Diclofenac (Sandoz Diclofenac Sodium Simple Regimen, Sandoz Diclofenac Na, Diclofenac Oethmaan, Anfenax)
Diclofenac
Oethmaan Biosims (Pty) Ltd
Registration
- Applicant
- Oethmaan Biosims (Pty) Ltd
- Registrations
- 4
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Sandoz diclofenac sodium 100 simple regimen EACH TABLET CONTAINS DICLOFENAC SODIUM 100,0 mg | 100 | 31015131/3.1/0151 | Registered | Not determined | None |
| Sandoz diclofenac na 25 EACH TABLET CONTAINS DICLOFENAC SODIUM 25 mg | 25 | V0083V/3.1/83 | Registered | Not determined | None |
| Diclofenac 50 oethmaan EACH TABLET CONTAINS DICLOFENAC SODIUM 50 mg | 50 | V0137V/3.1/137 | Registered | Not determined | None |
| Anfenax 75 MG injection EACH 3,0 ml CONTAINS: DICLOFENAC SODIUM 75,0 mg | 75 mgInjection | W0185W/3.1/185 | Registered | Not determined | None |
Regulatory status
This product is still scheduled by law even when this site could not determine which tier it falls under. The label carries the S number in a square border; ask a pharmacist if you need to know its schedule.
Listings for this ingredient that could not be applied to this product
S3: Diclofenac
- except when intended for application to the skin and containing 1 % m/m or less of diclofenac subject to a maximum pack size of 50 grams; (S0)
- except when intended for application to the skin and containing more than 1 % m/m of diclofenac; (S1)
- except when intended for the emergency treatment of acute gout attacks, subject to a maximum daily dose of 150 mg for a maximum treatment period of 3 days; (S2)
- except when intended for human use only in the treatment of fever or mild to moderate pain of inflammatory origin, or for the treatment of post-traumatic conditions subject to a maximum daily dose of 75 mg for a maximum treatment period of 5 days. (S2)
Consolidated Schedules 06 July 2026, lines 3415 to 3427
S2: Diclofenac
- when intended for the emergency treatment of acute gout attacks, subject to a maximum daily dose of 150 mg for a maximum treatment period of 3 days; (S3)
- when intended for human use only in the treatment of fever or mild to moderate pain of inflammatory origin, or for the treatment of post-traumatic conditions, subject to a maximum daily dose of 75 mg for a maximum treatment period of 5 days;
- except when intended for application to the skin and containing 1 % m/m or less of diclofenac subject to a maximum pack size of 50 grams; (S0)
- except when intended for application to the skin and containing more than 1 % m/m of diclofenac; (S1)
- except when intended for veterinary use. (S3)
Consolidated Schedules 06 July 2026, lines 1807 to 1821
S1: Diclofenac
- when intended for application to the skin and containing more than 1 % m/m of diclofenac; (S3)
- except when intended for application to the skin and containing 1 % m/m or less of diclofenac subject to a maximum pack size of 50 grams; (S0)
- except when intended for the emergency treatment of acute gout attacks, subject to a maximum daily dose of 150 mg for a maximum treatment period of 3 days; (S2)
- except when intended for human use only in the treatment of fever or mild to moderate pain of inflammatory origin, or for the treatment of post-traumatic conditions, subject to a maximum daily dose of 75 mg for a maximum treatment period of 5 day; (S2)
- except when intended for veterinary use. (S3)
Consolidated Schedules 06 July 2026, lines 365 to 379
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.
2-[2-(2,6-Dichloroanilino)phenyl]acetic acid
Drag to rotate. Structure from PubChem CID 3033.
SAHPRA documents
SAHPRA has not published a professional information or patient information leaflet for this product.