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Fluticasone propionate, salmeterol

Sold as Seretide accuhaler, Seretide, Sereflo hfa, Foxair accuhaler, Serehale, Salmetrol xinafoate/fluticasone propionate cipla, Sereflo dpi, Duoasma dpi, Douasma dpi

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
4
Registrations
19
Schedule source
SAHPRA documentation

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Glaxosmithkline South Africa (Pty) LimitedCertificate held by Glaxosmithkline South Africa (Pty) Ltd3 of 9 cancelledSeretide accuhaler, Seretide, Foxair accuhaler25/50, 25/125, 25/250, 50/100, 50/250, 50/500330413, 330414, 330415, 350411, 350412, 350413, 420581, 420582, 420583S4PIPIL
Cipla Medpro (Pty) LtdSereflo hfa, Salmetrol xinafoate/fluticasone propionate cipla, Sereflo dpi25/50, 25/125, 25/250, 50/500, 50/500 µg420218, 420219, 420220, 560068, 560069.068S4PIPIL
Innovata pharmaceuticalsSerehale50/100, 50/250, 50/500550730, 550731, 550732Not determinedNone
Glenmark Pharmaceuticals South Africa (Pty) LtdDuoasma dpi, Douasma dpi50/100, 50/250560500, 560501Not determinedNone

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Seretide 50/100 accuhaler

EACH BLISTER CONTAINS FLUTICASONE PROPIONATE 100,0 ug SALMETEROL XINAFOATE EQUIVALENT TO SALMETEROL 50,0 ug

50/10033041333/21.5.4/0413RegisteredNot determinedNone
Seretide 50/250 accuhaler

EACH BLISTER CONTAINS FLUTICASONE PROPIONATE 250,0 ug SALMETEROL XINAFOATE EQUIVALENT TO SALMETEROL 50,0 ug

50/25033041433/21.5.4/0414RegisteredNot determinedNone
Seretide 50/500 accuhaler

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

50/50033041533/21.5.4/0415RegisteredNot determinedNone
Seretide 25/50 inhaler

EACH METERED ACTUATION CONTAINS FLUTICASONE PROPIONATE 50,0 ug SALMETEROL XINAFOATE EQUIVALENT TO SALMETEROL 25,0 ug

25/50Inhaler35041135/21.5.4/0411CancelledNot determinedNone
Seretide 25/125 inhaler

EACH METERED ACTUATION CONTAINS FLUTICASONE PROPIONATE 125,0 ug SALMETEROL XINAFOATE EQUIVALENT TO SALMETEROL 25,0 ug

25/125Inhaler35041235/21.5.4/0412CancelledNot determinedNone
Seretide 25/250

EACH METERED ACTUATION CONTAINS FLUTICASONE PROPIONATE 250,0 ugSALMETEROL XINAFOATE EQUIVALENT TO SALMETEROL 25,0 ug

25/25035041335/21.5.4/0413CancelledNot determinedNone
Sereflo 25/50 hfa

EACH ACTUATION DELIVERS FLUTICASONE PROPIONATE 50,0 ug SALMETEROL XINAFOATE EQUIVALENT TO SALMETEROL 25,0 ug

25/5042021842/21.5.4/0218RegisteredNot determinedNone
Sereflo 25/125 hfa

EACH ACTUATION DELIVERS FLUTICASONE PROPIONATE 125,0 ug SALMETEROL XINAFOATE EQUIVALENT TO SALMETEROL 25,0 ug

25/12542021942/21.5.4/0219RegisteredNot determinedNone
Sereflo 25/250 hfa

EACH ACTUATION DELIVERS FLUTICASONE PROPIONATE 250,0 ug SALMETEROL XINAFOATE EQUIVALENT TO SALMETEROL 25,0 ug

25/25042022042/21.5.4/0220RegisteredNot determinedNone
Foxair 50/100 accuhaler

EACH BLISTER CONTAINS FLUTICASONE PROPIONATE 100,0 ug SALMETEROL XINAFOATE EQUIVALENT TO SALMETEROL 50,0 ug

50/100. 50/250. 50/500Powder for inhalation42058142/21.5.4/0581Approved 10 December 2015RegisteredS4PIPIL
Foxair 50/250 accuhaler

EACH BLISTER CONTAINS FLUTICASONE PROPIONATE 250,0 ug SALMETEROL XINAFOATE EQUIVALENT TO SALMETEROL 50,0 ug

50/100. 50/250. 50/500Powder for inhalation42058242/21.5.4/0582Approved 10 December 2015RegisteredS4PIPIL
Foxair 50/500 accuhaler

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

50/100. 50/250. 50/500Powder for inhalation42058342/21.5.4/0583Approved 10 December 2015RegisteredS4PIPIL
Serehale 50/100

EACH DOSE CONTAINS SALMETEROL XINAFOATE EQUIVALENT TO SALMETEROL 50,0 ug FLUTICASONE PROPIONATE 100,0 ug

50/10055073055/21.5.1/0730RegisteredNot determinedNone
Serehale 50/250

EACH DOSE CONTAINS SALMETEROL XINAFOATE EQUIVALENT TO SALMETEROL 50,0 ug FLUTICASONE PROPIONATE 250,0 ug

50/25055073155/21.5.1/0731RegisteredNot determinedNone
Serehale 50/500

EACH DOSE CONTAINS SALMETEROL XINAFOATE EQUIVALENT TO SALMETEROL 50,0 ug FLUTICASONE PROPIONATE 500,0 ug

50/50055073255/21.5.1/0732RegisteredNot determinedNone
Salmetrol xinafoate/fluticasone propionate 50/500 cipla

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

50/50056006856/21.5.1/0068RegisteredNot determinedNone
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
Duoasma dpi 50/100

EACH DOSE CONTAINS SALMETEROL XINAFOATE EQUIVALENT TO SALMETEROL 50,0 μg FLUTICASONE PROPIONATE 100,0 μg

50/10056050056/21.5/0500RegisteredNot determinedNone
Douasma dpi 50/250

EACH DOSE CONTAINS SALMETEROL XINAFOATE EQUIVALENT TO SALMETEROL 50,0 μg FLUTICASONE PROPIONATE 250,0 μg

50/25056050156/21.5.1/0501RegisteredNot determinedNone

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 propionate, salmeterol xinafoate equivalent to 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

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

Foxair 50/100 accuhaler, Glaxosmithkline South Africa (Pty) Limited is scheduled S4 in its official SAHPRA documents, read with 90% confidence.

Professional information (PI)For healthcare professionalsFoxair 50/100 accuhaler, Glaxosmithkline South Africa (Pty) LimitedPatient information leaflet (PIL)For patients and carersFoxair 50/100 accuhaler, Glaxosmithkline South Africa (Pty) Limited

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

Research articles

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