Azelastine
Sold as Rhinolast nasal, Optilast, Arzep nasal, Azelastine zydus, Azelastine pharma-q
4-[(4-Chlorophenyl)methyl]-2-(1-methylazepan-4-yl)phthalazin-1-one
Drag to rotate. Structure from PubChem CID 2267.
Background
Registration
- Applicants
- 4
- Registrations
- 5
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Viatris Healthcare (Pty) LtdCancelled | Rhinolast nasal | spray | 270590 | S2 | None |
| Viatris South Africa (Pty) LtdCancelled | Optilast | Not stated | 360011 | S2 | None |
| Zydus Healthcare (Pty) Ltd | Arzep nasal, Azelastine zydus | spray, 0,14 mg | 460107, 460108 | S2 | None |
| Pharma-q Holdings (Pty) Ltd | Azelastine pharma-q | Not stated | 470142 | S2 | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Rhinolast nasal spray EACH METERED SPRAY CONTAINS AZELASTINE HYDROCHLORIDE 0,14 mg | Spray | 27059027/5.7.1/0590 | Cancelled | S2 | None |
| Optilast EACH 1,0 ml DROPS CONTAIN AZELASTINE HYDROCHLORIDE 500,0 mg | Not listed | 36001136/15.4/0011 | Cancelled | S2 | None |
| Arzep nasal spray EACH METERED SPRAY CONTAINS AZELASTINE HYDROCHLORIDE 0,14 mg | Spray | 46010746/5.7.1/0107 | Registered | S2 | None |
| Azelastine zydus 0,14 MG EACH METERED SPRAY CONTAINS AZELASTINE HYDROCHLORIDE 0,14 mg | 0,14 mg | 46010846/5.7.1/0108 | Registered | S2 | None |
| Azelastine pharma-q Each 1 ml contains AZELASTINE HYDROCHLORIDE 0,5 mg | Not listed | 47014247/15.4/0142 | Registered | S2 | None |
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 Azelastine hydrochloride
S2: Azelastine
Consolidated Schedules 06 July 2026, line 1639
Pharmacological class: Antihistaminics. (class 5.7.1)
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
SAHPRA has not published a professional information or patient information leaflet for this product.