan | Not stated | 510618 | Not determined | None |
| Ranbaxy Pharmaceutical (Pty) LtdCancelled | Xoptolat ophthalmic | solution | 520077 | Not determined | None |
| Trinity Pharma (Pty) LtdCertificate held by Trinity Pharma (Pty) Ltd. | Trinopthal co, Tanotrin co, Trinlotan co | 50 μg/mL and 5 mg/mL | 540385, 540386.0385, 540387.0385 | S4 | PIPIL |
| FDC SA (Pty) Ltd | Latanoprost/timolol eye, Vistrolet | drops | 561205, 561206 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Xalacom EACH 1,0 ml SOLUTION CONTAINS LATANOPROST 50,0 ug TIMOLOL MALEATE EQUIVALENT TO TIMOLOL 5,0 mg | 5 mg/mLEye drops. Solution | 36004336/15.4/0043Approved 11 October 2022 | Registered | S4 | PIPIL |
| Co-atana ophthalmic solution EACH 1,0 ml SOLUTION CONTAINS LATANOPROST 50,0 ug TIMOLOL MALEATE EQUIVALENT TO TIMOLOL 5,0 mg | Solution | 47052847/15.4/0528 | Registered | Not determined | None |
| Oculatim Each 1,0 ml contains LATANOPROST 0,05 mg and TIMOLOL MALEATE EQUIVALENT TO TIMOLOL 5,0 mg | Not listed | 50040350/15.4/0403 | Registered | Not determined | None |
| Latanoprost and timolol cipla EACH 1,0 ml SOLUTION CONTAINS LATANOPROST 50,0 ug TIMOLOL MALEATE EQUIVALENT TO TIMOLOL 5,0 mg | Not listed | 50086250/15.4/0862 | Cancelled | Not determined | None |
| Comixol EACH 1,0 ml SOLUTION CONTAINS LATANOPROST 50,0 ug TIMOLOL MALEATE EQUIVALENT TO TIMOLOL 5,0 mg | Not listed | 500863.86250/15.4/0863.862 | Cancelled | Not determined | None |
| Aglatan Each Millilitre contains LATANOPROST 50,0 mcg TIMOLOL MALEATE EQUIVALENT TO TIMOLOL 5,0 mg | Not listed | 51061851/15.4/0618 | Registered | Not determined | None |
| Xoptolat ophthalmic solution Each 1,0 millilitre contains: LATANOPROST 50,0 μg and TIMOLOL MALEATE EQUIVALENT TO TIMOLOL 5,0 mg | Solution | 52007752/15.4/0077 | Cancelled | Not determined | None |
| Trinopthal co Each 1,0 ml Solution contains: Latanoprost 50,0 ug; Timolol Maleate equivalent to Timolol 5,0 mg | 50 μg/mL and 5 mg/mLEye drops, solution | 54038554/15.4/0385Approved 3 June 2025 | Registered | S4 | PIPIL |
| Tanotrin co Each 1,0 ml Solution contains: Latanoprost 50,0 ug ; Timolol Maleate equivalent to timolol 5,0 mg | 50 μg/mL and 5 mg/mLEye drops, solution | 540386.038554/15.4/0386.385Approved 3 June 2025 | Registered | S4 | PIPIL |
| Trinlotan co Each 1,0 ml Solution contains: Latanoprost 50,0 ug; Timolol Maleate equivalent to Timolol 5,0 mg | 50 μg/mL and 5 mg/mLEye drops, solution | 540387.038554/15.4/0387.0385Approved 3 June 2025 | Registered | S4 | PIPIL |
| Latanoprost/timolol eye drops Each 1,0 ml solution contains: Latanoprost 50,0 mg, Timolol Maleate equivalent to Timolol 5,0 mg | Drops | 56120556/15.4/1205 | Registered | Not determined | None |
| Vistrolet Each 1,0 ml solution contains: Latanoprost 50,0 mg, Timolol Maleate equivalent to Timolol 5,0 mg | Not listed | 56120656/15.4/1206.1205 | Registered | Not determined | 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, 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.
Consolidated Schedules listings for Latanoprost, timolol maleate equivalent to timolol
S4: Bimatoprost
Consolidated Schedules 06 July 2026, line 5499
S4: Latanoprost
Consolidated Schedules 06 July 2026, line 6878
S4: Travoprost
Consolidated Schedules 06 July 2026, line 8272
S3: Brinzolamide
Consolidated Schedules 06 July 2026, line 3235
S3: Dorzolamide
Consolidated Schedules 06 July 2026, line 3486
S3: Timolol
Consolidated Schedules 06 July 2026, line 4325
Pharmacological class: Others. (class 15.4)
Matched through the components Bimatoprost, Dorzolamide, Latanoprost, Brinzolamide, Travoprost.
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
Xalacom, Viatris Healthcare (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.