Indacaterol, mometasone furoate (Atectura Breezhaler, Bemrist Breezhaler)
Indacaterol, mometasone furoate
Novartis South Africa (Pty) Ltd
Registration
- Applicant
- Novartis South Africa (Pty) Ltd
- Certificate holder
- Novartis South Africa (Pty) Ltd
- Registrations
- 6
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Atectura breezhaler 150/80 EACH CAPSULE CONTAINS INDACATEROL ACETATE EQUIVALENT TO INDACATEROL 150,0 ug MOMETASONE FUROATE 80,0 ug | 80_g. 150_g. 160_g. 320_gPowder for inhalation | 54086754/10.2.1/0867Approved 12 October 2021 | Registered | Not determined | PIPIL |
| Atectura breezhaler 150/160 EACH CAPSULE CONTAINS INDACATEROL ACETATE EQUIVALENT TO INDACATEROL 150,0 ug MOMETASONE FUROATE 160,0 ug | 80_g. 150_g. 160_g. 320_gPowder for inhalation | 54086854/10.2.1/0868Approved 12 October 2021 | Registered | Not determined | PIPIL |
| Atectura breezhaler 150/320 EACH CAPSULE CONTAINS INDACATEROL ACETATE EQUIVALENT TO INDACATEROL 150,0 ug MOMETASONE FUROATE 320,0 ug | 80_g. 150_g. 160_g. 320_gPowder for inhalation | 54086954/10.2.1/0869Approved 12 October 2021 | Registered | Not determined | PIPIL |
| Bemrist breezhaler 150/80 EACH CAPSULE CONTAINS INDACATEROL ACETATE EQUIVALENT TO INDACATEROL 150,0 ug MOMETASONE FUROATE 80,0 ug | 80_g. 150_g. 160_g. 320_gPowder for inhalation | 540870.86754/10.2.1/0870.867Approved 12 October 2021 | Registered | Not determined | PIPIL |
| Bemrist breezhaler 150/160 EACH CAPSULE CONTAINS INDACATEROL ACETATE EQUIVALENT TO INDACATEROL 150,0 ug MOMETASONE FUROATE 160,0 ug | 80_g. 150_g. 160_g. 320_gPowder for inhalation | 540871.86854/10.2.1/0871.868Approved 12 October 2021 | Registered | Not determined | PIPIL |
| Bemrist breezhaler 150/320 EACH CAPSULE CONTAINS INDACATEROL ACETATE EQUIVALENT TO INDACATEROL 150,0 ug MOMETASONE FUROATE 320,0 ug | 80_g. 150_g. 160_g. 320_gPowder for inhalation | 540872.86954/10.2.1/0872.869Approved 12 October 2021 | Registered | Not determined | PIPIL |
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: Indacaterol
Consolidated Schedules 06 July 2026, line 6742
S4: Mometasone furoate
- except when intended for inhalation or nasal administration.
Consolidated Schedules 06 July 2026, line 7167
S3: Glycopyrronium
Consolidated Schedules 06 July 2026, line 3691
S3: Indacaterol
Consolidated Schedules 06 July 2026, line 3778
S3: Mometasone furoate
- when intended for inhalation or nasal administration, except when intended for nasal administration as an aqueous spray, other than by pressurized aerosol, and indicated for the treatment of the symptoms of seasonal or perennial allergic rhinitis (hay fever) in adults and children between the age of 2 and 11 years of age, subject to
- a maximum dose of 200 micrograms per nostril in adults and 50 micrograms per nostril in children; and
- a maximum pack size of 200 doses. (S2, S4)
Consolidated Schedules 06 July 2026, lines 3960 to 3965
S2: Mometasone furoate
- when intended for nasal administration as an aqueous spray, other than by pressurized aerosol, and indicated for the treatment of the symptoms of seasonal or perennial allergic rhinitis (hay fever) in adults and children between the age of 2 and 11 years of age, subject to
- a maximum dose of 200 micrograms per nostril in adults and 50 micrograms per nostril in children; and
- a maximum pack size of 200 doses. (S3, S4)
Consolidated Schedules 06 July 2026, lines 2284 to 2290
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
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.