Salmeterol (Serevent Accuhaler, Seretide Accuhaler, Seretide, Foxair, Foxair Accuhaler, Serevent Cfc-free)

Salmeterol

Glaxosmithkline South Africa (Pty) Limited

S4Read from the PI-PIL document and verified

Registration

Applicant: Glaxosmithkline South Africa (Pty) Limited
Registrations: 14
Schedule source: SAHPRA documentation

Variants

Product	Strength and form	Registration	Status	Schedule	Leaflets
Serevent accuhaler EACH BLISTER CONTAINS SALMETEROL XINAFOATE EQUIVALENT TO SALMETEROL 50 ug	Not listed	29035029/10.2.1/0350	Registered	Not determined	None
Seretide 50/100 accuhaler EACH BLISTER CONTAINS FLUTICASONE PROPIONATE 100,0 ug SALMETEROL XINAFOATE EQUIVALENT TO SALMETEROL 50,0 ug	50/100	33041333/21.5.4/0413	Registered	Not determined	None
Seretide 50/250 accuhaler EACH BLISTER CONTAINS FLUTICASONE PROPIONATE 250,0 ug SALMETEROL XINAFOATE EQUIVALENT TO SALMETEROL 50,0 ug	50/250	33041433/21.5.4/0414	Registered	Not determined	None
Seretide 50/500 accuhaler EACH BLISTER CONTAINS FLUTICASONE PROPIONATE 500,0 ug SALMETEROL XINAFOATE EQUIVALENT TO SALMETEROL 50,0 ug	50/500	33041533/21.5.4/0415	Registered	Not determined	None
Seretide 25/50 inhaler EACH METERED ACTUATION CONTAINS FLUTICASONE PROPIONATE 50,0 ug SALMETEROL XINAFOATE EQUIVALENT TO SALMETEROL 25,0 ug	25/50Inhaler	35041135/21.5.4/0411	Cancelled	Not determined	None
Seretide 25/125 inhaler EACH METERED ACTUATION CONTAINS FLUTICASONE PROPIONATE 125,0 ug SALMETEROL XINAFOATE EQUIVALENT TO SALMETEROL 25,0 ug	25/125Inhaler	35041235/21.5.4/0412	Cancelled	Not determined	None
Seretide 25/250 EACH METERED ACTUATION CONTAINS FLUTICASONE PROPIONATE 250,0 ugSALMETEROL XINAFOATE EQUIVALENT TO SALMETEROL 25,0 ug	25/250	35041335/21.5.4/0413	Cancelled	Not determined	None
Foxair 25/50 inhaler EACH ACTUATION PROVIDES FLUTICASONE 50,0 ug SALMETEROL XINAFOATE EQUIVALENT TO SALMETEROL 25,0 ug	25/50. 25/125. 25/250Inhaler	42024442/21.5.4/0244Approved 11 December 2015	Registered	S4	PI PIL
Foxair 25/125 inhaler EACH ACTUATION PROVIDES FLUTICASONE 125,0 ug SALMETEROL XINAFOATE EQUIVALENT TO SALMETEROL 25,0 ug	25/50. 25/125. 25/250Inhaler	42024542/21.5.4/0245Approved 11 December 2015	Registered	S4	PI PIL
Foxair 25/250 inhaler EACH ACTUATION PROVIDES FLUTICASONE 250,0 ug SALMETEROL XINAFOATE EQUIVALENT TO SALMETEROL 25,0 ug	25/50. 25/125. 25/250Inhaler	42024642/21.5.4/0246Approved 11 December 2015	Registered	S4	PI PIL
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 inhalation	42058142/21.5.4/0581Approved 10 December 2015	Registered	S4	PI PIL
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 inhalation	42058242/21.5.4/0582Approved 10 December 2015	Registered	S4	PI PIL
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 inhalation	42058342/21.5.4/0583Approved 10 December 2015	Registered	S4	PI PIL
Serevent inhaler cfc-free EACH METERED DOSE DELIVERS SALMETEROL 25,0 ug	25 μgMetered-dose inhaler	A400064A40/10.2.1/0064Approved 23 January 2023	Registered	S4	PI PIL

Regulatory status

Where S4 sits on the scale

S0S1S2S3S4S5S6S7S8

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, 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.

No structure available

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

SAHPRA documents

Schedule verified from official documents

Schedule Verification

This medication's schedule (S4) has been verified from official SAHPRA documents with 90% confidence.

Professional information (PI)For healthcare professionals Patient information leaflet (PIL)For patients and carers

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

Background

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Research articles

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