Vilanterol (Trelegy Ellipta, Elebrato Ellipta)
Vilanterol
Glaxosmithkline South Africa (Pty) Limited
Registration
- Applicant
- Glaxosmithkline South Africa (Pty) Limited
- Certificate holder
- Glaxosmithkline South Africa (Pty) Ltd
- Registrations
- 2
- Schedule source
- SAHPRA documentation
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Trelegy ellipta EACH DELIVERED DOSE CONTAINS FLUTICASONE FUROATE 92,0 μg; UMECLIDINIUM BROMIDE EQUIVALENT TO UMECLIDINIUM 55,0 μg; VILANTEROL TRIFENATATE EQUIVALENT TO VILANTEROL 22,0 μg | 100 μg/ 62,5 μg/ 25 μgPowder for inhalation | 52017752/21.5.1/0177Approved 11 April 2024 | Registered | S4 | PIPIL |
| Elebrato ellipta EACH DELIVERED DOSE CONTAINS FLUTICASONE FUROATE 92,0 μg; UMECLIDINIUM BROMIDE EQUIVALENT TO UMECLIDINIUM 55,0 μg; VILANTEROL TRIFENATATE EQUIVALENT TO VILANTEROL 22,0 μg | 100 μg/ 62,5 μg/25 μgPowder for inhalation | 52017852/21.5.1/0178Approved 11 April 2024 | Registered | Not determined | 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.
Consolidated Schedules listings for Fluticasone furoate, umeclidinium bromide equivalent to umeclidinium, vilanterol trifenatate equivalent to vilanterol
S4: Fluticasone furoate
- 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 55 micrograms per nostril; and (ii) a maximum pack size limit of 120 doses. (S2)
- when intended for inhalation or nasal administration. (S3)
Consolidated Schedules 06 July 2026, lines 6411 to 6421
S4: Vilanterol
Consolidated Schedules 06 July 2026, line 8376
S3: Fluticasone furoate
- 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 55 micrograms per nostril; and (ii) a maximum pack size limit of 120 doses. (S2)
- except when intended for administration other than by inhalation or nasal administration. (S4)
Consolidated Schedules 06 July 2026, lines 3622 to 3639
S3: Umeclidinium
Consolidated Schedules 06 July 2026, line 4366
S2: Fluticasone furoate
- 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 55 micrograms per nostril; and (ii) 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 2033 to 2040
Pharmacological class: Corticosteroids and analogues. (class 21.5.1)
Matched through the components Fluticasone furoate, Umeclidinium.
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.
No structure available
This product's active ingredient could not be matched to a single known compound.
SAHPRA documents
Schedule Verification
This medication's schedule (S4) 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.