Salmeterol (Sereflo Hfa, Salmeterol Xinafoate Fluticasone Propionate Cipla, Sereflo Dpi)
Salmeterol
Cipla Medpro (Pty) Ltd
Registration
- Applicant
- Cipla Medpro (Pty) Ltd
- Registrations
- 7
- Schedule source
- SAHPRA documentation
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Sereflo 25/50 hfa EACH ACTUATION DELIVERS FLUTICASONE PROPIONATE 50,0 ug SALMETEROL XINAFOATE EQUIVALENT TO SALMETEROL 25,0 ug | 25/50 | 42021842/21.5.4/0218 | Registered | Not determined | None |
| Sereflo 25/125 hfa EACH ACTUATION DELIVERS FLUTICASONE PROPIONATE 125,0 ug SALMETEROL XINAFOATE EQUIVALENT TO SALMETEROL 25,0 ug | 25/125 | 42021942/21.5.4/0219 | Registered | Not determined | None |
| Sereflo 25/250 hfa EACH ACTUATION DELIVERS FLUTICASONE PROPIONATE 250,0 ug SALMETEROL XINAFOATE EQUIVALENT TO SALMETEROL 25,0 ug | 25/250 | 42022042/21.5.4/0220 | Registered | Not determined | None |
| Salmeterol xinafoate + fluticasone propionate 50/100 cipla EACH BLISTER CONTAINS :FLUTICASONE PROPIONATE EQUIVALENT TO FLUTICASONE 100,0 mg, SALMETEROL XINAFOATE EQUIVALENT TO SALMETEROL 50,0 ug | + 50/100 | 54010954/21.5.1/0109 | Cancelled | Not determined | None |
| Salmeterol xinafoate + fluticasone propionate 50/250 cipla EACH BLISTER CONTAINS FLUTICASONE PROPIONATE EQUIVALENT TO FLUTICASONE 250,0 mg, SALMETEROL XINAFOATE EQUIVALENT TO SALMETEROL 50,0 ug | + 50/250 | 54011054/21.5.1/0110 | Cancelled | Not determined | None |
| Sereflo 50/100 dpi EACH BLISTER CONTAINS FLUTICASONE PROPIONATE EQUIVALENT TO FLUTICASONE 100,0 mg SALMETEROL XINAFOATE EQUIVALENT TO SALMETEROL 50,0 ug | 50/100Inhalation powder | 540111.10954/21.5.1/0111.109Approved 23 March 2023 | Registered | S4 | PIPIL |
| Sereflo 50/250 dpi EACH BLISTER CONTAINS FLUTICASONE PROPIONATE EQUIVALENT TO FLUTICASONE 250,0 mg SALMETEROL XINAFOATE EQUIVALENT TO SALMETEROL 50,0 ug | 50/250Inhalation powder | 540112.1154/21.5.1/0112.110Approved 23 March 2023 | Registered | S4 | PIPIL |
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 equivalent to 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
Pharmacological class: Corticosteroids and analogues. (class 21.5.1)
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.
No structure available
This product's active ingredient could not be matched to a single known compound.
SAHPRA documents
Schedule Verification
This medication's schedule (S4) has been verified from official SAHPRA documents with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.