Atovaquone, proguanil
Sold as Malanil, Falcirone, Numal, Mozitec, Malateq, Hetovanil, Atapro, Atapro paediatric, Atovaquone/proguanil glenmark, Malanil paediatric
Combination product
This product contains more than one active ingredient, so it has no single molecular structure.
Background
Registration
- Applicants
- 7
- Registrations
- 11
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Acino Pharma (Pty) LtdCertificate held by Litha pharma | Malanil, Malanil paediatric | 100mg, 250mg | 370075, A400165 | S2 | PIPIL |
| Cipla Medpro (Pty) LtdCancelled | Falcirone, Numal | Not stated | 460025, 460027 | Not determined | None |
| Activo Health (Pty) Ltd | Mozitec | Not stated | 471014 | Not determined | None |
| Forrester Pharma (Pty) Ltd | Malateq | Not stated | 471015 | Not determined | None |
| Hetero Drugs South Africa (Pty) Ltd | Hetovanil | 62,5/25 mg, 250/100 mg | 480526, 480527 | Not determined | None |
| Specpharm (Pty) LtdCancelled | Atapro, Atapro paediatric | 62,5/25 mg, 250/100 mg | 480674, 480675 | Not determined | None |
| Glenmark Pharmaceuticals South Africa (Pty) Ltd | Atovaquone/proguanil glenmark | 250/100 mg | 530615 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Malanil EACH TABLET CONTAINS ATOVAQUONE 250,0 mg PROGUANIL HYDROCHLORIDE 100,0 mg | 250mg. 100mgTablet | 37007537/20.2.6/0075Approved 5 March 2009 | Registered | S2 | PIPIL |
| Falcirone EACH TABLET CONTAINS ATOVAQUONE 250,0 mg PROGUANIL HYDROCHLORIDE 100,0 mg | Not listed | 46002546/20.2.6/0025 | Cancelled | Not determined | None |
| Numal EACH TABLET CONTAINS ATOVAQUONE 250,0 mg PROGUANIL HYDROCHLORIDE 100,0 mg | Not listed | 46002746/20.2.6/0027 | Cancelled | Not determined | None |
| Mozitec EACH TABLET CONTAINS ATOVAQUONE 250,0 mg PROGUANIL HYDROCHLORIDE 100,0 mg | Not listed | 47101447/20.2.6/1014 | Registered | Not determined | None |
| Malateq EACH TABLET CONTAINS ATOVAQUONE 250,0 mg PROGUANIL HYDROCHLORIDE 100,0 mg | Not listed | 47101547/20.2.6/1015 | Registered | Not determined | None |
| Hetovanil 62,5/25 MG Each tablet contains ATOVAQUONE 62,5 mg and PROGUANIL HCL 25,0 mg | 62,5/25 mg | 48052648/20.2.6/0526 | Registered | Not determined | None |
| Hetovanil 250/100 MG Each tablet contains ATOVAQUONE 250,0 mg and PROGUANIL HCL 100,0 mg | 250/100 mg | 48052748/20.2.6/0527 | Registered | Not determined | None |
| Atapro 250/100 MG tablet EACH TABLET CONTAINS ATOVAQUONE 250,0 mg PROGUANIL HYDROCHLORIDE 100,0 mg | 250/100 mgTablet | 48067448/20.2.6/0674 | Cancelled | Not determined | None |
| Atapro 62,5/25 MG paediatric tablet EACH TABLET CONTAINS ATOVAQUONE 62,5 mg PROGUANIL HYDROCHLORIDE 25,0 mg | 62,5/25 mgTablet | 48067548/20.2.6/0675 | Cancelled | Not determined | None |
| Atovaquone/proguanil 250/100 MG glenmark EACH TABLET CONTAINS ATOVAQUONE 250,0 mg PROGUANIL HYDROCHLORIDE 100,0 mg | 250/100 mg | 53061553/20.2.6/0615 | Registered | Not determined | None |
| Malanil paediatric EACH TABLET CONTAINS ATOVAQUONE 62,5 mg PROGUANIL HYDROCHLORIDE 25,0 mg | Not listed | A400165A40/20.2.6/0165 | Registered | Not determined | None |
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.
The Consolidated Schedules list this ingredient up to S4; the leaflet's S2 applies to this product.
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.
Consolidated Schedules listings for Atovaquone, proguanil hydrochloride
S4: Atovaquone
- when co-formulated with proguanil and intended and labelled for the chemoprophylaxis of malaria in those weighing 11 kilograms or more. (S2)
Consolidated Schedules 06 July 2026, lines 5380 to 5383
S4: Proguanil
- when co-formulated with atovaquone and intended and labelled for the chemoprophylaxis of malaria in those weighing 11 kilograms or more. (S2)
Consolidated Schedules 06 July 2026, lines 7661 to 7664
S2: Atovaquone
- when co-formulated with proguanil and intended and labelled for the chemoprophylaxis of malaria in those weighing 11 kilograms or more. (S4)
Consolidated Schedules 06 July 2026, lines 1622 to 1625
S2: Proguanil
- when co-formulated with atovaquone and intended and labelled for the chemoprophylaxis of malaria in those weighing 11 kilograms or more. (S4)
Consolidated Schedules 06 July 2026, lines 2579 to 2582
Pharmacological class: Medicines against protozoa. (class 20.2.6)
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
Malanil, Acino Pharma (Pty) Ltd is scheduled S2 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.