Codeine, morphine, papaverine (Omnopon-fresenius)
Codeine, morphine, papaverine
Bodene (Pty) Ltd Trading As Intramed
Registration
- Applicant
- Bodene (Pty) Ltd Trading As Intramed
- Certificate holder
- Fresenius Kabi Manufacturing SA (Pty) Ltd
- Registrations
- 1
- Schedule source
- SAHPRA documentation
Variants
Regulatory status
Where S6 sits on the scale
Prescription-only, no repeats without a new prescription.
Schedule 6 covers the most tightly controlled ordinary prescription medicines. Every dispensing needs its own new prescription; nothing can be repeated on the same script. When prescribed, the quantity must be written out in both figures and words. 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 S6, 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.
Consolidated Schedules listings for Codeine hydrochloride, morphine hydrochloride, papaverine hydrochloride
S6: Codeine
- single component codeine preparations;
- oral solid preparations, in combination with one or more therapeutically active substances, in preparations not registered in terms of the Act, or when intended for export; (S2, S3)
- liquid oral preparations and mixtures, in combination with one or more therapeutically active substances, in preparations not registered in terms of the Act, or when intended for export. (S2, S3)
Consolidated Schedules 06 July 2026, lines 10128 to 10136
S6: Morphine
- except preparations and mixtures of morphine containing 0,2 percent or less of morphine, calculated as anhydrous morphine. (S2)
Consolidated Schedules 06 July 2026, lines 10318 to 10319
S3: Codeine
- oral solid preparations, in combination with one or more therapeutically active substances, containing more than 10 milligrams of codeine (calculated as base) per dosage unit, when contained in products registered in terms of the Act, and not intended for export;
- liquid oral preparations and mixtures, in combination with one or more therapeutically active substances, containing more than 10 milligrams of codeine (calculated as base) per 5 millilitre dosage unit, when contained in products registered in terms of the Act, and not intended for export;
- except oral solid preparations, in combination with one or more therapeutically active substances, containing not more than 10 milligrams of codeine (calculated as base) per dosage unit, with a maximum daily dose not exceeding 80 milligrams, and in packs containing sufficient dosage units for a maximum treatment period of 5 days and limited to one pack per customer, when contained in products registered in terms of the Act, and not intended for export; (S2)
- except liquid oral preparations and mixtures, in combination with one or more therapeutically active substances, containing not more than 10 milligrams of codeine (calculated as base) per 5 millilitre dosage unit, with a maximum daily dose not exceeding 80 milligrams, and with a pack size not exceeding 100 millilitres and limited to one pack per customer, when contained in products registered in terms of the Act, and not intended for export; (S2)
- except single component codeine preparations. (S6)
Consolidated Schedules 06 July 2026, lines 3350 to 3372
S2: Codeine
- oral solid preparations, in combination with one or more therapeutically active substances, containing not more than 10 milligrams of codeine (calculated as base) per dosage unit, with a maximum daily dose not exceeding 80 milligrams, and in packs containing sufficient dosage units for a maximum treatment period of 5 days, and limited to one pack per customer, when contained in products registered in terms of the Act, and not intended for export;
- liquid oral preparations and mixtures, in combination with one or more therapeutically active substances, containing not more than 10 milligrams of codeine (calculated as base) per 5 millilitre dosage unit, with a maximum daily dose not exceeding 80 milligrams, and with a pack size not exceeding 100 millilitres, when contained in products registered in terms of the Act, and not intended for export;
- except oral solid preparations, in combination with one or more therapeutically active substances, containing more than 10 milligrams of codeine (calculated as base) per dosage unit; (S3)
- except liquid oral preparations and mixtures, in combination with one or more therapeutically active substances, containing more than 10 milligrams of codeine (calculated as base) per 5 millilitre dosage unit; (S3)
- except single component codeine preparations. (S6)
Consolidated Schedules 06 July 2026, lines 1758 to 1778
S2: Morphine
- mixtures containing 0,2 percent or less of morphine, calculated as anhydrous morphine.
Consolidated Schedules 06 July 2026, line 2355
S2: Papaverine
- substances, preparations and mixtures thereof.
Consolidated Schedules 06 July 2026, line 2488
Pharmacological class: Other analgesics. (class 2.9)
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.
Combination product
This product contains more than one active ingredient, so it has no single molecular structure.
SAHPRA documents
Schedule Verification
This medication's schedule (S6) has been verified from official SAHPRA documents with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.