Azelastine, fluticasone propionate (Dymista Nasal)
Azelastine, fluticasone propionate
Viatris Healthcare (Pty) Ltd
Registration
- Applicant
- Viatris Healthcare (Pty) Ltd
- Certificate holder
- Viatris Healthcare (Pty) Ltd
- Registrations
- 1
- Schedule source
- SAHPRA documentation
Variants
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, read from the product's PI-PIL leaflet.
The Consolidated Schedules list this ingredient up to S4; the leaflet's S2 applies to this product.
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, fluticasone propionate
S4: Fluticasone propionate
- when intended for nasal administration as an aqueous spray, in the short-term (less than 6 months prophylaxis and treatment of the symptoms of seasonal allergic rhinitis (hay fever) in adults and children over 12 years of age, subject to- (i) a maximum daily dose of 100 micrograms per nostril; and (ii) a maximum pack size of 120 doses. (S2)
- when intended for inhalation or nasal administration. (S3)
Consolidated Schedules 06 July 2026, lines 6423 to 6433
S3: Fluticasone propionate
- when intended for inhalation or nasal administration;
- except when intended for nasal administration as an aqueous spray in the short-term (less than 6 months prophylaxis and treatment of the symptoms of seasonal allergic rhinitis (hay fever) in adults and children over 12 years of age, subject to- (i) a maximum daily dose of 100 micrograms per nostril; and (ii) a maximum pack size of 120 doses. (S2)
- except when intended for administration other than by inhalation or nasal administration. (S4)
Consolidated Schedules 06 July 2026, lines 3641 to 3653
S2: Azelastine
Consolidated Schedules 06 July 2026, line 1639
S2: Fluticasone propionate
- when intended for nasal administration, as an aqueous spray, in the short-term (less than 6 months) prophylaxis and treatment of symptoms of seasonal allergic rhinitis (hay fever) in adults and children over 12 years of age, subject to- (i) a maximum daily dose of 100 micrograms per nostril; (ii) and a maximum pack size limit of 120 doses; (S3)
- except when intended for administration other than by inhalation or nasal administration. (S4)
Consolidated Schedules 06 July 2026, lines 2042 to 2052
Pharmacological class: Corticosteroids and analogues. (class 21.5.1)
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.
Combination product
This product contains more than one active ingredient, so it has no single molecular structure.
SAHPRA documents
Schedule Verification
This medication's schedule (S2) has been verified from official SAHPRA documents with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.