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Salmeterol

Sold as Serevent accuhaler, Serevent cfc-free

S4Read from the PI-PIL document and verified

No structure available

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

Background

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Registration

Applicants
1
Registrations
2
Schedule source
SAHPRA documentation

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Glaxosmithkline South Africa (Pty) LimitedCertificate held by Glaxosmithkline South Africa (Pty) LtdSerevent accuhaler, Serevent cfc-free25 μg290350, A400064S4PIPIL

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Serevent accuhaler

EACH BLISTER CONTAINS SALMETEROL XINAFOATE EQUIVALENT TO SALMETEROL 50 ug

Not listed29035029/10.2.1/0350RegisteredNot determinedNone
Serevent inhaler cfc-free

EACH METERED DOSE DELIVERS SALMETEROL 25,0 ug

25 μgMetered-dose inhalerA400064A40/10.2.1/0064Approved 23 January 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

  • 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: inhalants. (class 10.2.1)

Matched through the component Fluticasone propionate.

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.

SAHPRA documents

Schedule verified from official documents

Schedule Verification

Serevent inhaler cfc-free, Glaxosmithkline South Africa (Pty) Limited is scheduled S4 in its official SAHPRA documents, read with 90% confidence.

These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.

Research articles

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