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Sereflo Dpi

Fluticasone propionate, salmeterol

S4Read from the PI-PIL document and verified

Combination product

This product contains more than one active ingredient, so it has no single molecular structure.

Registration

Applicants
1
Registrations
1
Schedule source
SAHPRA documentation

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Cipla Medpro (Pty) LtdSereflo dpi50/500 µg560069.068S4PIPIL

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Sereflo 50/500 dpi

EACH BLISTER CONTAINS SALMETEROL XINAFOATE EQUIVALENT TO SALMETEROL 50,0 µg FLUTICASONE PROPIONATE 500,0 µg

50/500 µgInhalation powder560069.06856/21.5.1/0069.068Approved 17 October 2023RegisteredS4PIPIL

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 Salmeterol xinafoate equivalent to salmeterol, 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

  • S4: Salmeterol

    Consolidated Schedules 06 July 2026, line 7878

  • 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: 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.

Background

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SAHPRA documents

Schedule verified from official documents

Schedule Verification

Sereflo 50/500 dpi, Cipla Medpro (Pty) Ltd is scheduled S4 in its official SAHPRA documents, read with 90% confidence.

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

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