Fluticasone propionate
Sold as Cutivate, Flixotide accuhaler, Flixotide cfc-free, Flixonase nasules, Flonase aqueous nasal, Cipla-fluticasone dp-caps, Flohale dp-caps, Flomist, Cipla-fluticasone aqueous nasal, Nazulair, Maklomist, Flixonase aqueous nasal
[(6S,8S,9R,10S,11S,13S,14S,16R,17R)-6,9-Difluoro-17-(fluoromethylsulfanylcarbonyl)-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] propanoate
Drag to rotate. Structure from PubChem CID 444036.
Background
Registration
- Applicants
- 5
- Registrations
- 22
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Glaxosmithkline South Africa (Pty) Limited1 of 9 cancelled | Cutivate, Flixotide accuhaler, Flixotide cfc-free, Flixonase nasules, Flixonase aqueous nasal | cream, 50, 100, 125, 250, 400 micrograms/dose, spray | 270441, 300068, 300069, 300070, 320082, 320083, 330329, 350377, X0359 | Not determined | PIPIL |
| Pharmacare limited û woodmead | Flonase aqueous nasal | spray | 360504 | Not determined | None |
| Cipla Medpro (Pty) Ltd7 of 8 cancelled | Cipla-fluticasone dp-caps, Flohale dp-caps, Flomist, Cipla-fluticasone aqueous nasal | 50, 100, 250, spray | 370146, 370147, 370148, 370149, 370150, 370151, 370289, 370290 | Not determined | None |
| Kahma Biotech (Pty) Ltd | Nazulair | Not stated | 570618 | Not determined | None |
| Macleods Pharmaceuticals SA (Pty) Ltd | Maklomist | 50, 125, 250 | 570764, 570765, 570766 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Cutivate cream EACH 100 g CREAM CONTAINS FLUTICASONE PROPIONATE 0,05 g | Cream | 27044127/13.4.1/0441 | Cancelled | Not determined | None |
| Flixotide 50 accuhaler EACH BLISTER CONTAINS FLUTICASONE PROPIONATE 50 mcg | 50 | 30006830/21.5.1/0068 | Registered | Not determined | None |
| Flixotide 100 accuhaler EACH BLISTER CONTAINS FLUTICASONE PROPIONATE 100 mcg | 100 | 30006930/21.5.1/0069 | Registered | Not determined | None |
| Flixotide 250 accuhaler EACH BLISTER CONTAINS FLUTICASONE PROPIONATE 250 mcg | 250 | 30007030/21.5.1/0070 | Registered | Not determined | None |
| Flixotide 125 inhaler cfc-free EACH ACTUATION CONTAINS FLUTICASONE PROPIONATE 125,0 ug | 125Inhaler | 32008232/21.5.1/0082 | Registered | Not determined | None |
| Flixotide 250 inhaler cfc-free EACH ACTUATION CONTAINS FLUTICASONE PROPIONATE 250,0 ug | 250Inhaler | 32008332/21.5.1/0083 | Registered | Not determined | None |
| Flixonase nasules EACH DOSE CONTAINS FLUTICASONE PROPIONATE 400,0 mcg | 400 micrograms/dose.Nasal drops | 33032933/21.5.1/0329Approved 6 December 2020 | Registered | Not determined | PIPIL |
| Flixotide 50 inhaler cfc-free EACH METERED DOSE CONTAINS FLUTICASONE PROPIONATE 50,0 ug | 50Inhaler | 35037735/21.5.1/0377 | Registered | Not determined | None |
| Flonase aqueous nasal spray EACH METERED DOSE CONTAINS FLUTICASONE PROPIONATE 50,0 ug | Spray | 36050436/21.5.1/0504 | Registered | Not determined | None |
| Cipla-fluticasone 50 dp-caps EACH CAPSULE CONTAINS FLUTICASONE PROPIONATE 50,0 ug | 50 | 37014637/21.5.1/0146 | Cancelled | Not determined | None |
| Cipla-fluticasone 100 dp-caps EACH CAPSULE CONTAINS FLUTICASONE PROPIONATE 100,0 ug | 100 | 37014737/21.5.1/0147 | Cancelled | Not determined | None |
| Cipla-fluticasone 250 dp-caps EACH CAPSULE CONTAINS FLUTICASONE PROPIONATE 250,0 ug | 250 | 37014837/21.5.1/0148 | Cancelled | Not determined | None |
| Flohale 50 dp-caps EACH CAPSULE CONTAINS FLUTICASONE PROPIONATE 50,0 ug | 50 | 37014937/21.5.1/0149 | Cancelled | Not determined | None |
| Flohale 100 dp-caps EACH CAPSULE CONTAINS FLUTICASONE PROPIONATE 100,0 ug | 100 | 37015037/21.5.1/0150 | Cancelled | Not determined | None |
| Flohale 250 dp-caps EACH CAPSULE CONTAINS FLUTICASONE PROPIONATE 250,0 ug | 250 | 37015137/21.5.1/0151 | Cancelled | Not determined | None |
| Flomist EACH METERED SPRAY CONTAINS FLUTICASONE PROPIONATE 50,0 ug | Not listed | 37028937/21.5.1/0289 | Registered | Not determined | None |
| Cipla-fluticasone aqueous nasal spray EACH METERED SPRAY CONTAINS FLUTICASONE PROPIONATE 50,0 ug | Spray | 37029037/21.5.1/0290 | Cancelled | Not determined | None |
| Nazulair Each 0,4 ml Dose contains: Fluticasone Propionate 400,0 ug | Not listed | 57061857/21.5.1/0618 | Registered | Not determined | None |
| Maklomist 50 EACH SINGLE ACTUATION CONTAINS: FLUTICASONE PROPIONATE 50,0 μg | 50 | 57076457/21.5.1/0764 | Registered | Not determined | None |
| Maklomist 125 EACH SINGLE ACTUATION CONTAINS: FLUTICASONE PROPIONATE 125,0 μg | 125 | 57076557/21.5.1/0765 | Registered | Not determined | None |
| Maklomist 250 EACH SINGLE ACTUATION CONTAINS: FLUTICASONE PROPIONATE 250,0 μg | 250 | 57076657/21.5.1/0766 | Registered | Not determined | None |
| Flixonase aqueous nasal spray EACH METERED DOSE CONTAINS FLUTICASONE PROPIONATE 50 ug | Spray | X0359X/21.5.1/359 | Registered | Not determined | None |
Regulatory status
This product is still scheduled by law even when this site could not determine which tier it falls under. The label carries the S number in a square border; ask a pharmacist if you need to know its schedule.
Listings for this ingredient that could not be applied to this product
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
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
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
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.