Glycopyrronium
Sold as Seebri breezhaler, Glenispera, Glycostom, Glycopyrrolate fresenius, Robinul, Robinul injectable
(1,1-Dimethylpyrrolidin-1-ium-3-yl) 2-cyclopentyl-2-hydroxy-2-phenylacetate
Drag to rotate. Structure from PubChem CID 3494.
Background
Registration
- Applicants
- 6
- Registrations
- 8
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Novartis South Africa (Pty) Ltd | Seebri breezhaler | Not stated | 460840 | Not determined | None |
| Glenmark Pharmaceuticals South Africa (Pty) Ltd | Glenispera | 50 µg | 570042 | Not determined | None |
| Pharma-q (Pty) Ltd | Glycostom | 0,2 mg/ml | 570729 | Not determined | None |
| Fresenius Kabi Manufacturing SA (Pty) Ltd | Glycopyrrolate fresenius | 0,2 mg/1 ml, 0,4 mg/2 ml | A400044, A400101 | Not determined | None |
| Continental Ethicals (Pty) LtdCancelled | Robinul | tablets | C0561 | Not determined | None |
| Pharmacare limited û woodmead | Robinul injectable | 1 ml, 2 ml | J0050, W0129 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Seebri breezhaler EACH CAPSULE CONTAINS GLYCOPYRRONIUM BROMIDE EQUIVALENT TO GLYCOPYRRONIUM 50,0 ug | Not listed | 46084046/10.2.1/0840 | Registered | Not determined | None |
| Glenispera 50 µg EACH DOSE CONTAINS GLYCOPYRROLATE EQUIVALENT TO GLYCOPYRRONIUM 50,0 µg | 50 µg | 57004257/10.2.1/0042 | Registered | Not determined | None |
| Glycostom 0,2 mg/ml Each 1,0 ml solution contains: Glycopypronium Bromide 0,2 mg/ml | 0,2 mg/ml | 57072957/5.4/0729 | Registered | Not determined | None |
| Glycopyrrolate 0,4 mg/2 ML fresenius EACH 2,0 ml SOLUTION CONTAINS GLYCOPYRRONIUM BROMIDE 0,4 mg | 0,4 mg/2 ml | A400044A40/5.4/0044 | Registered | Not determined | None |
| Glycopyrrolate 0,2 mg/1 ML fresenius EACH 1,0 ml SOLUTION CONTAINS GLYCOPYRRONIUM BROMIDE 0,2 mg | 0,2 mg/1 ml | A400101A40/5.4/0101 | Registered | Not determined | None |
| Robinul tablets TABLET GLYCOPYRRONIUM BROMIDE A 1 MG | Tablets | C0561 | Cancelled | Not determined | None |
| Robinul 1 ML injectable EACH 1 ml CONTAINS GLYCOPYRRONIUM BROMIDE 0,2 mg | 1 ml | J0050J/5.4/50 | Registered | Not determined | None |
| Robinul 2 ML injectable EACH 2 ml CONTAINS GLYCOPYRRONIUM BROMIDE 0,4 mg | 2 ml | W0129W/5.4/129 | 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
S3: Glycopyrronium
Consolidated Schedules 06 July 2026, line 3691
1 of 2 approved products with this ingredient carry S4 on their leaflet.
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
SAHPRA has not published a professional information or patient information leaflet for this product.