Ketotifen
Sold as Parke-med ketotifen, Zetofen, Adco-ketotifen alcohol and sugar free, Zaditen eye, Ketagex eye, Ketotifen ipharma
2-(1-Methylpiperidin-4-ylidene)-6-thiatricyclo[8.4.0.03,7]tetradeca-1(14),3(7),4,10,12-pentaen-8-one
Drag to rotate. Structure from PubChem CID 3827.
Background
Registration
- Applicants
- 3
- Registrations
- 6
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Adcock ingram limited2 of 4 cancelled | Parke-med ketotifen, Zetofen, Adco-ketotifen alcohol and sugar free, Zaditen eye | drops | 300620, 320619, 330431, 350076 | S2 | None |
| Soflens (Pty) Ltd | Ketagex eye | drops | 471166 | S2 | None |
| Ipharma (Pty) Ltd | Ketotifen ipharma | 0,25 mg | 540176 | S2 | PIPIL |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Parke-med ketotifen Each tablet contains: Ketotifen | Not listed | 30062030/10.2.2/0620 | Registered | S2 | None |
| Zetofen EACH 5,0 ml SYRUP CONTAINS KETOTIFEN FUMARATE EQUIVALENT TO KETOTIFEN 1,0 mg | Not listed | 32061932/10.2.2/0619 | Registered | S2 | None |
| Adco-ketotifen alcohol and sugar free EACH 5,0 ml SYRUP CONTAINS KETOTIFEN FUMARATE EQUIVALENT TO KETOTIFEN 1,0 mg | Not listed | 33043133/10.2.2/0431 | Cancelled | S2 | None |
| Zaditen eye drops EACH 1,0 ml SOLUTION CONTAINS KETOTIFEN FUMARATE EQUIVALENT TO KETOTIFEN 0,25 mg | Drops | 35007635/15.4/0076 | Cancelled | S2 | None |
| Ketagex eye drops Each 1,0 ml contains 0,345 mg KETOTIFEN FUMARATE EQUIVALENT TO KETOTIFEN 0,25 mg | Drops | 47116647/15.4/1166 | Registered | S2 | None |
| Ketotifen ipharma EACH 1,0 ml SOLUTION CONTAINS KETOTIFEN FUMARATE EQUIVALENT TO KETOTIFEN 0,25 mg | 0,25 mgEye drops solution | 54017654/15.4/0176Approved 10 August 2022 | Registered | S2 | PIPIL |
Regulatory status
Where S2 sits on the scale
A pharmacist can sell it directly, without a prescription.
Schedule 2 medicines sit behind the pharmacy counter. A pharmacist can decide to sell one of these directly, using their own professional judgement, without a doctor's prescription. It can also be dispensed against a prescription like the higher tiers, in which case the usual repeat limits apply. A child under 12 may only be sold a Schedule 2 substance on a prescription, or on a written order that names the purpose and carries a signature the seller recognises. Even though it cannot be advertised to the public in the ordinary sense, 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 S2, matched to the Consolidated Schedules by ingredient, confidence high.
Who may supply: Only a pharmacist, pharmacist intern or supervised pharmacist's assistant may sell it without a prescription. It may otherwise be dispensed by a pharmacist 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); and, for animal treatment, a person practising a para-veterinary profession, on a veterinarian's written or verbal instruction.
Consolidated Schedules listings for Ketotifen
S2: Ketotifen
Consolidated Schedules 06 July 2026, line 2222
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
Ketotifen ipharma, Ipharma (Pty) Ltd is scheduled S2 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.