Fluticasone furoate, vilanterol (Revinty Elipta, Relvar Elipta)
Fluticasone furoate, vilanterol
Glaxosmithkline South Africa (Pty) Limited
Registration
- Applicant
- Glaxosmithkline South Africa (Pty) Limited
- Registrations
- 4
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Revinty elipta 92/22 ug EACH SINGLE INHALATION CONTAINS FLUTICASONE FUROATE 92,0 ug VILANTEROL 22,0 ug | 92/22 ug | 48024748/21.5.1/0247 | Registered | Not determined | None |
| Revinty elipta 184/22 ug EACH SINGLE INHALATION CONTAINS FLUTICASONE FUROATE 184,0 ug VILANTEROL 22,0 ug | 184/22 ug | 48024848/21.5.1/0248 | Registered | Not determined | None |
| Relvar elipta 92/22 ug EACH SINGLE INHALATION CONTAINS FLUTICASONE FUROATE 92,0 ug VILANTEROL 22,0 ug | 92/22 ug | 48024948/21.5.1/249 | Registered | Not determined | None |
| Relvar elipta 184/22 ug EACH SINGLE INHALATION CONTAINS FLUTICASONE FUROATE 184,0 ug VILANTEROL 22,0 ug | 184/22 ug | 48025048/21.5.1/0250 | Registered | Not determined | None |
Regulatory status
This product is still scheduled by law even when this site could not determine which tier it falls under. The label carries the S number in a square border; ask a pharmacist if you need to know its schedule.
Listings for this ingredient that could not be applied to this product
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
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
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
SAHPRA has not published a professional information or patient information leaflet for this product.