1 protein, human papillomavirus type
Sold as Gardasil, Cervarix
Combination product
This product contains more than one active ingredient, so it has no single molecular structure.
Background
Registration
- Applicants
- 2
- Registrations
- 2
- Schedule source
- SAHPRA documentation
Applicants and registrations
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Gardasil EACH 0,5 ml DOSE CONTAINS HUMAN PAPILLOMAVIRUS TYPE 11 L1 PROTEIN 40,0 ug HUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN 40,0 ug HUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN 20,0 ug HUMAN PAPILLOMAVIRUS TYPE 6 L1 PROTEIN 20,0 ug | 20 mcgInjection | 41014541/30.1/0145Approved 25 March 2015 | Registered | Not determined | PIPIL |
| Cervarix EACH 0,5 ml DOSE CONTAINS HUMAN PAPILLOMAVIRUS TYPE 16 L 1 PROTEIN 20,0 ug HUMAN PAPILLOMAVIRUS TYPE 18 L 1 PROTEIN 20,0 ug | 1 dose (0,5 mL)Suspensions for injection. | 41036641/30.1/0366Approved 26 November 2024 | Registered | S2 | PIPIL |
Regulatory status
Where S2 sits on the scale
A pharmacist can sell it directly, without a prescription.
Schedule 2 medicines sit behind the pharmacy counter. A pharmacist can decide to sell one of these directly, using their own professional judgement, without a doctor's prescription. It can also be dispensed against a prescription like the higher tiers, in which case the usual repeat limits apply. A child under 12 may only be sold a Schedule 2 substance on a prescription, or on a written order that names the purpose and carries a signature the seller recognises. Even though it cannot be advertised to the public in the ordinary sense, 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 S2, read from the product's PI-PIL leaflet.
Who may supply: Only a pharmacist, pharmacist intern or supervised pharmacist's assistant may sell it without a prescription. It may otherwise be dispensed by a pharmacist 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); and, for animal treatment, a person practising a para-veterinary profession, on a veterinarian's written or verbal instruction.
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
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.