Insulin lispro (Humalog, Humalog Mix, Humalog Kwikpen, Lyumjev U100, Lyumjev U200, Lyumjev Junior U100, Bemliru U100, Bemliru U200, Bemliru Junior U100)
Insulin lispro
Eli Lilly (S.A.) (Pty) Ltd
Registration
- Applicant
- Eli Lilly (S.A.) (Pty) Ltd
- Certificate holder
- Eli Lilly (S.A.) (Pty) Ltd
- Registrations
- 10
- Schedule source
- SAHPRA documentation
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Humalog* EACH 1 ml SOLUTION CONTAINS INSULIN LISPRO 100 iu | 100 units/mlSolution for injection. | 29078529/21.1/0785Approved 31 March 2025 | Registered | S3 | PIPIL |
| Humalog mix 25 EACH 1,0 ml SUSPENSION CONTAINS INSULIN LISPRO 100,0 u | 25 | 33007333/21.1/0073 | Registered | S3 | None |
| Humalog mix 50 EACH 1,0 ml SUSPENSION CONTAINS INSULIN LISPRO 100,0 u | 50 | 33007433/21.1/0074 | Registered | S3 | None |
| Humalog 200 units/ml kwikpen EACH 1,0 ml SOLUTION CONTAINS :INSULIN LISPRO 200 units/ml | 200 units/ml | 50068050/21.1/0680 | Cancelled | S3 | None |
| Lyumjev u100 EACH 1,0 ml SOLUTION CONTAINS INSULIN LISPRO 100,0 U | Not listed | 56004756/21.1/0047 | Cancelled | S3 | None |
| Lyumjev u200 EACH 1,0 ml SOLUTION CONTAINS INSULIN LISPRO 200,0 U | 200 units/mLSolution for injection | 56004856/21.1/0048Approved 17 September 2024 | Cancelled | S3 | PIPIL |
| Lyumjev junior u100 EACH 1,0 ml SOLUTION CONTAINS INSULIN LISPRO 100,0 U | Not listed | 56004956/21.1/0049 | Cancelled | S3 | None |
| Bemliru u100 EACH 1,0 ml SOLUTION CONTAINS: INSULIN LISPRO 100,0 U | Not listed | 560050.04756/21.1/0050.047 | Cancelled | S3 | None |
| Bemliru u200 EACH 1,0 ml SOLUTION CONTAINS :INSULIN LISPRO 200,0 U | Not listed | 560051.04856/21.1/0051.048 | Cancelled | S3 | None |
| Bemliru junior u100 EACH 1,0 ml SOLUTION CONTAINS INSULIN LISPRO 100,0 U | Not listed | 560052.04956/21.1/0052.049 | Cancelled | S3 | None |
Regulatory status
Where S3 sits on the scale
Needs a doctor's prescription, dispensed by a pharmacist.
Schedule 3 medicines can only be sold on a prescription from an authorised prescriber, such as a doctor or dentist. A pharmacist dispenses the medicine once they have the written prescription, or a verbal instruction from a prescriber they know. Its price, name, pack size and strength can still be told to the public, as long as nothing links it to what it treats.
Schedule S3, read from the product's PI-PIL leaflet.
Who may supply: A pharmacist dispensing against a written or verbal prescription from an authorised prescriber; a veterinarian, who may also prescribe, compound or dispense it directly; a medical practitioner or dentist, who may prescribe it and may compound or dispense it directly only if licensed under section 22C(1)(a); manufacturers and wholesalers may supply people who may lawfully possess it; and, for animal treatment, a person practising a para-veterinary profession, on a veterinarian's written or verbal instruction.
Consolidated Schedules listings for Insulin lispro
S3: Insulin lispro
Consolidated Schedules 06 July 2026, line 3802
Pharmacological class: Insulin preparations. (class 21.1)
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 (S3) 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.