Sodium cromoglycate (Cromobex, Lecrolyn Sdu, Lecrolyn)
Sodium cromoglycate
Ipharma (Pty) Ltd
Registration
- Applicant
- Ipharma (Pty) Ltd
- Certificate holder
- Ipharma (Pty) Ltd
- Registrations
- 5
- Schedule source
- SAHPRA documentation
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Cromobex EACH 1 ml CONTAINS SODIUM CROMOGLYCATE DIHYDRATE EQUIVALENT TO SODIUM CROMOGLYCATE 20 mg | 20 mg/mlEye drops, solution. | 29038229/15.4/0382Approved 14 April 2023 | Registered | S1 | PIPIL |
| Lecrolyn 20 mg/ml sdu EACH 1,0 ml SOLUTION CONTAINS SODIUM CROMOGLYCATE 20,0 mg | 20 mg/ml | 31032031/15.4/0320 | Registered | Not determined | None |
| Lecrolyn 40 mg/ml sdu EACH 1,0 ml SOLUTION CONTAINS SODIUM CROMOGLYCATE 40,0 mg | 40 mg/ml | 31032131/15.4/0321 | Registered | Not determined | None |
| Lecrolyn 20 mg/ml EACH 1,0 ml SOLUTION CONTAINS SODIUM CROMOGLYCATE 20,0 mg | 20 mg/ml | 31032231/15.4/0322 | Registered | Not determined | None |
| Lecrolyn 40 mg/ml EACH 1,0 ml SOLUTION CONTAINS SODIUM CROMOGLYCATE 40,0 mg | 40 mg/ML | 31032331/15.4/0323 | Registered | Not determined | None |
Regulatory status
Where S1 sits on the scale
Sold by a pharmacist, no doctor's prescription needed.
Schedule 1 medicines are normally sold by a pharmacist, or by a supervised pharmacist intern or assistant, without a doctor's visit; a veterinarian, or a licensed dispensing doctor, dentist or nurse prescriber, may also supply them. A nurse or other non-doctor prescriber may only prescribe the specific substances the Schedule names for that purpose, and may only dispense them if licensed to do so. A child under 12 may only be sold one of these medicines on a prescription, or on a written order that names the purpose and carries a signature the seller recognises.
Schedule S1, read from the product's PI-PIL leaflet.
The Consolidated Schedules list this ingredient up to S4; the leaflet's S1 applies to this product.
Who may supply: A pharmacist, or a supervised pharmacist intern or assistant; manufacturers and wholesalers supplying people who may lawfully possess it; a veterinarian, who may prescribe, compound or dispense it; a medical practitioner or dentist, who may prescribe it, and may compound or dispense it only if licensed under section 22C(1)(a); a nurse or other registered non-doctor prescriber, who may prescribe only the Scheduled substances the Schedule identifies for that purpose, and dispense them if licensed to do so; and, for animal treatment, a person practising a para-veterinary profession, on a veterinarian's written or verbal instruction.
Consolidated Schedules listings for Sodium cromoglycate dihydrate equivalent to sodium cromoglycate
S4: Sodium cromoglycate
- when intended for veterinary use.
Consolidated Schedules 06 July 2026, line 7946
S2: Sodium cromoglycate
- except when intended for veterinary use.
Consolidated Schedules 06 July 2026, line 2668
Pharmacological class: Others. (class 15.4)
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.
No structure available
This product's active ingredient could not be matched to a single known compound.
SAHPRA documents
Schedule Verification
This medication's schedule (S1) has been verified from official SAHPRA documents with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.