Formoterol, fluticasone propionate (Tizaglenn Co)
Formoterol, fluticasone propionate
Glenmark Pharmaceuticals South Africa (Pty) Ltd
Registration
- Applicant
- Glenmark Pharmaceuticals South Africa (Pty) Ltd
- Registrations
- 1
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Tizaglenn co 12 ug/250 ug Each Capsule contains: Formoterol Fumarate 12,0 ug; Fluticasone Propionate 250,0 ug | 12 ug/250 ug | 57033957/10.2.1/0339 | 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
S4: Formoterol
Consolidated Schedules 06 July 2026, line 6443
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.
Combination product
This product contains more than one active ingredient, so it has no single molecular structure.
SAHPRA documents
SAHPRA has not published a professional information or patient information leaflet for this product.