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Formoterol (Foratec Dp-caps, Foratec Hfa, Cipla-formoterol Fumarate Hfa)

Formoterol

Cipla Medpro (Pty) Ltd

Registration

Applicant
Cipla Medpro (Pty) Ltd
Registrations
3

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Foratec dp-caps

EACH CAPSULE CONTAINS FORMOTEROL FUMARATE 12,0 ug

Not listed37008437/10.2.1/0084RegisteredNot determinedNone
Foratec hfa

EACH METERED DOSE CONTAINS FORMOTEROL FUMARATE 12,0 ug

Not listedA400413A40/10.2.1/0413RegisteredNot determinedNone
Cipla-formoterol fumarate hfa

EACH METERED DOSE CONTAINS FORMOTEROL FUMARATE 12,0 ug

Not listedA400414A40/10.2.1/0414CancelledNot determinedNone

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: Budesonide

    • except when intended for the prophylaxis and treatment of seasonal and perennial allergic rhinitis in adults and children aged 12 years and older; (S2)
    • except when intended for inhalation or nasal administration, unless listed in another Schedule. (S3)

    Consolidated Schedules 06 July 2026, lines 5577 to 5582

  • S4: Formoterol

    Consolidated Schedules 06 July 2026, line 6443

  • S3: Budesonide

    • when intended inhalation or nasal administration, unless listed in another Schedule. (S4)
    • except when intended for the prophylaxis and treatment of seasonal and perennial allergic rhinitis in adults and children aged 12 years and older. (S2)

    Consolidated Schedules 06 July 2026, lines 3237 to 3242

  • S3: Glycopyrronium

    Consolidated Schedules 06 July 2026, line 3691

  • S2: Budesonide

    • when intended for the prophylaxis and treatment of seasonal and perennial allergic rhinitis in adults and children aged 12 years and older; (S3)
    • except when intended for inhalation and nasal administration, unless listed in another Schedule. (S4)

    Consolidated Schedules 06 July 2026, lines 1696 to 1701

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.

C19H24N2O4344.40 g/mol

N-[2-Hydroxy-5-[1-hydroxy-2-[1-(4-methoxyphenyl)propan-2-ylamino]ethyl]phenyl]formamide

Drag to rotate. Structure from PubChem CID 3410.

SAHPRA documents

SAHPRA has not published a professional information or patient information leaflet for this product.

Background

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Research articles

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