Candesartan cilexetil, hydrochlorothiazide
Sold as Atacand plus, Candesartan plus htz oethmaan, Candepres plus, Mylacand plus, Raphex plus, Abecard co, Canuretic
Combination product
This product contains more than one active ingredient, so it has no single molecular structure.
Background
Registration
- Applicants
- 7
- Registrations
- 9
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Equity Pharmaceutical (Pty) Ltd | Atacand plus | 16/12,5 mg, 32/12,5 mg, 32/25 mg | 350098, 430922, 430923 | Not determined | None |
| Oethmaan Biosims (Pty) Ltd | Candesartan plus htz oethmaan | Not stated | 440554 | Not determined | None |
| Sandoz South Africa (Pty) LtdCertificate held by Sandoz SA (Pty) Ltd | Candepres plus | 12.5 mg | 440555 | Not determined | PIPIL |
| Viatris South Africa (Pty) LtdCertificate held by Mylan (Pty) Ltd | Mylacand plus | 16/12,5 mg | 450394 | Not determined | PIPIL |
| Astrazeneca Pharmaceuticals (Pty) LtdCancelled | Raphex plus | 16/12,5 mg | 450803 | Not determined | None |
| Forrester Pharma (Pty) Ltd | Abecard co | 16/12,5 | 460230 | Not determined | None |
| Austell Pharmaceuticals (Pty) LtdCancelled | Canuretic | 16/12,5 mg, | 490054 | S3 | PIPIL |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Atacand plus 16/12,5 MG EACH TABLET CONTAINS CANDESARTAN CILEXETIL 16,0 mg HYDROCHLOROTHIAZIDE 12,5 mg | 16/12,5 mg | 35009835/7.1.3/0098 | Registered | Not determined | None |
| Atacand plus 32/12,5 MG EACH TABLET CONTAINS CANDESARTAN CILEXETIL 32,0 mg HYDROCHLOROTHIAZIDE 12,5 mg | 32/12,5 mg | 43092243/7.1.3/0922 | Registered | Not determined | None |
| Atacand plus 32/25 MG EACH TABLET CONTAINS CANDESARTAN CILEXETIL 32,0 mg HYDROCHLOROTHIAZIDE 25,0 mg | 32/25 mg | 43092343/7.1.3/0923 | Registered | Not determined | None |
| Candesartan plus htz oethmaan EACH TABLET CONTAINS CANDESARTAN CILEXETIL 16,0 mg HYDROCHLOROTHIAZIDE 12,5 mg | Not listed | 44055444/7.1.3/0554 | Registered | Not determined | None |
| Candepres plus 16/12,5 EACH TABLET CONTAINS CANDESARTAN CILEXETIL 16,0 mg HYDROCHLOROTHIAZIDE 12,5 mg | 12.5 mgTablet. | 44055544/7.1.3/0555Approved 30 May 2021 | Registered | Not determined | PIPIL |
| Mylacand plus 16/12,5 EACH TABLET CONTAINS CANDESARTAN CILEXETIL 16,0 mg HYDROCHLOROTHIAZIDE 12,5 mg | 16/12,5 mgTablets | 45039445/7.1/0394Approved 11 November 2022 | Registered | Not determined | PIPIL |
| Raphex plus 16/12,5 MG EACH TABLET CONTAINS CANDESARTAN CILEXETIL 16,0 mg HYDROCHLOROTHIAZIDE 12,5 mg | 16/12,5 mg | 45080345/7.1.3/0803 | Cancelled | Not determined | None |
| Abecard co 16/12,5 EACH TABLET CONTAINS CANDESARTAN CILEXETIL 16,0 mg HYDROCHLOROTHIAZIDE 12,5 mg | 16/12,5 | 46023046/7.1.3/0230 | Registered | Not determined | None |
| Canuretic EACH TABLET CONTAINS: CANDESARTAN CILEXETIL 16,0 mg HYDROCHLOROTHIAZIDE 12,5 mg | 16/12,5 mg,Tablets | 49005449/7.1.3/0054Approved 2 February 2023 | Cancelled | S3 | PIPIL |
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.
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.