Pegfilgrastim
Sold as Neulastim, Fulphila, Pegfilgrastim eurolab, Pegylastin, Ziextenzo, Stropeg
No structure available
This product's active ingredient could not be matched to a single known compound.
Background
Registration
- Applicants
- 5
- Registrations
- 6
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Amgen south africa (pty)ltdCertificate held by Amgen | Neulastim | 6mg / 0.6ml | 420598 | S4 | PIPIL |
| Imperial Market Access Healthcare SA (Pty) Ltd | Fulphila, Pegfilgrastim eurolab | Not stated | 520720, 520721.72 | S4 | None |
| Accord Healthcare (Pty) Ltd | Pegylastin | 6 mg | 530329 | S4 | PIPIL |
| Sandoz South Africa (Pty) LtdCertificate held by Sandoz SA (Pty) Ltd | Ziextenzo | 6,0 mg | 550736 | S4 | PIPIL |
| Kahma Biotech (Pty) Ltd | Stropeg | 6 mg | 560108 | S4 | PIPIL |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Neulastim EACH PRE-FILLED SYRINGE CONTAINS PEGFILGRASTIM 6,0 mg | 6mg / 0.6mlInjection | 42059842/8.5/0598Approved 9 September 2024 | Registered | S4 | PIPIL |
| Fulphila EACH 0,6 ml SOLUTION CONTAINS: PEGFILGRASTIM 6,0 mg | Not listed | 52072052/8.5/0720 | Registered | S4 | None |
| Pegfilgrastim eurolab EACH 0,6 ml SOLUTION CONTAINS: PEGFILGRASTIM 6,0 mg | Not listed | 520721.7252/8.5/0721.720 | Registered | S4 | None |
| Pegylastin EACH PRE-FILLED SYRINGE CONTAINS PEGFILGRASTIM 6,0 mg | 6 mgInjection | 53032953/8.5/0329Approved 15 September 2020 | Registered | S4 | PIPIL |
| Ziextenzo PEGFILGRASTIM | 6,0 mgSolution for injection | 55073655/8.5/0736Approved 27 August 2025 | Registered | S4 | PIPIL |
| Stropeg EACH 0,6 ml SOLUTION CONTAINS PEGFILGRASTIM 6,0 mg | 6 mgSolution for injection | 56010856/8.5/0108Approved 13 June 2023 | Registered | S4 | PIPIL |
Regulatory status
Where S4 sits on the scale
Prescription-only medicine.
Schedule 4 covers most ordinary prescription medicines. You need a prescription from an authorised prescriber, such as a doctor or dentist, and a pharmacist dispenses it. 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 S4, 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 Pegfilgrastim
S4: Pegfilgrastim
Consolidated Schedules 06 July 2026, line 7492
Pharmacological class: Others. (class 8.5)
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
Schedule Verification
Neulastim, Amgen south africa (pty)ltd is scheduled S4 in its official SAHPRA documents, read with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.