Skip to content
zameds

Elebrato Ellipta

Fluticasone furoate, umeclidinium, vilanterol

No structure available

This product's active ingredient could not be matched to a single known compound.

Registration

Applicants
1
Registrations
1

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Glaxosmithkline South Africa (Pty) LimitedCertificate held by Glaxosmithkline South Africa (Pty) LtdElebrato ellipta100 μg/ 62,5 μg/25 μg520178Not determinedPIPIL

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
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 inhalation52017852/21.5.1/0178Approved 11 April 2024RegisteredNot determinedPIPIL

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

  • 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

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.

Background

Loading...
Loading Wikipedia summary

SAHPRA documents

Professional information (PI)For healthcare professionalsElebrato ellipta, Glaxosmithkline South Africa (Pty) Limited. For TRELEGY ELLIPTA by GlaxoSmithKline South Africa (Pty) Limited, a registered product with the same active ingredient, strength and dosage formPatient information leaflet (PIL)For patients and carersElebrato ellipta, Glaxosmithkline South Africa (Pty) Limited

These documents come from SAHPRA's PI-PIL repository unless the line under a document says otherwise. Always consult with a healthcare professional for medical advice.

Research articles

Loading...
Loading PubMed articles